Subjects must be at least 4 weeks post last dose of temozolomide
Subjects has failed or intolerant to temozolomide therapy.
Subjects with Grade 2 toxicities that are deemed stable or irreversible (e.g. peripheral neuropathy) can be enrolled on a case-by-case basis with prior consultation and agreement with the Sponsor Study Physician.
Subjects who have received drugs that directly or indirectly inhibit calcineurin or Nuclear Factor of activated T cells (NFAT) activity .
Subjects must agree to undergo tumor biopsies until biopsies have been obtained from 20 subjects (i.e., biopsies are required in at least the first 20 enrolled subjects, or until a goal of 20 study biopsies are obtained); subjects in whom a biopsy is technically not feasible or in whom would result in unacceptable risk in the opinion of the investigator, may be exempted from the biopsy requirement with discussion with the principal investigator
Have documented relapse or refractoriness after at least 1 line (MB and ARMS subjects) or 2 lines (NB and ES subjects) of standard-of-care therapy, including each of the following:
Subjects may not be on other therapies that affect hormone levels, such as estrogens, testosterones, ketoconazole during this study; however, megestrol for hot flashes is permitted
Subjects with gastric mucosa-associated lymphoid tissue (MALT) lymphoma must be Helicobacter pylori (HP)-negative
Subjects may not be receiving any chemotherapy or other agents intended for oncologic treatment
Subjects exhibiting idiosyncratic reactions to psoralen compounds.
Subjects with history of osteoporosis
All subjects must:
Female or male subjects whose advanced HER2 expressing cancer has failed standard of care treatments, or for whom such therapy is not acceptable to the subject. Subjects with advanced breast and gastric cancer who test positive for HER2 by ASCO/CAP criteria (either IHC or FISH) must have received prior treatment with a trastuzumab containing therapy. Subjects who have been previously treated with pertuzumab, TDM-1, lapatinib, or other available and accessible HER2-directed therapies or investigational therapies are eligible.
Tumor tissue local laboratory HER2 testing results (clinical pathology report) based on FDA or other regulatory agency approved, validated or commercially available IHC or ISH HER2 assay. Pre-screening for HER2 is allowed only for subjects with breast and gastric cancer, GE junction or esophageal cancer, where applicable. Subjects with other types of cancer must have previously tested for HER2 status by HER2 IHC or ISH assay.
Subjects who are able and willing to give written informed consent\n\n - Documented primary or secondary AML, as defined by the WHO criteria (2008), by\n histopathology refractory to previous induction chemotherapy and/or relapsed after\n achieving remission with a prior chemotherapy and who are not candidates for other\n available therapy likely to confer clinical benefit.\n\n - For Phase 2a only: in addition to inclusion criteria 2 above, patients must have a\n FLT3 mutation of any type\n\n - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n\n - In the absence of rapidly progressing disease, the interval from prior treatment to\n time of FF-10101-01 administration should be at least 14 days for cytotoxic agents\n other than hydroxyurea, at least 5 half-lives for non-cytotoxic agents, and 14 days\n for monoclonal antibody therapies. Hydroxyurea may be continued for a maximum of 14\n days from the start of FF-10101-01 dosing, through Cycle 1 Day 14, with a maximal dose\n of 5 grams/day\n\n - Persistent chronic clinically significant toxicities from prior chemotherapy or\n surgery must be ?Grade 2\n\n - If subject has had a hematopoietic stem cell transplant, subject must be ?60 days\n post-transplant with no clinically significant GVHD requiring systemic therapy\n\n - Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ?3 times the\n upper limit of normal and total bilirubin of ?1.5x the upper limit of normal. If total\n bilirubin is equal to or exceeds 1.5x the upper limit of normal, the subject can still\n be included if direct bilirubin is ?1.5x the upper limit of normal\n\n - Calculated creatinine clearance of ?60 mL/min\n\n - Female subjects of childbearing potential and sexually mature male subjects must agree\n to use a medically accepted method of contraception other than an oral contraceptive\n for the duration of the study.\n\n Exclusion Criteria:\n\n - Subjects diagnosed with acute promyelocytic leukemia\n\n - Subjects with Bcr-Abl positive leukemia (chronic myelogenous leukemia in blast crisis)\n\n - Subjects with clinically active CNS leukemia\n\n - Subjects with major surgery within 28 days prior to the first administration of\n FF-10101-01\n\n - Subjects with radiation therapy within 28 days prior to the first administration of\n FF-10101-01\n\n - Subjects with active malignant disease requiring therapy other than AML or\n myelodysplastic syndrome with transformation into AML\n\n - Subjects with an active uncontrolled infection\n\n - Subjects with a medical condition, serious intercurrent illness, or other circumstance\n that, in the Investigator's judgment, could jeopardize the subject's safety as a study\n subject, or that could interfere with the study objectives\n\n - Subjects known to have human immunodeficiency virus infection, or who have active\n hepatitis B or C infection as determined by serological testing\n\n - Subjects with congestive heart failure, New York Heart Association (NYHA) Class 3 or\n 4, or subjects with a past history of congestive heart failure NYHA Class 3 or 4 and\n in whom echocardiogram or multiple gate acquisition (MUGA) scan performed within 3\n months prior to screening or at screening showed a LVEF <40%\n\n - Female subjects who are pregnant or breast feeding\n\n - Subjects on 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) or\n other drugs known to have muscle toxicity\n\n - Subjects taking strong inhibitors of CYP3A4 will be excluded from the study unless\n therapeutic substitution is possible\n\n - Subjects taking strong inducers of CYP3A4 will be excluded from the study unless\n therapeutic substitution is possible\n\n - Use of systemic immunosuppressive agents within 14 days prior to first dose of\n FF-10101\n\n - Subjects taking drugs known to cause Torsades de Pointes will be excluded from the\n study unless therapeutic substitution is possible\n\n - Subjects known to have long QT syndrome\n\n - Subjects with mean QTcF values following 3 ECGs conducted 5 minutes apart of >470 msec
Inclusion Criteria:\n\n Subjects are eligible to be included in the study only if they meet all of the following\n criteria:\n\n 1. Subjects who are males or females ? 18 years of age.\n\n 2. Subjects who are able to give written informed consent.\n\n 3. Subjects who have a documented diagnosis of MDS according to WHO criteria.\n\n 4. Subjects who have Revised International Prognostic Scoring System (IPSS-R) categories\n of Very Low, Low- or Intermediate-risk disease. Subjects with cytogenetic failure and\n ? 10% marrow blasts will be eligible.\n\n 5. Subjects who meet one of the following hematologic criteria within 8 weeks of\n registration (according to the IWG criteria) and as documented in prior transfusion\n logs or weekly hematology evaluations:\n\n - Symptomatic anemia untransfused with hemoglobin ? 9.0 g/dL or with RBC\n transfusion-dependence (i.e., ? 2 units/month) confirmed for a minimum of 8 weeks\n before randomization.\n\n - Platelet counts of < 100 x109/L\n\n - Absolute neutrophil count < 1500\n\n 6. Subjects with del(5q) who should have failed or not be a candidate for approved\n therapy (Lenalidomide) prior to enrolling on this study.\n\n 7. Subjects must meet accepted standard criteria for treatment and have failed or not be\n candidates for standard, accepted treatments.\n\n 8. Subjects who have sufficient hepatic function, defined as bilirubin 2 times the upper\n limit of normal (ULN) and alanine transaminase (ALT) and aspartate transaminase (AST)\n levels 2.5 times ULN.\n\n 9. Subjects who have sufficient renal function, defined as serum creatinine levels 1.5\n ULN.\n\n 10. Subjects who have a performance status of 2 on the Eastern Cooperative Oncology Group\n (ECOG) scale (refer to Appendix 2).\n\n 11. Subjects who have discontinued all previous therapies for MDS or other investigational\n therapy for at least 28 days prior to study enrollment and recovered to less than\n grade 2 toxicity from prior therapy.\n\n 12. Subjects who are able to swallow tablets.\n\n 13. Subject who are willing and able to comply with scheduled visits, treatment plans,\n laboratory tests and procedures.\n\n 14. Female subjects of childbearing potential must have a negative serum pregnancy test\n within 7 days of the first administration of study drug. For the purpose of this\n study, female subjects of childbearing potential are defined as all female subjects\n after puberty unless they are postmenopausal for at least 1 year, or are surgically\n sterile (hysterectomy or bilateral oophorectomy or tubal ligation).\n\n 15. Female subjects of child bearing potential who are willing to avoid the pregnancy\n during the duration of the study and for 30 days following the last dose of study\n drug. The effects of TEW-7197 on the developing human fetus are unknown. For this\n reason, women of child-bearing potential and men must agree to use adequate\n contraception (hormonal or barrier method of birth control; abstinence) prior to study\n entry and for the duration of study participation. Should a woman become pregnant or\n suspect she is pregnant while participating in this study, she should inform her\n treating physician immediately.\n\n 16. Subjects with QTc interval calculated according to Fridericia's formula (QTcF =\n QT/RR0.33; RR = RR interval) of ? 470 ms for males and 450 ms for females on screening\n electrocardiogram (ECG).\n\n 17. Subjects must have ejection fraction more than 50% and no clinically significant\n valvular dysfunction.\n\n 18. Subjects must have discontinued radiotherapy at least 14 days with resolution of any\n toxicity to Grade 1 or better prior to the start of treatment.\n\n Exclusion Criteria:\n\n Subjects will be excluded from the study if they meet any of the following criteria:\n\n 1. Subjects who have received treatment within the last 28 days with a drug that has not\n received regulatory approval for any indication at the time of study entry.\n\n 2. Subjects who have moderate or severe cardiac disease:\n\n 3. Subjects who have the presence of cardiac disease, including a myocardial infarction\n within 6 months prior to study entry, unstable angina pectoris, New York Heart\n Association (NYHA) Class III/IV congestive heart failure, or uncontrolled\n hypertension.\n\n 4. Subjects who have documented major electrocardiogram (ECG) abnormalities at the\n investigator's discretion (for example, symptomatic or sustained atrial or ventricular\n arrhythmias, second- or third-degree atrioventricular block, bundle branch blocks,\n ventricular hypertrophy, or recent myocardial infarction).\n\n 5. Subjects who have major abnormalities documented by echocardiography with Doppler (for\n example, moderate or severe heart valve function defect and/or left ventricular\n ejection fraction (LVEF) <50%, evaluation based on the institutional lower limit of\n normal).\n\n 6. Subjects who have predisposing conditions that are consistent with development of\n aneurysms of the ascending aorta or aortic stress (for example, family history of\n aneurysms, Marfan-Syndrome, bicuspid aortic valve, evidence of damage to the large\n vessels of the heart documented by CT scan with contrast).\n\n 7. Subjects who have documented iron, B12, folate deficiency as determined by the\n investigator.\n\n 8. Female subjects who are breastfeeding, or intend to breastfeed during the duration of\n the study and for 30 days following the last dose of study drug.\n\n 9. Subjects with any other serious medical condition which in the Investigator's opinion\n would preclude safe participation in the study.\n\n 10. Subjects, in the opinion of the Investigator, who are unsuitable to participate in the\n study.\n\n 11. Subjects with elevated Troponin 1 levels at screening or known to have persistently\n elevated brain natriuretic peptide (BNP).\n\n 12. Subjects with serious pre-existing medical conditions as follows:\n\n - History of cardiac or aortic surgery,\n\n - Hypertension that is not controlled by standard medication (to 150/90 mmHg or\n below),\n\n - Cirrhosis of the liver, Child-Pugh Stage B or C, or history of liver transplant,\n\n - Severe diabetes that is not currently controlled,\n\n - Current or history of interstitial pneumonitis,\n\n - Presence of aneurisms of the ascending aorta or aortic stress.\n\n 13. Subjects with known history of difficulty swallowing, malabsorption or other\n conditions that may reduce absorption of the product.\n\n 14. Subjects with major abnormalities identified by ECG or echocardiogram (ECHO), at the\n Investigator's discretion.\n\n 15. Subjects with active infection with human immunodeficiency virus, hepatitis B virus or\n hepatitis C virus.\n\n 16. Subjects with active infection requiring systemic antibiotic therapy.\n\n 17. Subjects who are currently using or planning to use:\n\n Drugs which are exclusively or primarily eliminated by cytochrome P-450 isozyme 3A4
For French subjects only: Is either affiliated with or a beneficiary of a social security category.
Subjects with known HIV, active hepatitis B, or active hepatitis C (detectable RNA); HIV positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with durvalumab and/or tremelimumab; in addition, these subjects are at increased risk of lethal infections when treated with immunosuppressive therapy
Subjects who consume more than 3 alcoholic beverages per day
Subjects who have taken 5a-reductase inhibitors (finasteride or dutasteride), saw palmetto, or PC-SPES within the last 6 weeks are ineligible; subjects will be eligible for the study after the wash out period of 6 weeks
Subject’s close household contacts include children less than the age of three
Subjects less than 18 years old are being excluded in this study as melanoma is extremely uncommon in this age group and insufficient data are available in adults using dendritic cell therapy to assess potential risk in subjects less than 18 years old. Participation of women and minorities is encouraged, although it is recognized that melanoma is much more common in the Caucasian population
Study subjects with known chronic infection with HIV, hepatitis B or C, since these infections may interfere with the evaluation of vaccine-induced immune responses. Infectious disease testing will be performed whenever a study subject exhibits clinical signs of infection or to confirm a history of infection. Testing will also be performed for all study subjects undergoing leukapheresis, as required by the blood bank for autologous blood products (standard donor transmissible disease testing)
PHASE II: For those subjects with marrow involvement, the first 15 subjects enrolled after the 03.28.2017 amendment must have detectable disease at the time of enrollment
In Part 1 and, Part 2, subjects must have AML, MM, or NHL. Subjects with AML, are eligible if they • have relapsed and/or refractory disease, OR are>=65 years of age and not candidates for or have refused standard chemotherapy. Subjects with multiple myeloma are eligible if they have progressed despite therapy with an alkylating agent, proteasome inhibitor, and immunomodulatory agent, either as individual regimens or in combination. Subjects with NHL are eligible if they have received at least two prior lines of systemic therapy, including at least one line of immunochemotherapy with an anti-CD20 antibody (if their tumor expresses CD20). In Part 2, the NHL cohort will separately enrol subjects with double- and triple hit lymphoma, so that a minimum of 10 subjects with this subset of disease will be enrolled. To be eligible for this sub-cohort, tumor sample from the subject must demonstrate rearrangement and/or overexpression of MYC and either BCL2 and/or BCL6 genes. Evaluation of double- or triple-hit status may be performed via appropriate local testing, and the determination of double- or triple-hit diagnosis will be at the discretion of the investigator and GSK Medical Monitor.
Eligibility of subjects receiving any medications or substances with the potential to affect the activity or pharmacokinetics of AZD1775 will be determined following review by the principal investigator
Subjects with neurofibromatosis type 1 (NF1) are also eligible
Patients with evidence of intra-tumoral hemorrhage > 5 mm maximal diameter. These subjects should be discussed with the study chair.
Subjects must be co-enrolled on protocol 03-C-0277 (Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols).
Subjects with delayed healing of wounds, ulcers, and/or bone fractures
Subjects 40 years of age and older must also have a negative stress cardiac test (i.e. EKG stress test, stress thallium, dobutamine echocardiogram or other stress test that will rule out cardiac ischemia). Stress test may be required of subjects less than 40 years of age if warranted by family history or risk factors by the treating investigator.
Subjects must refuse or be deemed ineligible for cisplatin-based chemotherapy.
Subjects must have histologically confirmed solid tumor malignancy that is metastatic or treatment refractory cancers which are not curable or do not have known palliative measures or treatments that are associated with a survival advantage (as defined by the subject or the physician investigator); enrollment of subjects with tumors that can be safely biopsied is encouraged
Subjects must be willing to refrain from sunbathing for the duration of the study.
Dose Escalation, Renal insufficiency, NSCLC and CPI-Treated Expansion Cohorts: For subjects with urothelial cancer and NSCLC: Subjects must submit a tumor tissue for Nectin-4 expression. Enrollment for these subjects is not dependent on the immunohistochemistry using the H-Score (IHC H-Score).
Subjects with central nervous system (CNS) involvement are eligible provided that they are asymptomatic and in the opinion of the study principal investigator (PI) have a reasonable expectation that disease burden can be controlled in the interval between enrollment and T cell infusion; subjects that have a significant neurologic deterioration will be not be eligible for T cell infusion until alternate therapies result in neurological stabilization
Subjects must be followed at the Cleveland clinic for AS
Subjects must be willing to adhere to the dietary modification outlined in the protocol.
Subjects not followed by the Cleveland clinic.
Subjects unable to adhere to the dietary modification outlined in the protocol.
Quantitative serum IgG levels for subjects with IgG MM must not exceed the institutional upper limit of normal (ULN)
Subjects with hydronephrosis, except for those subjects where hydronephrosis has been longstanding (i.e., predates the diagnosis of the CIS, Ta, or T1 by more than 2 years) and diagnostic evaluation at screening shows no evidence of tumor causing the hydronephrosis
Subjects with central nervous system (CNS) involvement are eligible provided that they are asymptomatic and in the opinion of the study principal investigator (PI) have a reasonable expectation that disease burden can be controlled in the interval between enrollment and T cell infusion; subjects that have a significant neurologic deterioration will be not be eligible for T cell infusion until alternate therapies result in neurological stabilization
Subjects not below specific total neutrophil count.
Patients with histologically confirmed HCC (documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable) or clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic subjects is required (presence of arterial hypervascularity with venous washout). For subjects without cirrhosis, histological confirmation is mandatory. The determination of resectability status will ultimately lie in the clinical judgment of the surgical oncologist and medical oncologist involved in the care of the patient
Subjects with prior anti-PD-1, anti-PD-L1 treatment. For Arms A and D, subjects may not have had prior 4-1BB treatment. For Arms B and E, subjects may not have had prior OX40 treatment. For Arms C and F, subjects may not have had prior 4-1BB or OX40 treatment.
For a clinical diagnosis of NF1 patients must have at least two of the diagnostic criteria for NF1 listed below:\r\n* Six or more cafe-au-lait macules (>= 0.5 cm in prepubertal subjects or >= 1.5 cm in post pubertal subjects)\r\n* Freckling in axilla or groin\r\n* A neurofibroma or plexiform neurofibroma\r\n* Optic glioma\r\n* Two or more Lisch nodules\r\n* A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex)\r\n* A first-degree relative with NF1
Known HIV-positive subjects on combination anti-retroviral therapy due to the potential for PK interactions with the study agent.
Patients with evidence of intra-tumoral hemorrhage > 5 maximal diameter; these subjects should be discussed with the study chair
Only for subjects enrolled in Arm 1 - Neratinib and everolimus: subjects requiring therapy with immunosuppressive agents such as anti-tumor necrosis factor alpha (TNFa) agents (etanercept, adalimumab), azathioprine, methotrexate, cyclosporine, etc. for active autoimmune disorder.
Subjects with prior hypomethylating agent therapy exposure may be eligible based on discussion with the principal investigator (PI)
Subjects for whom, in the opinion of their physician, a 24-hour discontinuation of somatostatin analogue therapy represents a health risk
Subjects who have unknown transfusion history
All subjects must have an identified pathogenetic constitutional NF1 mutation OR the clinical diagnosis of NF1 using the National Institutes of Health (NIH) consensus conference criteria; in addition to a plexiform neurofibroma, one or more of the following diagnostic criteria for NF1 must be present:\r\n* Six or more Cafe Au Lait spots (>= 0.5 centimeter [cm] in prepubertal subjects or >= 1.5 cm in post pubertal subjects)\r\n* Freckling in the axilla or groin\r\n* Optic glioma\r\n* Two or more Lisch nodules\r\n* A distinctive bony lesion (dysplasia of the spheroid bone or dysplasia or thinning of long bone cortex)\r\n* A first-degree relative with NF1
Subjects with pulmonary, cardiac, hepatic, or renal impairment that would limit their ability to receive cytoreductive therapy and compromise their survival; this includes, but is not restricted to, subjects with any of the following:
Non-clear subjects must be ENPP3 positive, defined as IHC H-score ?15
Subjects receiving consolidative chest radiation
CELL PROCUREMENT: Subjects with relapsed fulminant CD19+ ALL that is rapidly progressing who cannot safely delay definitive treatment for their ALL by at least 4 weeks in the opinion of the investigator
Subjects must be considered appropriate candidates for high dose (HD) IL-2 by one of the treating investigators listed on the protocol; HD IL-2 candidacy evaluation is per institutional guidelines at each site and should include a dobutamine stress echocardiogram or equivalent; subjects with a positive stress test for cardiac ischemia would be excluded from this trial
Subjects with ALT > 5 x ULN at day 1 are not eligible for enrollment
Has had encephalopathy in the last 6 months; subjects on rifaximin or lactulose to control their encephalopathy are not allowed
Subjects should be in otherwise satisfactory health in the opinion of the Investigator;
Subjects that have received experimental vaccines or other immune therapies should be discussed with the principal investigator to confirm eligibility
Subjects must not be receiving any chemotherapy agents (except hydroxyurea)\r\n* Intrathecal methotrexate and cytarabine are permissible
Subjects who have undergone any recent major surgery must have done so at least 4 weeks prior to starting therapy with DS3032b, with the following exceptions: vertebroplasty and/or kyphoplasty, which must have been performed at least 1 week prior to starting DS3032b; planned elective surgery unrelated to the subject’s diagnosis of multiple myeloma, such as hernia repair, may be allowed, at the discretion of the principle investigator, as long as it was performed at least 2 weeks prior to starting DS3032b, and subjects have recovered fully from this procedure
Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects)
Subjects who have required plasmapheresis and exchange less than 2 weeks prior to initiation of therapy with DS3032b
Subjects with conditions that carry high anesthetic risk in the opinion of the treating anesthesiologist are not eligible (i.e. subjects with significant airway compression by tumor or craniofacial abnormalities).
Subjects in whom treatment planning constraints cannot be met
Subjects in whom treatment planning constraints cannot be met
Subjects who screen fails can be re-enrolled if the causation of the screen fail has been corrected
Subjects with delayed healing of wounds, ulcers, and/or bone fractures
Males and females 65 years of age and older; subjects < 65 years of age that meet any of the following criteria: \r\n* Subjects that refuse to be treated with chemotherapy based agents (this should be documented in the consent form)\r\n* Subjects that are not candidates for treatment with chemotherapy agents based on any of the following:\r\n** ECOG performance status >= 2\r\n** Cumulative illness rating scale (CIRS score) >= 6\r\n** Creatinine clearance < 70 mL/min using the Cockcroft-Gault equation
Subjects with active herpes simplex or herpes zoster; subjects with a history of herpes zoster who have had an outbreak within the last year will also be excluded; subjects on prophylaxis for herpes who started taking medication at least 30 days prior to study entry, should continue to take the prescribed medication for the duration of the study
Subjects on any immunomodulatory drug
Subjects on systemic medications known to affect the Hedgehog pathway
Subjects with a history of keloids or excessive scarring
Have INR > 1.5 times the institution's upper normal limit (UNL), except in subjects who are therapeutically anticoagulated for medical conditions unrelated to HCC such as atrial fibrillation. Subjects may be re-screened after condition is treated or anticoagulant is withheld.
Successful T cell test expansion (first 10 subjects)
Subjects for whom there is concern about compliance with the protocol procedures
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as clinics, assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals
Subjects who are deemed to be poor surgical risks by the treating neurosurgeon because of medical comorbidities
Subjects on medications that may not be safely stopped during the fasting portion of the study, or which may not be safely consumed without food
Subjects who have other conditions which in the opinion of the investigator contraindicate the receipt of HSV1716 or indicate subject’s inability to follow protocol requirements
PART II; Subjects must have been enrolled in Part 1 of this study and have received 1 dose of HSV1716 and have completed at a minimum the day 28 follow-up; subjects must have been categorized at a minimum as having stable disease thought to be attributable to the virus; subjects who were minimally characterized as having stable disease are also eligible if their lesion re-occurs or re-grows; the same criteria will be applied to determine eligibility for a third dose, and again for a fourth dose
Subjects must have an indication for treatment as defined by the NCI Working Group Guidelines
Subjects with active hemorrhagic diathesis
Subjects with a history of hepatitis of any etiology or hepatic insufficiency
Urine dipstick positive (>1+) for blood during screening with investigation indicating glomerular haematuria. If other causes are identified, subjects may be enrolled on resolution of the abnormality
Large subjects not fitting comfortably into the MRI scanner
History of pathologically confirmed CIN1 by colposcopically-directed punch biopsy, within 12 weeks prior to administration of first study vaccination (CIN 2/3 subjects will not be eligible);
Subjects who refuse to have their catheter removed or subjects for whom, in the Investigator's opinion, catheter retention for the duration of the study is reasonable or required;
Subjects with septic shock that requires inotropic support or is unresponsive to fluid resuscitation;
Subjects with short-term CVCs indwelling less than 5 days;
Additional Exclusion Criteria for subjects Assigned to Treatment A: Subjects unable to tolerate antithrombotic prophylaxis must be excluded; Discontinuation of prior treatment with lenalidomide due to intolerable AEs.
Subjects with uncontrolled, systematic infection should be excluded
Subjects with carcinosarcoma
Subjects receiving investigational study drug for any indication or immunological-based treatment for any reason (Filgrastim may be used for prevention of severe neutropenia).
Subjects with glioblastoma mutated IDH by Immunohistochemistry (IHC)
Subjects must have either:
Subjects with FAB M3 (t(15;17)(q22;q21)[PML-RARalpha]) are not eligible
Subjects must not be receiving any chemotherapy agents (except hydroxyurea); intrathecal methotrexate and cytarabine are permissible
Subjects for whom a potential 29-day delay in treatment will interfere with the subject’s potential therapeutic options
Subjects with aphakia
Subjects using certain medications
Subjects must not have had prior pazopanib therapy
Eligibility of subjects receiving any medications or substances with the potential to affect the activity or pharmacokinetics of BMN 673 will be determined following review by the principal investigator
Subjects with an indication for AHCT for the treatment of PCM as determined by the principal investigator (PI) or lead associate investigator (LAI)\r\n* Subjects following induction treatment for PCM\r\n* Subjects with recurrent or persistent evaluable disease who have not undergone AHCT for the treatment of the PCM
Subjects with hydronephrosis, except for those subjects where hydronephrosis has been longstanding (i.e., predates the diagnosis of the CIS, Ta or T1 by more than 2 years) and diagnostic evaluation at Screening shows no evidence of tumor. Subjects with hydronephrosis that is unequivocally unrelated to upper tract malignancy may be considered eligible with Sponsor approval.
Subjects must have undergone orchiectomy, or have ongoing LHRH analogue therapy prior to drug initiation. Subjects on LHRH analogues must remain on these agents for the duration of the study.
The following are excluded: Subjects with liver transplants, clear invasion of the bile duct or main portal branch(es), or hepatorenal syndrome, or subjects who have required esophageal variceal ablation within 28 days of starting study treatment.
Subjects with classical carcinoid
Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study
Subjects with HNSCC:
Subjects with vitiligo or alopecia;
For treatment-naïve subjects only:
Part 2, Cohort 1: For subjects with only PAM pathway alterations, subjects must have only PAM alterations, excluding Akt2 activating mutations or amplifications, and no other genomic alterations.
Subjects with vitiligo or alopecia;
Subjects must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to prolong survival in an analogous population.
Subjects unwilling to use acceptable methods of contraception. -Female subjects should refrain from breastfeeding throughout this period.
Subjects must fall into one of the two populations below:
Subjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to them
Absence of active GVHD and off immunosuppression; subjects on tapering prednisone will be eligible if their dose is 0.25 mg/kg or less and being actively tapered; we suggest a 28 day waiting period off of immunosuppression but some subjects with rapidly progressive disease may need to be treated before 30 days and will still be eligible
Subjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to them
Subjects who desire to enroll in this study and for whom anti-HER-2 therapy is not available or contraindicated, may be eligible to enroll in this trial.
Subjects actively receiving duvelisib are to be excluded from this study if they have any ongoing ? Grade 3 AE considered related to duvelisib treatment at screening
Subjects must have at least 1 measurable or evaluable tumor lesion according to RECIST 1.1 (for nonsquamous NSCLC) or mRECIST (for epithelial pleural mesothelioma). Subjects with resected primary tumors who have documented metastases are eligible.
Negative hepatitis B serologic tests; if positive results are not indicative of active or chronic infection, the subjects can enter the study at the investigator’s discretion
Subjects unwilling to use acceptable methods of contraception. -Female subjects should refrain from breastfeeding throughout this period.
Subjects with evidence of extraprostatic extension (T3a) or seminal vesicle involvement (T3b) on clinical evaluation
OR for subjects receiving warfarin or LMWH, the subjects must, in the investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for these subjects may exceed 1.5 × ULN if that is the goal of anticoagulant therapy.
Predisposing colonic or small bowel disorders in which the symptoms are uncontrolled as indicated by baseline pattern of > 3 loose stools daily in subjects without a colostomy or ileostomy; subjects with a colostomy or ileostomy may be entered at investigator discretion
Previously untreated subjects that meet ANY of the following criteria:\r\n* Subjects that refuse to be treated with chemotherapy based agents (this should be documented in the consent form)\r\n* Subjects that are not candidates for treatment with chemotherapy agents based on ANY of the following:\r\n** ECOG performance status >= 2\r\n** Advance age (>= 65 years)\r\n** Cumulative Illness Rating Scale (CIRS score) >= 6\r\n** Cytopenias\r\n*** Hemoglobin (Hb) =< 100 g/L (10 g/dL)\r\n*** Platelet count =< 100 x 10^9/L (100,000/uL)\r\n*** Absolute neutrophil count (ANC) =< 1.5 x 10^9/L (1,500/uL)
Subjects must have received at least one prior treatment regimen\r\n* Subjects that have received a prior Bruton’s agammaglobulinemia tyrosine kinase (BTK) inhibitor or cyclin-dependent kinases 4 and 6 (CDK4/6) inhibition are ineligible\r\n* Subjects that have undergone prior allogeneic stem cell transplantation will only be eligible if the transplant occurred at least 1 year prior to study entry, the patient is no longer taking any immunosuppressive therapy, and there are no significant ongoing transplant-related adverse effects\r\n* Subjects must not have received chemotherapy =< 21 days prior to first administration of study treatment, monoclonal antibody =< 6 weeks prior to first administration of study treatment, and/or radiotherapy or other investigational agents =< 4 weeks prior to first administration study treatment unless the subjects’ tumor has progressed on the previous therapy and the investigator believes that the patient should not postpone further therapy and, all treatment-related toxicities have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 =< grade 1; subjects may be receiving equivalent to prednisone at a maximum dose of 20 mg/day orally
Subjects must be entered no more than 12 weeks postoperatively
Subjects with brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy, including those used to control symptoms, within 2 months of first dose. Subjects with glioma who are on a stable, steroid dosing regimen 5 days prior to the screening MRI may be permitted to enroll with Medical Monitor approval.
Subjects in whom everolimus is contraindicated.
Subjects of all genders and races are eligible
Symptomatic brain or spinal cord metastases (patients must be stable for > 3 months post radiotherapy or surgery) for subjects with mesothelioma, NSCLC, uveal melanoma excludes subjects with HCC or glioma).
Subjects with any prior exposure to a thrombopoietin-receptor agonist
For subjects who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the study.
Subjects must be able to discontinue any drug treatment aimed at lowering disease burden in CNL or aCML; subjects should discontinue hydroxyurea to treat underlying CNL or aCML disease no later than day -7 (one week before starting ruxolitinib); for drugs that have more long-lasting effects on the marrow, such as thalidomide and its analogs, and interferon, subjects should discontinue these no later than day -28
Subjects should not have severe peritoneal metastases. The following criteria were applied:
Subjects in second or later relapse;
Subjects with any prior exposure to a thrombopoietin-receptor agonist
Subjects who have been diagnosed with indolent NHL that has progressed.
Subjects with active hepatitis B or C on anti-viremic compounds may remain on such treatment, except for interferon
Inclusion Criteria:\n\n Subjects eligible for enrollment in the study must meet all the following criteria:\n\n 1. Male or female ?18 years of age\n\n 2. Able to provide written informed consent prior to any study procedures being\n performed; eligible subjects must be able to understand the informed consent form\n prior to inclusion into the study.\n\n 3. Confirmed diagnosis of newly diagnosed, persistent or recurrent CD if subjects are not\n candidates for surgery or radiotherapy CD is defined according to the criteria in the\n Endocrine Society Clinical Practice Guideline for diagnosis of CD (Nieman 2008).\n Previous medical records will be collected and used to support the diagnosis of CD.\n\n Specifically, CD is defined as\n\n - Mean 24-hour UFC level of ?1.5X ULN on repeated determination\n\n - Morning plasma corticotropin (ACTH) level of 5 ng/L (1.1 nmol /L) or more\n\n - Either MRI confirmation of pituitary macroadenoma, or inferior petrosal sinus\n gradient >3 after corticotropin-releasing hormone (CRH) stimulation for those\n patients with a microadenoma, or for subjects who have had prior pituitary\n surgery, histopathology confirming and ACTH-staining adenoma. If inferior\n petrosal sampling had been performed without CRH, then a central to peripheral\n pre-stimulation gradient >2 is required\n\n 4. Confirmed diagnosis of newly diagnosed, persistent or recurrent endogenous CS of other\n etiology if subjects are not candidates for surgery or radiotherapy. CS will be\n defined according to the criteria in the Endocrine Society Clinical Practice Guideline\n for diagnosis of CS (Nieman 2008). Previous medical records will be collected and used\n to support the diagnosis, and the differentiation of the cause of CS, specifically\n\n - Mean 24-hour UFC level of ?1.5X ULN on repeated determination\n\n - Ectopic ACTH secretion, not of pituitary origin\n\n - Ectopic CRH secretion\n\n - Adrenal-dependent CS (adrenal adenoma, adrenal autonomy)\n\n - Etiology unknown\n\n 5. Subjects MUST have elevated mean 24-hour UFC levels ?1.5X ULN of assay based on a\n minimum of four measurements from adequately collected urine. Urine may be collected\n on sequential days.\n\n 6. In addition to elevated mean UFC, presence of abnormal values from one of the\n following tests:\n\n - Abnormal DST: Elevated 8 AM serum cortisol ?1.8 ug/dL (50 nmol/L) after 1 mg\n dexamethasone orally at 11 PM the evening prior (if not conducted already in the\n diagnostic workup of the subject within the previous 2 months before start of\n Screening Phase; in that case previous test results and details of conduct will\n need to be available by the Baseline visit)\n\n - Elevated late night salivary cortisol concentrations (at least two measurements)\n >ULN NOTE: For subjects with estimated glomerular filtration rate (eGFR as\n determined by Modified Diet in Renal Disease MDRD equation) >40 and <60\n mL/min/1.73 m2 in addition to meeting the UFC criteria, late night salivary\n cortisol test results (?2 measurements) MUST also demonstrate evidence of CS.\n\n 7. Previously irradiated subjects with CD or CS of other etiology will be allowed as long\n as the radiation treatment occurred > 4 years ago and subjects have not exhibited\n evidence for improvement in their underlying Cushing's disease for 6 months. The total\n number of previously irradiated subjects enrolled in this study will not exceed 10.\n\n 8. Subjects with CD or CS of other etiology who are not candidates for surgery, refuse\n surgery, or in whom surgery will be delayed for >6 months. Subjects may be allowed to\n participate in the trial while awaiting surgery, but must agree to complete this study\n prior to surgery. For subjects who have already undergone surgery, a minimum of 3\n months should have elapsed before the subject can be deemed a surgical failure.\n\n 9. Subjects on treatment for CD or endogenous CS of other etiology for whom treatment has\n been inadequate or not well tolerated must agree to the following minimum washout\n periods prior to the Baseline Visit:\n\n - Inhibitors of steroidogenesis (including ketoconazole): 2 weeks\n\n - Dopamine agonists: bromocriptine (2 weeks), cabergoline (8 weeks)\n\n - Octreotide acetate LAR and lanreotide Autogel®: 12 weeks\n\n - Lanreotide SR/long-acting pasireotide: 8 weeks\n\n - Octreotide acetate (immediate release formulation) or short-acting pasireotide: 1\n week\n\n - Mifepristone (RU 486): 4 weeks\n\n 10. Subjects on megesterol acetate (medroxyprogesterone acetate) must agree to a washout\n period of at least 6 weeks prior to the Baseline Visit\n\n 11. A female is eligible to enter and participate in the study if she is of:\n\n Non-child bearing potential (i.e. physiologically incapable of becoming pregnant,\n including any female who is post-menopausal or surgically sterile). Surgically sterile\n females are defined as those with a documented hysterectomy and/or bilateral\n oophorectomy or tubal ligation.\n\n Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with\n an appropriate clinical profile, e.g. age > 45 years, in the absence of hormone\n replacement therapy. However in questionable cases, a blood sample with FSH > 40MIU/ml\n and estradiol < 40pg/ml (<140 pmol/L) is confirmatory.\n\n OR Child bearing potential and agrees to use highly effective methods of birth control\n while participating in the study and for 2 weeks after the study is completed.\n\n 12. Fertile men must also agree to use a medically acceptable form of birth control while\n on study drug and up to 2 weeks after the study is completed.\n\n 13. Able to comprehend and comply with procedures.\n\n Exclusion Criteria\n\n Subjects will be excluded from the study if any of the following criteria are met:\n\n 1. Subjects with Pseudo-Cushing's syndrome based on assessment of the investigator.\n\n 2. Subjects with cyclic Cushing's syndrome based on assessment of the investigator\n\n 3. Subjects with a non-endogenous source of hypercortisolism such as exogenous source of\n glucocorticoids or therapeutic use of ACTH.\n\n 4. Known inherited syndrome as the cause of hypercortisolism, including but not limited\n to multiple endocrine neoplasia Type 1, McCune Albright Syndrome and Carney Complex\n\n 5. Subjects with adrenal carcinoma\n\n 6. History of malignancy, other than thyroid, early stage prostate, squamous cell and\n basal cell carcinoma, within 3 years prior to the Screening Phase. Subjects with\n history of such allowed carcinoma must have a life expectancy of >1 year and must be\n on stable doses of their specific therapies. Subjects with early stage prostate cancer\n undergoing no treatment due to low grade potential may be enrolled.\n\n 7. Clinical or radiological signs of compression of the optic chiasm.\n\n 8. Major surgery within 1 month prior to enrollment (ICF signing)\n\n 9. Subjects with clinically significant abnormality in 12-lead ECGs during the Screening\n Phase needing medical intervention.\n\n 10. Subjects with QTc interval of >470 msec during the Screening Phase.\n\n 11. Subjects with a history of Torsades des Pointes, or ventricular tachycardia, or\n ventricular fibrillation, or history of prolonged QT syndrome (including family\n history), or use of medications resulting in QT/QTc prolongation, or hypokalemia <3.0\n meq/L.\n\n 12. Preexisting hepatic disease; subjects with mild to moderate hepatic steatosis\n consistent with fatty infiltration (non-alcoholic fatty liver disease [NAFLD] are\n allowed).\n\n 13. Positive for hepatitis B surface antigen (HbsAg) or positive hepatitis C test.\n\n 14. History or symptoms of recurrent symptomatic cholelithiasis or pancreatitis.\n\n 15. Liver function tests (LFT) must not be above the following cut-offs during the\n Screening Phase:\n\n - ALT and/or AST >3 X ULN\n\n - Total bilirubin >2 X ULN If all LFTs are within normal limits (WNL) and total\n bilirubin (TBN) is elevated, examination of direct and indirect bilirubin may be\n conducted. Subjects with isolated indirect TBN up to 3X ULN are presumed to have\n Gilbert's syndrome and may be enrolled if all other LFTs are within normal\n levels.\n\n 16. History of documented or suspected drug-induced liver injury requiring drug\n discontinuation of ketoconazole or any azole antifungals.\n\n 17. Pregnant or lactating women\n\n 18. HIV-positive.\n\n 19. History of persistent uncontrolled hypertension (>180/120 mmHg) despite medical\n intervention.\n\n 20. Subjects with hypercholesterolemia who are currently treated with atorvastatin,\n lovastatin or simvastatin and not willing or unable to change to alternative therapies\n with pravastatin, fluvastatin, and rosuvastatin within 2 weeks of start of the\n Screening Phase.\n\n 21. Body habitus preventing repeated venipuncture as required by protocol.\n\n 22. Subject is currently in another study or has received any investigational treatment\n (drug, biological agent or device) within 30 days or 5 half-lives of treatment,\n whichever is longer.\n\n 23. Repeated hospitalization for hyperglycemia or any complication of hyperglycemia and\n diabetes during the last 12 months\n\n 24. Subjects with decreased renal function as defined by eGFR <40 mL/min/1.73 m2, using\n MDRD equation for estimating renal function (eGFR).\n\n 25. Any other clinically significant medical condition, as determined by the Investigator\n that precludes enrollment and participation in the study through completion, including\n conditions that would preclude the subject from being able to follow instructions or\n to perform the necessary procedures (for example, psychiatric instability or severe\n disability).\n\n 26. Abnormal free T4. Subjects with TSH <LLN and normal free T4 are permitted to\n participate in the study.\n\n 27. Subjects who have a history of alcohol or drug abuse in the 6 month period prior to\n enrollment.\n\n 28. Subjects who have been treated with mitotane within 6 months of the Screening Phase.\n\n 29. Subjects who are currently taking any H2 receptor antagonists, proton-pump inhibitors,\n or sucralfate (all of which inhibit absorption of COR-003). A list of orally\n acceptable antacids (for example, Mylanta and Maalox) will be provided, and can only\n be taken a minimum of 2 hours after dosing of COR-003.\n\n 30. Subjects who receive any prohibited concomitant medication:\n\n - Weight loss medications (prescription or over the counter)\n\n - Acetaminophen >3 g total daily dose (due to increased hepatotoxicity)\n\n - Co-administration of strong inducers or inhibitors of CYP3A4 enzyme system that\n may interfere with the metabolism of COR-003 and cannot be discontinued prior to\n first dose\n\n - The following herbal medicines are prohibited: St John's Wort, echinacea, gingko,\n goldenseal, yohimbe, red rice yeast, danshen, silybum marianum, Asian ginseng,\n schissandra sphenanther, shankhapushi, and Asian herb mixture (Xiao chai hu tang\n and Salboku-to).\n\n - Topical or inhaled steroids\n\n - Carbamazipine, fenofibrate, carbenoxolone.\n\n - Ingestion of genuine licorice.
Subjects must not have received any chemotherapeutic agents for the AML (except hydroxyurea); intrathecal cytarabine (ARA-C) and intrathecal methotrexate are permissible
Subjects who failed at least one prior therapy (BT062/Len/dex)
Subjects who failed at least two prior therapy (BT062/Pom/dex)
Subjects with acute medical problems such as ischemic heart or lung disease that may be considered an unacceptable anesthetic or operative risk
Consult with a physician experience in care and management of subjects with hepatitis B to manage/treat subjects who are anti-hepatitis B core antibody (HBc) positive
Subjects with DCIS with microinvasion
Subjects with a cluster of microcalcifications whose diameter is larger than 10 mm.
Subjects with extensive intraductal component and other characteristics not well visualized by imaging studies
Eligibility of subjects receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of pazopanib will be determined following review of their cases by the Principal Investigator
Subjects must have active disease appropriate for therapy
Subjects, who participated in previous ARQ 197 studies that have reached their designated end-dates, who did not meet discontinuation criteria in their original study, and who may, in the opinion of the Investigator and the Sponsor, benefit from treatment
Subjects who screen fails can be re?enrolled if the causation of the screen fail has been corrected
All subjects are required to submit a list of medications consumed within 14 days prior to receiving the first dose of AMG232 and during the protocol AMG232 treatment (weeks 1-5)
Indication A - ASPS: Subjects with no prior therapy or subjects with prior treatment with chemotherapy or an angiogenesis inhibitor (e.g., sunitinib).
All subjects must:
CRITERIA FOR ALL SUBJECTS:
Subjects must have histological or serological proof of metastatic germ cell neoplasm (gonadal or extragonadal primary) with disease not amenable to cure with either surgery or chemotherapy; subjects with seminoma and non-seminoma are eligible, as are women with ovarian GCTs
Subjects who test positive for Clostridium difficile (C. difficile) at Screening.
All subjects must:
Subjects with known 11q23 MLL rearrangement are excluded.
Known thrombophilic risk factors. Exception: Subjects for whom the potential benefits of participating in the study outweigh the potential risks of thromboembolic events, as determined by the investigator
Eligible subjects are required to have > or = to 1 line of multi-agent chemotherapy either neoadjuvantly or adjuvantly. Subjects may have had 0-2 lines of therapy for metastatic disease.
Must meet the criteria for relapsed and/or refractory disease according to the IWCLL guidelines (Hallek, 2008) to ? 1 prior treatment (with the exception of Arm B) and have evidence of disease progression requiring treatment at the time of study entry as follows: a. For Arms A and C, subjects must have received either prior chemoimmunotherapy or therapy with an approved BTK inhibitor with the following exceptions: i. Chemoimmunotherapy is not required if subjects have specific comorbidities that preclude the use of standard chemoimmunotherapy meeting at least 1 of the following criteria;
All subjects must:
Subjects must have received treatment for CLL with chemotherapy agents or antibodies OR if subjects are previously untreated they must state in the consent form that they are refusing to be treated with chemotherapy or antibodies
NHL SUBJECTS:
ALL SUBJECTS:
Subjects with osteonecrosis of the jaw
Female subjects must have a negative serum human chorionic gonadotropic (hCG) test (pregnancy test not required for subjects with bilateral oophorectomy and/or hysterectomy or for those subjects who are >1 year post-menopausal); and
Subjects with uterine carcinosarcoma
Subjects with known photosensitivity diseases
Subjects with breast cancer must have been treated with at least two FDA-approved anti-HER2 directed therapies (more than two is also permissible), and subjects with gastric and gastroesophageal junction cancers must have been treated with at least one FDA-approved anti-HER2 directed therapy (more than one is also permissible); and all subjects must have refractory or relapsed/progressive disease during or following their last prior anti-HER2 directed therapy.
Subjects with negative metastatic involvement (M0).
Subjects to be treated with other than SOC
Subjects considered eligible for intensive chemotherapy
For subjects with gastric cancer:
Subjects with brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy, including to control symptoms, within 2 months of first dose. Subjects with glioma who are on a stable, steroid-dosing regimen prior to screening MRI may be permitted to enroll with Medical Monitor approval
Abnormal cardiac valve morphology (>=grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study). Subjects with moderate valvular thickening should not be entered on study.
Subjects with COPD or subjects with increased risk of respiratory depression
Subjects with narrow angle glaucoma
Subjects must have received an alkylating agent unless contraindicated; subjects may have received these agents alone or in combination with other myeloma treatments
Abnormal cardiac valve morphology (>=grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study). Subjects with moderate valvular thickening should not be entered on study
In the opinion of the Investigator, subjects with a low chance of survival during the first 5 days of treatment.
Subjects with a history of RSV or MPV
Subjects with a history of documented Pseudomonas aeruginosa pneumonia confirmed radiographically and by culture from BAL.
Subjects with calculated BSA < 0.40 m2 are not eligible for study participation as Sorafenib dosing for this study cannot accommodate subjects of this size utilizing commercially available drug formulation.
Measurable or evaluable tumors. Subjects with neuroblastoma that is only detectable by Meta-iodobenzylguanidine (MIBG) scan are eligible. Subjects with neuroblastoma that is only detected by bone marrow aspirate/biopsy or elevated homovanillic acid / vanillylmandelic acid (HVA/VMA) are not eligible.
Subjects with abnormal cardiac valve morphology (>=grade 2) documented by echocardiogram (NOTE: subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study).
Subjects with moderate valvular thickening.
Subjects with stage IIc-IV epithelial ovarian, fallopian tube and peritoneal cancer who have completed adjuvant treatment consisting of up to 8 cycles of paclitaxel and carboplatin chemotherapy or other acceptable chemotherapy after initial debulking surgery with evidence of a complete or partial response by radiological imaging. These subjects may remain on hormonal therapy during the trial if such treatment has been prescribed by their treating physician. These subjects may have been in a clinical trial for an investigational carboplatin based adjuvant therapy.
Subjects with recurrent ovarian, fallopian tube or peritoneal cancer who have clinical or radiologic evidence of a complete or partial response or stable disease after completion of first-line chemotherapy for their recurrent disease and are not suitable for additional cytotoxic therapy are eligible. These subjects may have previously received a course of adjuvant chemotherapy earlier in their disease management as described in point one above. These subjects are eligible regardless of their CA-125 results. These subjects may have been in a clinical trial of an investigational therapy.
Subjects may be on a biphosphonate provided it had not been initiated within 14 days prior to receiving the first injection of DPX-Survivac
Subjects with recent history of thyroiditis
For subjects assigned to take vorinostat, inability to take oral medications; vorinostat capsules must be administered whole; note: this criterion does NOT apply to subjects treated on the Expansion Cohort (accruals post February 1, 2013)
Respiration rate >24 breaths per minute. For those subjects who require ventilatory support or oxygen supplementation, this requirement is waived.
Subjects who have taken more than a total of 3 days (6 doses) of approved anti-influenza therapy in the period from onset of symptoms and prior to enrolment.
Subjects who, in the opinion of the investigator, are not likely to survive beyond 48 hours from Baseline.
Subjects who require Extra Corporeal Membrane Oxygenation (ECMO) at Baseline
Subjects who are part of the staff personnel directly involved with this study
Subjects who are family members of the investigational study staff
Abnormal cardiac valve morphology (subjects with minimal abnormalities can be entered on study with approval from the medical monitor.
Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
Subjects with ulcerative chest wall disease defined as non-healing wounds consistent with cancer are eligible.
Subjects with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) OR subjects whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity
Subjects assessed by consultant anesthetist as unsuitable for general anesthetic
Subjects assessed by consultant anesthetist as unsuitable for general anesthetic
Subjects receiving procoagulant agent including desmopressin acetate (DDAVP), recombinant human antihemophilic factor (FVII) or prothrombin complex concentrate within 24 hours of enrollment
Subjects currently admitted to an inpatient unit at Michigan Medicine
Subjects will be excluded if they do not attend pre-operative clinic dedicated to RC subjects.
Subjects who are actively suicidal or homicidal
Subjects who have massages on a regular basis; regular massage usage will be operationally defined as receiving 4 or more massages/year for the last 5 years
All subjects who receive a radial forearm free flaps in the included time period, including subjects with head and neck cancer, traumatic defects, chronic wounds, or any other problems that require a radical forearm free flap for reconstruction
Subjects who have had an osteocutaneous or musculocutaneous flap
Subjects who have a radial forearm flap with a proximal skin flap or subjects that receive a “reverse” radial forearm flap
Subjects who exhibit signs of infection or a significant change from baseline test measurements via safety labs will be informed
Subjects must have a phone
Diagnosis of NF1 through germline mutation OR clinical diagnosis; for the clinical diagnosis of NF1 all study subjects must have two or more diagnostic criteria for NF1 listed below (National Institutes of Health [NIH] Consensus Conference):\r\n* Six or more cafe-au-lait spots (>= 0.5 cm in prepubertal subjects or >= 1.5 cm in postpubertal subjects)\r\n* >= 2 neurofibromas or 1 plexiform neurofibroma\r\n* Freckling in the axilla or groin\r\n* Optic glioma\r\n* Two or more Lisch nodules\r\n* A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex)\r\n* A first-degree relative with NF1
Subjects currently using N-acetylcysteine, alpha-lipoic acid supplements, or dry whey protein supplements
Subjects are experiencing bothersome hot flashes per the study questionnaires.
Subjects already receiving other treatment for hot flashes.
Subjects who have lichen planus or lupus
Surgeon’s opinion at the time of dissection that the subject’s well-being (e.g. bleeding or other independent acute health problems) would be compromised
Subjects have to be willing to attend weekly voice therapy sessions
Subjects must have or have had at initial diagnosis, histologic proof of their malignancy; additionally they must have radiographic, nuclear image, or biopsy proof that they have had a recurrence of their disease within four weeks prior to study entry; subjects must have failed or relapsed from standard first-line chemotherapy for their tumor; young children with primary embryonal brain tumor treated according to Head Start protocol are eligible as well; subjects with bone marrow involvement are NOT eligible for study
Subjects must be deemed ineligible for cisplatin-based combination chemotherapy by the attending medical oncologist.
Subjects must have HL, NHL, or MM requiring PBSCT
Subjects must have a psychological and emotional state that, in the view of the investigators, allows adherence to the protocol
Female subjects capable of reproduction, and male subjects who have partners capable of reproduction, must agree to the following:
Female subjects who are surgically sterilized or who have not experienced menses for at least two years are not required to have a pregnancy test
Subjects who are actively suicidal or homicidal
Subjects who have massages on a regular basis; regular massage usage will be operationally defined as receiving 4 or more massages/year for the last 5 years
Subjects who will be receiving dasatinib
All consecutive subjects undergoing routine (standard of care) Lugol’s chromoendoscopic evaluation for suspected or known squamous cell neoplasia will be enrolled as well as any outgoing subjects referred to the clinic with any prior history of squamous cell dysplasia and/or neoplasia will also be considered eligible as they will serve as study population for the surveillance group
Inclusion Criteria:\n\n A. Subjects whose most recent (within 18 months) prior mammogram interpreted as\n heterogeneously dense (ACR BI-RADS Breast Density C) or extremely dense (ACR BI-RADS Breast\n Density D) breast tissue.\n\n AND\n\n B. Subjects who are asymptomatic and scheduled to undergo routine screening mammography.\n\n OR\n\n C. Subjects scheduled for image-guided needle biopsy as a result of findings obtained\n during standard of care imaging modalities (mammography, ultrasound and/or MRI) performed\n at the clinical site that participates in the study.\n\n Exclusion Criteria:\n\n 1. Male by birth.\n\n 2. Individual is less than 40 and greater than 70 years old.\n\n 3. Contraindication to bilateral mammography or MRI.\n\n 4. Subjects who are unable to read, understand and execute the informed consent\n procedure.\n\n 5. Subjects who have had mammography, ultrasound or MRI examination performed on the day\n of the study prior to RI8 scan.\n\n 6. Subjects who are pre-menopausal and are between the 14th and 28th day after the start\n of the menstrual cycle\n\n 7. Subjects who have significant existing breast trauma.\n\n 8. Subjects who have undergone lumpectomy/mastectomy.\n\n 9. Subjects who have undergone breast reduction or breast augmentation.\n\n 10. Subjects who have undergone any other type of breast surgery, including surgical\n biopsy.\n\n 11. Subjects who have large breast scar / breast deformation\n\n 12. Subjects who have undergone a breast needle biopsy within the 6-week period prior to\n their intended enrollment into the study.\n\n 13. Subjects who have a temperature > 100° F (37.8C) degrees on the day of the RI8\n imaging.\n\n 14. Subjects who are pregnant or lactating.\n\n 15. Subjects with known Raynaud's Disease.\n\n 16. Subjects with known Mastitis.\n\n 17. Subjects diagnosed with epileptic seizures.\n\n 18. Subjects with weight > 135kg (~300 Lbs.).\n\n 19. Subjects who are claustrophobic or have physical limitations that do not allow them to\n sit in the system chair for the required imaging session.\n\n 20. Subjects with implanted pacemaker/defibrillator, implanted venous access device\n (portacath) or other implanted devices.\n\n 21. Subject with kidney failure\n\n 22. Subject with known allergy to gadolinium\n\n 23. Subject with a history of multiple contrast MRI scans (more than 4 MRI scans over the\n past two year)\n\n 24. Inmates (45 CFR 46.306) or mentally disabled individuals.\n\n 25. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the\n purpose of planning cancer therapy).\n\n 26. Subjects currently participating in another investigational clinical study.\n\n 27. Subject scheduled for a biopsy due to suspicious symptomatic lump\n\n 28. Subjects who participated in the Validation Phase will not be able to participate in\n the Testing Phase
Patients determined to be at risk for esophageal cancer:\r\n* Subjects with a history of Barrett’s esophagus\r\n* Subjects with a history of low or high grade dysplasia\r\n* Subjects with a history of gastroesophageal reflux disease (GERD)\r\n* Subjects with a history of esophagitis\r\n* Subjects with symptoms of esophageal cancer (EC) referred for endoscopy (new onset dysphagia, weight loss, etc)
Subjects with severe, symptomatic dysphagia (unable to pass solids)
FOR THE 31 SUBJECTS ENROLLED IN YEAR 1: Receipt of IVIG < 27 days prior to calendar day of vaccination
Subjects deemed potentially eligible by their treating physicians will be screened for enrollment after d+60 from transplantation
Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.
If subjects are randomized to the control group they agree to not consume fish oil capsules during the 1-year study
Subjects demonstrating markedly inappropriate affect or behavior will be excluded from the study
For the LBGT cohort study, subjects will be excluded for unwillingness to provide contact information or if they do not self-identify as LGBT in the screener
Known diagnosis of short-segment or long-segment Barrett’s esophagus as previously made by upper endoscopy showing salmon-colored distal esophageal mucosa and biopsies revealing intestinal metaplasia with goblet cells; potential study subjects may be contacted by mailings or phone calls or may be approached in clinic; additionally, potential study subjects may be approached using a web-based recruitment tool; informed consent will be obtained by a research coordinator or study investigator
Subjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to them
Subjects who work night shifts are not eligible
Subjects with vitiligo or alopecia;
Subjects with diabetes on active treatment (for subjects treated on CC-223 containing arms only)
Patients receiving thiazides or furosemide diuretics, with the exception of subjects who have stable doses and have been on therapy for over six months
Subjects taking calcium supplements; if subjects are willing to discontinue these supplements, there must be a 2-month wash out period before enrollment
Subjects with suspected brain tumors undergoing surgical removal as their standard of care will be eligible; these may include subjects' status post chemotherapy and/or radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are felt to be candidates for resection
Subjects for whom exposure to a strong magnetic field would be a health risk (e.g., subjects with cardiac pacemakers or non-MR compatible metallic implants)
Subjects with risk factors for esophageal malignancy including Barrett’s esophagus and gastroesophageal reflux disease (GERD)
Subjects who have difficulty lying flat on their back for extended periods of time
Subjects must have an International Prostate Symptom Score of =< 15
For the clinical diagnosis of NF1 all study subjects must have at least two or more diagnostic criteria for NF1 listed below (NIH Consensus Conference):\r\n* Six or more cafe-au-lait spots (>= 0.5 cm in prepubertal subjects or >= 1.5 cm in postpubertal subjects)\r\n* >= 2 neurofibromas or 1 plexiform neurofibroma\r\n* Freckling in the axilla or groin\r\n* Optic glioma\r\n* Two or more Lisch nodules\r\n* A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex)\r\n* A first-degree relative with NF1
Eastern Cooperative Oncology Group (ECOG) =< 3; subjects who are wheelchair bound because of paralysis will be considered “ambulatory” when they are up in their wheelchair; subjects have to be able to travel to the NIH for evaluations
Subjects with any type of ferromagnetic bioimplant that could potentially be displaced or damaged
Subjects with permanent tattoo eye liner (may contain metallic coloring)
The medical monitor, Dr. Lois Ayash, at minimum, may discuss the research protocol with the investigators, interview human subjects, and consult with others outside of the study about the research, shall have authority to stop a research protocol in progress, remove individual human subjects from a research protocol, and take whatever steps are necessary to protect the safety and well-being of human subjects until the Institutional Review Board (IRB) can assess the monitor’s report; shall have the responsibility to promptly report their observations and findings to the IRB or other designate official and the Human Research Protection Office at the Department of Defense; the monitor may also observe recruitment and enrollment procedures and the consent process for individuals, groups or units overseeing study interventions and interactions, reviewing monitoring plans and reports; overseeing data matching, data collection and analysis
Subjects must have had no prior therapy for cancer of the rectum
Subjects must have had no prior therapy for cancer of the esophagus
Subjects found to have any constitutionally present non-MR compatible ferromagnetic materials will be excluded from this study
Subjects who are pregnant or lactating; subjects will be co-enrolled in this study and UPCC 13413 and therefore must comply with the UPCC 13413 requirements pertaining to pregnancy, lactation, conception and contraception use throughout their participation in both studies
Subjects who have difficulty lying flat on their back for extended periods of time
Normal subjects could be recruited from the population of patients routinely undergoing PET CT for assessment of a pulmonary nodule (presumed unlikely to have marrow disease); alternatively, normal subjects could be recruited from the cohort of myeloma patients termed “asymptomatic” who are assumed not to have marrow involvement
Subjects may be excluded at the discretion of the principal investigator or study team members
Subjects with suspected brain tumors undergoing surgical removal as their standard of care will be eligible; these may include subjects status post chemotherapy and/or radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are felt to be candidates for resection
Subjects who exhibit noticeable anxiety, claustrophobia, or vertigo when moved into the scanner
Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced
Subjects who will have a delay in clinically indicated radiation therapy due to the interval between Eovist MRI imaging and biopsy
Subjects with brain metastasis are acceptable if the clinical condition has been stable for at least one month; subjects who are on stable doses (as determined by the principal investigator) of steroids may enroll in the study
Subjects with congenital long QT syndrome or subjects taking Class IA, Class III or Class IC anti-arrhythmic medications will require a cardiologist's evaluation prior to eligibility assessment. subjects with cardiovascular diseases can be included as long as the benefits of androgen deprivation therapy outweigh the potential risk of cardiovascular events
Subjects participating in another clinical investigation at the time of signature of the informed consent.
Participant must obtain prior approval from insurance to reimburse for oral temozolomide for the duration of the study or agree to self-pay for oral temozolomide
the safety or well-being of the participant or study staff
Participant must consent to provide the following for biomarker analyses:
Participant has prior exposure to any pyrrolobenzodiazopine-containing agent
Participant has a history of major immunologic reaction to any Immunoglobulin G (IgG).
Documentation of participant's willingness to use approved contraception method until discontinuation of all immunosuppressive medications is to be documented in the medical record corresponding with the consent conference.
The participant has any known significant ophthalmologic abnormalities of the surface of the eye.
Progressive disease during the antecedent protocol. If approval to treat beyond progression was already given in the antecedent protocol, the participant may roll over into the current protocol without sponsor approval. Under special circumstances, enrollment into this protocol and dosing beyond progression may be considered and will require approval of the sponsor Participants meeting any of the following exclusion criterion of the antecedent study at the time the participant is considered for the extension (rollover) study:
Participant provides informed consent for prospective collection of relevant medical records for analysis of clinical outcome and treatment-planning techniques
Significant allergy to a biological pharmaceutical therapy that, in the opinion of the Investigator, poses an increased risk to the participant.
Participant must have progressed on the most recent therapy.
Participant has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate participant participation in the clinical study (e.g., chronic pancreatitis, active hepatitis, etc.).
Participant is ? 30 days and ? 90 days from hematopoietic cell infusion.
Participant has achieved engraftment. Engraftment is defined as ANC ? 500 cells/?L and platelets ? 20000/?L on 3 consecutive measurements (each occurring at least 1 day apart). The participant must not have had a platelet transfusion within 7 days prior to the first measurement.
Participant meets the following criteria as indicated on the clinical laboratory tests:
Participant requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the participant.
Participant has active hepatitis C infection as determined by NAAT. NAAT must be performed if the participant has positive serology for hepatitis C. Participants who have had past exposure and have no detectable virus either through spontaneous clearance or treatment are eligible.
Participant requires treatment with concomitant drugs that target serotonin 5HT1R or 5HT2BR or sigma nonspecific receptor with the exception of drugs that are considered by the investigator to be absolutely essential for the care of the participant and for which no acceptable alternative exists.
Participant has a lesion in the oral cavity or oropharynx that is not yet biopsied but is highly suspicious for cancer; (randomization will be placed on hold until the presence of cancer is histologically confirmed, and a treatment plan is established; if the presence of cancer is not confirmed, the participant will be considered a screen failure)
Participant is scheduled for an end of study biopsy within 22 days of starting study agent and within 36 days of their study screening visit; (if the participant is scheduled for surgical excision of the tumor and the surgery is delayed for any reason after the participant has started taking the study agent, study agent dosing may be extended up to a maximum of 25 days without compromising the evaluability of the end of study biomarkers)
Participant has a history of hypoglycemia
Participant has a history of macular edema
Participant in other clinical trials
RETREATMENT WITH MODIFIED T-CELLS INCLUSION CRITERIA: Research participant without clinically significant encephalopathy/new focal neurologic deficits
RETREATMENT WITH MODIFIED T-CELLS EXCLUSION CRITERIA: Research participant with current evidence of GVHD
EXCLUSION - PARTICIPANT: Participant received prior chemotherapy or any other targeted therapies within the past 28, or palliative radiation within the past 14 days, prior to going on-study.
STRATUM A: Participant must be able to swallow medication; it is acceptable to administer medication via a gastrostomy tube (g-tube) if participant has a g-tube; it is not acceptable to place a g-tube for the purpose of delivering study medication
STRATUM B: Participant must be able to swallow medication; it is acceptable to administer medication via a g-tube if participant has a g-tube; it is not acceptable to place a g-tube for the purpose of delivering study medication
STRATUM C: Participant must be able to swallow medication; it is acceptable to administer medication via a g-tube if participant has a g-tube; it is not acceptable to place a g-tube for the purpose of delivering study medication
Research participant has uncontrolled seizure activity and/or clinically evident progressive encephalopathy
Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I study; a legal guardian may substitute for the research participant
Research participants with any non-malignant intercurrent illness which is either poorly controlled with currently available treatment, or which is of such severity that the investigators deem it unwise to enter the research participant on protocol shall be ineligible
Research participant has a released cryopreserved CAR T cell product
Research participant serum total bilirubin or transaminases does not exceed 2 x normal limit
Research participant does not have uncontrolled seizure activity following surgery prior to starting the first T cell dose
Participant has received treatment with the following:
Patient has a planned complete macroscopic cytoreduction (visual) (CC0) cytoreduction – NOTE: registration occurs during surgery and not before; if, during surgery, the principal investigator (PI)/sub-investigator (SubI) discerns that all disease cannot be removed surgically, the participant will be considered a “screen failure”, HIPEC will not be performed, and the participant will be removed from the study
The participant is unable to swallow oral dosage forms
The reason a participant is not eligible should be documented in the electronic case report form (eCRF).
Failure of research participant or legally responsible parent or guardian to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I study.
Participant with a history of cirrhosis or other indication of significant possible hepatic dysfunction. Note: Those with non-alcoholic steatohepatitis (NASH) should be discussed with the AbbVie TA MD before enrollment.
Participant with a positive diagnosis of hepatitis A, B, or C.
Total bilirubin: =< 1.5 institutional upper limit of normal (ULN); if potential due to lymphoma, the first cycle may be given without ibrutinib and if transaminitis and bilirubinemia improves to meet parameters, participant mat be enrolled on the clinical trial
For Combination therapy, participant must not have had prior exposure to Rovalpituzumab Tesirine or a pyrrolobenzodiazepine (PBD) based drug.
Participant already enrolled in the study who has received at least one S64315 infusion.
The participant is on ixazomib monotherapy or on a drug combination with another medication, established while in his/her parent study; and
The participant meets any of the criteria for treatment discontinuation in the parent study.
Participant requires, or is likely to require, more than a two-week course of corticosteroids for intercurrent illness; participant must complete the course of corticosteroids 2 weeks before screening to meet eligibility
Participant is receiving medication(s) that might affect immune function
Investigator considers participant ineligible for intensive induction therapy based on medical reasons, disease characteristics such as genetics, type of AML (de novo or secondary), or participant characteristics such as age, performance status, co-morbidities, organ dysfunctions, or patient election of low-intensity treatment.
Participant has received no more than 1 other therapeutic regimen other than those listed above in (5).
Indications that participant is not appropriate for the study (e.g., aggressive, intoxicated, disruptive, visibly ill)
ELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: Research participant without clinically significant encephalopathy/new focal neurologic deficits
ELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: Research participant is not receiving systemically administered steroid therapy; glucocorticosteroid physiologic replacement therapy for management of adrenal insufficiency is allowed
RETREATMENT WITH MODIFIED T CELLS: Research participant without clinically significant encephalopathy/ new focal neurologic deficits
Be the only participant in his/her household
Research participant has a released cryopreserved T cell product
Research participant does not have a fever exceeding 38.5° Celsius (C); there is an absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to T cell infusion and/or there aren’t any indications of meningitis
Research participant serum total bilirubin does not exceed 2 x normal limit
Research participant transaminases does not exceed 2 x normal limit
Research participant does not have uncontrolled seizure activity following surgery prior to starting the first T cell dose
Research participant has uncontrolled seizure activity and/or clinically evident progressive encephalopathy
Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I study; a legal guardian may substitute for the research participant
Research participants with any non-malignant intercurrent illness which is either poorly controlled with currently available treatment, or which is of such severity that the investigators deem it unwise to enter the research participant on protocol shall be ineligible
Neurosurgeon finds the prospective participant is able to undergo neurosurgery
ELIGIBILITY TO UNDERGO LYMPHODEPLETION\r\nNote: evaluation should be performed no more than 7 days prior to lymphodepletion\r\n* Research participant with central nervous system (CNS) leukemic involvement that is refractory to intrathecal chemotherapy and/or cranio-spinal radiation but effectively treated to completion remission (< 5 white blood cell[WBC]/mm^3 and no blast in cerebrospinal fluid [CSF]) is eligible to proceed with lymphodepletion\r\n* Research participants must have a donor or stem cells source identified for allogeneic transplantation, either related (7/8 or 8/8 allele matched or haploidentical), unrelated 7/8 or 8/8 allele match) donor, or cord blood stem cell source (at lease 4/6 matched)\r\n* Research participants with a response less than a CR or complete response with incomplete hematopoietic recovery (CRi) or detectable minimal residual disease (MRD) positive disease\r\n* Research participant has a released cryopreserved T cell product for CAR T cell infusion on approximately day 0\r\n* Research participant must be at least 2 weeks out from having received the last dose of investigational agent\r\n* Karnofsky performance status (KPS) >= 70\r\n* Documented measurable or evaluable disease\r\n* Non hematological toxicity related to prior therapy must either have returned to =< grade 2, baseline, or deemed irreversible\r\n* Research participants of reproductive potential must agree to use and utilize and adequate method of contraception throughout treatment and for at least 8 weeks after T cell infusion\r\n*If a research participant has undergone prior allogeneic stem cell transplant, he/she must be off all immunosuppressants for GVHD for at least 7 days before beginning lymphodepletion\r\n* Pulmonary: not requiring supplemental oxygen or mechanical ventilation, oxygen saturation 90% or higher on room air\r\n* Cardiovascular: not requiring pressor support, no symptomatic cardiac arrhythmias, no acute coronary syndrome, or uncontrolled hypertension\r\n* Renal Function: calculated creatinine clearance (absolute value) of >= 50 mL/minute or creatinine < 2.0 mg/dl or < 2 times upper limit of normal for the research participant's age group\r\n* Liver Function: adequate liver function defined as total bilirubin =< 3.0 mg/dl \r\n* ALT and AST =< 5 times the institutional upper limits of normal\r\n* Neurological: research participant without clinically significant encephalopathy/new focal deficits\r\n* Infectious diseases: no clinical evidence of uncontrolled active infectious process
ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED T CELLS\r\n* Research participants has undergone lymphodepletion\r\n* Pulmonary: not requiring supplemental oxygen or mechanical ventilation, oxygen saturation 90% or higher on room air\r\n* Cardiovascular: not requiring pressor support, no symptomatic cardiac arrhythmias, no acute coronary syndrome, or uncontrolled hypertension\r\n* Renal Function: calculated creatinine clearance (absolute value) of >= 50 mL/minute or creatinine < 2.0 mg/dl or < 2 times upper limit of normal for the research participant's age group\r\n* Liver Function: adequate liver function defined as total bilirubin =< 3.0 mg/dl\r\n* ALT and AST =< 5 times the institutional upper limits of normal\r\n* Neurological: research participant without clinically significant encephalopathy/new focal deficits\r\n* Infectious diseases: no clinical evidence of uncontrolled active infectious process\r\n* Research participant must be off all anti-leukemic drugs, with the exception of the lymphodepleting regimens, at least 7 days prior to CAR T cell infusion
Study-Specific Exclusion\r\n* Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I study\r\n* History of allergic reactions attributed to compounds of similar chemical or biological composition to cetuximab\r\n* Dependence on corticosteroids:\r\n** If the participant is undergoing leukapheresis: physiological replacement doses of steroids are allowed - prednisone no more than 7.5 mg, hydrocortisone less than 12 mg.m^2/day\r\n*** However, all participants must be able to reduce steroid requirement to no more than physiological replacement doses prior to start of lymphodepletion\r\n* Active autoimmune disease requiring systemic immunosuppressive therapy
Research participant must be at least 2 weeks from having received the last dose of immunosuppressant medications (e.g. calcineurin inhibitors, methotrexate, immunosuppressive antibodies, etc)
Research participant has a released cryopreserved T cell product for T cell infusions on approximately day 0
Research participant without clinically significant encephalopathy/new focal deficits
(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): Research participant without clinically significant encephalopathy/new focal deficits
Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I study
If the research participant is to undergo leukapheresis, he/she must must have a serum bilirubin =< 2.0 mg/dl\r\n* Note: in the event a participant has elevated levels of liver enzymes possibly related to underlying disease, the participant will still be considered eligible
If research participant is undergoing leukapheresis and the research participant has undergone prior alloSCT, two months must have elapsed since allogeneic stem cell transplant to undergo PBMC collection for T cell manufacturing
Research participant has a released cryopreserved T cell product for T cell infusion on approximately day 0
Total bilirubin =< 2.0 mg/dL\r\n* Note: in the event a participant has elevated levels of liver enzymes possibly related to underlying disease/disease progression, the participant will still be considered eligible
ALT and AST =< 2.5 times the institutional upper limits of normal\r\n* Note: in the event a participant has elevated levels of liver enzymes possibly related to underlying disease/disease progression, the participant will still be considered eligible
Research participant has undergone lymphodepletion
Liver function: total bilirubin =< 2.0 mg/dL\r\n* Note: in the event a participant has elevated levels of liver enzymes possibly related to underlying disease/disease progression, the participant will still be considered eligible
Liver function: ALT and AST =< 2.5 times the institutional upper limits of normal\r\n* Note: in the event a participant has elevated levels of liver enzymes possibly related to underlying disease/disease progression, the participant will still be considered eligible
Research participant without clinically significant encephalopathy/new focal deficits
Research participant is scheduled for an alloSCT
Research participant has >= 1% chimeric antigen receptor (CAR) modified T cells in the peripheral blood
Liver function criteria: total bilirubin =< 2.0 mg/dL\r\n* Note: in the event a participant has elevated levels of liver enzymes possibly related to underlying disease/disease progression, the participant will still be considered eligible
Neurological: research participant without clinically significant encephalopathy/new focal deficits
Research participants receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy\r\n* Note: Please note that the above criterion is not applicable at the time of enrollment if the research participant's donor is undergoing leukapheresis
Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I study
Failure to confirm diagnosis of cancer in participant
Participant has received prior therapy with a BH3 mimetic.
Participant screening laboratory result must indicate HCV genotype 1, 4, 5 or 6-infection if historical result is not available.
Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.
Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.
safety or well-being of the participant or offspring
Participant may be either previously untreated for KS or refractory to or intolerant of any one or more prior KS therapies
Patient re-enrollment: this study permits the re-enrollment of a participant who has discontinued the study due to pre-treatment failure (ie, participant has not been treated); if re-enrolled, the participant must be re-consented
Written informed consent obtained from study participant or study participant’s legal representative and ability for study participant to comply with the requirements of the study
Type of Participant and Target Disease Characteristics
The participant is receiving therapy with any of the following:
The participant has either of the following:
The participant does not have:
Eligibility based on prior treatment with immunomodulatory agents depends on the mechanistic class of the drug and the cohort for which the participant is being considered
Given that the physician may select from an offered list of regimens to treat a specific participant, the participant may be refractory to an agent/s listed within the list of offered treatment choices
safety or well-being of the participant or offspring
Has fulfilled the following additional requirements regarding prior treatments for recurrent ovarian cancer (ROC) depending on the cohort participant is to be enrolled. Each participant must have documented evidence of clinical response or disease stabilization to the last regimen received.
The participant has:
Participant is amenable to compliance with protocol schedules and testing
Participant has had an allogenetic tissue/solid organ ransplant.
The participant has not received any previous treatment with anthracyclines.
The participant has squamous cell or undifferentiated gastric cancer.
Participant has chronic respiratory disease that requires continuous oxygen use.
Family relative or close friend is a trial staff member or a study participant
If a participant has received subsequent anticancer therapy (salvage therapy), the participant must have a \wash-out period\ defined as 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the planned start date of daratumumab monotherapy. The only exception is the emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day for a maximum of 4 days) before Daratumumab monotherapy
Research participant has a released cryopreserved T cell product
Research participant without clinically significant encephalopathy/new focal deficits
Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I study; a legal guardian may substitute for the research participant
safety and well-being of the participant or offspring
The participant must have undergone definitive surgical treatment for the current malignancy.
The participant must be randomized within 16 months from the time of surgery.
Written consent by the participant
Participant with evidence of recurrent malignancy
Participant with severe sepsis involving at least 1 organ failure
Participant is a family member or employee of the investigator
The participant is able to carry out daily life activities without difficulty
The participant does not have significant side effects from previous anti-cancer treatment
The participant has received anticoagulant therapy with the exception of aspirin within 1 week of starting the study
Any disorder or disease, or clinically significant abnormality on laboratory or other clinical test(s) (eg, blood tests and ECG), that in medical judgment of the investigator may impede the participant's participation in the study, pose increased risk to the participant, and/or confound the results of the study
Participant is a family member or employee of the investigator
Participant must have viable alternatives to the current ART regimen in the event of drug resistance related to study treatment
If participant is HIV positive, participants must be on a stable antiretroviral regimen for at least 12 weeks prior to study enrollment
The participant has radiologically documented evidence of major blood vessel invasion or encasement by cancer
Participant who received a prior treatment intended for antitumor effect (medication, surgery, radiotherapy, etc.) within 4 weeks prior to the planned first day of study drug dosing (or participant who received mitomycin C or Nitrosourea within 6 weeks prior to the planned first day of study drug dosing).
Participant with leukemia has M2 or M3 marrow at the time of enrollment; participant with M2 marrow must have definite cytogenetic, molecular, or immunophenotypic evidence of recurrent/refractory disease
Participant disease tested positive for FLT3-ITD or –TKD within 60-day screening period
For participants potentially receiving chemotherapy: if the participant has received prior bendamustine, response duration must have been greater than (>) 1 year
PART II: Per oncologist responsible for management of care or follow up, participant must have a predicted lifespan of 6-months or more
Any disorder or disease, or clinically significant abnormality on laboratory or other clinical test(s), that in medical judgment may impede the participant's participation in the study, pose increased risk to the participant, or confound the results of the study
Participant is a family member or employee of the investigator
In the opinion of the investigator the protocol treatment is appropriate for the participant
The participant has superior vena cava syndrome contraindicating hydration.
The participant has metastatic disease at the time of study entry
The participant's tumor has Ki-67 expression ? 20%
The participant is receiving depot octreotide therapy at the time of enrolling into the study
The participant has received therapeutic radiolabeled somatostatin analogues
The participant has a history of treatment with other agents targeting the IGF receptor
Able to participate in patient-report outcomes (MDASI-BT, DSQ-C, LASA) questionnaires; assistance by research personnel is acceptable if participant has disabilities that make reading or writing difficult
Participant must be scheduled for a total laparoscopic or robotic-assisted hysterectomy for a gynecologic condition
Participant is not eligible if the surgeon does not plan to use a uterine manipulator
Prior treatment with a regimen that includes the combination drug will not necessarily exclude a participant from that cohort if the investigator views treatment with that agent as appropriate. However, a participant who has a contraindication for a particular combination agent or who has been discontinued from prior therapy with a particular agent for toxicity will not be eligible for inclusion in that particular cohort.
The participant has access to short message service (SMS) text messaging or email
PROVIDER ELIGIBILITY: The participant is willing to provide informed consent in English
PROVIDER ELIGIBILITY: The participant is a healthcare provider at Columbia University Medical Center with a high-risk patient identified in the research database (IRB-AAAO1761 or IRB-AAAP4151)
Co-parents must reside with the consenting eligible cancer participant (and child) at least 50% of the time and be actively participating in the care of the child
WEBSITE VISITORS: Have visited the personal website of a PCO participant
WEBSITE VISITORS: Have not visited the personal website of a PCA participant
Participant had recent surgery (within two weeks)
Participant has any metallic object in or around their head
Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this pilot study; a legal guardian may substitute for the research participant
Sufficient proficiency and confidence to use the internet and follow video-based instructions, as determined by the eligibility questionnaire to be completed by the participant
Any participant who has urologic cancer or is enrolled in a competing trial
Participant must have non-curable cancer as judged by the primary oncologist
Participant must be cognitively intact as judged by their responsible clinician
Participant must not have already worked with the staff writer at Dartmouth Hitchcock prior to enrollment in this study
Participant must not have physical symptoms that they feel would interfere with creative writing
Participants with a diagnosis of diabetes, unless they are able to provide a letter from a physician who will continue to monitor the participant during the research study
Current St. Jude LIFE participant
Participant has ongoing hemolysis.
Participant has history of major immunologic reaction to any auristatin-based and /or Immunoglobulin G (IgG) containing agent.
Clinician believes that eradication of concomitant HSIL is reasonable and feasible based on the extent of disease and overall medical condition of the participant
Participant plans to relocate away from the study site during study participation
The participant received prior immunotherapy and is experiencing or has experienced any of the following (OLE cohort only):
The participant received prior immunotherapy and at the time of study enrollment, requires steroids or other immunosuppressive agents (OLE cohort only).
A St Jude Life participant who was previously treated at St. Jude Children's Research Hospital (SJCRH)
Participant is 10 or more years from diagnosis
Participant has a Full Scale Intelligence Quotient (FSIQ) score > 79
Female research participant of childbearing age and male research participant of child fathering potential must agree to use safe contraceptive methods
Participant is employed in a position that requires night work (i.e. 10 pm to 6 am)
Primary treating oncologist for at least one patient participant
Permission from participant's physician
Participant not planning on remaining at St Jude for at least 4 weeks
Participant is enrolled on Total XVI
Participant is receiving gabapentin for another indication at the time of diagnosis of NP/PN or has received gabapentin previously
Participant will not or cannot provide medical records of past/present clinical exams (including but not limited to palpation, mammograms, biopsies, and ultrasound) if needed
Participant will not sign “Waiver of Diagnosis” form
Participant has symptoms related to HSIL and would benefit more from immediate treatment than from entry into the study and potential for randomization to active monitoring arm
Participant must have a gynecology examination within the last 5 years (gynecology examination is not required if participant had a hysterectomy), with no atypical hyperplasia and no cancer
H/L: Participant whose medical records or self-report indicate an ethnicity aside from Hispanic.
Be the only participant in his/her household on active treatment in Protocol 2016-0626 at the time.
Be the only participant in their household
Be the only participant in their household
Participant must be receiving a planned lymphoscintigraphy procedure
Participant has
the safety or well-being of the participant or study staff
STUDY PARTICIPANT ELIGIBLITY:
Participant must be a hematologist, oncologist, nurse practitioner, or physician assistant who practices medicine in the Duke Cancer Network
The participant has a medical or psychological condition that would not permit the participant to complete the study or sign informed consent.
The participant has a medical or psychological condition that would not permit the participant to complete the study or sign informed consent.
Female participant must be scheduled for a total laparoscopic or robotic-assisted hysterectomy for a gynecologic condition
Female participant is not eligible if the surgeon does not plan to use a uterine manipulator
Patients who plan to receive yellow fever vaccine during the course of the study treatment.
Patients for whom radiation therapy (RT) to the affected breast or chest wall and regional nodal areas is clinically indicated as per NCCN treatment guidelines, should receive RT after randomization when possible, and receive MK-3475 (pembrolizumab) concurrent with RT, if randomized to the experimental arm; however, RT administered, or initiated, prior to registration is also allowed; pembrolizumab may be added to ongoing radiation, or started after its completion, if randomized to the experimental arm, provided there are no > grade 2 radiation-related skin toxicities; patients who have not yet started radiation must specify at the time of screening registration whether or not they will receive RT and the extent of intended RT
Patients must be able and willing to receive prophylaxis with daily aspirin, low molecular weight heparin, factor X inhibitors or warfarin if randomized to lenalidomide; patients must also be willing to receive pneumocystis jirovecii prophylaxis with sulfamethoxazole/trimethoprim, dapsone, atovaquone or inhaled pentamidine, in the event that they are randomized to TGR-1202; patients unable or unwilling to take any listed prophylaxis are NOT eligible
Patients may receive up to a maximum of 5 days of pre-treatment with ATRA prior to administration of protocol therapy
A patient may not participate in a concurrent treatment protocol; all patients will be eligible to receive chemotherapy alone, systemic therapeutic agents, or conventional chemo-radiotherapy at the time of clinical or radiographic disease progression or at 2 weeks following completion of SBRT
Patients not able to receive standard-dose cisplatin based on the judgement of the treating medical oncologist
Patients must have measurable disease and be eligible to receive nivolumab in combination with ipilimumab treatment per institutional guidelines
Planning to receive other medical, surgical, or radiological cancer treatments during the course of this study
Unable to receive oral or IV hydration
Participants who are receiving or will receive other concurrent chemotherapies or immunotherapies for their cancer (except for patients who will receive letrozole, anastrozole, exemestane, tamoxifen, fulvestrant, trastuzumab, bisphosphonates, denosumab or ovarian suppression therapy)
Patients who receive sirolimus (Rapamune®) as part of their transplant immunosuppression regimen
Patients who are not eligible to receive paclitaxel will be allowed to receive single agent DKN-01.
Participants who cannot receive gadolinium
Patients who are otherwise ineligible to receive the antibiotics in this study
Participants who cannot receive gadolinium
Patients who receive or are planned to receive any other investigational product within the 3 weeks before the planned day for the first NKR-2 administration
Did not receive concurrent chemoradiotherapy prior to surgery
Patients planned to receive immune checkpoint inhibitor with contra-indications to receive immunotherapy
Have received vaccination against Neisseria meningitidis at least 2 weeks prior to beginning study protocol (only for cohorts where patients receive eculizumab treatment) in accordance with the most current Advisory Committee on Immunization Practices (ACIP) recommendations
Intention to receive chemotherapy within 6 months after enrollment in protocol therapy
Receive non-conventional fractionation schedules, such as stereotactic radiation (5 fractions or less) or received higher than 54 gray (Gy) delivered conventionally
Patients must be able to receive protocol chemotherapy in the judgment of the treating medical oncologist
Patients who are eligible for and willing to receive treatment with blinatumomab, inotuzumab ozogamizin, or tisagenlecleucel
Patients already receiving hypomethylating agents will be allowed to enroll on the protocol and receive concurrent treatment with vitamin C
Patients must receive insurance approval for or be willing to pay for commercial gefitinib
Patients may not plan to receive any other approved or investigational agents to treat their glioblastoma besides temozolomide prior to the evaluation visit 10 weeks after the initiation of radiotherapy and temozolomide; Note: Exceptions may be made for non-therapeutic intervention at the discretion of the principal investigator; the recently Food and Drug Administration (FDA) approved NovoTTF electric field therapy begins after the study period and is therefore permitted
Breast implant on the side of the body that will receive HIFU application
Ejection fraction < 45% will be an exclusion criteria for intensive chemotherapy; such patients may receive low intensity therapy
Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
Patients must receive a minimum dose of azacitidine of 75mg/(m)(2) dose
Willing to receive an mpMRI
Prior somatostatin analogue therapy; (patients should receive the first dose of study drug no sooner than 4 weeks from the last dose of somatostatin analogue)
As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment; however, adequate recovery of blood counts will be required to receive subsequent cycles)
Patients who would have otherwise been eligible to receive routine post-RP care
Eligible for and planning to receive standard fractionated RT with concurrent TMZ
Unable to receive TKI for insurance reasons (uninsurable)
Patients who may receive the injections endoscopically should be eligible for sedation.
Patient may not receive concurrent chemotherapy with reirradiation, other than temozolomide or bevacizumab given at the discretion of the treating neuro-oncologist
For subjects being enrolled to receive PLD plus carboplatin, prior treatment with anthracyclines or anthracenodiones
Subjects in the combination therapy arms must be eligible to receive erlotinib, or nivolumab per most current prescribing information, or at the discretion of the Investigator.
Patients must agree to appropriate clinical monitoring to receive the study regimens
be considered unfit to receive chemotherapy on reason of age, concomitant morbidities, and/or residual toxicity from previous treatments, or unwillingness to receive chemotherapy. These patients must also have had a progression-free and treatment-free interval of at least 6 months after completion of the last rituximab-containing treatment. Patients in whom chemotherapy is contraindicated are defined by one of the following features:
Patient must be scheduled to receive temozolomide concurrent with and following radiation (temozolomide may be started late due to insurance reasons, insufficient counts, or other reasons)
Patients unable to receive cisplatin in the opinion of the medical oncologist
Able to receive outpatient treatment and follow-up at the treating institution.
Patients may receive radiation alone if the above criteria is not met
Patients who are unable to receive MRIs will be excluded from the study
Unable to receive prophylactic treatment for pneumocystis
EXCLUSION CRITERIA FOR REGISTRATION: subjects should not be participating in other clinical trials of interventions designed to reduce risk of ovarian cancer recurrence or plan to receive off –protocol maintenance therapy (e.g. paclitaxel or bevacizumab)
Food and Drug Administration (FDA) approval to receive compassionate use of TheraSphere
Patients in Cohort A will be randomized to receive either TIL alone or TIL plus dendritic cells
Clinically stable and eligible to receive conditioning chemotherapy
Planned to receive either primary or post-operative CRT
Planned to receive concomitant single agent chemotherapy with cisplatin given either weekly or tri-weekly
Patients must receive a myeloablative preparative regimen containing busulfan targeted to an area under the curve (AUC) of 1000/ dose for 16 doses combined with fludarabine 40 mg/M2 daily for 4 days
Patients intolerant or unable to receive these agents will be considered eligible.
Unable to receive prophylactic treatment for pneumocystis and herpes simplex virus (HSV)
Willingness to receive all outpatient treatment, all laboratory monitoring, and all radiological evaluations at the institution that administers study drug for the entire study
Patients who can only receive pentamidine therapy for PCP prophylaxis are excluded, since this drug prolongs the QT interval
Patients are eligible if they are going to receive TMZ as part of the standard adjuvant treatment regimen following concomitant TMZ/radiation therapy (RT)
As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment; however, adequate recovery of blood counts will be required to receive subsequent cycles
Plan to receive anti-myeloma therapies
TREATMENT: Patients who have had prior treatment with any of the other investigational agents or combinations on this protocol are eligible but will not receive the same investigational agent (everolimus or trametinib) or combination (AZD1775/combination or veliparib/temozolomide); instead, patients will receive an investigational agent or combination prospectively identified to work on a different target in their tumor’s mutation/aberrant pathway
TREATMENT: Patients who have received prior mitogen-activated protein kinase kinase (MEK) inhibitors would not be eligible to receive trametinib DMSO on study; if these patients have mutations of interest in pathways other than the rat sarcoma (RAS) pathway, they will be eligible to receive agents based on that mutation
TREATMENT: Patients must have >=10.0 g/dL Hb and no blood transfusion in the past 28 days to receive veliparib
Patients 18-54 years of age with “good risk” AML defined as the presence of t(8;21), inv(16), or t(16;16) as diagnosed by morphologic criteria, flow cytometric characteristics, and rapid cytogenetics or fluorescence in situ hybridization (FISH) (patients with t(8;21), inv(16), t(16;16) who are unable to receive anthracycline based induction will be allowed to enroll provided the medical reason they are unable to receive anthracyclines is clearly documented and provided they fulfill all other eligibility and criteria)
Patients for whom there is a plan to receive ipilimumab, vemurafenib, or other treatment for advanced melanoma
Patients must not be receiving any other concurrent therapy considered to be investigational; patients must not be planning to receive any radiotherapy (except localized radiation for palliative care); patients must not be planning to receive any concurrent chemotherapy, immunotherapy, radiotherapy or other treatment with curative intent
Patients who are carriers of hepatitis B will be included in this study; these patients are not eligible to receive rituximab as a component of their chemotherapy mobilization
Residual areas of limited disease should receive radiotherapy following and not prior to transplantation
Participants must have V20 (volume of lung to receive 20 Gy radiotherapy according to simulation) < 35%.
Patients must be able to receive weekly cisplatin
Consultation, agreement, and documentation in the patient’s chart by a radiation oncologist that patient is suitable to receive radiotherapy per this protocol
Have additional uncontrolled serious medical or psychiatric illness that in the point of view of the investigator can render the patient unable to receive therapy or make it unsafe to receive therapy.
Be considered ineligible to receive cisplatin-based combination therapy, based on protocol-defined criteria.
Subjects may be eligible to receive MK-3475 in the second course phase of this study if the study remains open and the subject meets the following conditions:
Did not receive any anti-cancer treatment since the last dose of MK-3475
Patients must not have plans to receive concomitant chemotherapy, other biological or immune therapies, or radiation therapy for the treatment of prostate cancer during the period of study treatment
Plans for the patient to receive other concomitant local therapy (including standard fractionated radiotherapy and surgery) while on this protocol except at disease progression
Age > or equal to 60 years; patients younger than 60 who are unsuitable for or unwilling to receive standard cytotoxic chemotherapy are also eligible to be enrolled
Inability to receive a port or peripherally inserted central catheter (PICC) line
Unable to receive oral or IV hydration
Able to receive ibrutinib through commercial supply, i.e., insured patients meeting Food and Drug Administration (FDA)-approved indications
Patient is unable to receive IV contrast
Patients with 17p deletion can only be enrolled on Arm C; these patients will receive the expanded T cells without lymphodepleting chemotherapy
Patients should have no contraindications for chemotherapy or radiation, and should receive either definitive chemoradiation therapy or preoperative chemoradiation therapy
Is unable to receive a port or peripherally inserted central catheter (PICC).
Any Chronic Myeloid Leukemia disease phase, as long as the patient is unable to receive treatment with imatinib, dasatinib and/or nilotinib for any reason.
Unable to receive prophylactic treatment for pneumocystis
Eligible to receive treatment with the selected doublet-chemotherapy
In the opinion of the investigator, patient must be able to receive at least 2 cycles of treatment
Planning to initiate adjuvant or neoadjuvant anthracycline (AC) chemotherapy (doxorubicin [doxorubicin hydrochloride] 60 mg/m^2 and cyclophosphamide 600 mg/m^2 every 2-3 weeks x 4 cycles)\r\n* Note: \r\n** Participants may be planning to receive additional adjuvant therapy after the completion of AC chemotherapy\r\n** Receipt of all standard chemotherapy and/or targeted therapy regimens after AC that deemed clinically appropriate by the treating physician are permitted; for example, patients may receive taxanes or carboplatin/paclitaxel; Her2 positive patients may receive trastuzumab with or without pertuzumab\r\n** HER2 positive patients must be planning to initiate trastuzumab therapy after AC chemotherapy
Patients with known active central nervous system leukemia should be excluded from this clinical trial; patient receiving intrathecal chemotherapy prophylaxis should not receive pomalidomide for >= 3 days after administration
Treatment Naive only: and a) do not want to receive chemoimmunotherapy or b) have comorbidities that would preclude chemoimmunotherapy.
Willingness by subject to be randomized to receive either ofatumumab or duvelisib at the dose and schedule defined in the protocol
Unable to receive prophylactic treatment for pneumocystis or herpes simplex virus (HSV)
Unable to receive background chemotherapy based on prior treatment history and cardiac function
Patients must have CA125 level >= 10 to participate in the immunotherapy aspect of the trial and receive oregovomab; if the patient has CA125 >= 10 who is not eligible to receive oregovomab (e.g. allergic to the drug) but is eligible for the rest of treatment, this patient should be accrued to the part of protocol without oregovomab
Subjects who are anticipated to receive a transplant within the first 6 months of treatment on trial
Eligible for and planning to receive maintenance temozolomide after completion of definitive radiotherapy plus temozolomide
Patients will be excluded if they are not planning to receive concurrent temozolomide
Patients must receive RT at the participating institution.
Unable to receive or previously intolerant of moderate and/or deep sedation
Subjects with mycosis fungoides (MF) and a known history of non-complicated staphylococcus infection/colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics
Staging laparoscopy is not required at the outset of the trial, including in patients who might otherwise receive staging laparoscopy per National Comprehensive Cancer Network (NCCN) guidelines (high-risk body and tail lesions), because patients will receive systemic chemotherapy at equivalent dose to patients who have documented stage IV disease
Patients with central nervous system involvement by APL are eligible and may receive concomitant treatment with radiation therapy and/or intrathecal chemotherapy in accordance with standard medical practice
Patients may receive any number of cycles of chemotherapy prior to treatment with SBRT, but not within 2 weeks of the first fraction of radiotherapy (RT); patients are not required to receive any chemotherapy to be eligible for study enrollment
Age greater than or equal to 1 but less than or equal to 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive total body irradiation (TBI) may receive reduced intensity regimen 3
Able to receive antibiotic prophylaxis against N. meningitides for the duration of the study.
Patients who cannot receive cyclophosphamide
Inability to receive TBI.
Subjects must be able to receive outpatient treatment and laboratory monitoring (where specifically indicated) at the institution that administers study drug for the entire treatment period
Pts with NSCLC who have received, are receiving or are planning to receive two to four cycles of standard frontline chemotherapy are eligible; choice of chemotherapy is at the discretion of the medical oncologist; concurrent chemoradiotherapy will not be permitted during the active study period; post-operative radiotherapy can be administered as clinically indicated
Patients aged >= 80 are not excluded; however, candidates in this age group should be thoroughly evaluated before enrollment in the study, to ensure they are fit to receive chemotherapy, and to potentially undergo pancreaticoduodenectomy; in addition to meeting all of the baseline patient selection criteria, clinical judgment on their susceptibility to infection and expected stability of their performance status and suitability to receive intensive chemotherapy cycles, should be paid special attention to; patients should not be enrolled in the study should there be any hesitation on any of these considerations; baseline criteria for all patients enrolled on the study must be carefully evaluated and all criteria followed appropriately
Concomitant chemotherapy and radiotherapy while on protocol is prohibited; prednisone therapy will not be permitted with the exception of brief courses (=< 14 days) used for inflammatory conditions unrelated to CLL; patients may receive intravenous immunoglobulin (IVIG) while on protocol; patients may receive erythropoietin, darbepoetin, filgrastim, peg filgrastim, or sargramostim while on protocol; patients with cellular immune cytopenias may receive cyclosporine (pure red cell aplasia, etc.) while on study but consultation with principal investigator (P.I.) (or designee) is required
Patients must be able to receive proton radiation treatment
Unable to receive medications by mouth
Patient’s must be eligible to receive melphalan dose of 200 mg/m^2
Patients are not allowed to receive prior surgery or chemotherapy for the IHC
Patient understands if he or she is randomized to receive molecularly guided treatment, they must meet all inclusion and exclusion criteria in the drug specific appendix for which they were randomized
Unable to receive medications by mouth
Planned to receive standard cisplatin chemotherapy administered either weekly or every third week.
Planned to receive 4 to 6 cycles of pemetrexed or gemcitabine in combination with cisplatin or carboplatin • For subjects to receive pemetrexed, planned to receive vitamin B12 and folate per pemetrexed approved labeling
Patients who are not appropriate to receive more intensive chemotherapy in the judgment of the investigator
Patients should receive concomitant therapy with bisphosphonates, regardless of the presence of bony lesions, although study physicians may use their discretion based on presence of renal insufficiency or other mitigating factors
Have undergone surgical, medical and radiation oncology evaluations to confirm:\r\n* Eligible for infusional fluorouracil (5-FU) or capecitabine\r\n* Will not undergo surgery for the study disease\r\n* Able to receive HDR brachytherapy
Patients may receive estrogen +/- progestin replacement
Patients may receive transfusion if necessary to reach the pre-apheresis hematology parameters; if elevated PT is concluded to be due to a circulating anticoagulant then patient may enroll despite the abnormal laboratory finding
May not receive chemotherapy until valacyclovir completed
Women who receive Oncotype Dx testing
Have an email address at which to receive CaringGuidance prompts
Newly diagnosed patients with stage 1 through 3a BC scheduled to receive a 12-week, 16-week, 18-week, 20- week, or 24-week chemotherapy regimen, adjuvant or neoadjuvant
Are receiving, or are likely to receive another intervention for the treatment of fatigue during the study period; (per provider report)
Patients intolerant to prior immunotherapy (unable to continue/receive due to immune-related AE).
Scheduled to receive RT with curative intent with the expectation that some portion of the mucosa of the upper aerodigestive tract will receive a dose of at least 50 gray.
PATIENTS: Diagnosed with a primary HNC and going to receive at least 4 weeks of RT with at least 20 fractions.
Patient is planned to receive interventional procedures (i.e. surgery) that may affect study outcomes
Participants must live within 35 miles of the University of Washington, Seattle, WA to receive the in-person version of the intervention
Patients who plan to receive chemotherapy at Dana-Farber Cancer Institute (DFCI) to treat recurrent, incurable gynecologic cancers (i.e., ovarian, uterine, and cervical that has recurred despite >= 1 prior treatments)
Patient’s oncologist advises against the trial – in which case they can choose to receive stimulation with letrozole + gonadotropin
PATIENTS: Planning to receive ongoing care from a participating oncologist.
Planning to receive first-line chemotherapy at Massachusetts General Hospital (MGH)
Planning to receive care at MGH
Eligible to receive, but not yet begun, aromatase inhibitor therapy
Participants must be willing and able to receive email newsletters via computer or smartphone for 12 months’ AND/OR willing and able to receive texts via cellphone for 12 months\r\n* Participants must have a personal email address to receive newsletters\r\n** If a participant does not have an email address but has access to a smartphone or a computer, at the baseline data collection visit Columbia University Medical Center (CUMC) study staff will create a free personal Google Gmail email account.
There must be no plans for the patient to receive other concomitant therapy while on this protocol treatment (other than sandostatin or BIS-phosphonate therapy)
Planning to receive ongoing care from a participating oncologist and willing to be seen at least monthly
Refusal to receive NIPPV
Patients anticipated to receive radiation therapy with protons
Failed to receive satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current depressive episode
Will receive radiotherapy of cranium within one week prior to or during the study
Patients MUST also be ready to receive a cycle of chemotherapy that predictably renders neutropenia at least 70% of the time OR has a risk of febrile neutropenia of at least 20%; this can be any cycle number; it does NOT need to be the FIRST cycle of chemotherapy they are to receive; it is also OK if the patient will be getting granulocyte stimulation factor support; however, if the patient meets above criteria and the chemotherapy he/she will receive causes neutropenia 70% of the time or confers a risk of febrile neutropenia of at least 20%, but is not listed, please contact study Karen Moody, MD, overall study principal investigator, for clarification of eligibility
PATIENTS ONLY: Diagnosed with a primary glioma and going to receive at least 4 weeks of radiotherapy with at least 20 fractions
Unable to receive R-CHOP chemotherapy
Inability to receive lumbar intrathecal injection because of other factors
Patients scheduled to receive broad-spectrum prophylactic antibacterial therapy are ineligible; patients only receiving prophylaxis for Pneumocystis pneumonia (PCP) (trimethoprim [TMP]/sulfamethoxazole [SMX]) or encapsulated organisms (penicillin) are eligible
Patients using prophylactic antimicrobial locks in the CVC at the time of enrollment and those who are scheduled to receive antimicrobial locks in the CVC as part of a treatment plan are ineligible
Treatment plan to receive standard cisplatin monotherapy administered either every three weeks (80-100 mg/m2 for 3 doses) or weekly (30-40 mg/m2 for 6-7 doses). The decision on which chemotherapy regimen to use in combination with IMRT and GC4419 will be at the discretion of the investigator.
Participant must plan to receive follow up care at Dartmouth-Hitchcock
Prospective study: completed primary treatment for breast malignancies; receive survivorship care at Thomas Jefferson University (TJU) or Reading Health System (RHS)
Receiving or planning to receive outpatient therapy for any cancer
Own a smartphone (in order to receive text messages and utilize the phone app)
Agree to receive text messages on their smartphone over a 3-month period
The patient cannot receive text messages
PATIENT: Planning to receive all medical care for cancer at the enrolling institution
Are unwilling to receive intensive (e.g. 7+3) chemotherapy, or
Patients ?60 years unfit to receive intensive (e.g., 7+3) chemotherapy who have:
Allergic to selinexor or any of the chemotherapy intended to receive
No prior renal disease that in the opinion of the attending physician would make the patient ineligible to receive the study drug
Patients may receive up to 2 doses of aerosolized ribavirin (modified regimen) before enrollment into the study
Planning to receive care at the participating institution
Plan to receive or is receiving primary frontline anti-myeloma therapies
Subjects are to receive autologous PBSC transplant following mobilization, CD34+ cells collected by apheresis, and conditioning chemotherapy
Plan to receive any RBC transfusion between randomization and study day 1.
Have a plan to receive a standard cisplatin chemotherapy regimen administered weekly (30-40 mg/m2) or approximately every 21 days (80-100 mg/m2)
Patient must have a valid mailing address within the United States to receive study materials
Able and willing to receive phone calls
Patient is expected to receive 2 weekly doses of vincristine as outlined by the Total XVI or “as per TOTXVI” protocol while on study drug (i.e. no known dosage reductions or planned missed doses)
Subjects who are planned to receive > 2 mg flat dose of vinca alkaloids
Women must have a cervix to receive cervical cancer screening
Patients aged 50-74 with no evidence of a colonoscopy within 9 years or fecal testing within 11 months, and no history of colorectal disease will be eligible to receive a mailed FIT.
Patients must not be expecting to receive radiation or additional chemotherapy
Patient is receiving or plans to receive other investigational therapy during study.
Owns a cell phone that can receive text messages and is willing to receive text messages for this study
Patients should receive their definitive treatment at Wake Forest University (WFU) Cancer Center or at Medical University of South Carolina (MUSC) Cancer Center
Patients who receive RT or CRT with palliative intent
Ability to send and receive emails
PILOTS I, II AND III: Have a cellular telephone and are able and willing to send and receive text messages
At screening has suspected or confirmed CDI, and is receiving or is planning to receive a 10- to 21-day course of antibacterial drug treatment for CDI
Willing and able to receive weekly phone “check-ins” from a study coordinator
Patient planned to receive altered fractionation radiotherapy or multiple fractions per day
Own a phone that has texting ability and free texting or be willing to receive a phone from study staff
Are willing to receive and respond to text messages from the study teams, throughout the duration of the study
Willing to receive anti-epileptic prophylaxis for the duration of study drug administration.
Willing to receive anti-epileptic prophylaxis for the duration of study drug administration
Subject has a history of central nervous system radiotherapy that encompasses all or part of the cochlea or will receive such radiation therapy during the course of the study.
Has had benzodiazepine, opioid or opioid like therapy initiated within 48 hours prior to study drug administration, or is expected to receive within 120 hours following initiation of chemotherapy except for single doses of midazolam, temazepam or triazolam
Received the following within 7 days before screening or plans to receive during the study: ganciclovir, valganciclovir, foscarnet, acyclovir, valacyclovir, or famciclovir
Patients who have received an investigational drug in the 30 days before CEUS, or will receive one within 72 hour after their CEUS exam
Cannot receive furosemide
Cannot receive furosemide
Patients who will receive radiotherapy as treatment for left-sided breast cancer
Patients with an estimated GFR (eGFR) > 90 ml/min reported within 30 days, and who have not had intervening chemotherapy or other treatment or condition that might deteriorate renal function, may receive any gadolinium agent
Patient must be planning to receive chemoradiation therapy with cisplatin
Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), and herpes zoster (varicella zoster virus [VZV]) at start of treatment
Patients meeting the criteria for enrollment on research protocol 11-016 to receive DSTP3086S antibody drug conjugate (ADC) (the therapeutic ADC based on MSTP2109A) will be preferred patients for this study; patients that are to receive DSTP3086S will not be injected with DSTP2086S until imaging with 89Zr-DFO-MSTP2109A is finished, approximately 1 week
Had or plan to receive any chemotherapy
Planned treatment with standard agents or investigational agents that can potentially activate herpesvirus TK, including but not limited to the following; concurrent radiation therapy is permissible:\r\n* Platinum compounds (for example, cisplatin, carboplatin)\r\n* Anthracyclines (for example, doxorubicin or pegylated doxorubicin)\r\n* Tubulin disrupting agents (for example, vincristine, vinblastine)\r\n* Rituximab\r\n* Gemcitabine\r\n* Cytarabine\r\n* Histone deacetylase inhibitors\r\n* Bortezomib; Note: patients who would not receive bortezomib as part of their usual care may receive a one-time dose of bortezomib for the purpose of imaging with 124I-FIAU and FIAU-PET-CT
Patients must be planning to receive one of the study-allowed regimens as their initial treatment for their current disease; myelosuppressive therapy must follow the standard regimen, although a dose reduction of up to 10% is permitted; this treatment may be neoadjuvant or adjuvant chemotherapy; patients must not be receiving or planning to receive concurrent radiation during systemic treatment
Referred from one of the above six centers, or chooses to receive care at one of the six centers
PHASE I: Women who state that there are still deciding on breast cancer treatment (e.g., whether or not to take hormone therapy or to receive radiation treatment)
Owns a cell phone that can receive text messages and is willing to receive text messages for this study
Patients must have interest in a legal consultation as specified by the I-Help model to receive free legal consultation.
At least 21 days must have elapsed from prior systemic therapy (chemotherapy or radiation)
At least 4 weeks must have elapsed since completion of antibody-directed therapy
Prior radiotherapy is allowed if more than 14 days have elapsed since the end of treatment
At least 7 days must have elapsed since the completion of therapy with a growth factor; at least 14 days must have elapsed after receiving pegfilgrastim
At least 4 weeks for focal radiation therapy (RT) or >= 6 weeks for craniospinal RT must have elapsed prior to study entry
Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of AMG 757 Exceptions: Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade .1 Prior palliative radiotherapy must have been completed at least 7 days before the first dose of AMG 757
At least 4 weeks must have elapsed from the use of palliative radiation, strontium-89, radium-223, or approved immunotherapy prior to registration
Prior carboplatin allowed provided greater than 12 months (mos) have elapsed since last dose of carboplatin
No prior carboplatin unless given in neoadjuvant/adjuvant setting for curative intent and more than 6 months have elapsed since last carboplatin dose; in the case of relapsed ovarian cancer, patients are eligible if more than 6 months have elapsed since last carboplatin dose
For patients whose most recent anti-DLBCL therapy induced a PR or CR, at least 60 days must have elapsed since the end of that therapy. For all other patients, at least 14 weeks must have elapsed since their most recent systemic anti-DLBCL therapy.
Prior radiation requirements\r\n* For bevacizumab-naive patients (groups 1 and 3) a minimum of 6 months must have elapsed since completion of initial radiation therapy for study entry, and there is no minimum time since completion of last chemotherapy\r\n* For bevacizumab-exposed patients (groups 2 and 4) minimum of 3 months must have elapsed since completion of initial radiation therapy and there is no minimum time since completion of last chemotherapy
Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
At least 7 days must have elapsed since the completion of therapy with a growth factor that supports platelet or white cell number or function. At least 14 days must have elapsed after receiving peg-filgrastim.
At least 3 months has elapsed from the time of transplant and
At least 2 weeks must have elapsed from any prior surgery or hormonal therapy.
Patients must have recovered from effects of prior therapy; at least 2 weeks should have elapsed since the last dose of high dose chemotherapy; hydroxyurea, steroids and vincristine are allowed to control counts until eligibility is confirmed and study treatment can be initiated
At least 14 days must have elapsed since the completion of cytotoxic therapy, with the exception of standard maintenance therapy and steroids
At least 42 days must have elapsed since chimeric antigen receptor (CAR)-T cell therapy
Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
At least 2 weeks must have elapsed since the research participant received his/her last dose of prior chemotherapy or radiation
Patients must have recovered from severe toxicity of prior therapy; an interval of at least 12 weeks must have elapsed since the completion of radiation therapy or placement of Gliadel wafers, and at least 6 weeks must have elapsed from the last dose of temozolomide (TMZ); no prior therapies are allowed other than radiation, temozolomide, and Gliadel wafers (placed during the first surgery at diagnosis of GBM)
PHASE II: At the time of enrollment, at least 6 weeks must have elapsed since the last dose of any nitrosourea, and the longer of 2 weeks or 3 half-lives must have elapsed since the last dose of any other tumor-directed medication, or biologic therapy
Patients may have received prior therapy including vincristine, irinotecan, or temozolomide; patients may not have previously been treated with combination therapy of irinotecan and temozolomide\r\n* Patients must be fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n** Patients must not have received myelosuppressive chemotherapy within 3 weeks of starting protocol therapy, or a minimum of six weeks must have elapsed since prior nitrosourea chemotherapy\r\n** At least 7 days must have elapsed since the last administration of filgrastim, or 14 days since administration of pegfilgrastim\r\n** At least 7 must have elapsed since the last administration of any biologic agent\r\n** At least 14 days since the last dose of local palliative radiation therapy; greater than 6 months must have elapsed since the last day of treatment if given total body irradiation, craniospinal irradiation\r\n** Complete resolution of graft versus host disease and no current need for immunosuppressive medication; greater than 3 months must have elapsed since engraftment and no longer requiring transfusion of platelets or injection of colony stimulating factors
Prior therapies\r\n* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy\r\n* Myelosuppressive chemotherapy: Must not have received within 3 weeks (6 weeks if prior nitrosourea)\r\n* Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor, 14 days for long- acting (e.g. PEG-filgrastim)\r\n* Biologic (anti-neoplastic agent): At least 7 days or 3 half-lives (whichever is longer) since the completion of therapy with a biologic agent\r\n* Radiation therapy: >= 12 weeks must have elapsed from craniospinal radiation; >= 2 weeks must have elapsed from focal radiation\r\n* Surgery: > 3 weeks from major surgery; if recent craniotomy, adequate wound healing must be determined by neurosurgical team\r\n* Autologous stem cell transplant or rescue: No evidence of active graft versus (vs.) host disease and >= 4 weeks must have elapsed
At least 21 days elapsed from prior systemic chemotherapy (at least 14 days elapsed from prior systemic chemotherapy in the setting of rapidly progressive disease without significant residual extramedullary toxicity). Hydroxyurea and dexamethasone permitted up to approximately 24 hours prior to the start of therapy. Interruption of tyrosine kinase inhibitor (TKI) not required in Ph positive ALL subset
At least 6 weeks must have elapsed prior to enrollment since the patient received any prior radiation therapy
Prior therapy: there is no limit to the number of prior therapies provided all eligibility criteria are met; however, patients must have recovered from the acute toxic effects of all prior treatment\r\n* Patients must not have received prior therapy with either gemcitabine or nab-paclitaxel\r\n* Myelosuppressive chemotherapy: patients must not have received myelosuppressive chemotherapy within 3 weeks of protocol therapy on this study\r\n* Hematopoietic growth factors: 7 days must have elapsed from the start of protocol therapy since the completion of therapy with filgrastim, and 14 days must have elapsed from the start of protocol therapy after receiving pegfilgrastim\r\n* Biologic (anti-neoplastic agent): 7 days must have elapsed from the start of protocol therapy since the completion of therapy with a biologic agent\r\n* Monoclonal antibodies: 3 half-lives must have elapsed from the start of protocol therapy since prior therapy that included a monoclonal antibody\r\n* Radiotherapy: 2 weeks must have elapsed from the start of protocol therapy since local palliative radiation therapy (XRT) (small port); 3 months must have elapsed if 50% radiation of pelvis; 6 weeks must have elapsed if other substantial bone marrow irradiation was given\r\n* Stem cell transplant or rescue: no evidence of active graft versus (vs.) host disease and 2 months must have elapsed from the start of protocol therapy since transplant
At least 4 weeks must have elapsed since receiving medical therapy directed at NF1 related tumor manifestations
PART 2 GROUP 1 INCLUSION CRITERIA: A sufficient interval must have elapsed between the last dose of prior anti-cancer therapy (including cytotoxic and biological therapies) and enrollment in this study, to allow recovery from the acute toxic effects of all prior anti-cancer therapy:\r\n* Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy\r\n* Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor\r\n* Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent\r\n* Immunotherapy: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1; at least 42 days after therapy with a cellular immunotherapy or anti-cancer vaccine\r\n* Radiation therapy: At least 14 days after local palliative radiation therapy (XRT) (small port); >= 6 weeks must have elapsed since treatment with therapeutic doses of metaiodobenzylguanidine (MIBG); >= 6 months must have elapsed from total body irradiation (TBI), craniospinal XRT or 50% radiation of pelvis\r\n* Stem Cell Transplant (SCT): At least 12 weeks after myeloablative therapy with autologous stem cell transplant (timed from start of protocol therapy); subjects must meet adequate bone marrow function definition (see organ function requirements, below) post-myeloablative therapy; patients who received stem cell reinfusion following non-myeloablative therapy are eligible once they meet peripheral blood count criteria below\r\n* Subjects with prior treatment with compound/s with the same mode of action used in one of the treatment groups are eligible if they have not previously received prior treatment with BOTH agents in the combination
PART 2 GROUP 2A INCLUSION CRITERIA: A sufficient interval must have elapsed between the last dose of prior anti-cancer therapy (including cytotoxic and biological therapies) and enrollment in this study, to allow recovery from the acute toxic effects of all prior anti-cancer therapy:\r\n* Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy\r\n* Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor\r\n* Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent\r\n* Immunotherapy: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1; at least 42 days after therapy with a cellular immunotherapy or anti-cancer vaccine\r\n* Radiation therapy: At least 14 days after local palliative XRT (small port); >= 6 weeks must have elapsed since treatment with therapeutic doses of MIBG; >= 6 months must have elapsed from TBI, craniospinal XRT or 50% radiation of pelvis\r\n* SCT: At least 12 weeks after myeloablative therapy with autologous stem cell transplant (timed from start of protocol therapy); subjects must meet adequate bone marrow function definition (see organ function requirements, below) post-myeloablative therapy; patients who received stem cell reinfusion following non-myeloablative therapy are eligible once they meet peripheral blood count criteria below\r\n* Subjects with prior treatment with compound/s with the same mode of action used in one of the treatment groups are eligible if they have not previously received prior treatment with BOTH agents in the combination
PART 2 GROUP 3 INCLUSION CRITERIA: A sufficient interval must have elapsed between the last dose of prior anti-cancer therapy (including cytotoxic and biological therapies) and enrollment in this study, to allow recovery from the acute toxic effects of all prior anti-cancer therapy:\r\n* Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy\r\n* Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor\r\n* Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent\r\n* Immunotherapy: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1; at least 42 days after therapy with a cellular immunotherapy or anti-cancer vaccine\r\n* Radiation therapy: At least 14 days after local palliative XRT (small port); >= 6 weeks must have elapsed since treatment with therapeutic doses of metaiodobenzylguanidine (MIBG); >= 6 months must have elapsed from TBI, craniospinal XRT or 50% radiation of pelvis\r\n* SCT: At least 12 weeks after myeloablative therapy with autologous stem cell transplant (timed from start of protocol therapy); subjects must meet adequate bone marrow function definition (see organ function requirements, below) post-myeloablative therapy; patients who received stem cell reinfusion following non-myeloablative therapy are eligible once they meet peripheral blood count criteria below\r\n* Subjects with prior treatment with compound/s with the same mode of action used in one of the treatment groups are eligible if they have not previously received prior treatment with BOTH agents in the combination
Before study therapy, a minimum of 21 days must have elapsed since any prior chemotherapy and 2 weeks from the last dose of prior targeted or immunotherapy
Prior therapy\r\n* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n* Myelosuppressive chemotherapy: Patients must not have received myelosuppressive chemotherapy within 2 weeks of enrollment onto this study (6 weeks if prior nitrosourea)\r\n* Hematopoietic growth factors: At least 14 days must have elapsed after receiving pegfilgrastim and least 7 days must have elapsed since the completion of therapy with a non-pegylated growth factor\r\n* Biologic (anti-neoplastic agent): At least 7 days must have elapsed since completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur\r\n* Monoclonal antibodies: At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody\r\n* Radiotherapy: >= 2 weeks must have elapsed since local palliative external beam radiation therapy (XRT) (small port); >= 6 weeks must have elapsed since treatment with therapeutic doses of metaiodobenzylguanidine (MIBG); >= 3 months must have elapsed if prior craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if traumatic brain injury (TBI) was received; >= 6 weeks must have elapsed if other substantial bone marrow irradiation was given\r\n* Stem cell transplant or rescue without TBI: No evidence of active graft versus (vs.) host disease and >= 2 months must have elapsed since transplant
At least 14 days must have elapsed after receiving pegfilgrastim and least 7 days must have elapsed since the completion of therapy with a non-pegylated growth factor
A minimum of 3 weeks must have elapsed from last intake of prior standard chemotherapy treatment.
A minimum of 6 weeks must have elapsed from the last dose of nitrosoureas.
Myelosuppressive therapy- At least 14 days must have elapsed since the administration of previous therapy. Six weeks must have elapsed from the administration of nitrosureas or mitomycin C. For patients with ALL on maintenance therapy, they may be eligible if 7 days have elapsed and they are recovered from the toxic effects of the chemotherapy. This restriction does not include intrathecal chemotherapy, which is permitted.
Biologic agents- At least 14 days must have elapsed since the completion of therapy with a biologic agent such as a monoclonal antibody. Seven days must have elapsed since the last dose of retinoids
Patient has fully recovered from the acute toxic effects of chemotherapy, immunotherapy, or radiation therapy prior to entering this study:\r\n* Myelosuppressive chemotherapy: patient has not received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (4 and 6 weeks if prior temozolomide and nitrosourea, respectively)\r\n* Hematopoietic growth factors: at least 7 days must have elapsed since the completion of therapy with a growth factor; at least 14 days must have elapsed after receiving pegfilgrastim\r\n* Biologic (anti-neoplastic agent): at least 7 days must have elapsed since completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur\r\n* Monoclonal antibodies: at least three half-lives must have elapsed since prior therapy that included a monoclonal antibody\r\n* Radiation therapy: at least 3 months must have elapsed since any previous irradiation; unless measurable disease progression occurs at a site separate from the irradiated area and the patient has recovered from toxicities associated with radiation therapy
Patients receiving maintenance biologic therapy are eligible, provided their recurrence is documented more than 6 months from completion of primary cytotoxic chemotherapy (includes maintenance chemotherapy) and a minimum of 3 weeks has elapsed since their last infusion of biologic therapy at the start of protocol intervention, day 1
At least 2 weeks must have elapsed since the administration of previous therapy; six weeks must have elapsed since administration of nitrosoureas or mitomycin C; seven days must have elapsed since the administration of filgrastim (G-CSF) and/or sargramostim (GM-CSF)
At least 14 days must have elapsed since the completion of therapy with a biologic agent such as a monoclonal antibody; seven days must have elapsed since the last dose of retinoids
Prior therapy: >= 3 weeks should have elapsed since last cytotoxic therapy, immunotherapy or radiation therapy; more than one week should have elapsed since major surgery
Greater than or equal to 2 weeks must have elapsed for local palliative radiotherapy (re-irradiation for progressive disease or upfront radiation therapy [RT] at initial diagnosis) and enrollment on study for stratum II; at least 24 weeks must have elapsed if patient received craniospinal radiotherapy due to any other prior malignancies
Prior treatment with vorinostat is allowed but at least 3 weeks must have elapsed from the last dose and effects of prior therapy have resolved
Patients must have fully recovered from the acute toxic effects of chemotherapy, immunotherapy, surgery, or radiotherapy prior to entering this study:\r\n* Myelosuppressive chemotherapy: patient has not received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)\r\n* Hematopoietic growth factors: at least 7 days must have elapsed since the completion of therapy with a growth factor; at least 14 days must have elapsed after receiving pegfilgrastim\r\n* Biologic (anti-neoplastic agent): at least 7 days must have elapsed since completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur\r\n* Monoclonal antibodies: at least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody\r\n* Radiotherapy: at least 2 weeks must have elapsed since any irradiation; at least 6 weeks must have elapsed since craniospinal radiation therapy (RT) or substantial bone marrow irradiation
At least 2 weeks must have elapsed from any prior surgery
At least 2 weeks must have elapsed since the research participant received his/her last dose of prior chemotherapy or radiation
An interval of at least 12 weeks must have elapsed since the completion of initial radiation therapy
At least 2 weeks must have elapsed from any prior surgery
At least 2 weeks should have elapsed since any chemotherapy causing myelosuppression
At least 7 days should have elapsed since the completion of therapy with a biologic agent
Three-months should have elapsed in the case of completing radiation to any of the following fields: craniospinal, total abdominal, whole lung, total body irradiation); for all other sites of radiation, at least 2 weeks should have elapsed
Patients must have had no chemotherapy, biologic therapy, or radiation therapy for their malignancy for at least 30 days prior to treatment; patients may have received localized radiation therapy to non-target lesions provided that the radiotherapy is completed 14 days prior to commencing therapy, and the patient has recovered from any toxicity; at least 3 half-lives must have elapsed since monoclonal antibody treatment; at least six weeks must have elapsed between mitomycin C or nitrosourea treatment
Prior to start of treatment must be more than 21 days elapsed from surgery, radiation therapy, or prior chemotherapy; more than 42 days elapsed from prior immune therapy including vaccines
A minimum of 2 weeks elapsed off of antiandrogen therapy prior to start of study drug (i.e. flutamide, nilutamide, bicalutamide)
A minimum of 2 weeks elapsed off of sipuleucel-T and radiation therapy prior to start of study drug
At least 4 weeks for focal radiation therapy (RT) or >= 6 weeks for craniospinal RT must have elapsed prior to study entry
Prior therapy: at least 4 weeks should have elapsed since any biologic therapy, or immunotherapy; three weeks should have elapsed since last dose of chemotherapy or radiotherapy
Subjects must have had prior treatment with temozolomide; at least 28 days must have elapsed since completion of temozolomide or other chemotherapy
Prior Therapy: at least 2 weeks should have elapsed since any biologic therapy; three weeks should have elapsed since last dose of chemotherapy
INCLUSION CRITERIA FOR CCT: at least 2 weeks should have elapsed since any biologic therapy; three weeks should have elapsed since last dose of chemotherapy
At least 21 days must have elapsed from prior therapy (chemotherapy or radiation)
30 days must have elapsed since previous treatment of the brain tumor with any other agents
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n* Myelosuppressive anti-cancer therapy: must not have been received within 2 weeks of study entry (4 weeks if prior nitrosourea)\r\n* Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent\r\n* Radiation therapy (RT): >= 2 weeks for local palliative radiation therapy (RT) (small port); >= 6 weeks must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation\r\n* Surgery: >= 2 weeks from last major surgery, including pulmonary metastasectomy, with the exclusion of a central line placement and core needle or small open biopsies
Subjects under the age of 18 must have had prior therapy according to the best available therapy as determined by their primary brain tumor specialist (to include oncology, neurosurgery and/or radiation oncology) including systemic and/or cranial or spinal radiation or chemotherapy; subjects over the age of 18 may be enrolled as part of first-line treatment; those subjects who enroll as first-line treatment will not be restricted from traditional treatments in the future; at least 14 days must have elapsed since completion of cranial radiotherapy and 28 days since completion of chemotherapy; at least 28 days must have elapsed since completion of total spine radiotherapy
Patients must have fully recovered from the acute non-hematologic toxic effects of all prior anti-cancer therapy, defined as resolution of all such toxicities to =< grade 2 or lower per the inclusion/exclusion criteria prior to entering this study\r\n* Myelosuppressive chemotherapy:\r\n** No waiting period will be required for patients receiving standard \maintenance-like\ chemotherapy including oral mercaptopurine, weekly low-dose oral methotrexate, and intermittent vincristine; otherwise, at least 14 days must have elapsed since the completion of cytotoxic therapy, with the exceptions of hydroxyurea or corticosteroids used for cytoreduction\r\n** Intrathecal cytotoxic therapy: No waiting period is required for patients having received intrathecal cytarabine, methotrexate, and/or hydrocortisone; intrathecal chemotherapy given at the time of diagnostic lumbar puncture (LP) to evaluate for relapse prior to study enrollment is allowed\r\n* At least 7 days must have elapsed since the completion of therapy with a growth factor; at least 14 days must have elapsed after receiving pegfilgrastim\r\n* At least 7 days must have elapsed since completion of therapy with a biologic agent (including tyrosine kinase inhibitors); for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur\r\n* At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody with the exception of blinatumomab; patients must have been off blinatumomab infusion for at least 3 days and all drug related toxicity must have resolved to grade 2 or lower as outlined in the inclusion/exclusion criteria \r\n* >= 2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port); >= 3 months must have elapsed if prior cranial or craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if total-body irradiation (TBI) was received; >= 6 weeks must have elapsed if other substantial bone marrow irradiation was given\r\n* At least 90 days must have elapsed since stem cell transplant and at least 30 days from donor lymphocyte infusion; patient must have had no more than one previous HSCT and currently have no evidence of active graft versus (vs.) host disease (GVHD)\r\n* At least 30 days must have elapsed from the last chimeric antigen receptor (CAR)-T cell infusion
Patients must have had no chemotherapy, biologic therapy, or radiation therapy for their malignancy for at least 30 days prior to treatment; patients may have received localized radiation therapy to non-target lesions provided that the radiotherapy is completed 14 days prior to commencing therapy, and the patient has recovered from any toxicity; at least 3 half-lives must have elapsed since monoclonal antibody treatment; at least six weeks must have elapsed between mitomycin C or nitrosourea treatment
A minimum of 6 weeks must have elapsed after 131I-MIBG therapy prior to start of protocol therapy
Patients must have received standard treatment appropriate for their tumor type\r\n* Myelosuppressive chemotherapy: patients with solid tumors must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)\r\n* Hematopoietic growth factors: at least 14 days must have elapsed after receiving pegfilgrastim and least 7 days must have elapsed since the completion of therapy with a non-pegylated growth factor\r\n* Biologic (anti-neoplastic agent): at least 7 days must have elapsed since completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur\r\n* Monoclonal antibodies: at least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody\r\n* Radiotherapy: >= 2 weeks must have elapsed since local palliative external beam radiation therapy (XRT) (small port); >= 6 weeks must have elapsed since treatment with therapeutic doses of MIBG; >= 3 months must have elapsed if prior craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if total body irradiation (TBI) was received; >= 6 weeks must have elapsed if other substantial bone marrow irradiation was given\r\n* Stem cell transplant or rescue without TBI: no evidence of active graft vs. host disease and >= 2 months must have elapsed since transplant
Prior therapy:\r\n* The patient’s malignancy must have relapsed after or failed to respond to frontline curative therapy and/or there must not be any curative treatment options available at the time of study entry\r\n* There is no limit to the number of prior treatment regimens; however, patients must have fully recovered from the acute toxic effects of prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment; any grade 3 or 4 non-hematologic toxicity of any previous therapy must have resolved to grade 2 or less\r\n* Myelosuppressive chemotherapy: patients must not have received myelosuppressive chemotherapy within 3 weeks of enrollment (6 weeks if prior nitrosourea)\r\n* Hematopoietic growth factors: at least 7 days must have elapsed since the completion of therapy with a growth factor; at least 14 days must have elapsed after receiving pegfilgrastim\r\n* At least 7 days must have elapsed since the completion of therapy with a biologic agent, targeted agent, tyrosine kinase inhibitor or a metronomic non-myelosuppressive regimen\r\n* Monoclonal antibodies: at least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody\r\n* Radiotherapy: 3 weeks must have elapsed since external beam radiation therapy (XRT)
At least 4 weeks must have elapsed between the patient’s last chemotherapy or radiation treatment and the first vaccination
Regarding radiation therapy, time elapsed prior to first dose of lenalidomide:
Previous radiotherapy for palliation of recurrent disease is allowed if > 4 weeks have elapsed since completion of therapy; if radiation therapy was received exclusively for bony metastases the minimum interval between completion of radiation treatments and the first infusion of study drug is 7 days
Minimum of 14 days elapsed since the end of any prior therapy
? 28 days elapsed from the administration of any prior cytotoxic agents, except ? 14 days from vincristine, ? 21 days from procarbazine, and ? 42 days from nitrosureas
A minimum of 28 days must have elapsed from the day of surgery to first dose of the study drug. For core or needle biopsy, a minimum of 7 days must have elapsed prior to study entry
Patients must have recovered from acute toxicities from surgery, radiation or chemotherapy; at least 3 weeks will have elapsed since any prior therapy directed at the malignant tumor
At least 2 weeks must have elapsed from the use of any other endocrine therapy
At least 3 weeks must have elapsed from the use of any chemotherapy
At least 4 weeks must have elapsed since the patient received any radiation therapy.
At least 14 days must have elapsed since completion of myelosuppressive therapy
At least 7 days must have elapsed since the completion of therapy with a non-myelosuppressive biologic agent or retinoid
A minimum of 4 weeks must have elapsed since the completion of prior chemotherapy; hydroxyurea for control of blasts is not counted as chemotherapy, and may be given until initiation of therapy
Patients must have fully recovered from the acute effects of all prior therapy and must meet the following criteria:\r\n* At least 14 days must have elapsed since the completion of myelosuppressive therapy\r\n* At least 24 hours must have elapsed since the completion of low-dose chemotherapy, such as hydroxyurea or low-dose cytarabine (up to 200 mg/m^2/day)\r\n* For patients who have received prior HSCT, there can be no evidence of graft-versus-host disease (GVHD) and greater than 60 days must have elapsed since the HSCT; patients cannot be receiving therapy, including steroids, for the treatment or prevention of GVHD; all such medications must be discontinued at least 24 hours prior to enrollment
Immunomodulatory therapy: greater than 28 days must have elapsed since last dose of an immune modulating agent, including vaccine therapy
Before starting study treatment, all patients must have recovered from toxic effects of prior therapies; at least 2 weeks must have elapsed since any prior signaling pathway modulators, (e.g., epidermal growth factor receptor [EGFR], fibroblast growth factor receptor [FGFR], or other tyrosine kinase inhibitors), at least 3 weeks must have elapsed since temozolomide, 4 weeks must have elapsed since carboplatin or cisplatin, and at least 6 weeks from nitrosoureas (e.g., carmustine [BCNU], lomustine [CCNU]); in general, at least 4 weeks must have elapsed from any other anticancer therapy; prior anticancer therapies not encompassed above will be permitted at the discretion of the investigator
At least 4 weeks must have elapsed since the last surgery and 2 weeks must have elapsed since radiotherapy
At least 12 weeks must have elapsed from the use of strontium-89, radium-223 or any investigational or approved immunotherapy (e.g., Provenge) prior to starting study drug
At least 8 weeks must have elapsed from the use of strontium-89, radium-223, samarium-153, or immunotherapy (e.g., Provenge) prior to beginning protocol therapy
Radiation therapy: >= 12 weeks must have elapsed from craniospinal radiation; >= 2 weeks must have elapsed from focal radiation
A minimum of 2 weeks elapsed off of antiandrogen therapy prior to start of study drug (i.e. flutamide, nilutamide, bicalutamide)
A minimum of 4 weeks elapsed off of sipuleucel-T prior to start of study drug
Prior external beam radiation therapy (to less than 30% of the bone marrow only) is allowed; at least 28 days must have elapsed since the completion of radiation therapy and the patient must have recovered from side effects; prior treatment with samarium-153 or strontium-86 is allowed if at least eight weeks have elapsed since dosing, and all toxicities have resolved to grade 1; soft tissue disease which has been radiated in the prior 2 months is not assessable as measurable disease
At least 2 weeks must have elapsed from any prior surgery
Less than 3 weeks elapsed since prior exposure to chemotherapy
Patients may have had any number of prior therapies; at least 3 weeks must have elapsed since the last dose of systemic therapy; at least 6 weeks must have elapsed if the last regimen included BCNU or mitomycin C; at least 6 weeks must have elapsed if the last regimen included an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) antibody; patients must have experienced disease progression on their prior therapy in the opinion of the treating investigator
Two weeks must have elapsed since administration of previous chemotherapy
At least 2 weeks must have elapsed since the completion of therapy with a monoclonal antibody; seven days must have elapsed since the last dose of retinoids
A minimum of 2 weeks must have elapsed from completion of any prior chemotherapy or radiotherapy or surgery and the start date of study therapy
14 days must have elapsed since the completion of myelosuppressive therapy; individuals may have received any of the following medications within 14 days without a “wash-out” period:\r\n* Hydroxyurea\r\n* Intrathecal chemotherapy with methotrexate, hydrocortisone and/or cytarabine
At least 6 weeks must have elapsed since administration of nitrosureas.
At least 12 weeks must have elapsed since administration of craniospinal or hemipelvic radiation.
At least 2 weeks must have elapsed from any prior surgery
At least 4 weeks must have elapsed from last dose of prior anti-cancer therapy and the initiation of study therapy
A minimum of 4 weeks must have elapsed since the administration of all other investigational agents
No more than 12 weeks must have elapsed from hysterectomy.
At least 2 weeks must have elapsed since the last anti-leukemia treatment (with the exception of hydroxyurea) before first dose in this study.
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n* Myelosuppressive chemotherapy: must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea)\r\n* Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent\r\n* Radiation therapy (RT): >= 2 weeks for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation\r\n* Monoclonal antibodies: must not have received any monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks, prior to study enrollment
Patient has fully recovered from the acute effects of all prior therapy and must meet the following criteria\r\n* At least 14 days must have elapsed since the completion of myelosuppressive therapy\r\n* At least 24 hours must have elapsed since the completion of low-dose of low-dose or non-myelosuppressive therapy, such as hydroxyurea or low-dose cytarabine (up to 200 mg/m^2/day)\r\n* At least 30 days must have elapsed since the use of investigational agents\r\n* For patients who have received prior HSCT, there can be no evidence of GVHD and greater than 60 days must have elapsed since the HSCT; patients cannot be receiving therapy, including steroids, for GVHD; all such medications must be discontinued at least 72 hours prior to enrollment
Participant must have recovered from the acute side effects of all prior anti-cancer therapy, and:\r\n* At least 2 weeks have elapsed since prior systemic cytotoxic chemotherapy (except intrathecal chemotherapy, and/or low dose maintenance therapy such as vincristine, mercaptopurine, methotrexate or glucocorticoids), and\r\n* At least 4 weeks have elapsed since treatment with an investigational agent or antibody-based therapy, if applicable, and\r\n* If the participant received a prior allogeneic hematopoietic stem cell transplant (HSCT), at least 3 months have elapsed and there is no evidence of active graft-versus-host disease (GVHD), participant has discontinued immunosuppression, and there is no history of veno-occlusive disease
Radiotherapy: At least 28 days must have elapsed since and radiation therapy.
Participant must have recovered from the acute side effects of all prior anti-cancer therapy, and:\r\n* At least 2 weeks have elapsed since prior systemic cytotoxic chemotherapy (except intrathecal chemotherapy, hydroxyurea, low-dose cytarabine, and/or low dose maintenance therapy such as vincristine, mercaptopurine, methotrexate or glucocorticoids), and\r\n* If the participant received a prior allogeneic HSCT, at least 30 days have elapsed and there is no evidence of clinically significant graft versus host disease requiring treatment and/or have > grade 2 persistent non-hematologic toxicity related to a transplant
14 days must have elapsed since the completion of cytotoxic therapy
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n* Myelosuppressive chemotherapy: must not have received within 2 weeks of entry onto this study (6 weeks if prior nitrosourea)\r\n* Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent\r\n* Bisphosphonates: at least 4 weeks since the completion of therapy with a bisphosphonate\r\n* Monoclonal antibodies: at least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody\r\n* Radiation therapy (RT): >= 2 weeks (wks) for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation
Minimum of 21 days have elapsed since prior major surgery, with recovery from any adverse events.
Minimum of 14 days have elapsed since any prior radiation therapy, with recovery from any adverse events.
A minimum of 6 weeks must have elapsed after 131I-MIBG therapy prior to start of protocol therapy.
Patients must have recovered from the effects of surgery and a minimum of 14 days must have elapsed from the day of surgery to the day of registration; for core or needle biopsy, a minimum of 7 days must have elapsed prior to registration
More than four weeks must have elapsed since any prior radiation therapy
At least 6 weeks must have elapsed since prior systemic mitomycin C
At least 8 weeks must have elapsed since any dose of Strontium-89
At least 4 weeks must have elapsed since prior Sm-153 lexidronam (Quadramet™)
At least 4 weeks must have elapsed since prior radiotherapy
Patients may have had any number of prior therapies, but cannot have previously been treated with a somatostatin analogue or an mechanistic target of rapamycin (mTOR) inhibitor; at least 3 weeks must have elapsed since the last dose of systemic therapy; at least 6 weeks must have elapsed if the last regimen included carmustine (BCNU) or mitomycin C; at least 3 months must have elapsed if the last regimen included an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) antibody; if the last regimen included an anti-CTLA4 antibody, radiographic disease progression since this therapy must be documented
A sufficient interval must have elapsed between the last dose of prior anti-cancer therapy (including cytotoxic and biological therapies and major surgery) and enrollment in this study, to allow the effects of prior therapy to have abated:
At least 3 weeks should have elapsed since the last cycle of cytotoxic therapy or since the last dose of radiation therapy, at least 4 weeks must have elapsed since the patient has received any investigational therapy or antibodies, and at least 7 days since the last dose of biologics (i.e. rapamycin or sorafenib), and patients should have recovered from toxic side effects of previous therapy to a grade 1 or less, with the exception of the following:\r\n* Hematological toxicity: recovered to levels required above\r\n* Low electrolyte levels (such individuals should receive appropriate supplementation)\r\n* For patients on anticoagulant therapy or with pre-existing coagulation abnormalities, PT and partial thromboplastin time (PTT) must return to baseline\r\n* Liver function tests must resolve to values required above\r\n* Grade 3 hypoalbuminemia\r\n* Alopecia\r\n* Sterility
COHORT A SPECIFIC INCLUSION: At least 12 weeks elapsed since prior radiotherapy
Before starting study treatment, patients must have recovered from toxic effects of prior therapies (except for residual alopecia or grade 2 peripheral neuropathy) and at least 3 weeks must have elapsed since any prior signaling pathway modulators, (e.g., EGFR, FGFR, or other tyrosine kinase inhibitors), at least 3 weeks must have elapsed since temozolomide, 4 weeks must have elapsed since carboplatin or cisplatin, and at least 6 weeks from nitrosoureas (e.g., carmustine [BCNU], lomustine [CCNU]); in general, at least 4 weeks must have elapsed from any other anticancer therapy (e.g. bevacizumab)
Patients must have had sufficient time between a prior therapy and resolution of toxicities from the prior therapies prior to registration as follows:\r\n* Prior EGFR inhibitor: A minimum of 7 days must have elapsed from the last dose of the prior EGFR inhibitor and resolution of any drug-related toxicity to =< grade 1 except for alopecia\r\n* Chemotherapy: A minimum of 21 days must have elapsed from the last dose and resolution of toxicity to =< grade 1 excluding =< grade 2 peripheral neuropathy or alopecia\r\n* Surgery: A minimum of 21 days must have elapsed following major surgery and resolution of toxicity to < grade 1 and complete wound healing must have occurred\r\n* Radiation: A minimum of 14 days must have elapsed following radiation therapy and resolution of all radiation induced toxicity excluding alopecia\r\n* Treatment with an investigational drug: A minimum of 3 months or five half-lives of the compound, whichever is greater, must have elapsed from last treatment date
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n* Myelosuppressive chemotherapy: must not have received within 3 weeks of entry onto this study\r\n* Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent\r\n* Immunotherapies: at least 42 days must have elapsed since a prior therapy that included a monoclonal antibody or any other type of immunotherapy (e.g. chimeric antigen receptor [CAR] T cell therapy)\r\n* Radiation therapy (RT): >= 2 weeks for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of the pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation
Participants must have histologically confirmed solid tumor malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; participants with uncontrolled Kaposi sarcoma are permitted (KS must be increasing despite HAART and HIV suppression for greater than or equal to 2 months, or stable KS despite HAART for greater than or equal to 3 months)\r\n* For participants in the 24 participant solid tumor cohort, only those histologies not known to respond to single agent nivolumab (such as pancreas, prostate, and microsatellite stable [MSS] colorectal cancer) will be excluded\r\n* For participants in the relapsed refractory HIV-cHL expansion cohort, participants must have histologically confirmed, relapsed/refractory (defined as relapsed/refractory to one or greater lines of therapy) HIV-associated classical Hodgkin lymphoma
Participants are required to be on antiretroviral regimens that are in accordance with the current International Acquired Immune Deficiency Syndrome (AIDS) Society guidelines concurrently with chemotherapy; the specific agents are at the discretion of the investigator and the use of investigational agents currently available on an expanded access basis is allowed; use of experimental antiretroviral agents or those containing zidovudine (including Combivir and Trizivir) or ritonavir (includes Norvir or Kaletra), cobicistat, didanosine (Videx or Videx EC), or similar potent cytochrome P450 (CYP)3 inhibitors are prohibited; in order to be eligible, participants taking zidovudine or ritonavir, or cobicistat, didanosine, or other CYP3 inhibitors must change to a different regimen 7 days prior to therapy initiation; changes to HAART therapy during the study may be made if medically necessary (toxicity, failure of regimen, etc.); participants must be on HAART at least 7 days prior to therapy
Radical or partial nephrectomy with lymphadenectomy in select participants
Eligible participants will be asked to sign a separate consent form for this optional study at the time they are enrolling on SJMB12; participants will then be randomly assigned to either the standard-of-care control group or the exercise intervention group
Eligible participants will be asked to sign a separate consent form for this optional study; participants will then be randomly assigned to either the standard-of-care control group or the Cogmed computerized intervention group
All participants must have screening prior to enrollment; participants whose results indicate that they are carrier of hepatitis B can still be treated per group B and C but will NOT receive rituximab
Participants known to be HIV positive (for therapeutic part of protocol, HIV participants are eligible for biology studies)
For participants in Part 2:
Participants cannot have received more than two prior regimens Specifically for participants in Arm B:
Female participants must not be pregnant, breastfeeding or considering becoming pregnant during the study or for at least 5 or 6 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.
Male participants must not be considering fathering a child or donating sperm during the study or for at least 3 or 6 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.
Male participants who are considering fathering a child or donating sperm during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.
Serum bilirubin =< 2.5 times ULN except for participants who are on atazanavir or indinavir, provided that the participant’s direct bilirubin is within normal institutional limits
Participants may not have been treated intratumorally with polyICLC.
For Parts A, B, and C, eligibility of participants who require blood transfusion before and after the start of the study treatment should be discussed by the Sponsor and investigator
Participants with prior Hepatitis B or C are eligible on the condition that participants have adequate liver function as defined by Inclusion Criterion number 16 and Exclusion Criterion number 5
Participants must be willing to undergo a research biopsy at baseline and at cycle 2 day 1 if extracranial metastases are safely accessible. Participants for whom biopsies cannot be safely performed must be willing to submit an archival primary and/or metastatic specimen. The biopsies may be waived with prior principal investigator (PI) approval for the first 6 participants enrolled to the safety run in phase
Participants =< 12-15 years Lansky 100-70%
Participants with symptomatic hyperviscosity or serum IgM > 5,000 mg/dL to undergo plasmapheresis prior to treatment initiation
Participants who have undergone a pneumonectomy due to known potential for pulmonary toxicities and heightened risk for complications
For participants treated with prior neoadjuvant chemotherapy: tumor stage of ypT2-4a or ypN+ (ypT2-4 or ypN+ for participants with upper urinary tract UC) and M0
For participants who have not received prior neoadjuvant chemotherapy: tumor stage of pT3-4a or pN+ (pT3-4 or pN+ for participants with upper urinary tract UC) and M0
Participating participants MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications, when clinically indicated and should be under the care of a physician experienced in HIV management; participants will be eligible regardless of antiretroviral medication (including no antiretroviral medication) provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 8 weeks following study entry; as study-specific (antiretroviral-based) strata fill, however, only participants who are receiving the therapies eligible for the remaining open strata will be accrued
Participants with relapsed primary malignancy, or who have been treated for relapse after the alloSCT was performed
Participants with neuroblastoma with only metaiodobenzylguanidine (MIBG)-positive evaluable disease may be enrolled
Participants must have operable breast cancer, with tumors greater than or equal to 2 cm in size; participants must not have any evidence of metastatic disease
Study participants will be women who have gone through a bi-lateral oophorectomy procedure
Participants who are azoospermic males are exempt from contraceptive requirements
Participants must not have a known additional malignancy that could confuse analysis of on-study treatment; inclusion of all study participants with more than one malignancy must be discussed and approved by the principal investigator (PI)
COHORT II ONLY: Participants are ineligible for ruxolitinib – do not have splenomegaly or symptoms of myelofibrosis as defined by the MPN-SAF. Or participants failed ruxolitinib as defined by loss of response to therapy and no allergy to ruxolitinib in the past
Research participants being treated for severe infection or who are recovering from major surgery are ineligible until recovery is deemed complete by the investigator
Research participants with any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
Participants with chronic autoimmune diseases
Participants must have had prior therapy
Participants must agree to undergo a research biopsy, if tumor is safely accessible, at baseline and within 14 days prior to course 3 day 1 (C3D1); participants for whom newly-obtained samples cannot be provided (e.g. inaccessible or participant safety concern) may submit an archived specimen\r\n* Note: After the first 6 participants undergo biopsy on cabozantinib, we will review their adverse event profiles to ensure no more than a 20% rate of grade 3 or higher bleeding or wound healing complications occur; if more than 2 patients (> 20%) have safety concerns, we will reassess the safety of collecting the research biopsies; full review of all grade (including grade 1 and 2) may also prompt changes and will be reviewed by the study team; Exelixis may be consulted if necessary
Participants may have received 0-3 prior chemotherapeutic regimens for metastatic breast cancer and must have been off treatment with chemotherapy for at least 14 days prior to registration; participants should also be adequately recovered from acute toxicities of prior treatment
Participants that cannot take alternate medications will be excluded from this study
Participants may have had any extent of prior surgery and/or chemotherapy
Western Safety Cohort Only: Participants with Japanese heredity.
Male or female study participants with sickle cell disease
All participants will undergo standard written informed consent procedures as dictated by the City of Hope Human Research Protections Office prior to performing any screening procedures that are not part of standard-of-care; informed consent will be obtained by the principal investigator, collaborating investigators, or other Institutional Review Board (IRB) designated personnel who will meet the training requirements established by the IRB; with the support of research personnel, he/she will explain the nature, duration, purpose of the study, potential risks, alternatives and potential benefits, and all other information contained in the informed consent document; in addition, they will review the experimental subject's bill of rights and the Health Insurance Portability and Accountability Act (HIPAA) research authorization form; prospective research participants will be informed that they may withdraw from the study at any time and for any reason without prejudice; prospective research participants will be afforded sufficient time to consider whether or not to participate in the research
Participants with treated brain metastases are allowed; radiation must be completed at least 2 weeks prior to pembrolizumab dosing and participants must not require ongoing steroids; participants with untreated brain metastases that are all < 5 mm with no clinical symptoms or vasogenic edema may be allowed on study on a case-by-case basis on discussion with sponsor; these participants will require MRI monitoring every 6 weeks to ensure stability
Previously treated with ixazomib (excluding comparator or placebo participants not on current treatment with ixazomib) in a Millennium-sponsored study. Participants will be eligible to enter the rollover study when:
Participants must not have an invasive infection at time of protocol entry
For Part 2 and Part 3 of the study, participants with R/R FL, MZL/MALT, MCL, or any other NHL subtypes according to the WHO classification.
Relapsed or refractory solid tumor malignancy that has progressed on standard anticancer therapy with no available curative options. (Note: Osteosarcoma participants must be in first or subsequent relapse [greater than or equal to first relapse]). Only the osteosarcoma participants enrolled to Cohorts 3A and 3B must be deemed candidates for ifosfamide and etoposide chemotherapy).
Research participants with presence of other active malignancy; however, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible; any history of myelodysplasia is excluded
Research participants being treated for severe infection or who are recovering from major surgery are ineligible until recovery is deemed complete by the investigator
Research participants with any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
All research participants must have the ability to understand and willingness to sign a written informed consent or age appropriate assent for pediatric patients\r\n* Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed
Research participants with presence of other active malignancy; However, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible
Research participants who received memory-enriched CD19R(EQ):CD28:zeta/EGFRt+ on IRB#13277
Research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of screening; research participants with any signs of symptoms of active infection, positive blood cultures or radiological evidence of infections
Research participants with presence of other active malignancy; however, research participants with history of prior malignancy treated within 2 years with curative intent and in a complete remission are eligible
Research participants with confirmed 1st or higher relapse of disease by morphology, cytogenetics or molecular, or research participants with refractory or residual disease
All research participants must have the ability to understand and the willingness to sign a written informed consent\r\n* Note: For research participants who do not speak English, a short form consent may be used with a COH certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent in processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed
Research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) positive based on testing performed within 4 weeks of enrollment; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
Research participants with presence of other active malignancy; however, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible
Participants must not have an invasive infection at time of protocol entry
Participants in Part E must have melanoma of any subtype.
For HER2+ breast cancer participants in parts A, C, and F: participants may receive concurrent treatment (ongoing or initiated simultaneously with abemaciclib) with IV trastuzumab.
Inclusion Criteria:\n\n - Study Participants must be 18 years or older.\n\n - Study Participants must have 2 sites of cutaneous metastatic melanoma that can not be\n removed with surgery.\n\n - Study Participants may have been previously treated with chemotherapy or immunotherapy\n but not with in 4 weeks of first dose of study treatment.
Participants must be currently participating in a PCI-32765 clinical study considered completed and have received at least 6 months of treatment with PCI-32765.
At study entry, participants must be actively receiving treatment with single-agent PCI-32765 or participants must have participated in a PCI-32765 randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior PCI-32765 treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments
Participants with a history of cranial nerve palsy
Specifically, for participants in Cohorts A1 and A2: Age greater than or equal to (>=) 18 years, disease progression or failure to achieve complete or partial response after intensive cytotoxic therapy, participants cannot have received more than two prior intensive regimens (e.g., induction + consolidation and one salvage therapy + consolidation)
Participants who have received prior chest radiation are excluded
Participants who have received any chemotherapy or radiotherapy for previous malignancy are not eligible; participants who have ever previously received any anti-neoplastic agent, including methotrexate, 6-mercaptopurine, 6-thioguanine, vincristine cyclophosphamide, cytarabine (except for IT cytarabine), or any anthracycline, for any reason (e.g., rheumatologic or autoimmune condition) are not eligible
Participants must have adequate organ function including:\n\n 1. Bone Marrow Reserve:\n\n 1. Absolute neutrophil count (ANC) ? 1.5x10^9/L prior to treatment.\n Participants on maintenance doses of granulocyte colony stimulating factor\n (G-CSF) are eligible.\n\n 2. Platelets ? 100x10^9/L\n\n 3. Hemoglobin ? 9 g/dL\n\n 4. Use of supportive care measures (eg, use of white blood cell [WBC] growth\n factors, antiemetics, epoetin) should follow the ASCO guidelines as listed\n at www.asco.org. Participants should receive full supportive care,\n including transfusion of blood as mandated by clinical need; however,\n transfusions administered for the sole purpose of meeting the study\n inclusion criteria between the time informed consent is signed and first\n dose of EC145/placebo/PLD is administered are not allowed.\n\n 2. Hepatic: Total bilirubin level < 1.5 x ULN and ALT, AST, GGT, and alkaline\n phosphatase levels < 2.5 x ULN.\n\n 3. Renal: Serum creatinine level ? 1.5 x ULN or for participants with serum\n creatinine levels above 1.5 x ULN, creatinine clearance ? 50 mL/min/1.73m^2\n\n 4. Cardiac: Left ventricular ejection fraction (LVEF) equal to or greater than the\n institutional lower limit of normal.
All Participants:
Participants who are newly diagnosed and not considered for high-dose chemotherapy due to: being age >=65 years; or participants less than (<) 65 years with presence of important comorbid condition(s) likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation. Sponsor review and approval of participants below 65 years of age is required before randomization
For Part E: Participants must have adenoid cystic carcinoma (ACC).
For Part F dose confirmation: Participants must have leiomyosarcoma and prescreened alterations in a defined pathway.
Measurable disease per RECIST v1.1 for participants with solid malignancies. Disease-specific criteria for participants with prostate cancer, glioblastoma multiforme (GBM), malignant lymphoma, or multiple myeloma
Have a histologically confirmed diagnosis of STS for which olaratumab and doxorubicin would be appropriate therapy. Participants with a diagnosis of Grade 1 liposarcoma are eligible if there is histological or radiographic evidence of evolution to more aggressive disease. Participants with Kaposi's sarcoma and gastrointestinal stromal tumors (GIST) will be excluded. Participants must have potentially resectable disease (as assessed by the study investigator) and have a primary tumor lesion deemed amenable to serial biopsy.
Has had encephalopathy in the last 6 months. Participants on rifaximin or lactulose to control their encephalopathy are not allowed
For CMML participants: WBC count <20,000/mcL before administration of the first dose of study drug on Cycle 1 Day 1; participants must have been off hydroxyurea for at least 1 week prior to WBC count assessment.
Participants with intracardiac defibrillators.
Recipient of any drug with potential QT interval prolonging effects within 14 days prior to the first dose for all participants and while on treatment through the end of the study for crizotinib-treated participants only
Participants must have stopped any hormonal therapy at least 1 week prior to treatment with nivolumab and bevacizumab; participants may continue on hormone replacement therapy administered for post-menopausal symptoms
Willing to use acceptable contraceptive measures as defined by the protocol during and at least for 6 months (male participants) or 12 months (female participants) after the last dose of study drug
Male participants, even if surgically sterilized (ie, status postvasectomy), who:
Research participants with any uncontrolled illness including ongoing or active infections; research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) positive based on testing performed within 4 weeks of enrollment; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
Research participants with presence of other active malignancy; however, research participants with history of prior malignancy treated with curative intent in complete remission are eligible
Warfarin use is excluded; other anticoagulants are permitted, but for participants enrolled in the RP2D cohort, the investigator must deem it safe to temporarily hold to facilitate pre and on-treatment tumor biopsies; participants where this is not feasible are excluded from participation
Participants who are >= 18 years of age or Legally Authorized Representative (LAR) of participants who are younger than 18 years must sign an informed consent for the Pediatric Oncology Branch (POB) Screening Protocol (01-C-0157: Eligibility Screening and Tissue Procurement for the National Cancer Institute [NCI], Pediatric Oncology Branch [POB] Clinical Research Protocols) prior to participating in studies required to determine eligibility for this trial; after confirmation of eligibility, participants who are >= 18 years of age or LAR of minor participants must sign an informed consent document for this trial, indicating that they are aware of the investigational nature of the proposed treatment, the risks and benefits of participating and the alternatives to participating, prior to the conduct of any study procedures
Participants must use effective birth control throughout study until at least 30 days after study treatment or 1 year after rituximab treatment, whichever is later; female participants must not be pregnant or breast-feeding
Phase 1b: Participants with AML who are refractory to or have relapsed after initial treatment for their disease, with no more than three prior lines of therapy. Participants who have received prior treatment with cytarabine or decitabine are not excluded.
Participants who have had or are planning to have the following invasive procedures
Participants may have had any number of previous hormonal therapies (antiandrogens, steroids, estrogens, finasteride, dutasteride, ketoconazole, abiraterone) provided these were discontinued >= 4 weeks before enrollment; participants on prednisone 10 mg daily or another equivalent steroid dose are eligible; participants on inhaled steroid are eligible
Participants must have had a diagnosis of symptomatic multiple myeloma (MM), MM + amyloidosis, or POEMS (osteosclerotic myeloma: polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) requiring treatment; participants with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy; note that study participants do not need to have active disease at the time of study entry, as participants may have received up to 12 months of prior chemotherapy, which might have induced a response
Participants must have received =< 12 months of prior chemotherapy for this disease without evidence of progressive disease with treatment; participants may have received prior radiotherapy provided approval has been obtained from the principal investigator (PI); participants with a history of radiation who have a platelet count < 150,000 due to radiation (disease, chemo, and other factors have been ruled out) will be excluded from this study
Participants who have undergone allogenic stem cell transplant are ineligible unless they meet the following criteria, a) participants who are off all immunosuppressive therapy, b) participants who have no signs and/or symptoms of acute or chronic graft versus host disease, or c) participants must have appropriate hematology counts
For Cohort 3, participants must have WHO grade II astrocytoma, oligoastrocytoma or oligodendroglioma that is histologically confirmed either by the previous biopsy or resection, or at the time of re-operation (re-operation before entry to the current study is allowed; however participants must be off post-surgery dexamethasone for at least 4 weeks before administration of the first vaccine)
Participants with relapsed and/or refractory multiple myeloma (RRMM) who had received 1 to 3 prior therapies. NOTE: population included the following 3 categories of participants:
Must have also adhered to the guidelines of the RevAssist program (US participants), RevAid program (Canadian participants), iAccess program (Australian participants), RevMate program (Japanese participants) or The Lenalidomide Pregnancy Risk Minimisation Plan as outlined in the study Manual (all other participants who were not using commercial supplies)
Participants may have received prior hydroxyurea but may not be currently being treated with hydroxyurea at the time of study initiation
Participants who have an indwelling draining IP catheter (to be drained only under medical supervision)
Inclusion Criteria -\n\n 1. Between the ages of greater or equal to (?) 6 months and less than (<) 18 years of age\n\n 2. Must have histologically proven B-cell acute lymphoblastic leukemia (ALL) or B-cell\n lymphoblastic lymphoma with marrow involvement\n\n 3. All participants (both ALL and participants with lymphoblastic lymphoma) must have M2\n or M3 bone marrow classification\n\n 4. Disease status: a) Participants must have relapsed or refractory disease b) In the\n event of relapse after prior allogeneic hematopoietic stem cell transplant (HSCT),\n participants must be at least 3 months post-transplant and have no evidence of active\n graft-vs-host disease, and must have been off immunosuppression for at least 4 weeks,\n c) Must have resolution of the acute toxic effects to less than or equal to (?) Grade\n 2 from prior chemotherapy before entry, in the opinion of the investigator\n\n 5. Participants with the following central nervous system (CNS) 1 or 2 status are\n eligible only in the absence of neurologic symptoms\n\n 6. Female participants of childbearing potential and post-pubertal male participants must\n use an approved method of contraception for the study.\n\n Exclusion Criteria\n\n 1. Concurrent enrollment in another clinical study for cancer treatment, unless the\n subject is in the follow-up period from a previous study.\n\n 2. Isolated testicular or CNS ALL\n\n 3. Participants with mixed-lineage leukemia (MLL) gene rearrangement\n\n 4. Inadequate Hepatic function\n\n 5. Inadequate Renal function\n\n 6. Radiologically-detected CNS lymphoma\n\n 7. Participants with clear laboratory or clinical evidence of disseminated intravascular\n coagulation (DIC)\n\n 8. Hyperleukocytosis or rapidly progressive disease that would compromise ability to\n complete study therapy\n\n 9. QT interval corrected using Fridericia's formula (QTcF) greater than or equal to a\n Grade 2, confirmed by 2 additional seperate electrocardiographs (ECG's) within 28 days\n prior to starting study drug. The initial screening ECG need not be repeated for\n confirmation if the QTcF interval is <481 milliseconds.\n\n 10. Pregnant or breast-feeding females\n\n 11. Prior treatment with CAT-3888 (BL22), moxetumomab pasudotox, or any\n pseudomonas-exotoxin-containing compound\n\n 12. Prior treatment with any anticancer biologic therapy within 2 weeks prior to starting\n study drug, including but not limited to therapeutic monoclonal antibodies or\n antibody-drug conjugates\n\n 13. Systemic chemotherapy ? 2 weeks (6 weeks for nitrosoureas) and radiation therapy ? 3\n weeks prior to starting study drug\n\n 14. Clinically significant ophthalmologic findings (evidence of retinal damage or injury)\n during the screening\n\n 15. Presence of a second invasive malignancy\n\n 16. Uncontrolled pulmonary infection, presence of pulmonary edema\n\n 17. Serum albumin < 2 gram per deciliter (g/dL). Albumin infusions for correction of\n hypoalbuminemia are allowed, but cannot have administered within 7 days prior to start\n of study drug\n\n 18. Radioimmunotherapy within 2 years prior to study start of study drug\n\n 19. Participants with prior history of thrombotic microangiopathy or hemolytic uremic\n syndrome (HUS)\n\n 20. T-cell ALL or T-cell lymphoblastic lymphoma\n\n 21. Participants currently receiving high-dose estrogen therapy defined as >0.625\n milligram per day (mg/day) of an estrogen compound or within 2 weeks prior to starting\n study drug.
Participants for whom front-line cytotoxic therapy is indicated (i.e., symptomatic visceral or pulmonary KS or symptomatic KS impairing functional status); all participants must have a chest X-ray to rule out pulmonary KS within 28 days of study enrollment
Participants MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications, when clinically indicated and should be under the care of a physician experienced in HIV management; participants will be eligible regardless of antiretroviral medication (including no antiretroviral medication) provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 8 weeks following study entry; as study-specific (antiretroviral-based) strata fill, however, only participants who are receiving the therapies eligible for the remaining open strata will be accrued
Participants must have recurrent or refractory disease after receiving at least one prior platinum-containing chemotherapy regimen, or standard therapy is refused or not suitable. For participants in Canada: participants should also not be suitable for treatment with topotecan hydrochloride
Participants with untreated central nervous system metastases, or history of previously treated disease. Participants must have stable hematological parameters, satisfying eligibility, platelet count must be stable for >=2 weeks prior to study drug administration
Participants with evidence of electrolyte imbalance
Participants who have failed at least one line of systemic therapy for advanced stage HCC or participants who are ineligible or unable to tolerate the standard of care treatment.
Participants who received prior treatment with a hypomethylating agent
Male participants, even if surgically sterilized (ie, status postvasectomy), who:
Participants with stable enhancement/edema are eligible if they require corticosteroids to control symptoms
Male participants, even if surgically sterilized (that is, status postvasectomy), who:
Participants who are willing to refrain from donating blood for at least 90 days after their final dose of MLN4924 and (for male participants) willing to refrain from donating semen for at least 4 months after their final dose of MLN4924.
Participants with a cardiac pacer whose heart rate is set at a fixed rate and participants on concomitant medication that may limit increase in heart rate in response to hypotension (example, high-dose beta blocker).
Donor-specific antibodies (DSA) will be assessed by the local laboratory 30 days or less prior to transplant using solid phase micro particle technology (by Luminex phenotype panel or Luminex single antigen bead test); the following criteria apply:\r\n* Participants without detectable DSA will be deemed eligible if they meet other entry criteria\r\n* Participants with detectable DSA and a positive flow cytometric crossmatch may undergo de-sensitization per standard of care if they are cytotoxic crossmatch negative; such participants must demonstrate a negative flow cytometric crossmatch by day -9 in order to receive the first dose of study therapy (ATG); participants who do not demonstrate an acceptable response to de-sensitization by day -9 will be considered screen failures and will be terminated from the study\r\n* Participants with a positive cytotoxicity crossmatch will be excluded
All participants must demonstrate a negative QuantiFERON (QFT) assay result within 52 weeks of transplant regardless of purified protein derivative (PPD) status; participants with a positive QFT assay must complete treatment for latent tuberculosis (TB) and have a negative chest x-ray; QFT testing done within 52 weeks before transplant is acceptable as long as there is documentation of the results; prior recipients of a bacillus calmette-guerin (BCG) vaccination are not exempt
Participants must have relapsed or progressed after at least 1 prior course of anti-lymphoma therapy
PART II: Oncology participants must have histologically or cytologically diagnosed malignancy; ideally the subject has completed treatment within 6 months to a year and cancer is stable
Participants must be ?18 years since no dosing or adverse event data are currently available on the use of OGX-427 in participants <18 years of age.
Participants with evidence of electrolyte imbalance greater than or equal to (>/=) Grade 2 which cannot be corrected prior to study initiation
Inclusion criteria:\n\n Phase 1 Part (dose escalation): Participants with a histologically confirmed solid tumor\n including tumors of the central nervous system that was recurrent or refractory and for\n which no further effective standard treatment was available. All participants must had\n measurable disease. Participants with diffuse pontine glioma were eligible without a biopsy\n after evidence of progressive disease post radiation therapy.\n\n Phase 2 Part (safety and activity): Participants with recurrent or refractory high grade\n glioma or diffuse intrinsic pontine glioma for whom no further effective therapy was\n available. All participants must had measurable disease. Participants with diffuse pontine\n glioma were eligible without a biopsy after evidence of progressive disease post radiation\n therapy. Participants with a grade III or grade IV glioma must had pathologic confirmation\n either at the time of initial diagnosis or at the time of recurrence.\n\n Participants aged ?2 years and ?18 years\n\n Participants met the body surface area (BSA) requirements to be eligible:\n\n 1. Minimal BSA requirements for a particular dose level;\n\n 2. During the Phase 1 part participants must had a BSA <2.1 m² at the time of enrollment\n\n 3. During the Phase 2 part participants with a BSA ?2.1 m² were eligible, however the\n actual dose of cabazitaxel for these participants were adjusted to a maximum dose\n calculated with (capped at) the BSA of 2.1 m²\n\n Performance status by:\n\n 1. Lansky score ?60 (participants ?10 years of age)\n\n 2. Karnofsky score ?60% (participants >10 years of age) Participants who were unable to\n walk because of paralysis, but who were mobile in a wheelchair, were considered\n ambulatory for the purpose of assessing the performance score.\n\n Participants must had adequate liver, renal and marrow function as defined below:\n\n 1. Total bilirubin ?1.0 x the upper limit of normal (ULN) for age\n\n 2. AST (SGOT) and ALT (SGPT) ?2.5 x ULN\n\n 3. Serum creatinine ?1.5 x ULN for age or creatinine clearance ?60 mL/min/1.73 m²\n\n 4. Absolute neutrophil count ?1.0x10^9 /L\n\n 5. Platelets ?75x10^9/L (transfusion independent)\n\n 6. Hemoglobin ?8.0 g/dL (could be transfused)\n\n Female participants of child-bearing potential must had a negative pregnancy test ?7 days\n before starting cabazitaxel treatment.\n\n Male and female participants of reproductive potential must agreed to use adequate\n contraception prior to study entry, for the duration of study participation and for 6\n months following the last dose of cabazitaxel.\n\n Written informed consent/assent prior to any study-specific procedures. Consent must be\n obtained from the participant and/or parent(s) or legal guardian(s) and the signature of at\n least one parent or guardian was required. Investigators also obtained assent of\n participants according to local, regional or national guidelines.\n\n Participants must have recovered from the acute toxic effects of all prior therapy to ?\n grade 1 before entering the study.\n\n Exclusion criteria:\n\n Prior treatment within the following timeframes:\n\n 1. Systemic anti-cancer treatment within 3 weeks (6 weeks for nitrosourea, mitomycin and\n monoclonal antibodies including bevacizumab)\n\n 2. Surgery or smaller field radiation therapy within 4 weeks\n\n 3. Treatment with an investigational agent within 4 weeks or within 5 half-lives of the\n agent, whichever was longer Craniospinal or other large field radiation therapy\n (defined as >25% of bone marrow irradiated) within 6 months prior to the first dose.\n\n Prior systemic radioisotope therapy (this did not include diagnostic imaging or\n radioimmunoconjugates lacking myelosuppressive properties) or total body irradiation.\n\n Prior bone marrow or stem cell transplant\n\n Participants with any clinically significant illness that, in the investigator's opinion,\n could not be adequately controlled with appropriate therapy, would compromise a\n participant's ability to tolerate cabazitaxel or result in inability to assess toxicity.\n This included, but was not limited to uncontrolled intercurrent illness including ongoing\n or active infection, cardiac disease, renal impairment, planned surgery or psychiatric\n illness/social situations that would limit compliance with study requirements.\n\n Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency-syndrome\n (AIDS)-related disease Known history of hepatitis C or known active hepatitis B infection.\n Pregnant or breast feeding women Treatment with strong inhibitors or strong inducers of\n CYP3A4 or enzyme inducing anti-epileptic drugs (EIAED) within 14 days prior to first dose\n of cabazitaxel and for the duration of study. Non-EIAEDs were permitted.\n\n Known history of hypersensitivity to taxanes or polysorbate 80 or G-CSF. Participation in\n another interventional clinical trial and/or concurrent treatment with any investigational\n drug.\n\n Participants not able to comply with scheduled visits, treatment plans, laboratory tests,\n and other study procedures.\n\n The above information was not intended to contain all considerations relevant to a\n participant's potential participation in a clinical trial.
Participants who have stopped study drug dosing for greater than 56 days
Participants continuing to require dose modifications
Participants who are less than 6 weeks post-131 I-metaiodobenzylguanidine (mIBG) therapy.
Participants with carcinoma of the cervical stump
Participants requiring anti-hyperglycemic therapy
Female participants must not be pregnant or breast-feeding. Female participants of childbearing potential and fertile male participants must agree to use a highly effective contraceptive during the trial and for a period of at least 6 months following the last administration of trial drug(s)
Part E - Diagnosed with cholangiocarcinoma, either intrahepatic or extrahepatic, that is unresectable, recurrent, or metastatic. Participants must not have received prior systemic front line therapy for metastatic or resectable disease (i.e. participants may have received adjuvant gemcitabine but have not yet received gemcitabine/cisplatin for recurrent metastatic disease). Participants must be, in the opinion of the investigator, an appropriate candidate for experimental therapy. Participants should be evaluated for the need to undergo biliary drainage by stent placement prior to study participation. Participants should have adequate biliary drainage with no unresolved biliary obstruction.
Participants in whom the required program of oral (PO) and IV fluid hydration is contraindicated
Participants who have received prior Pemetrexed treatment.
Inclusion Criteria:\n\n For more information regarding Bristol-Myers Squibb Clinical Trial participation, please\n visit www.BMSStudyConnect.com\n\n - Kidney tumor has been completely resected 4 to 12 weeks prior to randomization\n\n - Pathologic TNM staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G\n any, N0 M0; pT3, G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0\n\n - Post-nephrectomy tumor shows RCC with a predominantly clear cell histology, including\n participants with sarcomatoid features\n\n Exclusion Criteria:\n\n - Participants with an active known or suspected autoimmune disease\n\n - Known history of positive test for human immunodeficiency virus (HIV) or known\n acquired immunodeficiency syndrome (AIDS)\n\n - Any severe or serious, acute or chronic medical or psychiatric condition, or\n laboratory abnormality that may increase the risk associated with study participation\n\n - Participants with a condition requiring systemic treatment with corticosteroids\n\n Other protocol defined inclusion/exclusion criteria could apply
Glycosylated hemoglobin is <=6.5% hyperglycemic participants permitted if glucose is well controlled by hypoglycemic medication).
Pregnant participants will not be entered on this study
ALL PARTICIPANTS
Participants must self-identify as Hispanic/Latina
Participants must be willing and able to attend four 4-hour in-person sessions
Participants with untreated depression or anxiety as assessed by self-report and review of medical history
Participants must have documentation of a plexiform neurofibroma (PN), based on either clinical exam or imaging
PATIENT PARTICIPANTS:
Insurance information will be reviewed to ensure geriatric referral is covered for all potential participants
Participants must be oriented to person, place, and time
Research participants having any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of enrollment; research participants with any signs or symptoms of active infection, positive blood cultures, or radiological evidence of infections
Participants receiving any medications or antibiotics to treat Clostridium difficile infection prior to the initiation of the study will be ineligible for this study
Illiterate participants
Deaf participants
PATIENT PARTICIPANTS:
Participants may be on anti-depressants and/or anxiolytics as long as the dosing has remained stable over the preceding 4 weeks
Participants with acute, active gastrointestinal infection (e.g., typhlitis, diverticulitis, appendicitis)
Participants with non-evaluable or non-measurable cancer are eligible if they have a confirmed increase in tumor antigens >=2 x upper limit of normal (ULN).
The participant’s SISCCA must not have been ablated
Concurrent malignancy. Participants with carcinoma in situ of any origin and participants with prior malignancies in remission may be eligible with sponsor approval.
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Women with no history of cancer
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: No history of prior chemotherapy
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Willing to come to MDACC and HIAE for the assessment session
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Right handed
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Mini-Mental State Examination score of 23 or below
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Primary caretaker of a cancer patient
Participants may have had prior breast surgery and/or chemotherapy
Participants using other contraindicated medications (thioridazine, yohimbine)
PATIENT PARTICIPANTS
Participants will be diagnosed with breast cancer; the participants will be scheduled for a lumpectomy or a mastectomy at UH GMC Seidman Cancer Center
CHILD PARTICIPANTS:
ADULT PARTICIPANTS:
PATIENT PARTICIPANTS:
Participants must be diagnosed with cancer
All at-risk relatives of the participants found to have LS
Participants with a core biopsy diagnosis of atypia with associated malignancy (in the same quadrant) will be excluded.
Participants who have had a metal injury to the eye
Participants from Franklin County or from Appalachia Ohio (depending on program location)
Participants in other ongoing clinical trials are eligible for this study
Participants who only have a single HSIL lesion that is likely to be removed entirely with the initial screening biopsy
WHITE, NON-HISPANIC: Participants reporting sun-sensitive phenotypes.
If the study staff or principal investigator (PI) have serious concerns about the participant’s ability to engage in and/or complete the study protocol.
Participants will be excluded from participation in future stages
Participants must have the ability to safely undergo bronchoscopy in the judgment of the investigators
Participants must not have been treated with iloprost at any time; Note: participants on the placebo arm of previous iloprost trials are eligible, but participants on the placebo arm of cohort A of this study may not be enrolled in cohort B
Participants must not have used any other investigation agent within the last six months
Participants with known genotype for Thr1482Ile polymorphism in TRPM7
The number of participants from the same street address will be limited to 1
Participants must be willing to forego foods, beverages and supplements containing pomegranate for the duration of the study
Participants in the control group must be disease free, never-smokers and otherwise healthy
Participants with hyperplasia, in absence of dysplasia or carcinoma in situ, will be excluded
All participants must be nonsmokers at the time of the study (i.e., have not used any tobacco product); have not smoked an entire cigarette, cigar, or hookah session before
All participants must score 3 out of 5 or above on the place attachment scale (i.e., measuring adolescents’ feeling of attachment to their after-school program)
Participants who in the opinion of the principal investigator (PI) will be at higher risk of acetylsalicylic acid (ASA)-related complications
Participants with known genotype for rs174535 in fatty acid desaturase 1 (FADS1)
Participants must have an echocardiogram within normal limits within the last year
PARTICIPANTS: Self-identified as Filipino, Hmong, or Korean Americans
PARTICIPANTS: live in relevant area and intend to stay there for at least 12 months
Participants with a known Li-Fraumeni or Cowden’s disease
Participants with prior mantle radiation
Participants must have a pre-operative standard mammogram with or without ultrasound; these may be performed at outside institutions
Participants with known Li-Fraumeni or Cowden’s disease
Participants with prior mantle radiation
Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation
Participants at higher risk due to age, frailty, or the emergent nature of their condition
GROUPS 1, 2, AND 3: \All participants” described above
Participants who do not have residual calcifications present on mammogram following biopsy
BREAST CANCER PARTICIPANTS: Patients participating in other research imaging protocols will be excluded from this study
Women matched to age with our 16 post-cancer treatment participants
Participants with any extent of resection are eligible
Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
Participants with AML must either refuse or not be considered candidates for intensive induction chemotherapy. Previously treated participants should have evidence of persistent or recurrent AML in the peripheral blood and/or bone marrow. Participants must have white blood cell (WBC) < 15 x 10^9cells/L.
For CMML, participants must have been treated with at least one prior therapy (hydroxyurea or an hypomethylating agent [HMA]).
Participants with genetic diseases of the liver that may complicate review of safety data
Previous treatment with a selective FGF19-FGFR4 targeted therapy and/or selective pan-FGFR inhibitor 14. Use of any vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of study therapy 15. Presence of gastric or esophageal varices requiring active treatment 16. A clinically significant ECG abnormality, including a marked baseline prolonged QTc interval (eg, a repeated demonstration of a QTc interval >500 ms) 17. Significant cardiovascular impairment or any other major illness, medical condition 19. Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria 20. Hypersensitivity to the study drug or to any of the excipients 21. Intolerance or hypersensitivity to both CT and MRI contrast material that would preclude the ability to acquire the triphasic liver imaging required by the protocol 22. Participants with inorganic phosphorus > upper limit of normal for the institution 23. Participants with total or ionized serum calcium > upper limit of normal for the institution 24. Participants with endocrine changes that may result in increases in calcium or phosphate, including but not limited to hyperparathyroidism and tumoral calcinosis 25. Participants with past medical history and/or current evidence of tumoral calcinosis or tissue calcification 26. Participants who take calcium, vitamin D or systemic corticosteroids
Participants not capable of keeping moderately still for the imaging portion of the study session (~1 hour for imaging)
Participants whose girth exceeds the bore of the MRI scanner
If is neither a citizen of the United State nor a Permanent Resident Alien (Green Card holder) (to facilitate compensation of participants)
Male participants are required to use a condom during the entire study period with RO6958688 and up to 90 days after last administration of RO6958688. Male participants should not donate sperm for 90 days after the last dose of RO6958688.
Adequate cognitive status as determined by a research coordinator at recruitment; to assess the participant‘s capacity to take part in the interview, the interviewer will note and comment on the participant's spontaneous speech and capacity to write date at the time of consent; participants should be oriented to person, place, date, time, and events (RCT)
For Part B only, participants must have advanced or metastatic CRC expressing either low or high levels of GCC, for whom standard treatment is no longer effective or does not offer curative or life-prolonging benefit. A portion of participants should have tumors amenable for serial biopsy and a willingness to provide consent for pharmacodynamic assessment.
Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx is allowed, but these participants will not be included as response-evaluable participants for efficacy analysis of HNSCC.
Documented progression on or following most recent systemic chemotherapy regimen (not required for chemotherapy-naïve patients), within 4 months prior to screening
Patients must have completed standard neoadjuvant or adjuvant taxane and/or anthracycline based chemotherapy prior to randomization; completion of chemotherapy will be determined by the treating oncologist, but should include a minimum of 4 cycles (a cycle of weekly paclitaxel is considered 3 doses); patients must be registered within 42 weeks after the last dose of chemotherapy; patients may have started endocrine therapy at any time after the diagnosis of the current breast cancer
For patients who receive adjuvant chemotherapy after surgery, a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization; (if treatment delays occur, chemotherapy must be completed within 14 weeks); the dose and schedule of the adjuvant chemotherapy are at the investigator's discretion; Note: it is preferred that all intended chemotherapy be administered in the neoadjuvant setting
If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved
Patients may receive post-operative (adjuvant) chemotherapy for up to 24 weeks of duration (e.g. 8 cycles of capecitabine as in the CREATE-X trial) after completion of surgery at the discretion of the treating physician; patients must have resolution of adverse event(s) of the most recent prior chemotherapy to grade 1 or less, except alopecia and =< grade 2 neuropathy which are allowed; patients that have received adjuvant chemotherapy must be registered to screening within 35 days after completing treatment
Patients must have completed their final breast surgery (rendering them free from disease) with clear resection margins for invasive cancer and DCIS within the following timelines:\r\n* 90 days prior to screening registration for patients not receiving post-operative (adjuvant) chemotherapy OR\r\n* 270 days prior to screening registration for patients who have received post-operative (adjuvant) chemotherapy\r\nPatients who receive postoperative chemotherapy may receive radiation therapy before or after the chemotherapy; a short course of reduced dose chemotherapy concomitant with radiation for radiation sensitization is not considered to be adjuvant chemotherapy; positive margins are allowed only if the surgical team of the patient deems further resection impossible
Newly diagnosed and histopathologically confirmed, potentially resectable NRSTS of the extremity and trunk will be eligible for the chemotherapy or non-chemotherapy cohort based on:\r\n* Evidence of chemotherapy sensitivity of the histologic sarcoma subtype based on existing evidence from prior clinical trials\r\n* Sufficient risk of metastatic disease to warrant chemotherapy based on size and grade and\r\n* Medically deemed able or unable to undergo chemotherapy\r\n* Notes: an incisional biopsy or core biopsy is preferred; fine needle aspiration biopsy is not acceptable to establish the diagnosis
Patients meeting the above criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the chemotherapy cohort or the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort
Patients meeting the criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort; note that tumors arising in bone are NOT eligible for this study
Must have received 3-6 cycles of cisplatin-based chemotherapy as part of first-line (initial) chemotherapy; prior cisplatin, vincristine, methotrexate, bleomycin, actinomycin D, cyclophosphamide, etoposide (POMBACE), carboplatin, bleomycin, vincristine, and cisplatin-bleomycin, etoposide, and cisplatin (CBOP-BEP), or methotrexate, actinomycin-D, etoposide, cisplatin, peg filgrastim (GAMEC) are allowed; Note: for patients requiring immediate treatment, 1 cycle of conventional-dose salvage chemotherapy is allowed (including TI or TIP); therefore, these patients may have received 7 prior cycles of chemotherapy; 6 cycles as part of first-line chemotherapy and 1 cycle of salvage conventional chemotherapy
Participants who have had systemic chemotherapy or radiotherapy within 14 days prior to entering the study, except for hydroxyurea or 6-mercaptopurine (MP) as noted; empiric intrathecal chemotherapy during a diagnostic lumbar pucture is allowed, as long as central nervous system (CNS) disease is not suspected
Prior chemotherapy for castration resistant disease; chemotherapy given in the castration-sensitive setting is permissible if stopped at least 4 weeks prior to treatment start
At least three weeks since the last chemotherapy
Participants who received any lymphoma directed chemotherapy or radiotherapy with the exception of a single dose of intrathecal chemotherapy given at the time of the diagnostic lumbar puncture (spinal tap); patients who received chemotherapy or radiotherapy for Kaposi’s sarcoma > 2 years prior to study enrollment are allowed as long as the prior treatment did not include doxorubicin in its non-liposomal form; prior exposure to liposomal doxorubicin is allowed; prior exposure to intrathecal therapy given as prophylaxis within 30 days is allowed
Chemotherapy
Prior systemic chemotherapy requirements are as follows:\r\n* Nivolumab plus carboplatin and pemetrexed cohorts (Cohorts A and B): NO prior systemic chemotherapy is allowed; NOTE: Prior adjuvant or neoadjuvant chemotherapy is allowed if received more than 12 months prior to the study; in addition, one prior cycle (dose) of chemotherapy is allowed if there was no evidence of disease progression following the dose\r\n* Nivolumab plus ipilimumab cohorts (Cohorts C and D): Participants must have received a platinum-based combination chemotherapy for their advanced lung cancer and either progressed on/after this chemotherapy or are intolerant; up to two prior lines of chemotherapy are allowed; NOTE: Prior adjuvant or neoadjuvant chemotherapy does not count as an additional line of chemotherapy if received more than 12 months prior to the study
At least 4 weeks (112 days) from last induction cycle of combination/multi-agent cyto-reductive chemotherapy and no single agent chemotherapy/maintenance within 7 days (e.g. lenalidomide, pomalidomide, bortezomib, dexamethasone, etc).
Receiving prior hepatic intra-arterial chemotherapy
Prior chemotherapy for castration resistant disease; chemotherapy given in the castration-sensitive setting is permissible; at least 6 months from registration must have elapsed since chemotherapy was last received
Patient has had prior treatment with bevacizumab, a chemotherapy wafer implant (Gliadel), or any other FDA- approved chemotherapy except temozolomide.
Patients must have progressed after prior high dose chemotherapy (HDCT) treatment, been deemed not to be a candidate for high dose chemotherapy or refused high-dose chemotherapy, and be considered incurable by other standard therapies including further chemotherapy or surgery; there is no maximum allowable number of previous therapies\r\n* “Failure” of prior therapy is defined as:\r\n** A > 25% increase in the products of perpendicular diameters of measurable tumor masses during prior therapy which are not amenable to surgical resection\r\n** The presence of new tumors which are not amenable to surgical resection\r\n** An increase in AFP or beta-human chorionic gonadotropin (hCG) (two separate determinations at least one week apart are required if rising tumor markers are the only evidence of failure)\r\n* NOTE: patients with clinically growing “teratoma” (normal declining tumor markers and radiographic or clinical progression) should be considered for surgery
Prior chemotherapy for mCRPC prostate cancer; chemotherapy given neoadjuvantly, adjuvantly, or for hormone sensitive metastatic disease is permitted as long as the cancer did not progress on chemotherapy AND > 6 months have elapsed
Prior chemotherapy for metastatic castration-resistant prostate cancer; chemotherapy administered in the castration-sensitive setting is allowed provided last dose of chemotherapy was greater than 12 months prior to study entry
Progression at any time during initial asparaginase based chemotherapy and up to 3 months after end of initial asparaginase based chemotherapy, OR
Failure to achieve at least PR with initial asparaginase based chemotherapy.
Chemotherapy: 3 weeks
More than one prior line of chemotherapy administered at any time; a subject treated with chemotherapy in the hormone sensitive setting would count as one line of chemotherapy; a subject treated with chemotherapy in the hormone sensitive setting and subsequently treated with chemotherapy in the castration resistant setting would count as two lines of chemotherapy and would be excluded
Received a minimum of 2 cycles of standard of care platinum-based chemotherapy in the S1 setting and had a response of progressive metabolic disease (PMD), no metabolic response (NMR), partial metabolic response (PMR) as centrally assessed by PET-/ CT scan or received at least 1 cycle of S1 chemotherapy and had evidence of PMD as centrally assessed. A pre-salvage scan is required to be submitted to the central reader if a subject had only 1 cycle of pre-salvage chemotherapy.
CMR following S1 chemotherapy
Prior systemic chemotherapy
Previous treatment with chemotherapy for metastatic CRPC (mCRPC) (adjuvant chemotherapy is permitted), or chemotherapy for any reason within 2 years prior to registration
Must be at least 7 days since last chemotherapy was administered (this does not include intrathecal chemotherapy which can be administered at any given time pre study or upon enrollment nor does it include maintenance chemotherapy for the subset of patients who relapse during maintenance); for patients who were previously enrolled on the trial but were removed prior to receiving T cell therapy and are re-enrolling on the trial and already have a useable T cell product generated during previous enrollment, the duration and chemotherapy agents used is not restricted
Refusal to practice contraception during chemotherapy
TREATMENT WITH SJCAR19: Receiving intrathecal chemotherapy in the 7 days prior to CAR T-cell infusion
Subjects who progressed on at least one prior chemotherapy
Receiving any investigational agents or concurrent biological, intensive chemotherapy or radiation therapy for the previous 2 weeks from conditioning\r\n* NOTE: low dose chemotherapy or maintenance chemotherapy given within 7 days of planned study enrollment is permitted; these include: hydroxyurea, 6-meraptopurine, oral methotrexate, vincristine, oral etoposide, and tyrosine kinase inhibitors (TKIs); FLT-3 inhibitors can also be given up to 3 days before conditioning regimen
3 weeks from prior chemotherapy.
Treatment with any systemic chemotherapy within 3 weeks
Must be at least 7 days since last chemotherapy was administered (this does not include intrathecal chemotherapy which can be administered at any given time pre study or upon enrollment nor does it include maintenance chemotherapy for the subset of subjects who relapse during maintenance)\r\n* If subject has an apheresis product or T cells available for manufacturing of T cell product, the duration and chemotherapy agents used is not restricted
Completion of preoperative systemic chemotherapy.
History of prior chemotherapy (chemotherapy allowed for lead-in cohort in castration resistant disease)
Patients may have had prior chemotherapy or be chemotherapy naive
If HCC patients, they should have progressive disease (PD) on intolerant of or refusing sorafenib. If mCRC, they should have received at least one regimen of 5-fluouracil based systemic chemotherapy such as FOLFOX, FOLFIRI, CAPOX, or XELOX, with or without a VEGF or EGFR receptor inhibitor. For patients with metastatic gastric cancer, they should have failed at least one line of systemic chemotherapy. For patients with NSCLC, they should have been treated with a PD-1 inhibitor (either with or without chemotherapy) for at least 4 months but are not able to achieve a response.
Patients must discontinue therapies for mCRPC, with the exception of GnRH agent, for 14 days, with the exception of anti-androgens with which there may be a withdrawal PSA response\r\n* Prior chemotherapy is allowed if no progression of disease on chemotherapy\r\n* Prior treatment with sipuleucel-T, radium-223, or PARP inhibitor (e.g. olaparib) is allowed\r\n* Tissue biopsy may be performed during washout period
Must be at least 7 days since last chemotherapy was administered (this does not include intrathecal chemotherapy which can be administered at any given time pre study or upon enrollment nor does it include maintenance chemotherapy for the subset of subjects who relapse during maintenance)\r\n* If subject has an apheresis product or T cells available for manufacturing of T cell product, the duration and chemotherapy agents used is not restricted
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Compete history and physical examination will be required within 2 weeks prior to initiation of chemotherapy
Patients must have received platinum based chemotherapy; the submission of a tissue sample for the mesothelin assay to determine eligibility for the study may occur prior to, during or after receipt of the frontline chemotherapy; patients will not be required to submit another tissue sample after receipt of the chemotherapy
Patients should receive chemotherapy to attempt to achieve CR or minimal disease state pre-transplantation; the use of up to three cycles of non-cross resistant combination chemotherapy is advised
Chemotherapy resistant disease
Prior chemotherapy with nitrosoureas, prior mitomycin C cumulative dose ? 25 mg/m2, prior bone marrow transplant, or prior intensive chemotherapy with stem cell support;
CRITERIA FOR LYMPHODEPLETING CHEMOTHERAPY AND huJCAR014 TREATMENT
CRITERIA FOR LYMPHODEPLETING CHEMOTHERAPY AND huJCAR014 TREATMENT: Uncontrolled and serious infection
CRITERIA FOR LYMPHODEPLETING CHEMOTHERAPY AND huJCAR014 TREATMENT: DLI within 6 weeks prior to lymphodepletion chemotherapy
Radiotherapy and cancer chemotherapy (except for intrathecal chemotherapy, hydroxyurea, and cytarabine. Cytarabine and hydroxyurea are allowed to be used emergently in case of leukocytosis) or any investigational drug within 2 weeks before study entry
Must have received systemic chemotherapy, minimum 3 months or maximum 6 months, prior to enrollment\r\n* Systemic therapy should consist of at least fluoropyrimidine-based and/or platinum-based chemotherapy\r\n* Trastuzumab may be added for HER2-neu over-expressing cancers as clinically indicated\r\n* Last dose of chemotherapy within 8 weeks of enrollment with recovery to grade 1 from chemotherapy-related toxicities\r\n* Documentation of chemotherapy administration must be obtained
Patients at least 3 weeks from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least two weeks prior to administration of lymphodepleting chemotherapy.
Prior treatment with intravenous chemotherapy
Low dose chemotherapy (e.g., vincristine, rituximab, cyclophosphamide ?300 mg/m2) given after leukapheresis to maintain disease control must be stopped ?7 days prior to lymphodepleting chemotherapy.
At least 1 prior platinum-based chemotherapeutic regimen, but not more than 2 prior chemotherapeutic regimens, for management of endometrial carcinoma. Prior treatment may include chemotherapy, chemotherapy/radiation therapy, and/or consolidation/maintenance therapy. Chemotherapy administered in conjunction with primary radiation as a radio-sensitized therapy will be considered a systemic chemotherapy regimen.
LYMPHODEPLETION: Subjects currently receiving “maintenance” doses of chemotherapy are eligible and the need for intrathecal prophylaxis prior to lymphodepletion is left to the discretion of the investigator; maintenance chemotherapy is defined as methotrexate =< 30 mg/m^2/week, mercaptopurine =< 100 mg/m^2/day and vincristine =< 2 mg/28 days; for subjects who receive chemotherapy, including intrathecal chemotherapy, that does not fit this definition of maintenance chemotherapy, a two week washout between the last dose of standard of care chemotherapy and the beginning of lymphodepletion will be required
At least 4 weeks post-completion of chemotherapy
No major surgeries within 3 weeks of starting chemotherapy
Participants in cohort B must have completed 1 cycle of systemic chemotherapy; therapy with the combination must start no sooner than 3 weeks from the last dose of chemotherapy and no later than 5 weeks from the last dose of chemotherapy; participants in cohort B must not have had progression of disease prior to the start of therapy
Patients must have had no more than 3 prior lines of chemotherapy; this includes the initial treatment and two relapses; concurrent and adjuvant TMZ-based chemotherapy, including the combination of TMZ with another agent, is considered one line of chemotherapy; for clarification, please contact the principal investigator (PI), Dr. Orin Bloch, at (312) 695-6200
Undergone lumpectomy and/or mastectomy, are at 2 weeks from end of treatment with adjuvant chemotherapy or radiation and/or chemotherapy or are at a maximum of 5 years out from completion of such treatment;
Patients who have not previously undergone radiation therapy can have a history of treatment with either chemotherapy (for unresectable/borderline resectable disease) or any combination of surgery and chemotherapy (for resectable disease); patients with no history of prior radiation treatment will constitute Cohort B and will receive SBRT as 6.6 Gy x 5; please note that patients must have received at least two cycles of chemotherapy (with selection of drugs at the discretion of the treating oncologist) before SBRT treatment on protocol
At least 21 days must have elapsed after the last dose of myelosuppressive chemotherapy; patients who have been treated with chemotherapy at time of recurrence are NOT eligible for either Stratum
Patients must be at least 4 weeks from last dose of chemotherapy.
Prior chemotherapy within 28 days of starting treatment
Planned pre-operative chemotherapy (patients with planned post-operative chemotherapy are eligible)
Willing to reside < 50 kilometers from Kamuzu Central Hospital (KCH) until chemotherapy completion
Patients who failed to respond first line standard of care chemotherapy or chemotherapy suspended due to toxicity or other reasons
Patients with prior chemotherapy for this cancer
No other active cancer that requires systemic chemotherapy or radiation
At least one prior chemotherapy
Patients should be off all previous intensive therapy, chemotherapy or radiotherapy for 3 weeks prior to commencing therapy on this study\r\n* (NOTE: Low dose chemotherapy or maintenance chemotherapy given within 7 days of planned study enrollment is permitted; these include: hydroxyurea, 6-meraptopurine, oral methotrexate, vincristine, oral etoposide, and tyrosine kinase inhibitors [TKIs]; FLT-3 inhibitors such as sorafenib, crenolanib, midostaurin can also be given up to 3 days before conditioning regimen)
Patients may not be receiving any other investigational agents, or concurrent biological, intensive chemotherapy, or radiation therapy for the previous three weeks from conditioning\r\n* (NOTE: Low dose chemotherapy or maintenance chemotherapy given within 7 days of planned study enrollment is permitted; these include: hydroxyurea, 6-meraptopurine, oral methotrexate, vincristine, oral etoposide, and tyrosine kinase inhibitors [TKIs]; FLT-3 inhibitors such as sorafenib, crenolanib, midostaurin can also be given up to 3 days before conditioning regimen)
May have been previously chemotherapy-treated; patients may have received up to two prior lines of chemotherapy (excludes neoadjuvant or adjuvant therapy) for recurrent/advanced disease (it is anticipated that patients would have been previously treated with MVAC or GC, or variations of these standard frontline regimens); chemotherapy-naive patients who decline to receive frontline chemotherapy are eligible
Systemic chemotherapy or radiation cannot have been given within 4 weeks prior to the Y-90 dose of radioimmunotherapy (RIT), with the exception of single agent cyclophosphamide priming chemotherapy administered for mobilization
Must be at least 7 days since last chemotherapy or biologic therapy administered; for patients previously enrolled on this trial who had a usable T cell product generated but removed prior to receiving T cell therapy and are re-enrolling on the trial, the time from chemotherapy agent or biologic agent is not restricted
Administration of chemotherapy or any other cancer therapy in the pre-operative period
Patients must be anticipated to complete 2 cycles of chemotherapy
Patients previously treated with chemotherapy are eligible unless they have evidence of local or distant disease progression; patients must have completed their last cycle of chemotherapy at least two weeks prior to study enrollment
Prior first-line treatment with surgery or biopsy followed by fractionated radiotherapy with concurrent temozolomide-containing chemotherapy is required for glioblastoma patients; additional prior chemotherapy is allowed, without limitation on number of recurrences
Receiving intensive chemotherapy within 21 days of registration; maintenance type of chemotherapy will be allowed
Subjects must have received adjuvant post-operative chemotherapy meeting the following requirements:\r\n* Completed chemotherapy as per the discretion of their physician\r\n* Chemotherapy must have been completed within 1-6 months of starting study treatment
Subjects with rectal cancer must have received chemotherapy meeting the following requirements:\r\n* Completed chemotherapy as per the discretion of their physician\r\n* Chemotherapy must have been completed within 1-6 months of starting study treatment
If chemotherapy is planned, new chemotherapy regimen should have started no more than 21 days prior to enrollment
If systemic chemotherapy was given, patient must have had clips or markers placed at the time of surgery (if they are needed) and patient must have simulation scans within 6 weeks of the completion of the chemotherapy.
Patients must be anticipated to complete at least 2 cycles of chemotherapy on study
Participants may have undergone prior chemotherapy for their uterine malignancy or may undergo chemotherapy in conjunction with adjuvant proton therapy per discretion of treating physicians; the agents, doses, routes and schedule of administration will be determined by their attending gynecologic oncologist or medical oncologist; for participants who have undergone prior chemotherapy, protocol radiation may commence no sooner than 21 days after the last chemotherapy treatment
Systemic chemotherapy or radiation within 4 weeks prior to the Y-90 dose of radioimmunotherapy (RIT), with the exception of single agent Cytoxan priming chemotherapy administered for mobilization
Prior systemic chemotherapy
Chemotherapy-sensitive (at least stable disease) large cell, mantle cell or Hodgkin's lymphomas that have failed at least 1 prior regimen of multi-agent chemotherapy and are ineligible for an autologous transplant
Chemotherapy is allowed; if chemotherapy is indicated and brachytherapy boost is planned, it must be administered after the accelerated whole breast irradiation (AWBI) but should begin no earlier than 21 days following completion of radiation therapy; alternatively if chemotherapy is indicated and external beam boost is planned, the chemotherapy can be delivered first, followed by radiation therapy beginning 21-63 days after the last cycle of chemotherapy or the radiation therapy can be delivered first and the chemotherapy can be delivered no earlier than 21 days post radiation therapy
Patients must be enrolled within 6 months of completing chemotherapy or after surgery of the primary site; any acute/subacute > or = grade 3 toxicities from the chemotherapy must be resolved to < or = grade 2 at the time of study entry; it is suggested that patients undergo prophylactic cranial irradiation as a soon as they have recovered from chemotherapy or surgery, at a minimum of 2 weeks, and up to 6 months following chemotherapy or surgery
Prior chemotherapy (i.e., as administered strictly for cancer treatment) within the previous 3 years. Use of chemotherapy agents for non-cancer treatment purposes (i.e., arthritis treatment, etc.) are excluded from this criterion.
Prior chemotherapy (last 4 weeks)
Previous chemotherapy for this lung or mediastinum tumor; chemotherapy for another invasive malignancy is permitted if it has been treated definitively and the patient has remained disease free for > 3 years
At least one prior regimen of chemotherapy, with no maximum number of chemotherapy cycles
Chemotherapy-naïve
At least 2 weeks since chemotherapy
Subjects must refuse cisplatin-based combination chemotherapy (and understand the risk and benefits of doing so) or be deemed ineligible for cisplatin-based chemotherapy by meeting at least one of the following criteria:
Patients must be 7 days to 6 weeks out from prior therapy:\r\n* Chemotherapy cytotoxic: At least 21 days since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Chemotherapy nitrosoureas: At least 6 weeks since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Chemotherapy non-cytotoxic (e.g. small molecule inhibitor): At least 7 days or five half-lives, whichever is shorter, since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Monoclonal antibody(ies): At least 28 days since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Immunotherapy: At least 21 days since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Radiotherapy (RT): At least 28 days from last local site RT prior to first dose of tazemetostat\r\n* At least 21 days from stereotactic radiosurgery prior to first dose of tazemetostat\r\n* At least 28 days from craniospinal, > 50% radiation of pelvis or total body irradiation prior to first dose of tazemetostat
Previous chemotherapy or radiotherapy, except:\r\n* Pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin\r\n* Non-seminoma and poor prognosis by IGCCC criteria in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (e.g. organ failure, vena cava obstruction, overwhelming burden of disease); acceptable regimens include cisplatin 20 mg/m^2 days 1-2 and etoposide 100 mg/m^2 days 1-2; carboplatin area under curve (AUC) 3 days 1-2 and etoposide 100 mg/m^2 days 1-2; or baby-BOP; patients must meet all other inclusion and exclusion criteria at the time of registration\r\n* Participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomization; such patients must be discussed with the coordinating center prior to registration, and must be registered within 10 days of commencing study chemotherapy
Received more than 2 prior systemic chemotherapy regimens, including adjuvant systemic chemotherapy following definitive chemoradiation (OUTBACK chemotherapy); concurrent chemotherapy with prior radiation treatment is not to be counted
Patients must not be suitable for fluorouracil (5FU)/mitomycin chemotherapy
Subjects with not meeting the above criteria are still eligible provided the patient declines concurrent chemotherapy with radiation, after specific informed consent describing the known benefits of adding chemotherapy to the definitive bladder radiation regimen; the reason for declining must be documented
Patients must be anticipated to complete at least 2 cycles of chemotherapy
Chemotherapy-naive patients (for this malignancy)
Patients who have had chemotherapy or radiotherapy =< 14 days prior to registration are not eligible\r\n* NOTE: Patients may not have had systemic chemotherapy within 28 days
Subjects must have had prior high dose chemotherapy (HDCT) treatment when indicated
Subjects must be at least 3 weeks from last chemotherapy
No prior cancer chemotherapy allowed
Patients must have had at least one prior chemotherapeutic regimen for management of endometrial carcinoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen\r\n* Patients are allowed to receive, but not required to receive, up to a total of 3 lines of chemotherapy
At a maximum of twelve weeks after the last dose of chemotherapy, patients must fulfill the following criteria:\r\n* Complete clinical response after first-line chemotherapy for newly-diagnosed patients, or after second-line chemotherapy for relapsed patients who require secondary cytoreduction\r\n** Complete clinical response is defined as normal exam, normal computed tomography (CT) scan, and normal CA-125 level; tumor tissue for relapsed patients would be obtained under informed consent at the time of a secondary surgical debulking, which would be performed as part of standard relapse management in appropriate patients\r\n* Asymptomatic, low volume disease not requiring further chemotherapy prior to initiating vaccination
The patient should have no immediate need for chemotherapy
Up to 4 prior chemotherapy regimens for recurrent disease are allowed; adjuvant chemotherapy and maintenance Taxol after completion of six cycles of adjuvant carboplatin - Taxol will not be counted as a \prior chemotherapy regimen\ for the purpose of this study; treatment with targeted agents or hormones would not be considered as a systemic chemotherapy regimen; eligible Patients are those with documented disease recurrence/progression within 0-6 months of completing platinum-based chemotherapy; patients should not have received any non-oncology, viral vaccines within 30 days prior to starting protocol treatment
>= 28 days from completion of frontline chemotherapy for NHL
No prior chemotherapy
Prior chemotherapy within the last 4 weeks
Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen
Patients with chemotherapy prior to TEMLA are eligible
Patients receiving any systemic chemotherapy or targeted agents for treatment of the current HNSCC outside of induction chemotherapy per standard institutional practice
All previous cytotoxic chemotherapy must be completed at least 2 weeks prior to study entry; any prior non-hematologic vital organ toxicity (cardiac, pulmonary, hepatic, renal) of any previous therapy must have resolved to grade 1 or less, unless specified elsewhere\r\n* Exceptions:\r\n** There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects; or\r\n** Subjects receiving standard ALL maintenance chemotherapy will not require washout
Patients who have had prior chemotherapy for this tumor
Patients with chemotherapy resistant disease
Any prior chemotherapy; the only exception will be patients with a history of stage I seminoma treated with adjuvant carboplatin for 1 of 2 cycles
Patients should not be felt to have an immediate need for chemotherapy
Patients must consent to have voided urine (40-50 mL) submitted prior to initiating chemotherapy (pre-treatment) and after chemotherapy prior to surgery (post-treatment)
Subjects who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (docetaxel and prednisone)
Chemotherapy:
The following drugs must be stopped >2 weeks prior to CTL019 infusion: salvage chemotherapy (e.g. clofarabine, cytosine arabinoside > 100 mg/m2, anthracyclines, cyclophosphamide, methotrexate ? 25 mg/m2), excluding the required lymphodepleting chemotherapy drugs
Chemotherapy other than lymphodepleting chemotherapy within 2 weeks of infusion
Antiproliferative therapies other than lymphodepleting chemotherapy within two weeks of infusion
Subjects who are not eligible for standard chemotherapy
At least 2 weeks from end of chemotherapy with resolution of neutropenia to above level
No clinical evidence for locoregional or distant relapse during or after preoperative chemotherapy. Local progression during chemotherapy is not an exclusion criterion.
Chemotherapy: The following drugs must be stopped > 1 week prior to CTL019 infusion and should not be administered concomitantly or following lymphodepleting chemotherapy: hydroxyurea, vincristine, 6-mercaptopurine, 6-thioguanine, methotrexate < 25 mg/m2, cytosine arabinoside < 100 mg/m2/day, asparaginase (non-pegylated) The following drugs must be stopped >2 weeks prior to CTL019 infusion: salvage chemotherapy (e.g. clofarabine, cytosine arabinoside > 100 mg/m2, anthracyclines, cyclophosphamide), excluding the required lymphodepleting chemotherapy drugs Pegylated-asparaginase must be stopped > 4 weeks prior to CTL019 infusion
For patients who have not started their chemotherapy prior to registration, the interval between definitive tumor-related surgery and 1st step registration must be between 21-70 days; for patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, the interval between definitive tumor-related surgery and day one of adjuvant chemotherapy must be between 21-77 days
Patients receiving any systemic chemotherapy within 3 weeks prior to first dose of study treatment
Subject meets the criteria per investigator's institution to receive SOC R-chemotherapy (ie, R-CHOP [14 or 21] or R-DA-EPOCH or R-CHOEP) of 6 cycles. Subjects may be enrolled on study prior to cycle 1 or cycle 2 of SOC R-chemotherapy
Subject must have completed 6 cycles of SOC R-chemotherapy and achieved CR, PR or stable disease by PET/CT performed 3 weeks (± 3 days) after cycle 6 of SOC R-chemotherapy. Subjects with PD are not eligible for treatment with blinatumomab and will end the study.
Subject who has had cytotoxic chemotherapy within 3 weeks prior to lymphodepleting chemotherapy; immune therapy (including monoclonal antibody therapy, checkpoint inhibitors or biological therapy within 4 weeks prior to lymphodepleting chemotherapy; corticosteroids or any other immunosuppressive therapy within 2 weeks prior to lymphodepleting chemotherapy; tyrosine kinase inhibitor (TKI) (e.g. erlotinib, gefitinib) within 1 week prior to lymphodepleting chemotherapy.
Phase 1b Dose Escalation - Individuals may have had unlimited prior hormonal therapy and a total of 2 prior chemotherapy regimens (adjuvant chemotherapy is considered 1 regimen). Individuals may have progressed on fulvestrant or exemestane.
Within 3 weeks prior to the first dose of CDX-0158 of any biologic treatment or IV chemotherapy.
Patients may have a history of resectable urothelial cancer (including neoadjuvant chemotherapy) as long as patients meet one of the following:\r\n* pT0, Tis, or T1N0 and have no evidence of disease (NED) for more than 2 years from surgery or chemotherapy;\r\n* pT2-3aN0 and NED for more than 3 years from surgery or chemotherapy; or\r\n* > pT3b, or N+ and NED for more than 5 years from surgery or chemotherapy
Any chemotherapy less than 28 days before first dose of study
At least 2 weeks from last chemotherapy or before chemotherapy
Anticipated need for systemic chemotherapy within 2 weeks before apheresis and infusion of CART-meso cells
The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first
Use of chemotherapy
Patients must be treated with a standardly accepted chemotherapy regimen if chemotherapy is indicated; (certain tumors of low-grade or small size may not require chemotherapy)
No previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy)
History of prior chemotherapy
Any prior exposure to neurotoxic chemotherapy
MEDI4736 + nab-paclitaxel + gemcitabine chemotherapy cohort: treatment-naïve patients with metastatic PDAC who have received no previous systemic chemotherapy 5 MEDI4736 + Cohort: Patient should receive no more than 1 prior systemic chemotherapy regimen.
Chemotherapy < 2 weeks prior to the first planned dose of study treatment
Has had chemotherapy for castration-resistant disease; chemotherapy for castration-sensitive disease is permitted
Patients may have up to three prior lines of systemic cytotoxic chemotherapy for metastatic or unresectable disease; prior use of hormonal agents (agents targeting the androgen receptor or biosynthesis pathway [goserelin, leuprolide, bicalutamide, enzalutamide, abiraterone], tamoxifen, aromatase inhibitors, fulvestrant, etc) are allowed; other hormonal agents not listed need to be reviewed by the principal investigator prior to enrollment; combination chemotherapy is considered to be a single line of chemotherapy; docetaxel is a reasonable treatment option for their malignancy
Completion of cytoreductive surgery and has completed one (and only one) course of platinum-based chemotherapy (5-9 cycles) >= 4 but =< 20 weeks prior to registration; NOTE: cytoreductive surgery may have been prior to or after the first cycle of chemotherapy but must include hysterectomy and bilateral salpingo-oophorectomy, if the uterus and/or ovaries had not previously been removed; NOTE: patients may have had more than one chemotherapy regimen (ex: paclitaxel/carboplatin switched to docetaxel/carboplatin due to allergy; weekly treatment switched to every 3 week treatment due to intolerance), but may not have received a separate course of treatment for recurrent ovarian cancer (OC); NOTE: patients may receive both neoadjuvant and adjuvant chemotherapy provided both regimens are platinum-based and total 9 or fewer chemotherapy cycles
Completion of preoperative systemic chemotherapy
Prior chemotherapy\r\n* Up to 3 prior chemotherapy regimens for treatment of metastatic disease are allowed as long as study subject is in the investigator’s opinion acceptable for study treatment with the chemotherapy agents required on this study in cohort 2 study treatment at progression on T+P; all chemotherapy has to be discontinued >= 21 days before starting the study treatments with T+P\r\n* The chemotherapy regimen in cohort 2 will be based on the patients’ prior treatment; patient must not have previously progressed on the chemotherapy agent chosen by the principal investigator (PI) for the addition to the trastuzumab + pertuzumab backbone in this study\r\n* One of the following chemotherapy agents: eribulin mesylate (eribulin) or paclitaxel or nab-paclitaxel (abraxane) or docetaxel or vinorelbine tartrate (vinorelbine) or capecitabine at schedules and doses prespecified in the body of this protocol has to be acceptable for the study treatment and can be chosen by the PI at progression on trastuzumab and pertuzumab therapy\r\n* If needed chemotherapy dose adjustments are allowed per standard of care
For chemotherapy part of this study the study chemotherapy drug label guidelines have to be used to assure safety
Patients must have had one prior chemotherapeutic regimen for management of cervical carcinoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or chemotherapy as consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radiosensitizer will not be counted as a systemic chemotherapy regimen
Prior chemotherapy is allowed
Prior treatment with HAI chemotherapy
Prior chemotherapy or biologic therapy for the same HNSCC; prior chemotherapy or biologic therapy for a different previous HNSCC is allowed
History of prior chemotherapy
Patients must be, in the opinion of the investigator, in response (partial or complete radiological response), or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125, following completion of this chemotherapy course
Patients must be randomized within 8 weeks of their last dose of chemotherapy
Patients must be randomized within 8 weeks of their last dose of chemotherapy
Prior chemotherapy for prostate cancer, with the exception of neo-adjuvant chemotherapy, because of the potential effect of chemotherapy on the immune system.
Patients must complete the standard chemotherapy appropriate for the histologic subtype of lymphoma and be able to start radiation therapy within 3 months of completing chemotherapy
Prior chemotherapy (unless allowed for some study arms)
Prior systemic chemotherapy
Patients who have had chemotherapy or radiotherapy within 2 weeks except for intrathecal chemotherapy (i.e., methotrexate, cytarabine, or thiotepa)
Chemotherapy administered for the diagnosis of seminoma:\r\n* Prior chemotherapy for a different cancer is allowed, provided therapy was completed more than twelve months from first fraction of proton therapy administered in this study and the participant has recovered to grade =< 1 toxicity related to agents previously administered
The first dose of study treatment must be at least three weeks since prior chemotherapy, including sunitinib or everolimus
For patients > 60 years of age the 1 cycle of standard chemotherapy is not required if either of the following criteria is met:\r\n* Relapse within 6 months of last chemotherapy\r\n* Blast count < 30% within 10 days of starting protocol therapy
Prior anti-cancer therapy that fulfills the following criteria: a total of more than three (Arms A and B) or two (Arms C and D) prior cytotoxic chemotherapy regimens, high-dose chemotherapy requiring stem-cell support, and irradiation to >=25 percent (%) of bone marrow-bearing areas
More than 1 prior chemotherapy regimen for mCRC; previous adjuvant FOLFOX based chemotherapy is allowed; prior FOLFIRI or single agent irinotecan is prohibited
Documentation regarding the details of administration of all systemic chemotherapy must be available
Patients who are chemotherapy naive
Patients must have had one prior platinum-based chemotherapeutic regimen for management of endometrial carcinoma or carcinosarcoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as radio-sensitizer WILL be counted as a systemic chemotherapy regimen
Any chemotherapy within 30 days of enrollment.
Patients with complete response, partial response, or stable disease following 4, 5 or 6 cycles of first-line chemotherapy with pemetrexed AND either cisplatin or carboplatin; a maximum of 6 cycles of chemotherapy may have been given
Failed at least one prior chemotherapy
No previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy).
Prior treatment with chemotherapy for CRPC
Chemotherapy < 2 weeks prior to starting study drug with the following exception: There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such
Patients in first relapse must be chemoresistant or intolerant to chemotherapy
Prior chemotherapy.
ERLOTINIB HYDROCHLORIDE ARM: Patients with SCLC or thymic malignancies must have been treated with at least 1 previous standard of care chemotherapy regimen or refuse to be treated with conventional chemotherapy agents
SELUMETINIB ARM: Patients must have been treated with at least 1 previous standard of care chemotherapy regimen or refuse to be treated with conventional chemotherapy agents
AKT INHIBITOR MK2206 ARM: Patients must have been treated with at least 1 previous standard of care chemotherapy regimen or refuse to be treated with conventional chemotherapy agents
LAPATINIB DITOSYLATE ARM: Patients must have been treated with at least 1 previous standard of care chemotherapy regimen or refuse to be treated with conventional chemotherapy agents
SUNITINIB MALATE ARM: Patients must have been treated with at least 1 previous standard of care chemotherapy regimen or refuse to be treated with conventional chemotherapy agents
PRIOR THERAPY: Patients should have had NO prior chemotherapy agents for advanced or recurrent endometrial cancer; prior chemotherapy administration in conjunction with primary radiation therapy as a radiosensitizer would NOT exclude a patient from participation in this trial
Patients must have had at least one but no more than four prior chemotherapeutic regimens for management of endometrial carcinoma (including neo-adjuvant and/or adjuvant chemotherapy); initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen
Any of the following prior therapies:\r\n* Systemic chemotherapy for bladder cancer at any time; NOTE: intravesical chemotherapy is allowed\r\n* Systemic chemotherapy for other malignancies =< 3 years prior to pre-registration
Prior chemotherapy regimen given for first (1st) relapse, not including the use of hydroxyurea or plasmapheresis that is used prior to the initiation of chemotherapy
Key inclusion criteria:\n\n 1. Histological or cytological confirmation of epithelial ovarian, primary peritoneal, or\n fallopian cancer from any previous time point.\n\n 2. Recurrent or relapsed after completion of initial therapy of epithelial ovarian,\n primary peritoneal, or fallopian cancer from any previous time point (includes\n completion of surgery with or without postoperative chemotherapy, including\n maintenance chemotherapy)\n\n 3. Elevation of CA-125 according to the following definitions:\n\n - Patients with an elevated CA-125 before chemotherapy and normalization of CA-125\n with/after chemotherapy must show evidence of CA-125 greater than or equal to 2\n times the upper limit of normal (ULN) on 2 occasions at least 1 week apart\n\n - Patients with an elevated CA-125 before cancer chemotherapy, which never\n normalizes, must show evidence of CA-125 greater than or equal to 2 times the\n nadir value on 2 occasions at least 1 week apart\n\n - Patients with CA-125 in the normal range before cancer chemotherapy must show\n evidence of CA-125 greater than or equal to 2 times the ULN on 2 occasions at\n least 1 week apart\n\n - For patients who have received subsequent treatment for recurrent cancer,\n \chemotherapy\ in the above criteria refers to the most recent round of\n chemotherapy.\n\n 4. Patients with a history of ovarian cancer who are asymptomatic and who do not have\n documented previous CA-125 levels may enroll if the CA-125 is greater than three times\n the ULN on two occasions, at least one week apart\n\n 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0\n\n Key exclusion criteria:\n\n 1. Symptoms (other than ? grade 1 fatigue, anxiety, depression, or other psychological\n symptoms) that, in the opinion of the treating oncologist, are a direct result of\n cancer recurrence. (Examples of symptoms that would preclude enrollment include\n unintentional weight loss, ? grade 2 fatigue, and new abdominal pain unrelated to\n operative procedures for the ovarian malignancy.)\n\n 2. Receiving any other investigational agent that would be considered a treatment for the\n primary neoplasm. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or\n investigational agents ?14 days of first dose of study drug\n\n 3. Major surgery ?28 days before start of treatment\n\n 4. History of another primary malignancy with an associated disease-free interval of less\n than 5 years, except for curatively treated basal cell or squamous cell carcinoma of\n the skin or in situ cancer of the cervix.
Subject has had chemotherapy within 4 weeks prior to the first study dose.
Prior systemic anticancer therapy: patients will have received no more than 2 prior chemotherapy regimens; the regimen(s) may have included biological, molecularly targeted or immune therapies; patients with primary refractory disease (i.e., those patients with progressive disease on first line chemotherapy) and patients with disease relapse within 90 days of completion of initial chemotherapy (chemotherapy resistant) are excluded; patients with limited stage small cell lung cancer (SCLC) and systemic relapse who are not felt to be candidates for repeat platinum-based chemotherapy at relapse are eligible for enrollment
Up to 2 prior chemotherapy regimens for recurrent disease are allowed; adjuvant chemotherapy and maintenance Taxol after completion of six cycles of adjuvant carboplatin-Taxol will not be counted as a “prior chemotherapy regimen” for the purpose of this study; treatment with targeted agents or hormones would not be considered as a systemic chemotherapy regimen; previous treatment with gemcitabine is not allowable
Prior primary chemotherapy.
Prior chemotherapy
Untreated relapse of cHL (with the exception of steroids) as follows:\r\n* HL that relapsed >= 3 months after completion of first-line chemotherapy or combined modality therapy, and has not yet been treated with salvage chemotherapy\r\n* Stage I-II HL that relapsed >= 3 months after first-line chemotherapy, then relapsed after radiation therapy delivered with curative intent, and has not yet been treated with salvage chemotherapy
Prior treatment and relapse following chemotherapy and autologous bone marrow or stem cell transplant. Patients who are not transplant eligible or who did not respond to chemotherapy may be considered for the study following a single regimen of chemotherapy such as R-CHOP or R-EPOCH. There is no limit to number of prior therapies allowed.
Chemotherapeutic agents for chemotherapy
Chemotherapy =< 21 days before first study treatment
If a transplant is used as consolidation following chemotherapy, without intervening disease progression, it will be considered 1 line of treatment with the preceding chemotherapy
Prior radiation or chemotherapy exposure inclusive of low dose chemotherapy such as methotrexate for autoimmune conditions.
Prior chemotherapy is acceptable if last dose given >= 3 weeks prior to registration to this study; (Note: no chemotherapy to be given after resection of liver lesions prior to treatment on this study)
RT must be administered within 12 weeks of definitive surgery if the patient is not treated with chemotherapy; if adjuvant chemotherapy is given, RT must begin within 2-8 weeks after the last dose
Prior cell transfer therapy which included a myeloablative chemotherapy regimen (i.e. 1200 total body irradiation [TBI] or 200 TBI plus chemotherapy)
Patients with locally advanced or metastatic disease, any solid tumor except hepatocellular carcinoma, who have been previously treated with systemic chemotherapy (chemotherapy administered through the blood) and who have had relapsed or had progressive disease following standard of care treatment with chemotherapy prior to enrollment, or intolerant to prior standard of care treatment with chemotherapy
Chemotherapy within 2 weeks of first planned fraction of SBRT
Prior chemotherapy within the last 4 weeks
Patients must have had at least one prior chemotherapy regimen that included temozolomide and no more than one prior salvage chemotherapy
No prior chemotherapy
Previous chemotherapy, and/or biological therapy for cancer are permitted provided that the acoustic properties of the tumor were not affected, but the subject should have recovered from the effects of these or of any prior surgery; chemotherapy can be within 70 days of operation
Prior systemic chemotherapy for cholangiocarcinoma or gallbladder carcinoma; NOTE: adjuvant chemotherapy is allowed if completed > 6 months prior to the start of registration
Be scheduled to receive a single-day chemotherapy regimen that contains doxorubicin and/or cyclophosphamide and/or carboplatin; Herceptin (trastuzumab) and other chemotherapy agents will be allowed with any of these regimens
At the time of enrollment, patient must have completed at least 24 weeks of maintenance chemotherapy, and is scheduled to receive at least 24 more weeks of maintenance chemotherapy
Concurrent chemotherapy; patients may be on other non-chemotherapy anti-cancer treatments, per Food and Drug Association (FDA) labeling of radium-223, provided that these are not changed during the primary pain assessment period
with same chemotherapy regime (as documented from patient medical dossier), And
do NOT plan to initiate a new chemotherapy for pain palliation should be eligible for the study. Note: Planned multiple courses of chemotherapy are not considered New Chemotherapy.
Patients initiating a new chemotherapy regime for pain purposes only, or radiation (for the targeted most painful lesion) within the last 2 weeks Note: Planned multiple courses of chemotherapy are not considered New Chemotherapy.
Planned chemotherapy during radiosurgery
Clinical indication for additional doses of the chemotherapy as determined by the patient’s oncologist
Patients stable enough to undergo chemotherapy as determined by the patient’s oncologist
COHORT C SPECIFIC INCLUSION: Histologically confirmed PCNSL that has recurred after prior methotrexate-based chemotherapy or for whom methotrexate-based chemotherapy is deemed medically not in the patient's best interest
Patients who are candidates for treatment with standard chemotherapy agents (there is no limit to the number of lines of chemotherapy);
No prior chemotherapy
Patients receiving intensive chemotherapy requiring a prolonged 4-6 week hospitalization
Active treatment with chemotherapy
Has not yet begun chemotherapy
Prior chemotherapy is allowed
Unresectable pancreatic adenocarcinoma, receiving either 1) no chemotherapy 2) 1st cycle of chemotherapy or 3) greater than 1 cycle of chemotherapy if the patient’s prognosis is greater than 6 months as determined by oncology collaborators
Off active chemotherapy treatment for minimum of 6 months
Patients with previously diagnosed peripheral neuropathy pre-dating their neurotoxic chemotherapy administration or from causes other than chemotherapy
Have at least 6 weeks of cancer treatment (e.g. chemotherapy or biologics such as Herceptin) remaining
Planned treatment with R-CHOP chemotherapy
Off active chemotherapy treatment for minimum of 6 months.
PATIENTS: Treatment plans to include weekly outpatient chemotherapy
Diagnosed with incurable cancer (defined as receiving treatment with palliative intent as per chemotherapy order entry designation, trial consent forms, or not receiving chemotherapy but followed for incurable disease as per oncology clinic notes)
Patients who have or have not undergone chemotherapy are both eligible; if the patient has undergone chemotherapy she must have completed adjuvant chemotherapy for >= 3 months and =< 5 years prior to study enrollment
Patients must have completed all of their prescribed chemotherapy at least one week prior to study entry; the plan for PCI should be such that PCI begins no more than 240 days from the start of induction chemotherapy
Recent administration (less than 1 week) of highly emetogenic chemotherapy (Hesketh scale class 4-5); subjects may otherwise be undergoing chemotherapy
Willing to participate in blood draws and cognitive testing at three time points: baseline prior to starting chemotherapy, prior to the final cycle of neo-adjuvant chemotherapy, several weeks prior to scheduled surgery or several weeks after final cycle of adjuvant chemotherapy; and ~ 6 months after completion of chemotherapy
Individuals who have already started chemotherapy for breast cancer or who have previously had systemic chemotherapy for a malignancy
Pain or symptoms of CIPN of >= 3 months duration, for which the patient wants intervention\r\n* Note: neurotoxic chemotherapy must have been completed >= 3 months prior to registration and there must be no further planned neurotoxic chemotherapy for > 5 months after registration
Receiving weekly chemotherapy
Prior exposure to neurotoxic chemotherapy
Randomized cohort only:\r\n* No prior chemotherapy within 12 months of start date of study\r\n* No planned chemotherapy at least 12 months from study entry
Prophylactic intrathecal chemotherapy;
Current systemic chemotherapy or radiation therapy that potentially causes bone marrow suppression that would preclude safe treatment of HSIL; Note: Kaposi’s sarcoma limited to the skin is not exclusionary unless requiring systemic chemotherapy
Receiving outpatient chemotherapy
Expected to receive at least 1 additional cycle of chemotherapy after the recruitment visit (i.e., day of randomization); participants will be retained on study if treatment regimens change during the study period (e.g., change in chemotherapy drugs or doses prescribed)
There are no restrictions on the amount or types of prior therapy; eligible patients must be receiving ongoing chemotherapy that is planned to continue for at least one month following enrollment in this trial; any dose or schedule of chemotherapy administration is allowed as long as patients have self-reported taste disturbance that has either: 1) developed since the initiation of chemotherapy, or 2) a pre-existing, treatment-induced taste disturbance has subjectively worsened since initiating chemotherapy
Patients receiving chemotherapy at the University of Wisconsin-Madison
chemotherapy or radiotherapynaïve
Be receiving chemotherapy in either weekly, 2-week or 3-week cycles and have at least 6 weeks of chemotherapy treatment remaining; patients are eligible any time before chemotherapy cycle 3 if on a 2- or 3-week cycle, or cycle 4 if on a 1-week cycle; (Note: use of biologics [e.g., Herceptin (trastuzumab)] is permitted)\r\n* For patients on a weekly regimen, there should be at least 3 dosages of chemotherapy remaining\r\n* For patients on either a 2 week or 3 week cycle, there should be at least 2 dosages of chemotherapy remaining\r\n* Patients will not be dropped from the study if their chemotherapy is discontinued after they are enrolled
Subjects may have had chemotherapy prior to radiation; a minimum of two weeks is required between end of chemotherapy and start of RT
Anticipate receiving chemotherapy for at least 12 weeks total from the time of recruitment (ongoing chemotherapy not required for focus group participants)
Must have received at least one taxane or platinum based chemotherapy drug within two years prior to enrollment; must exhibit a typical symptom of CIPN that was not present prior to chemotherapy; symptoms include numbness, tingling, thermal hyperalgesia, cold allodynia in the hands and/or feet, muscle weakness or unsteady gait in at least two of the last seven days prior to registration
Be chemotherapy naïve and about to begin her first course of chemotherapy.
No prior chemotherapy
Receiving chemotherapy known to cause alopecia within 60 days of study or during the study.
Chemotherapy =< 6 months prior to randomization (Note: topical chemotherapy will be assessed on a case-by-case basis)
Pathologic complete response following preoperative chemotherapy
Receiving chemotherapy during study period
Low dose chemotherapy given after leukapheresis to maintain disease control must be stopped ? 7 days prior to lymphodepleting chemotherapy.
Patients who elect to shave the scalp hair prior to the initiation of chemotherapy or who plan to do so during the chemotherapy treatment.
Prior exposure to neurotoxic chemotherapy
Participants must be willing to have research biopsies at baseline and after 2 cycles of preoperative chemotherapy, and possibly at the completion of preoperative chemotherapy
Group I: Treatment plan to include or have included chemotherapy
Group II: Treatment plan does not and has not included chemotherapy
Chemotherapy (taxanes) or Radium-223 alpha-particle treatment within the last 6 weeks prior to imaging
No preoperative treatment for endometrial cancer including radiation or chemotherapy
For study arm 2, patients that are currently undergoing chemotherapy for recurrence; maintenance chemotherapy is not considered an exclusion criteria; additionally, as noted above if a patient has not yet begun chemotherapy for recurrence or adjuvant chemotherapy for initial diagnosis they are still a candidate to be enrolled on this study arm; patients undergoing neoadjuvant chemotherapy are not eligible for the study under the current protocol at this time
Chemotherapy in the last four weeks
Treated with at least one other chemotherapy that did not work or where cancer relapsed
hospitalized for consolidation chemotherapy within 1 day (+/- 2 days)
Histologically proven trophoblastic neoplasia, or clinically demonstrated trophoblastic neoplasia that has progressed following treatment with at least one chemotherapy regimen that included 2 or more chemotherapy agents.
No radiation therapy =< 4 weeks before pre-registration
No prior radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks prior to registration
Washout period should be at least 2 weeks for prior chemotherapy or radiation therapy
Subject is within 12 weeks of completion of radiation.
Radiation therapy within 2 weeks of study treatment start
Treatment with radiation therapy within 2 weeks prior to the initiation of study drug.
Radiation therapy for breast cancer within 2 weeks of dosing and planning to have radiation therapy during participation in this study.
Radiation therapy within 4 weeks of enrollment
At least 4 weeks after the last dose of chemotherapy or radiation therapy; 6 weeks for mitoxantrone or mitomycin therapy
Radiation within 2 weeks of starting study treatment
Prior radiation therapy is allowed; patients must not have received radiation therapy within 4 weeks prior to the initiation of study treatment
Prior radiation therapy within 2 weeks prior to the first dose of the study regimen
Any radiation therapy in prior 2 weeks
Radiation therapy less than or equal to 4 weeks prior to registration
Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before planned first dose of study drug. Systemic treatment with radionuclides within 6 weeks before planned first dose of study drug. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible
Had therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment or palliative radiation therapy within 2 weeks before study drug treatment.
Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible
Radiation therapy within 2 weeks of study treatment
Radiation within 2 weeks prior to registration
Prior radiation therapy: patients must be at least 2 weeks from prior radiation therapy
Treatment with radiation therapy within 2 weeks prior to the initiation of study drug administration.
At least 4 weeks (wks) since prior radiation
Radiation therapy in the previous 4 weeks prior to first dose.
>= 2 weeks off radiation therapy
Recent prior therapy:\r\n* Systemic chemotherapy =< 2 weeks (6 weeks for clofarabine or nitrosoureas) or radiation therapy =< 3 weeks prior to apheresis;\r\n** Exceptions:\r\n*** There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such;\r\n*** Subjects receiving hydroxyurea may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis;\r\n*** Patients who are on standard ALL maintenance type chemotherapy (vincristine, 6-mercaptopurine, oral methotrexate, or a tyrosine kinase inhibitor for patients with Philadelphia chromosome positive [Ph+] ALL) may be enrolled provided that chemotherapy is discontinued at least 1 week prior to apheresis\r\n*** Subjects receiving steroids may be enrolled, provided there has been no increase in dose for at least 1 week prior to starting apheresis;\r\n*** For radiation therapy: radiation therapy must have been completed at least 3 weeks prior to enrollment (including CNS radiation), with the exception that there is no time restriction if the volume of bone marrow treated is less than 10% and also the subject has measurable/evaluable disease outside the radiation port
Radiation therapy to a study target tumor within 1 year prior to enrollment, or any radiation therapy within 4 weeks prior to enrollment
Minimum interval since completion of radiation treatment is 12 weeks
Prior major surgical procedure or radiation therapy within 4 weeks of initiation of therapy (this does not include limited course of radiation used for management of bone pain within 7 days of initiation of therapy)
Systemic chemotherapy ? 2 weeks (6 weeks for clofarabine or nitrosoureas) or radiation therapy ? 3 weeks prior to apheresis; exceptions:\r\n* There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such\r\n* Subjects receiving hydroxyurea may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis\r\n* Patients who are on standard ALL maintenance type chemotherapy (vincristine, 6-mercaptopurine, oral methotrexate or tyrosine kinase inhibitors in patients with Philadelphia [Ph]+ ALL) may be enrolled provided that chemotherapy is discontinued at least 1 week prior to apheresis\r\n* Subjects receiving steroid therapy are allowed provided there has been no increase in dose for at least 1 week prior to starting apheresis; patients on physiologic steroids will not be excluded\r\n* For radiation therapy: Radiation therapy must have been completed at least 3 weeks prior to enrollment, with the exception that there is no time restriction if the volume of bone marrow treated is less than 10% and also the subject has measurable / evaluable disease outside the radiation port
1 week for prior palliative radiation therapy, or 2 weeks if prior brain radiation therapy.
STRATUM A: Participants must have had their last fraction of radiation at least 4 weeks prior to study enrollment; participants who received radiation therapy for palliation must have had their last fraction of radiation at least 2 weeks prior to study enrollment
STRATUM B: Participants must have had their last fraction of radiation at least 4 weeks prior to study enrollment; participants who received radiation therapy for palliation must have had their last fraction of radiation at least 2 weeks prior to study enrollment
STRATUM C: Participants must have had their last fraction of radiation at least 4 weeks prior to study enrollment; participants who received radiation therapy for palliation must have had their last fraction of radiation at least 2 weeks prior to study enrollment
Treatment with radiation therapy within 2 weeks
Radiation therapy within 3 weeks (if single fraction of radiotherapy within 2 weeks) of enrollment (day 1 visit)
Subjects who have had radiation therapy within 2 weeks prior to first dose of drug
Subjects must be at least 2 weeks from prior anti-lymphoma therapy (including radiation therapy)
Prior major surgical procedure or radiation therapy within 4 weeks of the first dose of study treatment (this does not include limited course of radiation used for management of bone pain within 7 days of first dose of study therapy)
Radiation treatment must begin >= 3 weeks and =< 8 weeks after surgery
Has received radiation therapy within 2 weeks of study drug administration
Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment; systemic treatment with radionuclides within 6 weeks before the first dose of study treatment; subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible
Patients must be >= 2 weeks from most recent systemic therapy or radiation therapy
Radiation therapy (other than palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of study treatment
Radiation therapy within 3 weeks (within 2 weeks, if single fraction of radiotherapy) before day 1.
Patients who have had chemotherapy or radiation therapy within 2 weeks prior to beginning protocol therapy
No prior radiation therapy or radionuclide therapy for the treatment of metastasis within four weeks prior to enrollment
Patients must not have had radiation therapy =< 12 weeks prior to starting study treatment
Radiation therapy within 2 weeks prior to randomization and not recovered to baseline from any AE due to radiation
Prior chemotherapy or radiation therapy is allowed if received >= 3 weeks before study enrollment
Any chemotherapy or radiation therapy within 4 weeks of the first dose of study drug
The following minimum intervals are required between prior treatment and initiation of study therapy:\r\n* Cytotoxic chemotherapy: 3 weeks\r\n* Molecularly targeted therapy or immunotherapy: 2 weeks\r\n* Conventional fractionated radiation therapy: 2 weeks\r\n* Stereotactic radiation therapy: 1 week\r\n* Major surgery: 3 weeks
Radiation therapy within four weeks prior to administration of the first dose of ARQ 751
Use of chemotherapy within 4 weeks of the planned start of radiation therapy
Radiation therapy within 4 weeks of study enrollment (exception is radiotherapy expansion arm which requires radiation treatment within 2 week period)
Local Skin Radiation Therapy (< 10% skin surface): 4 weeks
Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment; systemic treatment with radionuclides within 6 weeks before the first dose of study treatment; subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible
Radiation therapy for bone metastases within 2 weeks, other external radiation therapy within 4 weeks of enrollment
Radiation or chemotherapy within 4 weeks of enrollment
Subject has had radiation therapy to the tumor selected for research collection, or has had radiation therapy to any site within 4 weeks prior to study day 1
Patients who have had chemotherapy or radiation =< 2 weeks of registration
Radiation therapy for bone metastasis within 2 weeks, or any other external radiation therapy within 4 weeks before the first dose of study treatment; subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible
Patients must not have received radiation for a minimum of two weeks prior
Patients must not have received radiation therapy within the past 4 weeks
Minimum interval since completion of radiation treatment is 12 weeks
Screening magnetic resonance imaging (MRI) must be obtained at least 4 weeks after any salvage surgery, and at least 12 weeks after radiation therapy, or at least 4 weeks after radiation for a new lesion outside the prior primary radiation field unless relapse is confirmed by tumor biopsy or new lesion outside of radiation field, or if there are two MRIs confirming progressive disease that are 8 weeks apart
Radiation therapy within 2 weeks before the first dose of study treatment
At least 12 weeks since the completion of radiation therapy to a total of >= 50 Gy
Patients must have failed prior radiation therapy and must have an interval of greater than or equal to 12 weeks from the completion of radiation therapy to registration; except if patients underwent surgery within 12 weeks and pathology is consistent with recurrent tumor
Radiation Therapy: Hepatic radiation within 4 weeks of PV-10 administration.
Prior radiation within 2 weeks of study registration
Radiation therapy within 4 weeks of Day 1
Subjects who received radiation therapy within 2 weeks of randomization (C1D1)
Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment; systemic treatment with radionuclides within 6 weeks before the first dose of study treatment; subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible
Subjects who have had radiation therapy within 2 weeks prior to first dose of drug
Treatment with radiation therapy within 3 weeks prior to the initiation of study drug administration.
Prior radiation therapy is allowed; patients must not have received radiation therapy within 3 weeks prior to the initiation of study treatment
Prior chemoembolization or radiation therapy (including Y90) must be performed at least 2 weeks before study enrollment
Has had radiation therapy within 2 weeks of the first protocol treatment
At least 12 weeks from completion of radiation therapy except if there is unequivocal evidence for tumor recurrence in which case at least 4 weeks
Radiation therapy within 3 weeks prior to enrollment
Recent prior therapy:\r\n* Systemic chemotherapy =< 2 weeks (6 weeks for nitrosoureas) or radiation therapy =< 3 weeks prior to apheresis; exceptions: \r\n** There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such; \r\n** Subjects receiving hydroxyurea may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis; \r\n** Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study provided they meet all other eligibility criteria; \r\n** Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis; \r\n** For radiation therapy: radiation therapy must have been completed at least 3 weeks prior to enrollment, with the exception that there is no time restriction if the volume of bone marrow treated is less than 10% and also the subject has measurable/evaluable disease outside the radiation port
Radiation therapy within 4 weeks prior to randomization on this study and not recovered to baseline from adverse events due to radiation therapy
Subject has radiation therapy within 4 weeks prior to the first study dose.
Radiation therapy within 4 weeks prior to screening.
Last dose of prior chemotherapy, radiation therapy, or investigational agents occurred at least 4 weeks before the start of therapy;
Radiation therapy within 12 weeks of registration
Radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) or radionuclide treatment within 6 weeks of randomization.
Prior radiation therapy within 2 weeks of infusion
At least 2 weeks from end of radiation therapy
Radiation therapy (other than radiation to bony metastases) as cancer therapy </= 4 weeks before study treatment
Therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment or palliative radiation therapy within 2 weeks before study drug treatment
Radiation therapy within 2 weeks prior to enrollment
Radiation therapy within 12 weeks before randomisation.
Chest radiation ? 24 weeks prior to first dose
Has received prior treatment including radiation and chemotherapy, with radiation completed > 12 weeks prior to Day 1 (or ? 4 weeks if the recurrence is outside of the prior radiation field).
Received radiation therapy within 4 weeks prior to Week 0, Day 1 of study treatment. Patients may not receive or have received any radiation therapy at the biopsy sites.
Subject has radiation therapy within 4 weeks prior to the first study dose.
Radiation therapy for bone metastases within 2 weeks, other external radiation therapy within 2 weeks of enrollment
Radiation therapy to bone within 4 weeks before enrollment;
Radiation therapy =< 2 weeks prior to randomization
Radiation or chemotherapy within 4 weeks of enrollment
Patient has had radiation therapy within 2 weeks of beginning study treatment
Subject has received chemotherapy and/or radiation therapy (except palliative radiation therapy for disease-related pain) within ?2 weeks of first ADXS11-001 infusion.
No prior systemic therapy, immunotherapy, investigational agent, or radiation therapy within the last 4 weeks. Radiation therapy for symptomatic relief is allowed within the last 2 weeks.
No radiation therapy =< 4 weeks prior to registration
Patients must be at least two weeks from prior radiation therapy (RT)
At least 2 weeks since prior chemotherapy or radiation therapy
Chemotherapy, radiation therapy, or ablative therapy within 3 weeks of randomization
Radiation therapy within 3 weeks before first dose. Radioimmunotherapy within 8 weeks before first dose.
Subject has radiation therapy within 4 weeks prior to the first study dose.
Patients currently receiving radiation therapy, or who have received radiation within 2 weeks from the start of therapy
No prior radiation therapy or radionuclide therapy for the treatment of metastasis within four weeks prior to enrollment
Patients must have failed prior radiation therapy and must have an interval of greater than or equal to 12 weeks from the completion of radiation therapy to study entry
Radiation therapy within 2 weeks prior to first dose
Radiation therapy within 2 weeks prior to first dose. Localized radiation therapy within 1 week prior to first dose.
Prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of enrollment
Concomitant anticancer therapy, immunotherapy, or radiation therapy (no radiation within prior 2 weeks)
Radiation therapy within 2 weeks prior to initiation of study treatment
At least two weeks since receipt of any biological therapy, chemotherapy, and/or radiation therapy
Concomitant anticancer therapy, immunotherapy, or radiation therapy (no radiation within prior 4 weeks)
Patients currently receiving radiation therapy or those having received radiation within 4 weeks of study entry
If palliative radiation to non-breast sites is required prior to initiation of systemic therapy, scans may be completed within 8 weeks prior to or 4 weeks following the start of radiation therapy
If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation therapy
Radiation therapy within 2 weeks prior to first study drug administration.
Radiation therapy =< 2 weeks prior to registration
Prior palliative radiation therapy less than 2 weeks prior to administration of study treatment or prior whole brain radiation therapy (WBRT) less than 4 weeks prior to study treatment
Radiation treatment within 2 weeks.
Radiation therapy within 2 weeks prior to the first dose of study medication
Therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment; or palliative radiation within 2 weeks before study drug treatment
Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment
At least 12 weeks from completion of radiation therapy except if there is unequivocal evidence for tumor recurrence in which case at least 4 weeks
Patients may not have had radiation therapy within the last 4 weeks prior to initiation of study treatment.
=< 2 weeks since radiation therapy
Radiation therapy within 2 weeks.
At least two weeks since receipt of any biological therapy, chemotherapy, and/or radiation therapy
Radiation therapy within 2 weeks of first administration of study drug
Subject has had radiation therapy within 4 weeks prior to the first study dose.
Any radiation within 2 weeks prior to starting treatment on protocol
Subject has had radiation therapy within 4 weeks prior to the first study dose
Radiation treatment within 2 weeks.
Radiation therapy or immunotherapy in the previous four weeks; localized radiation therapy within 1 week prior to first dose
Radiation therapy within 4 weeks before first dose
Patients must not have received radiation for a minimum of two weeks prior to study enrollment.
Radiation therapy to any Study Lesion within 6 weeks of initial study treatment.
The subject has received radiation therapy within 4 weeks (=< 2 weeks for palliative radiation therapy)
Radiation therapy for bone or brain metastasis within 2 weeks, any other external radiation therapy within 4 weeks of first dose of study drug; systemic treatment with radionuclides within 4 weeks; subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible
Certain drugs or radiation within 2-4 weeks of enrollment
Patients must be at least 4 weeks from the completion of any radiation therapy
Radiation therapy as cancer therapy within 4 weeks, or palliative radiation to bony metastases within 2 weeks, prior to starting study treatment
Subject has received radiation within the past 6 weeks
Planned surgeries or radiation treatment within 10 weeks following study inclusion
Interval from radiation therapy at least 4 weeks and no more than 1 year
Radiation therapy within 2 weeks of the first administration of study drug
Treatment with radiation within 6 weeks
Prior radiation therapy of the index tumor <3 weeks prior to screening
Focal radiation ? 4 weeks
Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Systemic treatment with radionuclides within 6 weeks before randomization. Subjects with complications from prior radiation therapy are not eligible and AEs must return to baseline or ? Grade 1.
3 weeks since last chemotherapy or therapeutic radiation therapy
Prior chemotherapy within 2 weeks; prior immunotherapy or biologic therapy within 4 weeks; prior radiation therapy within 3 weeks
Therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment or palliative radiation therapy within 2 weeks before study drug treatment.
chemotherapy or radiation therapy within three weeks
Children who have previously received chemotherapy, radiation therapy or any anti-leukemic therapy are not eligible for this protocol, with the exception of cytarabine for the treatment of TMD
Metastases located within 3 cm of previously irradiated (< 3Gy per fraction) structures if not a candidate for surgery for these lesions and if:\r\n* Spinal cord previously irradiated to > 40 Gy\r\n* Brachial plexus previously irradiated to > 50 Gy\r\n* Small intestine, large intestine, or stomach previously irradiated to > 45 Gy\r\n* Brainstem previously irradiated to > 50 Gy\r\n* Lung previously irradiated with prior V20 Gy > 35%
Metastases located within 3 cm of the previously irradiated structures:\r\n* Spinal cord previously irradiated to > 40 Gy (delivered in =< 3 Gy/fraction)\r\n* Brachial plexus previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)\r\n* Small intestine, large intestine, or stomach previously irradiated to > 45 Gy (delivered in =< 3 Gy/fraction)\r\n* Brainstem previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)\r\n* Whole lung previously irradiated with prior V20Gy > 30% (delivered in =< 3 Gy/fraction)\r\n* Primary tumor irradiated with SBRT\r\n* Metastasis irradiated with SBRT
Must have previously received first line treatment regimen
Patients who have received previously a high dose chemotherapy regimen and autologous transplant are excluded from this study
Received systemic investigational drug within 6 weeks prior to AVB-620 administration or has received AVB-620 previously.
At least 4 months since completion of curative therapy, if given previously
Have previously been enrolled in this study or any other study investigating SM-88 or who have previously received any component of SM-88 in a clinical trial.
All NF-1 patients with a LGG are eligible for Stratum 2, with or without histologic confirmation, provided they have never previously received adjuvant therapy with the exception of surgery
Patients with HGG: Have previously received radiotherapy and temozolomide with a maximum of 2 prior relapses on treatment
Have previously completed or withdrawn from this study or any other study investigating an ERK1/2 inhibitor.
The patient has previously received treatment with SL-801 or another investigational agent that inhibits the XPO1/CRM1 pathway.
PHASE IB: Patients in the expansion cohort must have a measurable site of disease according to RECIST (v 1.1) that has not been previously irradiated, or evidence of at least 20% progression in a previously irradiated lesion, and assessed by imaging within 28 days prior to registration for protocol therapy
Patients who have previously received PGG-Betafectin (Betafectin) or Imprime PGG
INCLUSION - PROCUREMENT: Either previously infected with varicella zoster virus (VZV; chicken pox) or previously vaccinated with VZV vaccine
Patients with previously documented macular degeneration or diabetic retinopathy are excluded from the trial
Patients who have previously received recombinant (r)IL-12
Patients who have previously received radiation therapy
Patient has previously taken ruxolitinib or is allergic to components of the study drug
Patients who have previously received either AG120 or venetoclax.
The patient has previously been enrolled in the study or received ESK981
Target tumor in region not in previously irradiated field
STRATUM C: Participants previously treated with a smoothened inhibitor must have received their last dose > 6 months prior to study enrollment
Currently or previously being on hydroxyurea
Previously untreated patients who decline standard therapy for their cancer are allowed to enroll
Subjects may have previously progressed on treatment with one of the 3 agents being used in this trial or treatment with other checkpoint inhibitors, as long as they have recovered from previous toxicity; subjects that previously progressed on treatment with a combination of any 2 of the 3 agents being used in this trial are eligible for the triplet cohort only
The participant has received prior treatment with gemcitabine or docetaxel. Note: Participants previously enrolled in the I5B-MC-JGDJ (NCT02451943) or any other blinded study with olaratumab are not eligible to participate in this trial.
Patients with previously documented macular degeneration or diabetic retinopathy are excluded
Have previously received an indoleamine- 2,3-dioxygenase (IDO) inhibitor.
Patient has been previously permanently discontinued from study treatment in the parent protocol.
Subjects who previously received IACS-010759 or oxidative phosphorylation (OXPHOS) inhibitors.
Previously diagnosed with MM requiring treatment based on IMWG diagnostic criteria;
Have previously completed or withdrawn from any study investigating olaratumab.
Patients who previously participated in CH-ACM-01 or OOC-ACM-302
Subject previously dosed with isavuconazonium sulfate.
Participants who have previously received TAS-102
Patients who have previously received systemic topotecan for their tumor
Has previously received a btk inhibitor and had progressive disease during therapy; patients who have previously discontinued btk inhibitor therapy because of intolerance may be considered for eligibility per the assessment of the PI and treating physician if there is reason that the patient may better tolerate btk inhibitor therapy at enrollment versus previously
Subjects who received GCB systemically previously are eligible for participation
Clinical target volume (CTV) size must be < 250 cc, no more than 74 Gy of prior radiation in 2 Gy fractions previously administered
Patients with previously documented macular degeneration or untreated diabetic retinopathy (stable retinopathy is allowed)
Patients must not have previously undergone an intracranial LITT procedure.
Have previously completed, discontinued, or have been withdrawn from this study.
Have previously received maribavir.
Scenario 1: No prior cdk 4/6 inhibitor; if patient has not previously received letrozole, letrozole will be supplied by Novartis; if previously progressed on letrozole, another aromatase inhibitor that the patient has not previously received is allowed, per standard of care (anastrazole or exemestane, not supplied by study); ribociclib will be supplied by Novartis; if patient has previously received letrozole, anastrazole, and exemestane, (s)he is not eligible; for scenario 1, patients are allowed to have started the aromatase inhibitor within 4 consecutive weeks prior to protocol registration; for instance, it is acceptable for patient who will be treated with letrozole in scenario #1, to have started letrozole within 4 consecutive weeks prior to protocol registration; no prior fulvestrant allowed
Since selumetinib is not expected to cause substantial myelosuppression, there will be no limit to number of prior myelosuppressive regimens previously received for NF1 related; or other tumor manifestations
Patients must have previously received at least one standard therapy for their cancer (if available) and have been either non-responders (progressive disease) or have recurred
Patients with HM, as previously defined, without confirmed response to standard, first-line antineoplastic therapy, and/or who do not fulfill all Inclusion Criteria as stated, will be ineligible to participate in this study.
Patients who have previously received alemtuzumab are ineligible
The subject has previously participated in this study.
Patients who have previously received therapeutic radiation therapy to the chest
Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous mebendazole or benzimidazole class drug for a parasitic infection
Patient has previously participated in the Toca 5 trial (Tg 511-15-01).
Patients may not have previously received alisertib
Newly diagnosed Philadelphia chromosome-positive (Ph+) ALL, previously untreated, except for the below allowances:\r\n* Previously received hyperfractionated cyclophosphamide, vincristine, doxorubicin and dexamethasone (HyperCVAD) cycle 1A +/- cycle 1B\r\n* Previously received induction phase I +/- induction phase II of Berlin-Frankfurt-Munster (BFM)-modeled (pediatric or pediatric-inspired) ALL regimen\r\n* Previously received other representative (modified from HyperCVAD, BFM, or AML-like) ALL induction course, including ABL tyrosine-kinase inhibitor (TKI) plus corticosteroid\r\n* If the patient has received any of the above prior therapy, they may be enrolled, regardless of remission status
Subject previously has entered this study
Patients with previously documented macular degeneration or untreated diabetic retinopathy (stable retinopathy is allowed)
Patients previously exposed to bosutinib are eligible unless they carry T315I
The patient has previously received definitive surgical, radiation, or chemoradiation treatment for HNSCC
Patients with previously documented macular degeneration or diabetic retinopathy are excluded
Previously untreated patients with locoregional-only disease are not eligible
Subjects with metastatic disease exclusively present within a previously irradiated field\r\n* Subjects with metastasis within and outside of previously irradiated field that is eligible for SABR are eligible
Patients may not have previously failed treatment with salvage temozolomide
Patients who have previously received therapeutic radiation therapy to the chest
Patients who have received previously a high dose chemotherapy regimen and autologous transplant are excluded from this study
Subjects who have been previously randomized into the present study;
Patients may have previously failed non-platinum containing therapy or may never have previously progressed on treatment
Previously diagnosis of alpha- or beta-thalassemia since these patients may have significantly higher PK levels than patients without these disorders
Active intracranial metastases; patients with previously resected intracranial disease and/or previously irradiated intracranial metastases that have been clinically stable for four weeks are eligible
Subjects who had previously received an experimental agent for MDS may not be randomized until a washout period has elapsed since the last dose of that agent.
Participants who have ever previously received any anti-neoplastic agent, including methotrexate, 6-mercaptopurine, 6-thioguanine, vincristine cyclophosphamide, cytarabine (except for IT cytarabine), or any anthracycline, for any reason (e.g., rheumatologic or autoimmune condition) are not eligible
Have previously received maribavir.
Participants may not have been vaccinated previously with any of the synthetic peptides included in this protocol
Subjects who have previously received anetumab ravtansine
Have previously completed or withdrawn from this study or any other study investigating dasatinib; prior treatment with other tyrosine kinases, including afatinib, is acceptable
Symptomatic, previously untreated (with exception of corticosteroids) secretory myeloma
All laboratory and imaging studies must be completed and satisfactory within 30 days of signing the consent document, with the exceptions of: negative serum pregnancy test for women of child-bearing potential which must be negative within 7 days of screening, human leukocyte antigen (HLA)-typing which will not be repeated if performed previously, and pulmonary function tests (PFTs)/cardiac stress tests whose results are valid for 6 months if performed previously
All laboratory and imaging studies must be completed and satisfactory within 30 days of signing the consent document, with the exceptions of: negative serum pregnancy test for women of child-bearing potential must be negative within 7 days of starting vemurafenib, human leukocyte antigen (HLA)-typing which will not be repeated if performed previously, and pulmonary function test (PFTs)/cardiac stress tests whose results are valid for 6 months if performed previously
previously received:
The patient has previously received treatment with SL-401.
Subjects who have previously undergone intraperitoneal chemotherapy
Previously received X4P-001
Have previously completed or withdrawn from this study or any other study investigating LY3039478 or other Notch inhibitors.
Has previously received TAS-102.
If enrolled in Part 2SA, new, growing, or previously untreated lesions since the start of anti-PD-1 therapy.
Received glembatumumab vedotin (CR011-vcMMAE; CDX-011) or other MMAE-containing agents previously.
Subjects must have previously completed standard radiation therapy and been exposed to temozolomide. Patients must be in first or second relapse.
Patients with previously documented macular degeneration or diabetic retinopathy
Patients who have previously received systemic, radiation or other treatment for uterine cancer
Patients must not have previously received a histone deacetylase (HDAC) inhibitor in a clinical trial setting (entinostat, romidepsin, belinostat, panobinostat, vorinostat)
For participants enrolled in the expansion phase: lymphoma classified as either previously untreated Grade 1, 2, or 3a FL that requires treatment or previously untreated advanced DLBCL
Metastases located within 3 cm of the previously irradiated structures:\r\n* Spinal cord previously irradiated to > 40 Gy (delivered in =< 3 Gy/fraction)\r\n* Brachial plexus previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)\r\n* Small intestine, large intestine, or stomach previously irradiated to > 45 Gy (delivered in =< 3 Gy/fraction)\r\n* Brain stem previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)\r\n* Whole lung previously irradiated with prior volume 20 Gy (V20Gy) > 30% (delivered in =< 3 Gy/fraction)\r\n* Primary tumor irradiated with SBRT\r\n* Metastasis irradiated with SBRT
Patients who received PDGFR inhibitors (imatinib, sunitinib, nilotinib, etc.) previously are excluded (patients who received PDGFR antibody based treatment however are allowed)
Patients who have previously received radiation therapy
Patients may not have received eribulin or lenvatinib previously
Patients who have previously received mithramycin, strontium-89, samarium-153 or rhenium
Patients who have received trabectedin (Yondelis, ET-743) or participated in the phase III clinical study of trabectedin NCT01343277 previously will not be eligible
Patient was previously exposed to PBI 05204.
Not recovered from AEs due to a previously administered therapy
Subjects who have received radiation to the orbit at any time previously
Previously untreated participants are eligible if their tumor(s) are measurable
COHORT II: Patients must not have previously received treatment with chemotherapy for MM
In the Phase 2 portion of the trial only, subjects who have previously received treatment with an inhibitor of IDH.
Patients with previously documented macular degeneration or diabetic retinopathy are ineligible
Previously received eribulin.
Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous mebendazole or benzimidazole class drug for a parasitic infection
Use previously of intra-articular treatment within 4 weeks prior dosing.
Previously untreated patients with lymphoplasmacytic lymphoma (of any subtype: IgG, IgA, IgM) in the asymptomatic phase
Retreatment of previously irradiated tumor will be excluded; this will in general be described as an anticipated overlap of a region that has previously received >= 50 Gy and would now be included within the D90 region of the SBRT plan; there is no restriction on prior stage as long as dosimetry guidelines can be met
Has previously undergone a left sided colon resection.
Subject has received ASP2215 previously.
Must have previously received at least one prior chemotherapeutic regimen for RT.
Previously untreated RT patients deemed ineligible for, or that refuse, intensive chemotherapy are eligible.
COHORT 2 ONLY: A Smoothened inhibitor must have been previously administered as monotherapy
Previously received photodynamic therapy for cholangiocarcinoma
Previously undergone metal stent insertion
No documentation of prior cytotoxic or other therapy for malignancy if such therapy was previously received; Note: This does not apply to patients with synchronous metastases at initial diagnosis
Has previously received X4P-001.
Subjects who were previously enrolled in a clinical study with caplacizumab and received caplacizumab or for whom the assigned treatment arm is unknown
Patients who have previously received CDX-011 (CR011-vc monomethyl auristatin E [MMAE]; CDX-011) or other MMAE-containing agents
Patients who have previously received CDX-011 (glembatumumab vedotin) or other monomethyl auristatin E (MMAE)-containing agents
Have previously received an investigational BET inhibitor (including previous participation in this study or Study ZEN003694-002)
Patients who have previously received eribulin, halichondrin B, or analogues of halichondrin B
Patients who have previously received romidepsin or Abraxane
Patients previously randomized in any other Onyx-sponsored phase 3 trial
Have previously been exposed to MGAH22 in this or any other trial
Patients who are receiving or have received any other investigational agents within 30 days of study day 1, or who have previously received MK-2206 at any time
The patient previously received treatment with SL-401.
GIST subjects must have previously received all FDA-approved therapies (imatinib mesylate, sunitinib malate, and regorafenib) for which they are eligible
Patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.
Patients who have previously received treatment with LY2940680
Patients who have previously received radiation therapy to areas of the lung or mediastinum near target(s)
Subjects who have previously received hyperthermia in conjunction with either radiation therapy or chemotherapy are eligible.
Must have presumed resectable or partially resectable malignant glioma based on clinical and radiologic evaluation (pathologic confirmation of malignant glioma must be made at the time of surgery if not previously determined). Patients who have previously received AdV-tk + prodrug on this study may receive an additional AdV-tk + prodrug course at recurrence if eligibility criteria are still met.
Previously enrollment in this study
Patients with a feeding tube previously placed
Subject has previously been enrolled in this study and received at least 1 per protocol PLT transfusion
All subjects previously discontinued from an elotuzumab study for any reason
Survivors must not have previously received an SCP or are unwilling to receive one
No prior chemotherapy or radiation therapy for osteosarcoma; subjects who develop osteosarcoma as a second cancer are eligible if they have not previously received cisplatin, doxorubicin or other anthracyclines, or MTX
Previously on ADT
Patients who may have previously received SP-SAP on the study
Previously participated in any type of research study
Patients having previously undergone large surgical resections of the larynx or hypopharynx will be excluded
Have previously received an investigational BET inhibitor (including previous participation in this study or Study ZEN003694-001)
No documentation of prior cytotoxic or other therapy for malignancy if such therapy was previously received; Note: This does not apply to patients with synchronous metastases at initial diagnosis
Previously randomized to this study.
Patients who have previously utilized art therapy at Maroone Cancer Center
Subjects who have previously completed primary treatment for a gynecologic malignancy
Phase I: Previously screened or not screened
Patient must not have previously had a breast MRI
If previously measured, known LVEF < 50%
CONTROL (HEALTHY) GROUP: If previously measured, known LVEF < 50%
Patients who have been previously vaccinated with vaccinia
Has previously participated in this study, has previously received bezlotoxumab, has received an experimental monoclonal antibody against C. difficile toxin B, or has received a vaccine directed against C. difficile or its toxins.
Patients who have previously received SCH727965
Has previously participated in a MK-8228 (letermovir) study
Any patient who previously underwent spinal surgery at these levels will be excluded to eliminate late postoperative changes
Have a previously diagnosed condition of dry mouth
Have a previously diagnosed condition of gum disease this included gingivitis, gingival bleeding and plaque
Patient has previously participated in this study.
Patient has previously received [18F]NaF in the last thirty days
Previously untreated sarcomas
Previously untreated subjects must have a lesion on an imaging study
Have not previously viewed the Pathways decision aid
Only subjects previously participating in two specific studies are eligible to enroll into this study. Enrollment is not open to subjects if not previously enrolled in studies B1871006 or B1871008.
All subjects are excluded unless previously participating in studies B1871006 or B1871008.
Subjects may have previously received pre-operative radiation therapy.
For all patients:\r\n* Radiation dose should range from 4500 cGy to 6000 cGy\r\n* No treatment for this disease following radiation therapy
Prior radiation therapy with 400 cGY or more of TBI.
Prior radiation therapy with 400cGy or more of TBI.
Patient must be able to pass radiation evaluation (i.e.: able to receive 200 cGy)
Any prior therapeutic radiation therapy > 500 cGy has been delivered
Have received radiation therapy with concurrent temozolomide; total radiation dosage can range from 5400 to 6000 cGy administered in daily fractions of 150 to 200 cGy over 6 weeks, or the equivalent in a hypofractionated protocol (for example, 4000cGy in 15 fractions or 2500cGy in 5 fractions); patients who are MGMT negative do not need to have received temozolomide
Prior radiation doses equivalent to, or greater than, 8000 cGy to the target lesions at 200 cGy fractions at any timepoint
No thoracic radiation > 3000 cGy allowed
Patients may enter this study with or without salvage therapy for recurrent tumor; patients must have fully recovered from the toxic effects of any prior therapy; \r\n* Myelosuppressive chemotherapy and/or biologics: must not have received within 3 weeks of entry onto this study; (6 weeks in the case of mitomycin C or nitrosourea-containing therapy)\r\n* Radiation therapy (XRT): 6 weeks must have elapsed since completing radiation therapy to any site (6 months in the case of craniospinal, whole lung); patients are excluded if they have received local radiation which includes any of the following:\r\n** 1200 cGy to more than 33% of both kidneys (patient must have at least one kidney that has not exceeded the dose/volume of radiation listed)\r\n** 1800 cGy to more than 30% of liver and/or 900 cGy to more than 50% of liver\r\n** Prior MIBG therapy: should be at least 42 days from previous 131I-MIBG therapy and have recovered completely from all clinically significant treatment associated toxicities; patients must not exceed a lifetime cumulative injected activity of 54 mCi/kg for patients with neuroblastoma and 36 mCi/kg for patients with other MIBG avid diseases; patients must have demonstrated a response to prior MIBG therapy (either clinical, pathological and/or radiographic improvement)
Significant prior external beam dose-limiting radiation to a critical organ based on review of the prior radiation treatment records by the Radiation Oncology PI; patients who have had prior external beam radiation > 2000 cGy (at 180 to 200 cGy per day) to the lung will be ineligible; patients with ANY prior radiation to the heart are ineligible; patients with > 500 cGy to the kidney will be excluded from the study; Note: patients who have had electron beam therapy are still eligible and will be evaluated on a case by case basis by the Radiation Oncology PI
Patients who had prior radiation to more than 20% bone marrow containing areas or to any areas exceeding 2000 cGy
Patients will be ineligible if any prior therapeutic radiation therapy > 500 cGy has been delivered
Significant prior external beam dose-limiting radiation to a critical organ based on review of the prior radiation treatment records by the radiation oncology PI; patients who have had prior external beam radiation > 2000 cGy (at 180 to 200 cGy per day) to any portion of the lung will be ineligible; patients with ANY prior radiation to the heart are ineligible; patients with > 500 cGy to any portion of the kidney will be excluded from the study
Patients with no previous radiation or up to a maximum 2000 cGy to non thoracic-spine and rib bone lesions or < 20% of bone marrow are eligible for TMI conditioning regimen
Kidney: 500 cGy
Liver: 1000 cGy
Lungs: 500 cGy
Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of TBI
Patients may have had prior systemic therapy without constraint on the number of prior treatment regimens except:\r\n* Patients may not have had > 450 mg/m^2 doxorubicin \r\n* Patients may not have had > 3000 centigray (cGy) to fields encompassing the entire pelvis
Patients undergoing a total body irradiation (TBI)-based conditioning regimen (TBI 1200 cGy)
Patients will be ineligible if any prior therapeutic radiation therapy > 200 cGy has been delivered to the target volume
Prior radiation therapy with 400 cGy or more of TBI; if 200 cGy of prior TBI then only 400 cGy of TBI on this protocol is permitted
Patients will be ineligible if any prior therapeutic radiation therapy > 200 cGy has been delivered to the target volume
Patients will be ineligible if any prior therapeutic radiation therapy > 200 cGy has been delivered to the central nervous system
Previous radiation therapy to more than 20% of bone marrow containing areas, or to any area exceeding 2000 cGy, is an exclusion
Patients who have received > 500 cGy radiation to the kidneys will be excluded from the study
Patients are not eligible if they have received local radiation which includes any of the following: 1200 centigray (cGy) to more than 33% of both kidneys (patient must have at least 1 kidney that has not exceeded the dose/volume of radiation listed) or 1800 cGy to more than 30% of liver and/or 900 cGy to more than 50% of liver; emergency local irradiation is allowed prior to study entry, provided the patient still meets eligibility criteria
One or more radiation treatment(s) to the chest wall or breast up to a maximum prior dose of 12,000 cGy in the hyperthermia field (not administered less than 28 days prior to enrollment).
Received >= 2000 centigray (cGy) radiation to the heart/chest
>= Ten years post-radiation therapy following an accumulated dose of >= 2000 cGY to the heart/chest
Histologic documentation of malignancy currently undergoing a course of RT (with or without chemotherapy) including the oral cavity and/or oropharyngeal area to a dose of at least 4500 cGy using more than 5 fractions (i.e., stereotactic body radiation therapy [SBRT] is not allowed)
Receiving a dose of radiation therapy greater than or equal to 6000 centigray (cGy) to one third of the oral cavity
Current diagnosis of cancer that supports the use of continuous definitive or adjuvant external-beam RT to the pelvis to a minimum dose of 4500 cGy with the following parameters:\r\n* The pelvis must be encompassed by the planned RT fields; the superior border may not lie inferior to the most inferior aspect of the sacroiliac joints; portions of the rectum may have special blocking, depending upon disease site\r\n* The total prescription dose must lie between 4500-5350 cGy (inclusive); a boost to primary tumor or tumor bed may be planned\r\n* Planned treatment is to be given 4-5 times per week on a one–treatment-per-day basis; the daily prescribed dose must lie between 170-210 cGy (inclusive) per day
Patient must be cleared pre-transplant by Radiation Oncology to be able to receive 400 cGy
Patients whose clinical treatment plans include a continuous course of external beam radiotherapy by intensity-modulated radiation therapy (IMRT) and/or image-guided radiation therapy (IGRT), given as a cumulative dose of 5000 – 7000 centigray (cGy) in single daily fractions of 180 - 200 cGy, combined with a concurrent course of weekly or tri-weekly cisplatin or carboplatin chemotherapy
The participant has received radionuclide treatment within 6 weeks of the first dose of study treatment
Radionuclide treatment within 6 weeks of the first dose of study drug in this study
mCRPC EXPANSION COHORT: The patient has received radionuclide treatment within 6 weeks prior to the first dose of the study treatment
Received radionuclide treatment (i.e. iodine [I]-131 meta-iodo-benzyl guanidine) within 6 months of the first dose of study treatment
The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment
The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment
The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment
No prior radionuclide treatment within 6 weeks of the first dose of study treatment
Radionuclide treatment, including yttrium-90 treatment, within 6 weeks of the first dose of study treatment
The subject has received radionuclide treatment within 6 weeks before the first dose of study treatment
Systemic therapeutic radionuclide delivery within 30 days prior to treatment
The subject has received radionuclide treatment within 6 weeks prior to the first dose of the study treatment
Biological agents (antibodies, immune modulators, cytokines, or vaccines) or radionuclide treatment within 6 weeks of the first dose of study treatment
The participant has received radionuclide treatment within 6 weeks of the first dose of study treatment
Cannot have received radionuclide treatment within 6 weeks of first dose of study treatment
The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment
The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment
The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment
The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment
Major surgery or other loco regional treatment within 4 weeks before the first dose of study drug or radionuclide treatment within 8 weeks
For patients with CNS tumors, any baseline neurologic deficit, including seizures, must be stable for at least one week prior to initiating study treatment
Chemotherapy within 2 weeks of initiating study treatment; there is no maximum allowable number of previous therapies
Patients who received any of the following within the 14 days before initiating study treatment:
Participants who underwent minor surgical procedure within 7 days prior to initiating therapy
Major surgery within 28 days prior to initiating therapy
Progressive disease before initiating study treatment
Central nervous system (CNS) metastasis, unless asymptomatic and stable with no change in CNS disease status for at least two (2) weeks prior to initiating protocol-indicated treatment.\r\n* Anticonvulsant and/or corticosteroid prophylaxis (=< 10 mg/day prednisone or equivalent daily) will be allowed if patient is on a stable or decreasing dose of such treatment for at least 14 days prior to initiating protocol-indicated treatment.
At time of registration and within 4 weeks prior to initiating on-protocol treatment: Platelets >= 100 x 10^9 /L
Platelets >= 75,000 per mm^3 obtained within 14 days prior to initiating study treatment.
Symptomatic hypothyroidism without replacement\r\n* Patients may be rescreened after initiating adequate replacement therapy
Central nervous system (CNS) metastasis, unless asymptomatic or previously treated and stable; and no evidence of CNS progression for at least 30 days prior to initiating protocol-indicated treatment; anticonvulsant and/or corticosteroid therapy will be allowed if patient is on a stable or decreasing dose of such treatment for at least 30 days prior to initiating protocol-indicated treatment
Pregnant and nursing: female patients must have a negative serum pregnancy test within 72 hours prior to initiating protocol therapy and be practicing an effective form of contraception during protocol therapy and for at least 4 weeks following completion of protocol therapy
Any skin-directed therapy within 14 days prior to initiating protocol therapy
Any radiation therapy within 21 days prior to initiating protocol therapy
Systemic estrogens or androgens within 14 days before initiating therapy; vaginal estrogens are allowed if necessary for patient comfort
Systemic estrogens or androgens within 14 days before initiating therapy; vaginal estrogens are allowed if necessary for patient comfort
Major surgery within the four weeks prior to initiating protocol therapy
Anticancer therapy within 2 weeks prior to initiating study treatment
Systemic oral corticosteroid treatment within 28 days prior to initiating treatment on study except as detailed above
Contraindication to antiangiogenic agents, including:\r\n* Serious non-healing wound, non-healing ulcer, or bone fracture\r\n* Major surgical procedure or significant traumatic injury within 4 weeks prior to initiating study treatment\r\n* Pulmonary hemorrhage/bleeding event >= grade 2 within 12 weeks prior to initiating study treatment\r\n* Any other hemorrhage/bleeding event >= grade 3 within 12 weeks prior to initiating study treatment
The use of anti-convulsants is allowed, as long as the patient is on a stable dose with no seizure activity for at least 2 weeks prior to initiating trial therapy
Systemic oral corticosteroid treatment within 28 days prior to initiating treatment on study
Participation in an investigational new drug trial within 28 days prior to initiating treatment on study
Treatment with any investigational drug within 28 days prior to initiating study medications
Patient has had any systemic therapy within 2 weeks prior to initiating study drug.
Patient has participated in a prior investigational study within 3 weeks prior to initiating study drug.
Contraindication to antiangiogenic agents, including:\r\n* Serious non-healing wound, non-healing ulcer, or bone fracture\r\n* Major surgical procedure or significant traumatic injury within 4 weeks prior to initiating study treatment; other surgical procedures within 2 weeks prior to initiating study treatment\r\n* Pulmonary hemorrhage/bleeding event >= grade 2 within 12 weeks prior to initiating study treatment\r\n* Any other hemorrhage/bleeding event >= grade 3 within 12 weeks prior to initiating study treatment
No hormonal therapy is allowed within 1 week of initiating study treatment
Patients must consent to whole blood (2 x 10 mL) submitted prior to initiating chemotherapy
Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
Within 72 h of initiating study treatment: Albumin >= 2.5 g/dL
Patients receiving anti-herpes medication within 1 week prior to initiating HF10 treatment.
PHASE I: Prior chemotherapy or radiation administered within 2 weeks from initiating study treatment
Fully recovered from any prior surgery and/or radiation and none within 2 weeks of initiating treatment
Prior systemic therapy within 14 days of initiating protocol treatment
Systemic infection that has not resolved > 2 months prior to initiating lenalidomide
Systemic infection that has not resolved > 2 months prior to initiating lenalidomide treatment in spite of adequate anti-infective therapy
Participation in any clinical study or having taken any investigational therapy for a disease other than CLL within 28 days prior to initiating maintenance therapy.
In the unlikely event that patients are still of childbearing potential, these patients must have a negative serum pregnancy test within 72 hours prior to initiating protocol therapy and be practicing an effective form of contraception during protocol therapy and for at least 4 weeks following completion of protocol therapy
Definitive therapy of the primary uveal melanoma must have been performed within 120 days of initiating protocol therapy
Prior systemic therapy within 14 days of initiating protocol treatment
ELIGIBILITY PRIOR TO INITIATING CT-011:
Corticosteroids discontinued ?7 days of initiating therapy
Progression during the first 3 months of initiating treatment
Initiating focal cranial radiation therapy (photon or proton)
NON-RANDOMIZED OBSERVATIONAL COMPONENT ELIGIBILITY:\r\nUndergoing or initiating active surveillance
Initiating or within 30 days of initiating ADT
Patients who will be initiating therapy with any investigator-initiated mTOR inhibitor based therapy in the Department of Investigational Cancer Therapeutics (phase I program) or initiating radiation therapy to the esophagus
Parts C, D, and E: patients who have received prior ipilimumab are not eligible
Patients must not have received prior systemic treatment for this melanoma
Patients having received palliative radiotherapy for extracranial metastasis(es) are eligible as long as there are 2 cancerous deposits that have not received prior radiation therapy (RT) and they meet the following criteria\r\n* No prior radiation therapy (> 5 Gy) to the metastasis intended to be treated with SBRT
Patients must not have received enzyme–inducing anticonvulsants within 14 days prior to enrollment
Prior lapatinib is allowed as long as the last dose received was > 21 days prior to study entry and provided the patient has not received it at any time after the diagnosis of brain metastasis
Prior treatment. Patients must have received:
Patients are not required to have received or progressed on a prior therapy.
Patients who have received prior ipilimumab treatment for metastatic melanoma are not eligible.
Subjects who have received prior therapy with any hypomethylating agents
Received prior treatment with radioimmunotherapy, (e.g. radionuclides, holmium).
Phase 1: Subjects with a RET rearrangement must have had disease progression after at least one prior line of systemic therapy; subjects with an ALK rearrangement may be either treatment naive or may have received prior treatment, and must have CNS disease present at baseline; subjects cannot have received more than one prior RET TKI (such as, but not limited to, vandetanib, sorafenib, sunitinib, ponatinib, or cabozantinib); subjects enrolling to the phase 1 portion of the trial must not have received prior alectinib therapy
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy prior to participating in this trial\r\n* No prior myelosuppressive chemotherapy for at least 21 days prior to study enrollment\r\n* Must not have received craniospinal radiation therapy within 24 weeks prior to study entry and no involved field radiation therapy for 12 weeks prior to study enrollment\r\n* If patients received prior monoclonal antibody treatment, at least three half-lives must be elapsed by the time of treatment initiation\r\n* No investigational drugs for 4 weeks prior to study enrollment\r\n* No prior therapy with mTOR inhibitors (including sirolimus, temsirolimus or everolimus)
PHASE I SUBJECTS ONLY: Prior therapy is allowed; for patients enrolled in the Phase I portion of the study, patients may have received any number of prior lines of therapy including treatment with a BRAF and/or MEK inhibitor; prior navitoclax use will not be allowed, unless the patient received < 7 days of navitoclax lead-in on this or another study and had to stop for reasons other than toxicity or disease progression
Patients who have received any steroids in the week prior to diagnosis except as stated in Section 4.1.4 of the protocol.
Patients can have received any number of prior therapies for treatment of their uveal melanoma excluding prior treatment with an ERK inhibitor; patients who have received prior MEK inhibition or other MAPK targeted agents will be allowed on study
Patients who received prior anti-tumoral radionuclide therapy (with unsealed sources) are not eligible for the study
Has received prior radiotherapy within 2 weeks of start of study therapy or received lung radiation therapy of >30 Gray (Gy) within 6 months of the first dose of study therapy
Patients may be newly diagnosed or have received any number of lines of prior anticancer therapy; however, patients are required to have received available therapies for their primary disease, as deemed appropriate by the treating investigator
Patients who have received another cancer therapy within 2 weeks before the planned day for the apheresis
Patients must not have received prior exposure to VX15/2503
Patients may have had treatment (chemotherapy and/or radiotherapy) or no treatment for any number of relapses prior to this recurrence\r\n* Patients must have received their last dose of myelosuppressive anticancer chemotherapy at least three (3) weeks prior to study registration or at least six (6) weeks of nitrosourea\r\n* Patients must have received their last dose of other investigational or biological agent > 7 days prior to study entry\r\n** For agents that have known adverse events occurring beyond 7 days after administration, this period should be extended beyond the time during which adverse events are known to occur; this should be discussed with the study chair\r\n* If patients received prior monoclonal antibody treatment, at least three half-lives must be elapsed by the time of treatment initiation; these patients should also be discussed with the study chair\r\n* Patients must have received their last fraction of craniospinal or focal radiation to primary tumor or other sites > 12 weeks (3 months) prior to registration
Patients with NF1 will only be eligible if complete tumor resection is not considered to be feasible without substantial risk or morbidity, or if a patient with a surgical option refuses surgery\r\n* Since there is no standard effective chemotherapy for patients with NF1 and PN, patients may be treated on this trial without having received prior medical therapy directed at their PN\r\n* Since selumetinib is not expected to cause substantial myelosuppression, there will be no limit to number of prior myelosuppressive regimen for PN or other tumor manifestations associated with NF1 such as optic glioma\r\n* Patients who have received previous investigational agents or biologic therapy, such as tipifarnib, pirfenidone, Peg-Intron, sorafenib, or other VEGFR inhibitors are eligible for enrollment\r\n* Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days and are not permitted while on the study\r\n* At least 6 weeks must have elapsed prior to enrollment since the patient received any prior radiation therapy, and no prior radiation therapy should have been directed at the target PN\r\n* At least 4 weeks must have elapsed since receiving medical therapy directed at the PN\r\n* At least 4 weeks must have elapsed since any surgeries, with evidence of completed wound healing\r\n* Patients who received prior medical therapy for their PN must have recovered from the acute toxic effects of all prior therapy to =< grade 1 Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) before entering this study
Patients will be excluded from Arms A and C if they have received a previous myeloablative transplant; patients who have received a prior HCT at least 6 months prior may be considered for inclusion on Arms B or D after discussion with the principal investigator (PI)
Received prior treatment targeting the signaling pathway of TGF-?.
Patients who have received prior systemic therapy for metastatic RCC or have previously received IL-2 are not eligible; patients on hydroxychloroquine (HCQ) in neoadjuvant protocols or in the past for clinical indications ARE eligible
Subjects must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study and meet time restrictions from end of prior therapy as stated below: \r\n* Myelosuppressive chemotherapy: Subjects must have received the last dose of myelosuppressive therapy at least 3 weeks prior to study registration or at least 6 weeks if therapy included nitrosourea\r\n* Investigational/biological agent: Subjects must have received the last dose of other investigational or biological agent > 7 days prior to study registration; subjects must not have received poly-ICLC in the past\r\n* Radiation therapy (XRT): Subjects must be >= 8 weeks since the completion of radiation therapy\r\n* Study specific limitations on prior therapy: There is no limit on the number of prior treatment regimens or received doses of radiation therapy\r\n* Growth factor(s): Subjects must not have received any hematopoietic growth factors within 7 days of study entry or 21 days for pegfilgrastim\r\n* Prior surgery: Subjects must be >= 2 weeks from prior surgery\r\n* Steroids: Subjects must be on a stable steroid dose for 7 days prior to study entry if they are on steroid treatment
Patients who have received prior taxanes, including weekly taxanes are allowed
Patients who received other chemotherapeutics or investigational agents in addition to their radiation therapy and concomitant temozolomide treatment
Has received prior therapy with an indoleamine-pyrrole 2,3-dioxygenase (IDO) inhibiting agent
Patients may not have received prior cell therapy
Has not received any prior therapy for the disease
Patients must have received < 2 cycles of systemic anti-myeloma therapy.
Patients who have received mid-intensity melphalan (>50 mg IV) as part of prior therapy.
Received prior treatment for cancer with a camptothecin-derived agent.
Received any cell-based anti-AdV therapy within 6 weeks prior to Day 1 or previously received an anti-AdV vaccine at any time.
Patients may have received one prior depot injection of LHRH agonist or LHRH antagonist (degarelix) within 30 days prior to study entry. Patients who have received any other prior hormonal therapy or any chemotherapy for prostate cancer will be excluded. (Patients who have discontinued finasteride or dutasteride or testosterone supplement for at least 2 weeks will be allowed to enroll).
Patients who have received no prior systemic treatment
Has received prior therapy with an immunomodulatory agent.
Patients must not have received zoledronic acid (ZA) for any reason prior to the study
Patients with a confirmed diagnosis of multiple myeloma who have received two or more lines of therapy including an IMiD and PI, and are relapsed and/or refractory to their most recent line of therapy. Patients who have received a prior autologous bone marrow transplant and otherwise meet the inclusion criteria are eligible for this study.
Patients may be treated on this trial without having received prior medical therapy directed at their GIST, patients who have had prior GIST-directed surgery may enroll provided they have measurable disease
Patients who have received previous investigational agents or biologic therapy, such as tipifarnib, pirfenidone, Peg-Intron, sorafenib, imatinib or other targeted therapies are eligible for enrollment; at least 4 weeks must have elapsed since receiving medical therapy directed at the plexiform neurofibromas (PN) and patients who received previous GIST-directed therapy must either demonstrate progression as defined by RECIST, or be unable to tolerate their previous therapy; patients who received prior medical therapy for their PN must have recovered from the acute toxic effects of all prior therapy to =< grade 1 before entering this study
Patients can or cannot have receive prior therapy with hypomethylating agent but will be allocated to specific patient cohorts based on their prior exposure. Patients that had received prior hypomethylating agent therapy should have at least received 6 cycles of therapy and not achieved any response or had progressed after any given number of cycles
Patients may not be receiving or have received Zometa during/or within 3 weeks prior to treatment with Zometa
Received prior obinutuzumab.
Patients who received prior local therapy (e.g., transarterial chemoembolization [TACE]) are eligible
Concurrent treatment with other anti-cancer systemic therapies is not allowed. No other concomitant intrathecal therapy with another agent will be allowed. For patients that have received other systemic therapies, the minimum wash out period is as follows:\r\n* Patients that received previous IT therapy must have received their last treatment >= 14 days prior to the start of treatment\r\n* Patients who have received systemic chemotherapy must have received their last treatment >= 21 days prior to the start of treatment\r\n* Patients who have received an approved biologic therapy (e.g. anti-PD-1, anti-CTLA4, IL2, interferon) must have received their last treatment >= 4 weeks prior to the start of treatment\r\n* Patients who have been treated with an approved targeted therapy (BRAF inhibitor and/or MEK inhibitor) must have received their last treatment >= 28 days or 5 half-lives (whichever is shorter) prior to the start of treatment\r\n* Patients who have received any other investigational agents must have received their last treatment >= 28 days or 5 half-lives (whichever is shorter) prior to the start of treatment
Receiving, or received during the four weeks prior to first dose, cytotoxic treatment for their malignancy Receiving, or received during the week prior to first dose, corticosteroids for any reason
Patients must not have received previous radiation therapy or investigational therapy for the treatment of advanced metastatic disease.
Has received prior anti-myeloma therapy of any type
Patients who received ? 28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial are eligible.
Insurance pre-authorization must be received
Subjects who have not received radiation therapy as part of their prior treatment are excluded
Has received prior systemic cytotoxic chemotherapy, antineoplastic biological therapy (e.g., cetuximab), major surgery within 3 weeks of the first dose of trial treatment; received thoracic radiation therapy of > 30 Gy within 6 months of the first dose of trial treatment
Participant may have received prior investigational therapy (including immune therapy)
Since there is no standard effective chemotherapy for patients with NF1 and cutaneous neurofibromas, patients may be treated on this trial without having received prior medical therapy directed at their plexiform neurofibromas (PN)
Patients must have received prior radiation therapy and standard temozolomide; patients who have received additional therapies for previous progressions will be considered eligible
Patients must have received one course of induction treatment with BCG (4-6 weekly doses), irrespective of the interval since last treatment; patients are allowed to have received any number of prior chemotherapy instillations\r\n* NOTE: Patients may have received prior intravesical interferon
Subjects must have received or be receiving, at time of enrollment, “RVD” therapy (combination therapy with lenalidomide, bortezomib, and dexamethasone); patients must have received =< 6 cycles of RVD at time of enrollment and must not have progressed (by IMWG criteria) on RVD; patients may have received other regimens prior to RVD if such therapy was limited to =< 3 cycles; patients may have received radiation therapy prior to enrollment; patients must not have received infusional chemotherapy (e.g., bortezomib/thalidomide/dexamethasone-cisplatin/doxorubicin/cyclophosphamide/etoposide [VTD-PACE] or similar regimen) prior to enrollment
Prior treatment:\r\n* Patients must not have received chemotherapy, radiation or surgical resection of malignancy within 3 weeks prior to the start of study drug; however, if they have received nitrosourea or mitomycin C then they should not be enrolled in the study until 6 weeks after therapy was last received\r\n* No limitations to number of prior therapies\r\n* Prior treatment with volasertib or any PLK1 inhibitor\r\n* Prior treatment with a histone deacetylase inhibitor (anti-epileptics ok)
Patients who have received organ transplantations.
PRIOR TO LYMPHODEPLETION: Received any investigational agents or received any tumor vaccines within the previous six weeks prior to cell infusion
PRIOR TO INFUSION OF ATLCAR.CD30 CELLS: Received any investigational agents or received any tumor vaccines within the previous six weeks prior to cell infusion
Patients must have received at least one prior therapy for metastatic disease to be eligible
Patients must have received at least one prior therapy for metastatic melanoma
Patients who have received prior radiation therapy for HNSCC
PHASE II:\r\n* Patients must have received at least one course of platinum-based chemotherapy for the management of primary disease including carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, biologic/targeted agents, or extended therapy administered after surgical or non-surgical assessment\r\n* There are no restrictions on the total number of prior regimens patients may have received
Received prior treatment of TAS3681
Subjects who have received prior Doxil and progressed on this therapy are not eligible, but subjects may have received prior doxorubicin.
Any number of lines of prior hormone therapy are allowed\r\n* Patients with clear progression on either tamoxifen or fulvestrant should receive the alternate agent if feasible; if a patient has received both agents in the past, the drug received while on study is at the discretion of the treating physician
Have received CAR-T therapy;
For the phase II portion of the study, patients must be chemo-naive, i.e. not have received any prior chemotherapy (except hydrea or one dose of ara-C [cytarabine] =< 2 g) for AML or MDS; they could have received hypomethylator agents, transfusions, hematopoietic growth factors or vitamins; temporary prior measures such as apheresis or hydrea or one dose of ara-C =< 2 g in order to safely control hyperleucocytosis prior to enrollment
Patients must not have received prior therapy with dasatinib and temsirolimus for any indication
Patients who have received radiation to the spleen within 3 months prior to registration
Unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens; radiation therapy counts as a biologic regimen; patients may not have received radiation therapy to the index lesion within 1 year of enrollment; patients may have tumor spread within the central nervous system (CNS); histologic confirmation of eligibility is required if tissue is available
Patients may not have had prior SGT-53. Patient who have received prior topotecan, cyclophosphamide, or both are eligible.
Study specific limitations on prior therapy:\r\n* Patients who have received poly-ICLC are eligible for this trial if all acute poly-ICLC -related toxicity has resolved\r\n* Patients must not have received pegylated interferon previously
Patients must have received prior external beam radiation therapy to the region proposed for SRS re-irradiation at least 6 months prior to planned re-irradiation\r\n* For patients who were previously treated at an outside institution, adequate records must be available to determine the true dose the cord/cauda received during prior radiation therapy (RT); sufficiency of the treatment records will be assessed and signed-off by the Medical Physics investigator
Patients who have not received any prior treatment
Patient are eligible if they have received one or more prior treatment
Patients must not have received prior bone seeking radionuclides
Received no more than 1 prior treatment for ALL/LBL
Patients may have received other prior activating immunotherapies (i.e. checkpoint inhibitors), but must not have received them within 6 months prior to registration, and there must be no serious unresolved complication of therapy at the time of registration; for the purposes of this study monoclonal antibodies and antibody drug conjugates are not considered to be activating immunotherapies and there are no additional time restrictions on prior exposure to these agents (except prior brentuximab vedotin)
Patients who have received prior anti-cancer treatment within the following time frames:\r\n* Received systemic therapies less than 14 days prior to starting on treatment\r\n* Received radiation therapy less than 14 days prior to starting on treatment\r\n* Received biologic therapy less than 14 days prior to starting on treatment
Subjects must not have received medical therapy for any cancer within ONE year prior to registration
Patients must have previously received standard initial therapy, including attempted gross total resection, where safely feasible, and in appropriate circumstances (e.g., those older than one year at initial diagnosis, with non- metastatic tumors and at least microscopic residual disease) involved field fractionated radiation therapy (RT); patients may have received re-irradiation but not to the index lesion within 4 weeks
Patients must not have received prior radiation therapy to the involved breast at any time for any reason
Patients who received cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy directed against the brain tumor; patients who received Gliadel wafers will be excluded; patients may have received or be receiving corticosteroids, analgesics, and other drugs to treat symptoms or prevent complications
Patients are eligible whether they have received or not prior tyrosine kinase inhibitor (TKI) therapy; for the phase I portion of the study, patients who had received prior therapy with dasatinib should have been able to tolerate the dose equivalent to the starting dose of dasatinib in the dose level at which the patient is being entered; patients who previously received dasatinib but never at the dose being proposed are eligible provided they tolerated the maximum dose they were prescribed with no grade 3-4 toxicity not responding to optimal management
Received >360 mg/m2 equivalents of daunorubicin
Received antileukemic therapy within the last 3 weeks (with the exception of hydroxyurea or if the patient has definite refractory disease). Refractory patients who received therapy within the last 3 weeks may be eligible with prior approval of the Medical Monitor.
Patient must not have received: cimetidine within 48 hours prior and for the duration of the study
Patients who received > 450 mg/m^2 doxorubicin and have a cardiac ejection fraction on echocardiogram =< 40% on protocol entry are not eligible to received DA-EPOCH-R
Received prior therapy with eribulin mesylate
Patients who have received prior treatment with PTK7-ADC (PF-06647020)
Patients who have received prior immunotherapies
Patient received nitrosureas within 6 weeks prior to the first dose.
Patient received plasmapheresis within 4 weeks prior to the first dose.
Received allogeneic BMT
Histological confirmation of WM for which the patient has received at least one prior treatment; patients may have relapsed or refractory disease;(definition: relapse; patients who have received prior treatment for WM and now have disease recurrence; refractory; patients who have received anti-WM therapy and are noted to have progressive disease while on therapy, or those patients who demonstrated disease progression within 6 months of the last anti-WM treatment)
Patients who have received RAI within 8 weeks
Has received prior therapy with an anti-IDO-1 agent
The subject must have recovered (=< grade 1) from the acute toxic effects of prior therapy\r\n* NOTES: Subjects may have received a single platinum-based cytotoxic chemotherapy regimen; subjects having received prior cytotoxic chemotherapy must have completed their treatment more than 6 months prior to registration; subjects may have received prior therapy with hormones or biologic agents, but such therapies must be discontinued at least 28 days prior to registration for protocol therapy
Patients may have received previous NY ESO 1 vaccine therapy; patients who received bevacizumab or other experimental therapies are eligible for enrollment provided they have discontinued therapy (at least 4 weeks) prior to randomization and recovered from toxicities to less than grade 2
TREATMENT: Patients who have received prior carboplatin or AZD1775 (MK-1775) would not be excluded unless the two drugs were administered in combination; patients who have received prior carboplatin in combination with AZD1775 (MK-1775) would still be eligible to receive other study treatment regimens based on identified genetic mutation(s), other than carboplatin plus AZD1775 (MK-1775)
Patients who have received any tumor-directed therapy prior to biopsy are not eligible; concurrent treatment with corticosteroids is allowed
Patients may have received prior interferon alpha (IFN-alpha), but must not have received IFN-alpha in the 4-week period prior to enrollment on the trial; patients who have not received prior adjuvant therapy should be informed of the potential therapeutic benefit of IFN-alpha; previous radiation therapy, including after the surgical resection, is allowed as long as 14 days have elapsed between the radiation and initiation of first vaccination with NeoVax
Received more than one course of radiation therapy or more than a total dose of 65 Gy. May have received radiosurgery as part of initial therapy; however, the dose counts against the total dose limit.
Patients who have received previous radiation therapy to critical organs exceeding any of the limits shown below, are excluded:
Prior anti-disialoganglioside (GD2) antibody, isotretinoin, or lenalidomide therapy:\r\n* Patients who have received prior anti-GD2 antibody therapy are eligible if they did not have tumor relapse/progression while receiving this therapy\r\n* Patients who have received either isotretinoin or lenalidomide are eligible, but not if they have received the two agents concomitantly
Participants are allowed to have received, but are not required to have received, one\n additional non-cytotoxic antitumor agent (eg, biologic or cytostatic) for the\n management of ovarian cancer.
Patients who have received prior immunosuppressive therapy within 30 days prior to enrollment
Patients who have received prior biologic agents less than 30 days prior to enrollment
Arm 2 patients may have an unlimited number of prior therapy regimens but may not have received prior antiangiogenesis therapy except for bevacizumab (patients may not have received aflibercept, ramucirumab, cediranib, cabozantinib, or XL184)
Patients with acute or lymphoma forms must have received at least one cycle of combination chemotherapy (with or without mogamulizumab) or interferon (with or without zidovudine and/or arsenic); individuals with chronic or smoldering acute T-cell lymphoma (ATL) are not required to have had prior treatment or could have received any number of previous courses of therapy
Patients who have received prior therapy with eribulin mesylate are not eligible
Patients who have received prior pulmonary radiation
Patients who have received radiation therapy as part of their leukemia treatment may be ineligible and individual cases must be presented to the study principal investigator (PI) for determination of eligibility
Patients may have received prior bortezomib therapy.
Patient who has received any prior anthracyclines
Received at least one prior treatment with standard therapy (previous antibody\n therapy is acceptable)
Patients that have received prior radioimmunotherapy
Patients must not have received prior therapy with PF-02341066
Subjects must have received prior antiangiogenic therapy.
Patients must not have received prior chest radiation therapy for NSCLC
Before the first dose of study medication: a) Has received prior systemic cytotoxic chemotherapy for metastatic disease, b) Has received antineoplastic biological therapy (e.g., erlotinib, crizotinib, cetuximab), c) Had major surgery (<3 weeks prior to first dose)
Have received prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines or anthracenediones; the participant has received treatment with olaratumab or has participated in a prior olaratumab trial.
Has received prior therapy with vorinostat or other epigenetic agent
Have received prior treatment with everolimus
Patients may have received one or more lines of prior chemotherapy with/without rituximab (including high dose therapy plus stem cell transplant which is counted as one regimen); prior bortezomib is allowed; patients must not have received bortezomib in the past 6 months
Patients who have received hyperthermia to the target area within 10 weeks prior to first dosing of study agent
Have received prior radiation to maximally tolerated levels to any critical normal organ
Patients who have received prior therapy with a TLR agonist, excluding topical agents. Patients who have received experimental vaccines or other investigational immune therapies should be discussed with the Medical Monitor to confirm eligibility.
Patients who have received prior capecitabine therapy are not eligible
Patients must not have received any drug that is a moderate or strong inhibitor of 2B6, 2C9, 3A4, and 2C19 within 1 week prior to receiving cyclophosphamide dosing through 72 hours after cyclophosphamide dosing; patients must not have received any drug that is a moderate or strong inducer of 3A4 within 2 weeks prior to cyclophosphamide dosing
Patients who have received prior treatment with GEN-1.
Patients who received other chemotherapeutics or investigational agents in addition to their radiation therapy and concomitant temozolomide treatment
Have received at least one prior therapy for WM
Subjects who have received extensive radiation therapy, including sternum, pelvis, scapulae, vertebrae or skull, within 4 weeks of the first day of study drug or received palliative low dose radiation therapy limited to limbs within 1 week of the first day of study drug, or subjects who have not recovered from side effects of such therapy.
All patients need to have received at least one prior CNS directed therapy; there is no restriction on the number of recurrences
There is no limit on the number or type of prior chemotherapies except:\r\n* Patients must not have received prior treatment with convection enhanced delivery, other catheter based intra-tumoral treatment, or carmustine (BCNU)/Gliadel wafers\r\n* Patients with prior therapy that included stereotactic radiosurgery (including gamma-knife or cyber-knife) during therapy for newly diagnosed or recurrent disease, or re-irradiation of any type, must have confirmation of true progressive disease rather than radiation necrosis based upon surgical documentation of recurrent/progressive disease; imaging with magnetic resonance (MR)Spectroscopy, MRPerfusion, positron emission tomography (PET), or other techniques is not adequate to exclude radiation necrosis for this study\r\n* Patients may not have received prior treatment with an agent designed to inhibit mTOR or PI3K/AKT including, but not limited to, temsirolimus, rapamycin (sirolimus), RAD001 (everolimus), other rapalogs, BKM120, or perifosine; any question regarding the definition of an agent designed to inhibit mTOR or PI3K/AKT targeting should be discussed with the sponsor\r\n* Patients may not have received prior treatment with direct VEGF/VEGFR inhibitors such as bevacizumab (Avastin), aflibercept (VEGF-Trap), cediranib (AZD2171), trebananib (AMG 386), or XL-184 (Cabozantinib)
Patients must have received prior radiation therapy and standard temozolomide
Patients may not have received prior interferon, either systemic or intra-cystic
Patients must not have received prior treatment with pazopanib or topotecan
Patients with colon cancer (cohort A and B) must have received at least 2 prior cancer therapy regimens; patients with other cancer types (cohort C) must have received at least 1 prior cancer therapy regimen; patients in cohort D must have received at least 1 prior cancer therapy regimen; patients must have progressive disease on study entry
Patients who have received =< 1 cycle of therapy after most recent progression/relapse are eligible to enroll on study\r\n* Treatment of hypercalcemia or spinal cord compression or aggressively progressing myeloma with current or prior corticosteroids is permitted\r\n* Bisphosphonates are permitted\r\n* Concurrent or prior treatment with corticosteroids for indications other than multiple myeloma is permitted\r\n* Prior treatment with radiotherapy is permitted\r\n* Patients with measurable disease who received up to one cycle of any therapy within 60 days with a washout period of 4 weeks from last dose (on a trial or outside a trial) are eligible
Patients that have received the study medication (Xgeva/Prolia)
Patient must not have received prior temozolomide, dacarbazine (DTIC), or capecitabine, or 5-FU (fluorouracil) therapy
Patients who have received radiation therapy =< 2 weeks prior to study entry; patients who have received prior radiotherapy must have recovered from toxicity (=< grade 1) induced by this treatment
Subjects who received any prior treatment with docetaxel are excluded. Subjects who have received gemcitabine in first line therapy but do not have squamous cell carcinoma, will be eligible as they can receive pemetrexed for the salvage regimen.
Patients must not have received prior therapy other than standard chemoradiation according to Stupp et al and Gliadel
Patients must have been treated with at least one prior treatment regimen that included carboplatin; patients who have received prior radiation therapy for this tumor are eligible
For dose escalation cohorts - subjects who received prior Sunitinib or Pazopanib and required permanent discontinuation due to toxicity or required dose reduction or delay during the first 12 weeks of therapy due to toxicity, or received both prior Sunitinib and Pazopanib
Patients are eligible even if they have not received prior treatment; they are also eligible if they have received prior treatment, and any number of treatments is allowed
Patients must not have received prior Gliadel wafers
Prior therapy: patients with prior history of mediastinal radiation exposure will be ineligible; patients may not have received prior chemotherapy, or antibody therapy for esophageal or GE-junction adenocarcinoma
Received other recent antitumor therapy
Patients who have received prior therapy with ADXS11-001
Received randomized double-blind treatment in PREVAIL;
For Ph+ ALL patients, received corticosteroids within 24 hours before the first dose of ponatinib; or vincristine within 7 days prior to the first dose of ponatinib; or received other chemotherapy within 14 days prior to the first dose of ponatinib.
Glioblastoma disease-specific concerns: Patients must have received cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy directed against the brain tumor; patients who received Gliadel wafers will be excluded; patients may have received or be receiving corticosteroids, AED's, analgesics, and other drugs to treat symptoms or prevent complications
Subject may have received prior investigational therapy (including immune therapy)
Follicular lymphoma patients must have received at least 3 prior lines of therapy; patients are eligible regardless of whether they have received an autologous transplant
Received prior treatment with a hypomethylating agent, except as allowed in Exclusion Criterion 7.b
Patients must not have received prior Gliadel wafers
Patients must not have received systemic chemotherapy or monoclonal antibody therapy within 2 weeks of study enrollment; patients who have previously received bolus nelarabine are still eligible; hydroxyurea or corticosteroids for control of blood counts is allowed, but must be discontinued 24 hours prior to initiating nelarabine
Relapse patients should have NOT received chemotherapy for 4 weeks, and no patient should have received nitrosoureas (melphalan, lomustine [CCNU] or mustard); no patient should have received radiation therapy in the previous 42 days
Patients who received DEPDC1, MPHOSPH1, URLC10, CDCA1, or KOC1 peptide vaccines before
Patients who have received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of the study treatment.
For the phase I portion of the study, patients who had received prior therapy with nilotinib should have been able to tolerate the dose equivalent to the starting dose of nilotinib in the dose level at which the patient is being entered; patients who previously received nilotinib but never at the dose being proposed are eligible provided they tolerated the maximum dose they were prescribed with no grade 3 or 4 toxicity not responding to optimal management
Patients who have received prior immunotherapies
Pts who have received prior mantle or extensive mediastinal radiation
Patients are permitted to have received prior therapy, but must have received a minimum of 30 Gy to the chest wall with a minimal interval since completion of radiation therapy equal to or greater than 6 months; patients who have previously received more than one course of radiotherapy to the breast and/or chest wall OR have received a cumulative dose to the chest wall in excess of 70 Gy will not be considered eligible
Patients who have received prior chemotherapy are allowed, provided they have been off systemic therapy for 21 days and all acute toxicities have resolved to less than grade 2; patients who have received paclitaxel within 3 months of study entry and have developed documented progressive disease despite therapy
Received more than one course of radiation therapy or more than a total dose of 65 Gy. May have received radiosurgery as part of initial therapy; however, dose counts against total dose limit.
Patients who have received prior lenalidomide therapy are not eligible for this study; further there should be at least a 14-day window from the patient’s last prior therapy before initiation of treatment on clinical trial
Received prior HD IL-2 therapy.
Received maintenance Temozolomide
NON-PROGRESSED DIPG (STRATUM 2): Patients must have received a minimum of 54 Gy focal irradiation administered over approximately 42 days prior to enrollment; patients must not have received any other prior therapy for treatment of their central nervous system (CNS) malignancy besides standard radiation therapy
For Part 3, the patient has not received prior treatment with a TKI.
Subjects must have received adequate prior therapy including at a minimum:
Prior therapy with bortezomib is allowed; patients who have received prior bortezomib therapy must have received bortezomib > 6 months ago, and must have shown some response; patients that did not respond to prior bortezomib therapy are not eligible
Patients who have never received radiation to the chest
Have received at least one prior therapy. Patients who are over age 65 and have not received therapy for AML are also eligible, if they are not candidates for induction chemotherapy
Received any prior therapy for lymphoma
Participants must have received at least one prior therapy for FL
Patients has received prior treatment with LEE011.
Received Tivantinib as prior therapy
Received at least 4 weeks of one prior sorafenib containing systemic therapy and then experienced documented radiographic disease progression; or inability to tolerate prior therapy received for at least a minimum period of time.
Received other recent antitumor therapy
Patients who have received prior biologic agents less than 4 weeks prior to enrollment
Patients who have received prior interferon or IL-2 therapy less than 4 weeks prior to enrollment
Must have been receiving or have received crizotinib
Patients who have received prior treatment with cyclophosphamide and topotecan are eligible if they did not have tumor relapse/progression while receiving this combination.
Patients going on Arm 2 must have received planned treatment with radiation therapy and concomitant temozolomide at least 28 days but no more than 49 days prior to starting treatment on this study; patients must have received at least 80% of planned temozolomide and radiation therapy with no grade 3 or grade 4 toxicity (except lymphopenia) attributed to the temozolomide; Arm 2 patients may not have received any other prior chemotherapy, immunotherapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor; prior Gliadel wafers are allowed; glucocorticoid therapy is allowed
Patients with NF1 will only be eligible if complete tumor resection is not considered to be feasible without substantial risk or morbidity\r\n* Patients may be treated on this trial without having received prior medical therapy directed at their PN\r\n* There will be no limit to number of prior myelosuppressive regimen for PN or other tumor manifestations associated with NF1 such as optic glioma\r\n* Patients who have received previous investigational agents or biologic therapy, such as tipifarnib, pirfenidone, peginterferon alfa-2b (Peg-Intron), sorafenib, imatinib, or other targeted therapies are eligible for enrollment; at least 4 weeks must have elapsed since receiving medical therapy directed at the PN; patients who received prior medical therapy for their PN must have recovered from the acute toxic effects of all prior therapy to =< grade 1 before entering this study\r\n* Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment\r\n* At least 6 weeks must have elapsed prior to enrollment since the patient received any prior radiation therapy\r\n* At least 4 weeks must have elapsed since any surgeries, with evidence of good wound healing
Patients must have not received any prior therapy other than surgery and/or steroids
Received nitrogen mustard agents, melphalan, or BCNU therapy within 6 weeks prior to the first study dose
Patients must have received adequate prior alkylator therapy
Received investigational therapy or procedure ? 30 days prior to enrollment.
Patients who have received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days and bevacizumab within 28 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of the study treatment
Patients who have received prior Yttrium-90 radioembolization
Subject who received any other systemic anticancer treatment after parent study entry (radiation to local areas such as bone or brain if received in the parent ASP8273 study is permitted).
Patients who have tested positive for a v-Raf murine sarcoma viral oncogene homolog B (BRAF) mutation may have received prior BRAF inhibitor therapy as a prior line of systemic therapy; patients may have received up to 2 prior lines of therapy with a checkpoint inhibitor (CPI), which may have included pembrolizumab, nivolumab, or ipilimumab; these agents may have been administered as single-agent treatment, in combination with each other, or in combination with other agents; patients who have received prior treatment with ipilimumab must have relapsed after achieving a response to prior ipilimumab treatment; this response may have been achieved with ipilimumab administered as single-agent therapy or in combination with another treatment; patients who have received prior treatment with pembrolizumab or nivolumab must have progression of disease after at least 4 doses of either drug alone or in combination with other agents
Patients who have previously received anti CD40 (agonistic) therapy prior adjuvant interferon (IFN), is allowed if last dose was received at least 6 months from enrolling to protocol
Subjects who have received prior oncolytic therapy or prior therapy with and toll-like receptor (TLR) agonist including topical agents; subjects that have received experimental vaccines or other immune therapies should be discussed with the medical monitor or the primary investigator (PI) to confirm eligibility
Patients with persistent or recurrent disease must have received definitive chemoradiation therapy as first line therapy; patients with advanced (stage IVB) disease may have received palliative radiation therapy
Prior treatment:\r\n* Patients must not have received chemotherapy, radiation or surgical resection of malignancy within 3 weeks prior to the start of study drug; however, if they have received nitrosourea or mitomycin C then they should not be enrolled in the study until 6 weeks after therapy was last received\r\n* No limitations to number of prior therapies\r\n* Prior therapy with other ALK inhibitor investigational agents with the exception of crizotinib (i.e., prior treatment with crizotinib is allowed)
Patients who have received previous cytotoxic chemotherapy including an AC-T regimen or previous therapeutic radiation therapy for any reason in the last 5 years; because of possible limitations in bone marrow reserve, patients with such prior treatments are not appropriate candidates for this trial; patients who have had prior hormonal therapy (for instance, tamoxifen for prevention of breast cancer) are eligible; patients who have participated in a window study (treatment with an investigational agent prior to surgery for =< 2 weeks) are eligible but must have discontinued the investigational agent at least 14 days before enrollment
Subject has received prior therapy with a BH3 mimetic.
Patients must not have received prior treatment with talimogene laherparepvec (T-VEC) or other oncolytic virus agents
Has received voriconazole within 5 days prior to starting study therapy
Has received the full dose of CTX over the course of their treatment
Have received at least one prior therapy for WM
Patients who have received chemotherapy within 3 weeks of first fenretinide treatment, or who have received investigational drugs within 6 weeks of first fenretinide treatment. Patients must have otherwise recovered from toxicities of prior therapy.
Received Pap test within ONE year
Received any investigational agents or received any tumor vaccines within the previous six weeks prior to cell infusion
Has received any formulation of POS within prior 10 days
Patients who have received prior romidepsin use are eligible
Patients who have received no prior therapy are eligible, as well as those who have received prior treatment
Participants who received biopsy only or have received more than 2 prior courses of radiation for meningioma
Women should have received no prior therapy for their disease
Participants with HCC must have received prior sorafenib therapy. ICC participants must have received prior platinum (cisplatin or oxaliplatin) based therapy unless contraindicated.
Subjects must not have received BLZ-100 within 30 days prior to re-treatment
Subjects must have received adequate prior therapy including at a minimum:
Received radiation therapy to the lung > 30 Gy within 6 months of first dose of study treatment.
Patients who have received radiation within 14 days before the first dose of study treatment
The subject has received therapeutic radiation:\r\n* To the bladder/prostate/rectum pelvis\r\n* To any other site(s) within 28 days of the first dose of study treatment
Other clinically significant disorders such as:\r\n* Active infection requiring systemic treatment within 28 days before the first dose of study treatment\r\n* Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment\r\n* History of organ transplant\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
Radiation therapy within 14 days of the first dose of study drug
Patient received radiotherapy within 2 weeks prior to the first dose of study treatment except localized radiation therapy for symptomatic bone metastasis
The subject has received radiation therapy as follows: \r\n* To the thoracic cavity, abdomen or pelvis within 3 months of the first dose of study treatment or has with ongoing complications or is without complete recovery and healing from prior radiation therapy\r\n* To bone or brain metastasis within 14 days of the first dose of study treatment\r\n* To any other site(s) within 28 days of the first dose of study treatment
The subject has received radiation therapy:\r\n* To the thoracic cavity, abdomen or pelvis within 3 months of the first dose of study treatment that has with ongoing complications or is without complete recovery and healing from prior radiation therapy (CT changes related to radiation treatment which are not clinical significant are allowed)\r\n* To bone or brain metastasis within 14 days of the first dose of study treatment\r\n* To any other site(s) within 28 days of the first dose of study treatment
The subject has received radiation therapy:\r\n* To bone metastasis within 14 days before the first dose of study treatment \r\n* To any other site(s) within 28 days before the first dose of study treatment
Patients enrolled to the prior treatment arm of the dose escalation cohort must not have received anti-cancer therapy less than 14 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug
The subject has received radiation therapy:\r\n* To the thoracic cavity or gastrointestinal tract within 3 months of the first dose of study treatment\r\n* To bone or brain metastasis within 14 days of the first dose of study treatment\r\n* To any other site(s) within 28 days of the first dose of study treatment
No prior radiation therapy within the last 4 weeks, except as below \r\n* To the thoracic cavity, abdomen, or pelvis within 12 weeks before the first dose of study treatment, or has ongoing complications, or is without complete recovery to < grade 1 toxicity\r\n* To bone or brain metastasis within 14 days before the first dose of study treatment\r\n* To any other site(s) within 28 days before the first dose of study treatment\r\n* Prior radiation treatment may have included no more than 3000 centigray (cGy) to fields including substantial bone marrow
Radiation therapy:\r\n* To the thoracic cavity, abdomen or pelvis within 3 months of the first dose of study treatment or has ongoing complications or is without complete recovery and healing from prior radiation therapy\r\n* To bone metastases within 14 days of the first dose of study treatment\r\n* To any other site(s) within 28 days of the first dose of study treatment
The subject has received radiation therapy:\r\n* To the thoracic cavity or gastrointestinal tract within 3 months before the first dose of study treatment\r\n* To brain metastasis within 14 days before the first dose of study treatment\r\n* To any other site(s), with the exception of bone, within 28 days before the first dose of study treatment
The subject has received radiation therapy:\r\n* To bone or brain metastasis within 14 days of the first dose of study treatment\r\n* To any other site(s) within 28 days of the first dose of study treatment
Other clinically significant disorders such as:\r\n* Active infection requiring systemic treatment within 28 days before the first dose of study treatment\r\n* Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
Anticancer treatment (e.g., radiation therapy, chemotherapy) within 21 days of first dose\r\n* An exception is cetuximab treatment, which can be received within 21 days of the first treatment on study.
The subject has received radiation therapy:\r\n* To the thoracic cavity or gastrointestinal tract within 3 months before the first dose of study treatment\r\n* To bone or brain metastasis within 14 days before the first dose of study treatment\r\n* To any other site(s) within 28 days before the first dose of study treatment
The participant has received radiation therapy:\r\n* To the thoracic cavity or gastrointestinal tract within 3 months of the first dose of study treatment\r\n* To bone or brain metastasis within 14 days of the first dose of study treatment\r\n* To any other site(s) within 28 days of the first dose of study treatment
Received radiation (including therapeutic radioisotopes such as strontium 89) therapy ? 3 months prior to the first dose of study treatment and have not recovered from side effects of such therapy (? Grade 1) prior to the first dose of study treatment, except for alopecia.
The subject has received radiation therapy:\r\n* To the thoracic cavity or gastrointestinal tract within 3 months of the first dose of study treatment\r\n* To bone or brain metastasis within 14 days of the first dose of study treatment\r\n* To any other site(s) within 28 days of the first dose of study treatment
The subject has received radiation therapy:\r\n* To the thoracic cavity or abdomen within 3 months before the first dose of study treatment, or has ongoing complications, or is without complete recovery and healing from prior radiation therapy\r\n* To bone or brain metastasis within 3 weeks before the first dose of study treatment\r\n* To any other site(s) within 28 days before the first dose of study treatment
The subject has received radiation therapy:\r\n* To the thoracic cavity, abdomen or pelvis within 3 months of the first dose of study treatment or has with ongoing complications or is without complete recovery and healing from prior radiation therapy\r\n* To bone or brain metastasis within 14 days of the first dose of study treatment
Treatment within 28 days prior to Dose 1 with:
The subject has received radiation therapy within 14 days of the first dose of study treatment
Focal radiation therapy within 4 weeks before first dose of study treatment, or full spinal radiotherapy within 3 months before first dose of study treatment.
Radiation therapy within 28 days of the first dose of study drug
Patients who received radiation therapy within the last 4 weeks; radiation exposure may not exceed 30% of marrow area
For patients pre-registering after the completion of radiation therapy, documentation of a bone marrow aspirate and biopsy containing < 10% clonal plasma cells prior to start of radiation therapy
Prior radiation therapy is allowed; patients must not have received minimal radiation therapy (=< 5% of their total marrow volume) within 3 weeks prior to the initiation of study treatment; otherwise, patients must not have received radiation therapy (> 5% of their total marrow volume) within 4 weeks prior to the initiation of study treatment; patients who have received prior radiation to 50% or more of their total marrow volume will be excluded
Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy within 28 days prior to study entry
Prior radiation therapy is allowed to < 25% of the bone marrow, but is not permitted within 28 days prior to study registration
Concurrent malignancy requiring active therapy\r\n* Patients with localized prostate cancer having undergone surgery or radiation (field confined to =< 30% of marrow-bearing bone) at least 30 days prior to study treatment are eligible
Patients who have received radiation to more than 25% of marrow-bearing areas
No prior radiation to > 25% of the marrow.
Prior radiotherapy within 2 weeks of the first dose of study treatment; patients who have received radiation to more than 25% of the bone marrow are not eligible at any time
Patients must not have received any prior chemotherapy, radiation therapy, immunotherapy or bone marrow transplant for the treatment of DIPG; prior dexamethasone and/or surgery are allowed
Patients must not have received any prior chemotherapy, immunotherapy or bone marrow transplant for the treatment of their tumor; prior use of temozolomide during radiation at maximum of the standard pediatric dosing (defined as 90 mg/m^2 /dose continuously during radiation therapy for 42 days) or dexamethasone is allowed
Participants who have received prior radiation therapy to > 25% of the bone marrow.
The patient has received radiation to ? 25% of his or her bone marrow within 4 weeks of the first dose of study drug.
Prior treatment with radiation therapy involving >=25% of the hematopoietically active bone marrow within 3 months before the first dose of study drug.
Patients must not have had radiotherapy encompassing > 20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to day 1 of protocol therapy
If the patient received previous radiation therapy, the total absorbed radiation dose at the bone marrow level must be ? 1 Gy
Radiation therapy to >30% of bone marrow prior to study entry;
Prior radiation therapy for treatment of cancer is allowed to <25% of the bone marrow.
Prior radiation to chest or abdomen, or to > 30% of the marrow cavity
Prior pelvic radiation therapy or patients who have undergone prior radiation to greater than or equal to 25% of the bone marrow within the past year are excluded; patients who received radiation for prostate cancer are also excluded
Subjects who have received radiation therapy targeting > 10% of the bone marrow space must have completed this at least 2 weeks prior to starting therapy with DS3032b
History of radiation therapy to >= 25% of the bone marrow for other diseases
Prior radiation to > 30% of the red marrow or to maximal tolerable level for any organ
Radiation therapy to more than 25% of the bone marrow
Prior radiation therapy is allowed to < 25% of the bone marrow; note: no radiation therapy within 30 days prior to registration for protocol therapy
A minimum of 12 weeks prior to start of vorinostat is required following prior large field radiation therapy (i.e., craniospinal, whole abdominal, total lung, > 50% marrow space)
Subjects who have received radiation therapy targeting > 10% of the bone marrow space must have completed this at least 2 weeks prior to starting therapy with AMG-232 + KRd
Prior radiation therapy irradiating more than 10% of total bone marrow
Participants may not have had radiation to > 25% of the bone marrow
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those whose adverse events have not resolved to grade 1 or less (except alopecia) from agents administered more than 4 weeks earlier; patients must have completed prior biological therapies and/or targeted therapies >= 2 weeks prior to study enrollment; patients who have had radiation to the pelvis or other bone marrow-bearing sites will be considered on a case by case basis and may be excluded if the bone marrow reserve is not considered adequate (i.e. radiation to > 25% of bone marrow)
Radiation: \r\n* Patients must not have received radiation (small port) for a minimum of two weeks prior to protocol therapy\r\n* Except for patients with a history of progressive disease, patients whose only site(s) of disease have been radiated are eligible if at least one lesion meets at least one of the criteria listed in sites of disease above\r\n* A minimum of 12 weeks prior to start of protocol therapy is required following large field radiation therapy (i.e. total body irradiation, craniospinal, whole abdominal, total lung, > 50% marrow space)\r\n* A minimum of 6 weeks must have elapsed prior to start of protocol therapy for other substantial bone marrow radiation
Prior abdominal or pelvic radiation therapy or radiation therapy to > 10% of the bone\n marrow at any time in the past or prior radiation therapy within the past 3 years to\n the breast/sternum, dermal lesions, head or neck.
Prior radiation therapy to whole pelvis or greater amount of marrow-forming bone
6 weeks if other bone marrow radiation has been administered.
Patients may have received prior radiation therapy; radiation therapy must be completed at least 14 days prior to registration, and all toxicities related to prior radiation therapy must have resolved to CTCAE v4.0 grade 1 or lower; patients may not have had > 25% of their bone marrow radiated
No history of radiation therapy to >= 25% of the bone marrow for other diseases or history of anthracycline therapy
Prior radiation therapy is allowed; patients must not have received minimal radiation therapy (=< 5% of their total marrow volume) within 3 weeks prior to the initiation of study treatment; otherwise, patients must not have received radiation therapy (> 5% of their total marrow volume) within 4 weeks prior to the initiation of study treatment; patients who have received prior radiation to 50% or more of their total marrow volume will be excluded
Prior radiation therapy encompassing > 25% of bone marrow
Patients cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy, chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), or radiation therapy to > 30% of the bone marrow, within 6 months of the first vaccination; treatment or salvage radiation therapy encompassing =< 30% of bone marrow must have been completed 4 weeks prior to the first vaccination
Prior radiation to maximally tolerated levels to any critical normal organ, or > 20 Gy prior radiation to large areas of the bone marrow (e.g., external radiation therapy to whole pelvis)
Participant has received irradiation to a major bone marrow area as defined as > 25% of bone marrow (such as, pelvic or abdominal radiation) within 30 days prior to randomization
Radiation therapy (other than palliative) =< 2 weeks prior to randomization; note: patients who have had > 25% of their functional bone marrow irradiated are not eligible for this trial
Patients who had radiation to greater than 25% marrow in the past 5 years
Has received prior radiation to > 50% of the bone marrow
Radiation including large bone marrow fields such as sternum or pelvis within 6 weeks prior to leukapheresis
Prior radiation to greater than 25% of the bone marrow or whole pelvis radiation
Prior radiation to greater than 25% of the bone marrow or whole pelvis radiation
Radiation therapy to more than 25% of the bone marrow; whole pelvic radiation is considered to be over 25%; (ongoing small field radiation therapy for palliation only is allowed)
Prior radiation to maximally tolerated levels to any critical normal organ, or > 20 Gy prior radiation to large areas of the bone marrow (e.g., external radiation therapy to whole pelvis)
No prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis) within 30 days prior to registration for protocol therapy. See Study Procedures Manual to calculate percent of prior radiation.
Prior radiation therapy is allowed provided exposure does not exceed an area of 25% of marrow space and occurred ? 6 weeks prior to the first dose of MEDI-551 (Arm A only)
Patients who have received radiation to more than 25% of marrow-bearing areas
Radiation therapy to greater than 25% of the bone marrow
No prior radiation therapy to the whole pelvis or to ?25% of the total bone marrow area.
prior radiation therapy with volume of bone marrow treated over 25%.
Prior radiation therapy allowed to < 25% of the bone marrow
Prior treatment with radiation therapy involving ? 25% of the hematopoietically active bone marrow within 42 days before the first dose of study drug.
Prior treatment with radiation therapy involving >= 25 percent (%) of hematopoietically active bone marrow.
Focal radiation therapy within 14 days prior to randomization; radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to randomization (i.e., prior radiation must have been to less than 30% of the bone marrow)
Prior treatment with radiation therapy involving ? 25% of the hematopoietically active bone marrow
Radiation therapy to 25% of bone marrow within 2 weeks of first dose
Focal radiation therapy within 7 days prior to randomization. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to randomization (i.e., prior radiation must have been to less than 30% of the bone marrow).
Received radiation therapy to more than 25% of the bone marrow-containing spaces < 84 days prior to first dose of study medication
Previous radiation therapy is allowed to less than 25% of the bone marrow, but should have been limited and must not have included whole pelvis radiation.
Prior radiation therapy to < 25% of the bone marrow [see bone marrow radiation chart in the study procedure manual (SPM)] allowed if completed within 30 days prior to registration for protocol therapy.
Prior radiation to ? 30% of bone marrow or any radiation therapy within 28 days prior to randomization
Diagnosis of another primary cancer for which the patient is currently undergoing radiation therapy, chemotherapy, or bone marrow transplant
Current systemic chemotherapy or radiation therapy that potentially causes bone marrow suppression that would preclude safe treatment of HSIL
Prior radiation therapy is allowed; patients must not have received any radiation within 3 weeks prior to the initiation of study treatment; patients may not have areas of irradiated marrow exceeding 40% of bone marrow volume
Prior treatment with radiation therapy involving greater than or equal to (>=) 25% of the hematopoietically active bone marrow.
The patient has received radiation to ? 25% of his or her bone marrow within 4 weeks of the first dose of study drug.
