The participant has a primary brain tumor
Female participants must have a negative pregnancy test within 1 week of enrollment and all participants must agree to use two reliable methods of contraception simultaneously if conception is possible during the study and for 6 months after stopping treatment; should a woman subject become pregnant or suspect she is pregnant while the subject is participating in this study, she should inform her treating physician immediately; the participant will then be removed from protocol therapy; participants who father a child while participating in the study will be permitted to continue with the protocol; the participant, however, is required to notify the investigator if he fathers a child
the safety or well-being of the participant or study staff
the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
Bisphosphonates will not be allowed on the study while the participant is receiving sotatercept; prior bisphosphonate use is allowed
Participant must be previously untreated, (no more than 72 hours of steroids, one intrathecal chemotherapy treatment, and/or emergency radiation)
PARTICIPANTS FROM COLLABORATING SITES PARTICIPATING IN BIOLOGICAL OBJECTIVES ONLY: Participant must be previously untreated, (no more than 72 hours of steroids, one intrathecal chemotherapy treatment, and/or emergency radiation)
Inability or unwillingness of research participant or legal guardian to consent
Inability or unwillingness of research participant or legal guardian to consent
Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
To qualify for Part 1, the participant must be t(11;14) positive as determined by an analytically validated Fluorescent In Situ Hybridization (FISH) assay per central laboratory testing.
Participant must consent to provide the following for biomarker analyses:
Participant received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic, or any investigational therapy within 21 days before Study Day 1; participant received palliative radiotherapy or small molecule targeted anti-cancer agents within 14 days of Study Day 1.
Participant has prior exposure to any pyrrolobenzodiazopine-containing agent
Participant has a history of major immunologic reaction to any Immunoglobulin G (IgG).
Participant has a history of >= grade 3 AST, ALT, or bilirubin increase or has extensive liver resection (i.e., left lobe resection).
Participant must not have a history of a coagulopathy or a platelet disorder.
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.
Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in this study
The participant has any known significant ophthalmologic abnormalities of the surface of the eye.
For Part H: (abemaciclib + trastuzumab + pertuzumab): The participant must have received at least 1 chemotherapy regimen for metastatic disease. The participant may be receiving ongoing therapy with trastuzumab and/or pertuzumab at the time of study entry. The participant must have an estimated left ventricular ejection fraction (LVEF) within the normal range by either echocardiogram or multigated acquisition (MUGA) scan.
For Part I (abemaciclib + endocrine therapy): The participant must have demonstrated evidence of disease progression on a Cyclin Dependent Kinase 4 (CDK4) and Cyclin Dependent Kinase 6 (CDK6) inhibitor (either palbociclib or ribociclib) plus endocrine therapy for advanced or metastatic disease as the most recent therapy immediately preceding study entry. The participant should remain on the current endocrine therapy while receiving abemaciclib.
Participant has not adequately recovered from toxicity of previous therapy
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:
Expectation by the investigator that the participant may continue to benefit from additional single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment or Expectation of the investigator that the participant may continue to benefit from control arm treatment as given in study BO21976/TDM4450g and at the time of disease progression may benefit from single-agent trastuzumab emtansine treatment
Participant must have histologically or cytologically confirmed advanced malignancies, except all forms of leukemia and lymphoma, for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the participant
Participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis, enteritis, colitis.
Participant has symptoms of gross hematuria or gross hemoptysis
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.).
If participant was treated with bevacizumab, at least 4 weeks must elapse before treatment with either agent (cyclophosphamide or rQNestin34.5v.2)
Participant may not have a percutaneous endoscopic gastrostomy (PEG) tube or be receiving total parenteral nutrition (TPN)
Treating physician intends to put participant on anticoagulation therapy for at least three months.
The participant has received radionuclide treatment within 6 weeks of the first dose of study treatment
The participant has a primary brain tumor
The participant requires concomitant treatment with the following inhibitors of CYP3A4:\r\n* Antibiotics: clarithromycin, erythromycin, telithromycin, troleandomycin\r\n* Antifungals: itraconazole, ketoconazole, voriconazole, fluconazole, posaconazole\r\n* Antidepressants: nefazodone\r\n* Antidiuretic: conivaptan\r\n* Gastrointestinal (GI): cimetidine, aprepitant\r\n* Hepatitis C: boceprevir, telaprevir\r\n* Miscellaneous: Seville oranges, grapefruit, or grapefruit juice and/or pummelos, star fruit, exotic citrus fruits, or grapefruit hybrids); use of any of anti-retrovirals (delavirdine) or protease inhibitors (ritonavir, indinavir, lopinavir/ritonavir, saquinavir, nelfinavir) is permitted; specifically, ritonavir and cobicistat is permitted for participants considered for the CYP3A4-inhibitor based ART regimen arm (Stratum A) of the trial; as part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product
The participant has radiographic evidence of cavitating pulmonary lesion(s)
The participant has tumor invading or encasing any major blood vessels
Participant is considered a legal adult by local regulation at the time of signing informed consent form (ICF).
Participant has presence of the FLT3/ITD activating mutation in the BM or PB as determined by the local institution at diagnosis.
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.
If the participant has developed overall grades II-IV acute GVHD, the following criteria must be met to be randomized:
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 need for supplemental oxygen with the exception of using previously existing non-invasive continuous positive airway pressure (CPAP) at night.
Participant has used investigational agents within 4 weeks of randomization.
Participant has used experimental therapy for acute GVHD within 4 weeks of randomization. If unsure of the definition of \experimental\, discussion with one of the protocol chairs is recommended.
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)
The participant’s primary tumor is accessible to biopsy in the outpatient clinic setting and the participant is willing to have baseline and end of study (day 15-26) 4 mm punch biopsies of tumor and adjacent visually normal appearing tissue for biomarker analysis\r\n* If the participant has a biopsy-confirmed cancer, the baseline biopsy to collect tissue for biomarker analysis will be in addition to the pre-study diagnostic biopsy\r\n* If the participant is having surgical treatment, the end of study biopsies may be collected at the time of surgery unless surgery is delayed beyond day 26\r\n* If the participant is not having surgical treatment, the end of study biopsies will be collected prior to initiation of non-surgical treatment
Participant is able to complete a minimum of 14 days of study agent dosing prior to initiation of definitive treatment for their cancer
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 is willing and able to participate for the duration of the study
Participant is currently taking a strong CYP2C8 inhibitor (e.g. gemfibrozil [Lopid])
Participant is currently taking topiramate (Topamax) commonly used in epilepsy or to prevent migraines or other carbonic anhydrase inhibitors (e.g. zonisamide [Zonegran]; acetazolamide [Diamox Sequels]; or dichlorphenamide [Keveyis, Daranide])
Participant has a history of liver disease
Participant has a history of hypoglycemia
Participant has a history of macular edema
Participant taking medications that might interact with 9cUAB30
Participant in other clinical trials
Has a known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
Completed 6 to 12 months (± 2 weeks) of initial therapy, during which the participant was treated to best response, defined as the best response maintained for 2 cycles after the M-protein nadir is reached.
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
Participant must be willing to undergo a pre-treatment screening biopsy for enrollment and subsequent biomarker analyses.
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.
Concomitant receipt of the breast cancer resistance protein (BCRP) transporter-sensitive substrate rosuvastatin (unless the participant can be transferred to another medication at least 5 half-lives prior to the start of study treatment)
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: \r\n* Not a woman of childbearing potential (WOCBP) OR\r\n* A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at 120 days after the last dose of study treatment. \r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant
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 requires supplemental oxygen to keep saturation greater than 95% and the situation is not expected to resolve within 2 weeks
Research participant requires dialysis
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 must not require more than 2 mg three times daily TID of dexamethasone on the day of PBMC collection.
At least 2 weeks must have elapsed since the research participant received his/her last dose of prior chemotherapy or radiation
Research participant has a released cryopreserved CAR T cell product
Research participant does not require supplemental oxygen to keep saturation greater than 95% and/or does not have presence of any radiographic abnormalities on chest x-ray that are progressive
Research participant does not have a fever exceeding 38.5 degrees 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 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
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.
Participant has received treatment with the following:
Participant has the following: a. Favorable risk cytogenetics such as t(8;21), inv(16) or t(16;16) or t(15;17) as per the National Comprehensive Cancer Network (NCCN) Guidelines Version 2, 2016 for Acute Myeloid Leukemia.
Participant has a history of other malignancies within 2 years prior to study entry, with the exception of:
Participant has a white blood cell count > 25 × 10^9/L. (Hydroxyurea or leukapheresis are permitted to meet this criterion.)
The participant must have histological or cytological evidence of a diagnosis of solid tumor, excluding lymphomas and melanoma, but including central nervous system (CNS) tumors, that is relapsed or refractory, not be amenable to curative treatment.
Participants that have received prior anthracycline therapy if the participant is to be enrolled in the doxorubicin combination arm.
A female participant is eligible to participate if she is not pregnant , not breastfeeding, and at least one of the following conditions applies:
Research participant or parent/legal guardian must agree to participate in long-term follow-up for up to 15 years, if they are enrolled in the study and receive T-cell infusion
Has been a participant in Study WRI-GEV-007, \A Phase I/IIa Study of SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer Patients\
Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
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 has tumor in contact with, invading, or encasing major blood vessels or radiographic evidence of significant cavitary pulmonary lesions
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).
Participant's current disease state must be one for which there is no known curative therapy.
Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in this study
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.
Participant has a history of other malignancies prior to study entry, with the exception of:
Participant has a white blood cell count > 25 × 109/L. (Note: Hydroxyurea administration or leukapheresis is permitted to meet this criterion).
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
Documented informed consent/assent of the participant or legally responsible guardian
As per self report, participant has another sleep disorder provided that it is not adequately treated (e.g., sleep apnea without continuous positive airway pressure [CPAP] treatment)
As per self report, participant has major depressive disorder, alcohol or drug dependence and
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 must have histological or cytological evidence of cancer.
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 may have received prior hormonal therapy
Participant may have received bevacizumab (or other antiangiogenic agent) and/or cyclophosphamide in the past
Participant has clinical symptoms or signs of partial or complete gastrointestinal obstruction or, requires parenteral hydration and/or nutrition
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 has organ allografts
Participant is receiving medication(s) that might affect immune function
Documented informed consent of the participant
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).
Male or female participant
Indications that participant is not appropriate for the study (e.g., aggressive, intoxicated, disruptive, visibly ill)
Research participant or parent/legal guardian must agree to participate in long-term follow-up for up to 15 years, if they are enrolled in the study and receive T-cell infusion
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
Shares the same address as a currently enrolled participant
Research participant must not require more than 2 mg three times daily (TID) of dexamethasone on the day of PBMC collection.
At least 2 weeks must have elapsed since the research participant received his/her last dose of prior chemotherapy or radiation
Research participant has a released cryopreserved T cell product
Research participant does not require supplemental oxygen to keep saturation greater than 95% and/or does not have presence of any radiographic abnormalities on chest x-ray that are progressive
Research participant does not require pressor support and/or does not have symptomatic cardiac arrhythmias
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 requires supplemental oxygen to keep saturation greater than 95% and the situation is not expected to resolve within 2 weeks
Research participant requires pressor support and/or has symptomatic cardiac arrhythmias
Research participant requires dialysis
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
Research participants' last dose of prior chemotherapy or radiation must be >= 2 weeks before leukapheresis; Note: this criterion is not applicable if the research participant's donor is undergoing leukapheresis
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
COH pathology review confirms that research participant's diagnostic material is consistent with a lymphoproliferative B-cell neoplasm
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 has completed prescribed lymphodepletion
(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, he/she must be at least 2 weeks from having received the last dose of immunosuppressant medications\r\n* Exceptions:\r\n** Steroids and tyrosine kinase inhibitors are allowed up to 7 days prior to leukapheresis\r\n** Research participant cannot be on more than 5 mg prednisone or equivalent doses of other corticosteroids at the time of leukapheresis
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
If research participant is undergoing leukapheresis the last dose of prior chemotherapy, immunotherapy or radiation must be at least 2 weeks before the leukapheresis procedure\r\n* Exception rule: the wash out period for Hydrea is 48 hours
ELIGIBILITY TO UNDERGO LYMPHODEPLETION:\r\n* Please note that none of these criteria are applicable of the research participant's donor is undergoing leukapheresis
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 must have the ability to understand and communicate with the investigator
Participant must have documented diagnosis of de novo MDS with:
Participant has received prior therapy with a BH3 mimetic.
Participant must be evaluated by surgical oncologist and felt to have potentially resectable tumor and be medically fit for proposed surgery
Therapeutic options: Participant's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.
Female participant without childbearing potential must meet at least one of the following:
Female participant of childbearing potential must meet at least one of the following:
Participant screening laboratory result must indicate HCV genotype 1, 4, 5 or 6-infection if historical result is not available.
Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.
Participant has hypersensitivity to any component of TMZ or dacarbazine.
Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.
Participant has a history of herpetic keratitis.
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
Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
If received prior brentuximab vedotin or lenalidomide, must be able to tolerate the dose level to which the participant will be enrolled to
Participant may be either previously untreated for KS or refractory to or intolerant of any one or more prior KS therapies
Participant has known leptomeningeal metastases.
Participant has received more than one prior systemic therapy regimen for SCLC.
Participant had prior exposure to topotecan, irinotecan or any other topoisomerase I inhibitors.
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
Participant is a candidate for, and agrees to receive conventional external beam radiotherapy
The participant has breast biopsy consistent with ductal carcinoma in situ (DCIS)
Type of Participant and Target Disease Characteristics
The participant has a diagnosis of gastric or GEJ adenocarcinoma.
The participant received combination chemotherapy, which must include a platinum and/or a fluoropyrimidine and must not include a taxane or antiangiogenic agent.
The participant is receiving therapy with any of the following:
The participant received radiotherapy within 14 days prior to randomization.
The participant experienced any arterial thromboembolic event within 6 months.
The participant has either of the following:
The participant experienced any Grade 3 or 4 venous thromboembolic event that is not adequately treated.
Participant who has hypersensitivity to bortezomib, boron, or mannitol
participant must have received trastuzumab emtansine (T-DM1) in any disease setting
Participant has a diagnosis of Waldenström's disease, or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
Participant has had radiation therapy within 14 days of randomization
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
Participant must not have been previously treated with proteasome inhibitors. (The sponsor reserves the right to open the study to proteasome inhibitor-exposed participants in the future, at some time point after the first interim analysis (IA). In that case, the participant may not be refractory to proteasome inhibitor therapy.)
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 any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements
Participant for whom treatment with monotherapy chemotherapy such as gemcitabine or capecitabine is a reasonable choice.
Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in this study.
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.
Participant has received anti-myeloma treatment within 2 weeks before Cycle 1 Day 1
Unresectable disease (defined as the participant not being a candidate for curative surgery)
The participant has:
Participant agreement to undergo mastectomy or breast-conserving surgery after neoadjuvant therapy
Any significant concurrent medical or surgical conditions or findings that would jeopardize the participant's safety or ability to complete the study
For Part D (abemaciclib + LY3023414): Any subtype. The participant must have received at least two, but not more than three prior therapies for advanced/metastatic NSCLC. The participant must not have received prior treatment with any phosphoinositide 3-kinase (PI3K) or mammalian target of rapamycin (mTOR) inhibitor.
Participant is amenable to compliance with protocol schedules and testing
Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80
Participant has a known sensitivity to agents of similar biologic composition as ramucirumab or other agents that specifically target vascular endothelial growth factor (VEGF)
Participant has a history of chronic diarrheal disease within 6 months prior to randomization
Participant has participated in clinical trials of experimental agents within 4 weeks prior to randomization
Participant has adequate organ functions, evidenced by the following:
Have two negative pregnancy tests as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the participant practices true abstinence* from heterosexual contact.
Participant has been previously treated with azacitidine (any formulation), decitabine, or any other hypomethylating agent.
Participant has had radiotherapy ? 4 weeks or limited field radiation for palliation
Participant has received radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of trial treatment
Participant has had an allogenetic tissue/solid organ ransplant.
Participant has any condition that confounds the ability to interpret data from the study.
Participant is or has an immediate family member (spouse or children) who is investigational site or sponsor staff directly involved with this trial, unless prospective Institutional Review Board (IRB) approval (by chair or designee) is given allowing exception to this criterion for a specific participant.
Participant may have failed to achieve a response or progressed after treatment with brentuximab vedotin or may be brentuximab vedotin naïve
The participant has not received any previous treatment with anthracyclines.
The participant is currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device.
The participant has undergone chest irradiation within 2 weeks prior to receiving study treatment.
The participant has a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ).
The participant received combination chemotherapy prior to disease progression.
The participant has squamous cell or undifferentiated gastric cancer.
The participant is receiving chronic therapy with any of the following within 7 days prior to randomization:
The participant received radiotherapy within 14 days prior to randomization.
The participant received previous treatment with agents targeting the vascular endothelial growth factor (VEGF)/VEGF receptor 2 signaling pathway.
Participant has received treatment with cytarabine for a pre-existing myeloid disorder.
Participant has chronic respiratory disease that requires continuous oxygen use.
Participant has a white blood cell count greater than 25 × 10^9/L. Hydroxyurea is permitted to meet this criterion.
Participant has a diagnosis of Waldenstrom's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
Participant has had radiation therapy within 14 days of randomization
Participant has had plasmapheresis within 28 days of randomization
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
Disease shows evidence of refractoriness or intolerance to lenalidomide or if previously treated with a lenalidomide-containing regimen the participant is excluded if he or she discontinued due to any adverse event related to prior lenalidomide treatment
City of Hope (COH) pathology review confirms that research participant's diagnostic material is consistent with history of intermediate or high grade B-cell NHL (e.g., DLBCL, MCL, or transformed NHL)
Research participant has a released cryopreserved T cell product
Research participant did not have evidence of disease progression after salvage therapy and therefore underwent an autologous myeloablative transplantation with hematopoietic progenitor cell autologous (HPC[A]) rescue procedure
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
Has any medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol, or complete the study.
safety and well-being of the participant or offspring
Participant has an active infection or unexplained fever > 38.5 degrees Celsius (C) (101.3 degrees Fahrenheit [F])
The participant has received radionuclide treatment within 6 weeks of the first dose of study treatment
The participant has a primary brain tumor
The participant has radiographic evidence of cavitating pulmonary lesion(s) or tumor in contact with, invading or encasing major blood vessels
For all Parts (Dose escalation and expansion): The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy either after available standard therapies have ceased to provide clinical benefit (Parts A, B, C, D, E and F) or in combination with fulvestrant (Part G only)
For Dose Expansion (Parts B, C, D, E, F and G): The participant must have histological or cytological evidence of one of the following cancers:
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.
The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden cardiac arrest. Any participant with a history of venous thromboembolism (VTE) (for example, deep vein thrombosis [DVT] of the leg or arm and/or pulmonary embolism) will be excluded.
Rapidly progressive, symptomatic, visceral spread of disease placing participant at risk of life-threatening complications in the short term
Written consent by the participant
The disease indication for which the participant required HSCT must be in remission
Participant with manifestations of chronic GvHD
Participant with acute/chronic GvHD overlap syndrome
Participant with evidence of recurrent malignancy
Participant with veno-occlusive disease (ie, sinusoidal obstruction syndrome)
Participant receiving GvHD treatment other than continued prophylaxis (eg, cyclosporine and/or mycophenolate mofetil, etc) or corticosteroid therapy. In addition, a participant who received the first dose of corticosteroid therapy for acute GvHD with lower GI involvement more than 72 hours before the first dose of study treatment is not eligible for the study
Participant with severe sepsis involving at least 1 organ failure
Participant is a family member or employee of the investigator
Negative T and B cell flow crossmatches with the designated donor; as assessed by local laboratories; if one or more of the crossmatches is positive, the participant will be considered a screen failure unless combined results of antibody and cross match testing implicate a non-HLA antibody as the cause of the positive flow crossmatch; in this case, the protocol chair must approve the participant as a screening success after consultation with the HLA laboratory director
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 adequate organ and blood cell counts
The participant has an untreated brain tumor
The participant has high blood pressure or diabetes that is not well-controlled with medication
The participant has received anticoagulant therapy with the exception of aspirin within 1 week of starting the study
Bilirubin ?2.0 times ULN, unless participant has known Gilbert's syndrome
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
Clinically significant abnormalities, other than HCV infection, in a participant with HCC based upon the medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the participant an unsuitable candidate for this study in the opinion of the investigator.
In the opinion of the investigator, the participant or legal guardian is capable of understanding and complying with protocol requirements for the duration of the study.
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 investigator's belief that the participant is medically unfit to receive eribulin mesylate and pembrolizumab or unsuitable for any other reason.
Participants must have histological or cytological confirmed diagnosis of the following tumor types that is advanced and/or metastatic cancer and must be, in the judgment of the investigator, an appropriate participant for experimental therapy
Have an estimated life expectancy, in the judgment of the investigator, that will permit the participant to complete 8 weeks (2 cycles) of treatment.
The participant has radiologically documented evidence of major blood vessel invasion or encasement by cancer
The participant has radiographic evidence of intratumor cavitation, regardless of tumor histology
Participant must meet at least one of the following criteria in the judgment of the investigator or sub-investigator:
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 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
Participant disease tested positive for FLT3-ITD or –TKD within 60-day screening period
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
For participants potentially receiving chemotherapy: if the participant has received prior bendamustine, response duration must have been greater than (>) 1 year
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or that could increase risk to the participant
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
Serious active infection at the time of randomization, or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment
If the participant has received prior bendamustine, response duration must have been greater than (>) 1 year (for participants who have relapse disease after a prior regimen)
In the opinion of the investigator the protocol treatment is appropriate for the participant
If under age 18, parent(s) or guardian(s) able to participate in informed consent and initial assessment (unless the participant provides evidence of emancipated status)
Serious active infection at time of randomization or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment
Any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements OEP phase:
Is indicated with standard melphalan prednisone (MP) treatment and is not a candidate for high-dose therapy plus stem cell transplantation (HDT-SCT) for 1 of the following reasons: the participant is 65 years of age or older OR the participant is less than 65 years of age but has significant comorbid condition(s) that are likely to have a negative impact on tolerability of HDT-SCT
Any significant psychological, medical, or surgical condition thought to compromise the participant, the study, or prevent informed consent
The participant's tumor fully or partially contains Small Cell Lung Cancer (SCLC).
The participant has leptomeningeal disease.
The participant has a history of treatment with other agents targeting the Insulin-like or Epidermal Growth factor receptors.
The participant has superior vena cava syndrome contraindicating hydration.
The participant is unwilling or unable to take premedications (folic acid, vitamin B12, or corticosteroids) required by the pemetrexed label.
The participant has received a recent (within 30 days of enrollment) or is receiving concurrent yellow fever vaccination.
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 0 - 2 systemic anticancer regimens in addition to depot octreotide, which may have included chemotherapy, interferon, antiangiogenic therapy, other targeted treatments, or a combination of such treatments
The participant is no longer a candidate for surgery, embolization, or radiofrequency ablation therapy
The participant has experienced radiographic, biochemical, and/or scintigraphic disease progression while on a regimen that includes octreotide
The participant has adequate hematologic function as defined by absolute neutrophil count ? 1500/microliters (?L), hemoglobin ? 9 gram/deciliter (g/dL), and platelet count ?100,000/?L
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
Hearing loss that would preclude participating in telephone sessions (determined by brief hearing assessment administered by research staff at each National Cancer Institute Community Oncology Research Program [NCORP] component); individuals who can compensate for hearing loss through the use of a hearing device or telecommunication device for the deaf (TDD) phone, and through the use of such devices are able to communicate with the study therapist by telephone, will be included; if the therapist cannot communicate with the participant by telephone, the participant will be excluded
Participant has adequate understanding of the English language
CAREGIVER: Relative or friend who is identified by the patient participant and lives with the patient or has contact with them at least twice per week
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.
Known hypersensitivity (example, anaphylactic and anaphylactoid reactions) to any particular combination drug will result in a participant being ineligible for inclusion in that particular cohort.
For participant in the lenalidomide combination arm, demonstrated hypersensitivity (example, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide.
Participant must be able to swallow pills (psychology staff will be available to assist with pill swallowing training if needed)
The participant understands and is willing to provide informed consent in English or Spanish
The participant does not have an active cancer diagnosis
PROVIDER ELIGIBILITY: The participant is greater than 18 years of age
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
Self-identifies as partner, spouse or caregiver of a patient who is eligible as a patient participant and who has consented to participate
SUPPORT PROVIDER: Has been identified by the bereaved parent participant as a support or someone important to bereaved parent
Participant had recent surgery (within two weeks)
Participant is undergoing chemotherapy
Participant has any metallic object in or around their head
Participant has a pacemaker
Any disorder that would predispose the participant to seizures
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (0=participant has either normal activity, 1= participant has some symptoms but is nearly full ambulatory)
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
Availability of a reliable parent or legal guardian who is willing and able to complete all of the outcome measures and fulfill the requirements of the study, including administration of medications and accompanying the participant to all study visits
Participant must plan to receive follow up care at Dartmouth-Hitchcock
Participant must have a lung or gastrointestinal (GI) primary cancer diagnosed in the last 3 months
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
Any participant who is not competent to provide informed consent for study participation per the investigator
Any participant who cannot be present for the related study visits and/or complete the post-test assessment
Concurrent cancer treatment of any kind is allowed, but the participant can also have completed all treatment
CAREGIVER: Relative or friend who is identified by the patient participant who plans to regularly accompany the patient to the majority of their clinic visits
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
The participant has disease that is not amenable to a curative approach
Participant is receiving standard \7+3\ induction chemotherapy regimen as specified in the protocol;
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).
3. Participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
Participant has had pulmonary embolism or any other thrombo-embolic event within 6 months prior to study entry
Participant is scheduled to initiate treatment with everolimus combined with exemestane or another form of endocrine therapy
Participants may not enroll in this study if they are receiving a study agent at the time of enrollment; a participant who chooses to enroll in a medication trial AFTER initial enrollment in our study will be allowed to stay in the study at the discretion of the study PI
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 currently is taking melatonin
Participant has known sleep apnea or medically treated sleep disorder (e.g. restless leg syndrome)
Participant has current major psychiatric illness (i.e. schizophrenia, bipolar disorder)
Participant is currently receiving treatment with fluvoxamine
Participant is currently receiving treatment with anticoagulants (e.g. Coumadin)
Participant is currently receiving treatment with immunosuppressants or corticosteroids
Participant is currently receiving treatment with nifedipine (Procardia XL)
Participant is employed in a position that requires night work (i.e. 10 pm to 6 am)
Participant has a history of neurologic event (i.e. traumatic brain injury) unrelated to cancer or its treatment
Participant has a sensory impairment (vision, hearing) that prohibits completion of neurocognitive examination
Relative or friend of patient participant who will likely accompany the patient to clinic visits
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
Cognitive impairment that prevents participant from answering questions in standardized assessments
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
Documented informed consent of the participant
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
Clinician is comfortable that cancer has adequately been ruled out and is willing to follow the participant for up to 5 years without treatment of the HSIL
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 plans to relocate away from the study site to a location that does not have an Anal Cancer/HSIL Outcomes Research (ANCHOR) study site during study participation
Willing to undergo two surgical procedures (if participant chooses the ISDO 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
Any condition that, in the clinical judgement of the investigator, would place a participant at unreasonably increased risk
H/L: Participant whose medical records or self-report indicate an ethnicity aside from Hispanic.
If the participant is of childbearing potential, she should be at least 3 months postpartum
Individuals who have used any topical medication other than emollients on the test area within 30 days prior to study enrollment; if a study participant requires topical medication to the test area during the study, they will be withdrawn from the study.
Be the only participant in his/her household on active treatment in Protocol 2016-0626 at the time.
Intercurrent illness which makes potential participant unsuitable for study or started hormone replacement therapy between RPFNA and enrollment on study
Be the only participant in their household
Participant is taking any anticoagulant agent (e.g. warfarin) or antiplatelet agent (e.g. clopidogrel)
Be the only participant in their household
Physical limitations that prevent participant from exercising
A known deleterious mutation in BRCA1, BRCA2, PTEN, or TP53. (Note: The participant must be a documented carrier to meet this criterion. If there is a known mutation in a hereditary breast cancer susceptibility gene in a participant's family member, the participant herself must have undergone genetic testing as per National Comprehensive Cancer Network guidelines to be eligible per this criterion.)
Participant and/or parent or caregiver must be able to read, understand, and complete the daily diary
Participant has a known diagnosis of mental incapacitation that may affect their ability to consent and be compliant with the protocol
Participant has an underlying predisposition to gastrointestinal (GI) or rectal bleeding are considered ineligible for study participation
Must agree to use medically acceptable barrier and/or chemical method of contraception while on study and for at least one month following the last vaccine injection; should a participant's partner become pregnant or suspect she is pregnant while the participant is participating in this study, the study physician should be informed immediately; in the event a participant’s partner becomes pregnant, the study sponsor may request additional information regarding the course of the pregnancy and if the pregnancy is carried to term, the birth of the child (i.e., the outcome of the pregnancy)
Participant reported history of congestive heart failure
In this pediatric & adult study, the participant or parent/guardian is consented, and the patient when a minor is given an assent form and involved in the discussion as appropriate
In this pediatric & adult study, the participant or parent/guardian is consented, and the patient when a minor is given an assent form and involved in the discussion as appropriate
Participant can be a male or a non-pregnant female
The participant will be excluded from participation in another clinical research trial (i.e., a trial in which an agent is actively administered to the study subject), while being imaged (on active treatment) on this protocol
Participant must be receiving a planned lymphoscintigraphy procedure
Participant must be scheduled to undergo radioembolization for any indication
Participant must not have any contraindications to MRI scanning
Participant must have either radiological (presumptive) or established (proven) histological diagnosis of a brain tumor or lesion
Participant in a clinical trial involving an investigational drug within the past 30 days
Has a known psychiatric and/or substance abuse disorder that would make it difficult for the participant to cooperate with the requirements of the trial
Participant has
The participant must meet the following criteria relevant to their specific diagnosis:
Participant is candidate for hematopoietic stem cell transplants at the time of enrollment.
the safety or well-being of the participant or study staff
the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
Report any level of cognitive difficulty to the question, “Are you currently experiencing any cognitive problems (such as in your memory, attention, concentration, multi-tasking) since your cancer diagnosis?” at chemotherapy cycle 4 or after; participant must answer YES to this question\r\n* NOTE: If a participant answers NO, you may re-approach them at a subsequent cycle
STUDY PARTICIPANT ELIGIBLITY:
Participant must be a hematologist, oncologist, nurse practitioner, or physician assistant who practices medicine in the Duke Cancer Network
Participant is willing to participate in the educational component of this project
Eligible caregivers who will be recorded are those present in the room with the enrolled oncologist and the patient participant receiving oncology care during the audio-recorded clinic visit
Obvious physical or mental disability that would prevent participant from interacting with a tablet device
Identification of cost being the primary reason why person does not smoke daily (so that the study outcome variable of smoking rate isn’t influenced by participant receiving research cigarettes)
Criteria 1, Participant is a candidate for hepatic surgery or local regional therapy of liver metastases with curative intent
Criteria 4, Participant is currently receiving or has received liver metastatic-directed therapy ( eg: radiation, ablation, embolization) less than 4 wks prior to enrollment or hepatic surgery
The participant is receiving therapy with immunosuppressive agents.
The participant has a medical or psychological condition that would not permit the participant to complete the study or sign informed consent.
The participant is receiving therapy with immunosuppressive agents.
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
Participant must be able to understand and give consent to participate in the study