Must not have received prior EBV or LMP-specific T cells within 90 days of entry onto this study
Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months PRIOR TO registration\r\n* Transmural myocardial infarction within the last 6 months prior to study entry\r\n* Unstable ventricular arrhythmia within the last 6 months prior to study entry\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics within 28 days prior to study entry\r\n* Hepatic insufficiency resulting in clinical jaundice, encephalopathy and/or variceal bleed within 28 days prior to study entry\r\n* Bleeding within 28 days prior to study entry due to any cause, requiring transfusion\r\n* Thrombolytic therapy within 28 days prior to study entry; subcutaneous heparin is permitted\r\n* Known bleeding or clotting disorder\r\n* Uncontrolled psychotic disorder
Patients fulfilling the following criteria will be eligible for entry into this study:
Patients who have met the pre-entry requirements
Patients who have met the pre-entry requirements
Patient may have started imatinib prior to study entry but has not received more than 14 days of imatinib
Grade 2 or greater rash of any cause at time of study entry
Use of orlistat or any other known FASN inhibitor within 6 months prior to study entry
Patients with whole blood transfusion in the last 120 days prior to entry to the study
Participants who have had anti-cancer therapy within 2 weeks prior to entering the study or those who have not recovered from acute adverse events due to agents administered more than 2 weeks earlier; palliative radiation to bony metastases >= 2 weeks prior to study entry is allowed; chronic use (defined as starting at least 3 months prior to registration) of GnRH agonist therapy, such as leuprorelin, at the time of study entry is not exclusionary and participants can continue the GnRH agonist therapy while on study
Must not have received any biological modifier within 14 days of entry on to this study
The subject may have had other systemic chemotherapy for PCNSL during the 90 days since PCNSL diagnosis; prior systemic chemotherapy must have been given at least 4 weeks prior to study entry (6 weeks for nitrosourea agents), with the exceptions of methotrexate and rituximab which may have been given at least 10 days prior; ocular lymphoma treatment may have been given any time prior to study entry; if the subject has undergone treatment for parenchymal disease and the parenchymal disease has progressed on a stable or increasing dose of steroids, the subject is not eligible for enrollment
Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry; palliative radiation (=< 10 fractions) must have been completed at least 48 hours prior to study entry; stereotactic or small field brain irradiation must have completed at least 2 weeks prior to study entry; whole brain radiation must have completed at least 4 weeks prior to study entry
Patients must not be receiving other investigational medications (covered under another IND) within 30 days of study entry or while on study.
At the time of study entry, blood counts performed within 2 weeks prior to study entry must meet the following criteria:
Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing should be performed within 14 days prior to study entry according to institutional standards for women of childbearing potential.)
Whole blood transfusion in the last 120 days prior to entry to the study
Prior radiation therapy within 14 days prior to study entry
Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound, and/or MRI) within 84 days prior to study entry. If suspicious or abnormal, FNA or core biopsy is recommended. Findings of these evaluations will be used to define the nodal status prior to study entry according to the following criteria:
Excisional biopsy or lumpectomy performed prior to study entry.
Baseline tumor measurements must be documented from tests within 28 days of study entry; other non-laboratory tests must be performed within 28 days of study entry
Laboratory tests required for eligibility must be completed within 14 days prior study entry; baseline tumor measurements must be documented from tests within 28 days of study entry; other non-laboratory tests must be performed within 28 days of study entry
Patients taking sertraline at the time of study entry will not be eligible for the study
The subject has tested positive for the Clostridium difficile toxin within 7 days of study entry.
Active infection =< 7 days prior to study entry
Any of the following prior therapies:\r\n* Chemotherapy =< 3 weeks prior to study entry\r\n* Immunotherapy =< 4 weeks prior to study entry\r\n* Biologic therapy =< 4 weeks prior to study entry\r\n* Extensive abdominal surgery if it includes enterotomy(ies) =< 3 weeks prior to study entry; (NOTE: this criterion does not apply to placement of the peritoneal Port-A-Cath or lysis of adhesions at the time of study entry)\r\n* Any viral or gene therapy prior to study entry
Patients with NHL must have objective, documented evidence of disease prior to study entry
Initial diagnosis of metastatic disease must have occurred ?8 weeks prior to entry in the study.
Hepatic inclusion within 2 weeks of entry
Normal mammogram of unaffected breast within 12 months prior to study entry
No other therapy (i.e. chemotherapy, interferon) for 4 weeks prior to study entry, or cladribine for 6 months prior to study entry
Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study
Patients who have uncontrolled infection are not eligible; patients must have any active infections under control; fungal disease must have been adequately treated for at least 2 weeks before study entry; subjects with bacteremia must have documented negative blood cultures prior to study entry
Radiotherapy or cancer chemotherapy (except for intrathecal prophylaxis and/or low-dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, steroids) or any investigational drug within 2 weeks before study entry
Imaging evaluations necessary to establish eligibility for study entry must be done within three (3) weeks prior to registration
All other evaluations necessary to establish eligibility for study entry must be done within two (2) weeks prior to registration
Subject who have received ferumoxytol within 3 weeks of study entry
Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study
Subject who have received ferumoxytol within 3 weeks of study entry
History of acute urinary retention within 6 months of study entry;
Chemotherapy must not have been received within 2 weeks of entry onto this study
Radiation therapy (except palliative to relieve bone pain) within 7 days of study entry; palliative radiation (=< 10 fractions) must have been completed at least 48 hours prior to study entry; stereotactic or small field brain irradiation must have been completed at least 7 days prior to study entry; whole brain radiation and radiation for leptomeningeal metastasis must have been completed at least 2 weeks prior to study entry; acute effects of radiation must have resolved to baseline severity or to CTCAE grade =< 1 except for AEs that in the investigator’s judgment do not constitute a safety risk for the patient
Whole blood transfusion in the last 120 days prior to entry to the study
Has history of wound dehiscence or complications requiring medical intervention within 6 months of study entry
Previous intravesical therapy within 6 months of study entry.
Hyperleukocytosis (leukocytes ?25 x 109/L) at study entry. These patients may be treated with hydroxyurea according to routine practice, and enroll in the study when the leukocyte count falls below 25 x 109/L.
No prior chemotherapy, radiation therapy, or breast resection within 6 months of study entry
Appropriate stage for protocol entry including no clinical evidence for distant metastases based upon the following minimum diagnostic workup:\r\n* History/physical examination, documentation of weight and Zubrod performance status 0-2 within 60 days prior to study entry\r\n* Right and left mammography within 90 days of diagnostic biopsy establishing diagnosis
The etiology of abnormal bilirubin and transaminase levels should be evaluated prior to study entry
Previous radiotherapy within 3 months before study entry
No abnormalities on pre-entry electrocardiogram, obtained within 28 days prior to being registered on study
Patients treated with any Cyp17-lyase inhibitor, any 2nd generation AR antagonist (e.g. enzalutamide), cabazitaxel or carboplatin whose disease progressed while on treatment or within 3 months of its discontinuation; patients who have received any of these treatments more than 12 months from study entry and whose disease did not progress while on treatment or within 3 months of its discontinuation are allowed on study
Major bleeding in the last 4 weeks prior to study entry
Patients who are receiving treatment with medications that cannot be discontinued prior to study entry and that are considered to be any of the following:
Subjects with bacteremia must have documented negative blood cultures prior to study entry
Fully resected disease at study entry (residual CIS acceptable)
Entry into the study is limited to no more than 8 weeks from the date of surgery.
Platelets > 100 x 10^9/L within 14 days of study entry
Radiotherapy and cancer chemotherapy (except for intrathecal prophylaxis and/or low-dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, steroids) or any investigational drug within 2 weeks before study entry
Biologic therapy (anti-neoplastic)\r\n* Must not have received oral tyrosine kinase inhibitors (other than dasatinib) or other similar agents within 3 weeks of the study entry and all toxicities must have resolved to < grade 2 prior to enrollment\r\n* Must not have received bevacizumab or other monoclonal antibody therapy within 4 weeks of study the entry
At the time of study entry, blood counts performed within 4 weeks prior to study entry must meet the following criteria:
Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing should be performed within 14 days prior to study entry according to institutional standards for women of childbearing potential.)
Patients receiving erythropoietin (darbepoetin, epoetin alfa) must be on a stable dose and with stable transfusion requirement or hemoglobin level during the 8 weeks prior to study entry
Tumor not suitable for resection at the time of study entry; (transplant eligible patients are allowed)
Histologically confirmed AML by hematopathology review performed within four weeks prior to study entry
Allogeneic or autologous transplant for AML with infusion of stem cells within 90 days of study entry or on active immunosuppressive therapy for (GVHD) within 2 weeks before study entry
No prior chemotherapy, radiation therapy, or breast resection within 6 months of study entry
Patients who have uncontrolled infection are not eligible; patients must have any active infections under control; fungal disease must be stable for at least 2 weeks before study entry; patients with bacteremia must have documented negative blood cultures prior to study entry
Skin biopsy performed at least 5 days and no longer than 10 weeks from the time of initial entry into the study
All patients must undergo pre-treatment evaluation of tumor extent prior to study entry through imaging studies and clinical examinations, including computed tomography (CT) and/or magnetic resonance imaging (MRI) of skull base, brain and neck within 28 days prior to study entry; physical examination +/- nasal endoscopy within 28 days prior to study entry; and CT of the chest within 60 days prior to study entry
Must not have received any biological modifier within 14 days of entry on to this study
No other therapy (i.e. chemotherapy, interferon) for 4 weeks prior to study entry, or cladribine for 6 months prior to study entry, unless progressive disease more than 2 months after cladribine is documented
Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing should be performed within 14 days prior to study entry according to institutional standards for women of childbearing potential.)
Receiving treatment with any medication known to produce QT prolongation within 7 days of study entry
Did not receive any investigational treatment for at least 28 days prior to study entry
Completed autologous BMT (if received) at least 3 months prior to study entry; completed allogeneic BMT (if received); at least 6 months prior to study entry
Patients must not be receiving other investigational medications (covered under another IND) within 30 days of study entry or while on study.
Patients must not be receiving other investigational medications (covered under another IND) within 30 days of study entry or while on study
Surgery within 21 days prior to study entry.
Consultations: all patients should be evaluated by a surgeon prior to study entry
Subjects with bacteremia must have documented negative blood cultures prior to study entry
Meet laboratory parameter requirements at study entry
Mini Mental Status Exam (MMSE) >= 18 prior to study entry
Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study
A history of prior trans-urethral surgery requires cystoscopy for evaluation before study entry to rule out stricture
Patients who have met the pre-entry requirements
Diabetic patients requiring insulin for glucose control at the time of study entry
Mini Mental Status Exam (MMSE) >= 18 prior to study entry
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 (6 weeks if prior nitrosourea)\r\n* Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent; at least 3 weeks for biologic agents with a long half life, such as antibodies\r\n* External beam radiation therapy (XRT): Must not have received craniospinal radiotherapy within 24 weeks prior to study entry; the tumor designated as “measurable” for protocol purposes must not have received radiation within 12 weeks prior to study entry); focal radiation to areas of symptomatic metastatic disease must not be given within 14 days of study entry\r\n* Stem cell transplant (SCT): For autologous SCT, >= 3 months must have elapsed prior to study entry\r\n* Study specific limitations on prior therapy:\r\n** Patients must not have previously received bevacizumab, irinotecan, temozolomide or other anti-vascular endothelial growth factor (VEGF) inhibitor\r\n** Patients must not be taking enzyme-inducing antiepileptic medicines within 1 week of study entry
Any acute, inter-current infection that may interfere with planned protocol treatment; participants with mycobacterium avium will not be excluded from study entry; chronic therapy with potentially myelosuppressive agents is allowed provided that entry hematologic criteria are met
Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Whole brain radiation must have completed at least 4 weeks prior to study entry.
Proliferative disease (WBC > 30 x 109 /L) (confirmed at time of study entry prior to first dose)
History of ischemic cardiac disease that has occurred within 6 months prior to study entry.
Hgb < 100 g/L, have received ? 2 units PRBC in the 12 weeks prior to study entry, and be intolerant of or had inadequate response to ruxolitinib;
Patients who have met the pre-entry requirements
have had unprotected sexual intercourse within 30 days before study entry,
Group B Phase 2: No prior systemic treatment for advanced or metastatic disease (adjuvant and/or neoadjuvant therapies are allowed if completed at least 6 months prior to study entry. No prior tyrosine kinase inhibitor therapy is allowed at any time prior to study entry)
Normal carcinoembryonic antigen (CEA) prior to study entry
Chemotherapy or other investigational anticancer therapeutic drugs in the two weeks prior to study entry; in the event of rapidly proliferative disease, however, the use of hydroxyurea is permitted up to 24 hours before study entry in core
Patient is premenopausal or perimenopausal at the time of study entry
Evidence of nonhealing wounds, ulcers, or bone fractures within 28 days prior to study entry.
Patients who have received any treatment with SGN-35 prior to study entry
Patients must not have received any prior chemotherapy, radiation therapy, biologic therapy, or bone marrow transplant; surgery and dexamethasone are permitted prior to study entry; in patients who require anticonvulsants prior to study entry, it is permissible to start VPA, but trough VPA concentration must be repeated within 48 hours of study entry
Patients with abnormality of the tibial metaphyseal plate on plain x-ray prior to study entry are not eligible
Concurrent treatment with estrogens or progestins; patients must stop these drugs at least two weeks prior to study entry
The subject has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study; specifically these include the topical use to the study tumors of: glucocorticoids (ii) retinoids (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene) systemically or topically (iii) alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to more than 5% of the skin during the six months prior to study entry (iv) 5-fluorouracil or imiquimod; also, treatment with systemic chemotherapy or agents known to be inhibitors of HH signaling within 60 days to starting study medication
Previous local therapy (e.g., chemoembolization or bland embolization) is allowed if completed > 6 weeks prior to study entry; for such patients, there must be either progression of measurable disease documented within the treatment field, or measurable progressive disease outside the treatment field prior to study entry
Previous chemotherapy and/or investigational agents are allowed if completed > 4 weeks prior to study entry (> 6 weeks if last regimen contained bis-chloroethyl nitrosourea [BCNU] or mitomycin C); for patients who received systemic therapy prior to study entry, there must be documented progression of measurable disease since receiving systemic therapy prior to study entry
Treatment with surgery or chemotherapy within 21 days prior to study entry or radiation within 14 days of study entry.
Patients who have completed sipuleucel-T (Provenge ®) treatment within 30 days of study entry.
Diabetics on insulin or antihyperglycemics must be on a stable dose (i.e., no titrations within the last 2 weeks) at the time of study entry
Diabetics on insulin or antihyperglycemics must be on a stable dose (i.e., no titrations within the last 2 weeks) at the time of study entry
Receiving baseline systemic glucocorticoid therapy (at stable dose) for cGVHD at study entry.
Patients will be registered on study based on the local exam under anesthesia (EUA) done for diagnostic purposes prior to study entry; the EUA done at study entry should be done within 14 days prior to study entry
Patient should have a normalized or normal uric acid level prior to study entry
History of arterial or embolic events (within 6 months prior to study entry)
Laboratory tests required for eligibility must be completed within 7 days prior study entry; baseline tumor measurements and ECHO or MUGA must be documented from tests completed within 28 days of study entry; other non-laboratory tests must be performed within 21 days of study entry
Patients with the following within the last 6 months prior to registration must be evaluated by a cardiologist and/or neurologist prior to entry into the study
Participants must not have a concurrent malignancy unless it can be adequately treated by non-chemotherapeutic intervention; participants may have a history of prior malignancy, provided that he/she has not had any chemotherapy within 365 days of study entry AND that life expectancy exceeds 5 years at the time of study entry
Patients treated with interferon or other anti-HCV therapy within 3 months prior to study entry
Subjects with bacteremia must have documented negative blood cultures prior to study entry
Patient has failed to recover from any prior surgery within 4 weeks of study entry
Participants must have achieved a complete or partial response per disease-appropriate imaging technique (to be determined by the study principal investigator) within 4 weeks of study entry following administration of chemotherapy
Participants must have baseline echocardiogram and pulmonary function tests within 3 months prior to study entry
Patient has failed to recover from any prior surgery within 4 weeks of study entry
Vaginal bleeding of unknown etiology within 12 months of study entry
Patient has been treated with nelfinavir within 3 months of entry into this trial
Patient has at least 2 years of nilotinib treatment prior to study entry.
Except for steroid refractory or intolerant cases, participants must be receiving baseline systemic glucocorticoid therapy for cGVHD at study entry; the dose of steroids must be stable for 14 days prior to starting study drug
Patients must be off hydroxyurea (HU) or erythropoietin (EPO) treatment for at least three months prior to entry onto the study
Oral retinoid therapy for any indication within 3 weeks of study entry
Patients must have recovered (to Common Toxicity Criteria [CTC] version [v.]4.0 =< grade 1 unless indicated below) from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study, with the exception of alopecia, weight changes and grade I or II lymphopenia\r\n* Myelosuppressive chemotherapy: must not have received within 3 weeks of entry onto this study (6 weeks if prior nitrosourea or mitomycin-C)\r\n* Biologic (anti-neoplastic agent): at least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\r\n* Immunotherapy: at least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines\r\n* Monoclonal antibodies: at least 3 half-lives of the antibody after the last dose of a monoclonal antibody\r\n* Radiation therapy (RT): patients must have had their last fraction of craniospinal RT >= 6 months prior to study entry and their last fraction of focal RT >= 4 weeks prior to study entry; if the lesion used for on-study criteria is in the radiation field, there must be evidence of tumor progression after radiation therapy was completed\r\n* Study specific limitations on prior therapy:\r\n** Patients who have received thalidomide are eligible if all acute thalidomide-related toxicity has resolved\r\n** Patients must not have received lenalidomide previously
Patient has failed to recover from any prior surgery within 4 weeks of study entry
Prior radiation therapy (RT) within 2 months of study entry
Note: laboratory tests required for eligibility must be completed within 4 weeks prior to study entry; baseline measurements in the CNS must be documented from tests within 14 days of study entry; other non-laboratory tests must be performed as indicated
Radiation therapy for splenomegaly within 6 months prior to study entry
Previous treatment for APL, except tretinoin, which may be given for up to 7 days prior to study entry
Recovered from side effects that might interfere with the protocol therapy and:\r\n* >= 4 weeks must have elapsed from last radiation treatment to time of study entry\r\n* >= 4 weeks must have elapsed from the last chemotherapy administration to time of study entry\r\n* >= 8 weeks from the last immunotherapeutic agent administered to time of study entry
Study participant must use birth control measure prior to study entry (during screening), during study participation, and for 12 weeks after bevacizumab is discontinued
No other investigational anti-tumor agents within 30 days prior to study entry or during active participation in the study (defined as from study entry until tumor progression)
Patients must not be receiving other investigational medications (covered under another IND) within 30 days of study entry or while on study.
Evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study entry.
Hepatic insufficiency resulting in clinical jaundice, encephalopathy and/or variceal bleed within 60 days prior to study entry
Any chemotherapy and/or radiation therapy received =< 3 months of study entry and any immunotherapy received =< 6 months of study entry (with the execption of Bacillus Calmette-Guerin [BCG] treatment)
Imaging evaluations necessary to establish eligibility for study entry must be done within three (3) weeks prior to registration; all other evaluations necessary to establish eligibility for study entry must be done within two (2) weeks prior to registration; in the event that the patient’s condition deteriorates (performance score < 60) within 48 hours prior to the injection the patient is no longer eligible to receive HSV1716 injection
Women who participate in this study must agree not to breastfeed from study entry to a period of no less than four months post the HSV1716 injection
Patients must have measurable disease as defined by palpable lesion with both diameters >= 1 cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension >= 1 cm; bilateral mammogram and clip placement is required for study entry; baseline measurements of the indicator lesions must be recorded on the Patient Registration Form; to be valid for baseline, the measurements must have been made within the 14 days if palpable; if not palpable, a mammogram or magnetic resonance imaging (MRI) must be done within 14 days; if palpable, a mammogram or MRI must be done within 2 months prior to study entry; if clinically indicated, x-rays and scans must be done within 28 days of study entry
Patient must be able to be treated with remestemcel-L within 4 days of study entry.
Congenital TTP (known at the time of study entry).
Treatment with surgery or chemotherapy within 21 days prior to study entry
Individuals must have been on a stable dose of ruxolitinib for at least 4 weeks prior to study entry
Chemotherapy or other investigational anticancer therapeutic drugs within 1 week prior to study entry unless AEs have resolved and there is no interference with the assessment of efficacy or safety; in the event of rapidly proliferative disease, however, the use of hydroxyurea is permitted up to 12 hours before study entry. Patients with prior bone marrow or stem cell transplant, considered for inclusion, should be discussed with the medical monitor first.
Diagnostic examination under anesthesia (EUA) must be performed within 14 days prior to study entry
Symptomatic metastatic brain or meningeal tumors unless the patient is > 3 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry.
Received bisphosphonates (e.g., etidronate, clodronate, tiludronate, pamidronate, neridronate, olpadronate, alendronate, ibandronate, risedronate, zoledronate) within 2 weeks prior to study entry
Mini Mental Status Exam (MMSE) >= 18 prior to study entry
Patients with cirrhosis must have had esophagogastric endoscopy within the previous 6 months prior to study entry for the assessment of varices; if the patient has not had this done they must be willing to undergo this procedure prior to study entry
Because the effects of ofatumumab on fetuses and nursing infants are not known, the following are ineligible for study entry:
Patients must have met all pre-entry requirements
If biopsy of metastatic lesion is performed prior to study entry, HER2 expression by IHC must be 1+ or 2+
Patients must have measurable disease as defined by palpable lesion with both diameters >= 1 cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension >= 1 cm; bilateral mammogram and clip placement is required for study entry; baseline measurements of the indicator lesions must be recorded on the patient registration form; to be valid for baseline, the measurements must have been made within the 14 days if palpable; if not palpable, a mammogram or magnetic resonance imaging (MRI) must be done within 14 days; if palpable, a mammogram or MRI must be done within 2 months prior to study entry; if clinically indicated, x-rays and scans must be done within 28 days of study entry
Prior therapy: patients must have fully recovered from the acute toxic effects of all prior therapy prior to enrolling on study\r\n* Myelosuppressive chemotherapy: must not have received myelosuppressive therapy within 2 weeks prior to study entry (4 weeks if nitrosourea)\r\n* Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with biologic agent, including retinoic acid; participants receiving Intravenous Immunoglobulin (IVIG) are eligible; however, participant must not receive IVIG during the 4 days of antibody infusion\r\n* Radiation therapy: at least 2 weeks since prior local radiation therapy at the time of study entry\r\n* Growth factors: must not have received hematopoietic growth factors (filgrastim [G-CSF], sargramostim [GM-CSF]) for at least 1 week prior to study entry\r\n* Investigational agent: must not have received investigational agent within 14 days of study entry\r\n* Immune therapy: must not have received immunosuppressive (including glucocorticoids), immunostimulatory or any immunomodulatory treatment within 2 weeks of study entry; steroid\r\ncontaining inhalers, steroid replacement for adrenal insufficiency and steroid premedication for prevention of transfusion or imaging contrast-agent related allergic reaction will be permitted
Chemotherapy or other investigational anticancer therapeutic drugs within 1 week prior to study entry. AEs from prior therapy must have resolved or stabilized so that there is no interference with the assessment of efficacy or safety; in the event of rapidly proliferative disease, however, the use of hydroxyurea is permitted up to 12 hours before study entry. Patients with prior bone marrow or stem cell transplant, considered for inclusion, should be discussed with the medical monitor first.
Prior biologic or immunologic therapy =< 4 weeks prior to study entry
Patients who have received any treatment of ponatinib prior to study entry
Uncontrolled angina within 6 months prior to study entry;
Patients who have met the pre-entry requirements
In remission at time of study entry, may be receiving chemoprevention
Presence of do not resuscitate (DNR)/do not intubate (DNI) orders at study entry
Use of finasteride or dutasteride within 3 weeks or 6 months, respectively, of study entry
If patients are on opioids for the treatment of cancer pain, they must have had no dose changes (> 25%) for at least 48 hours prior to study entry; change in opioid dose after study entry is allowed
Patients must have met pre-entry requirements
Patients may be on steroids at study entry
Presence of oral mucositis (WHO Score ? Grade 1) at study entry
Prior use of acupuncture within 3 months prior to the study entry
Presence of hot flashes for > 30 days prior to study entry
If patients are on opioids for the treatment of cancer pain, they must have had no major dose change (> 25%) for at least 48 hours prior to study entry; change in opioid dose after study entry is allowed
Non-randomized pilot cohort:\r\n* Concurrent chemotherapy (initiated within 3 months of study entry) or planned chemotherapy within 3 months of study entry
Prior use of acupuncture for CIPN within 6 months prior to study entry
Vaginal dryness or dyspareunia must be present for at least two months prior to study entry
The patient has a clinical negative node status at the time of study entry (i.e. T0-4, M0, tumor staging criteria)
Presence of oral mucositis at study entry
Use of allopurinol within 72 hours of the study entry
Subjects who are taking drugs known to interact with posaconazole and that may lead to life-threatening side effects (terfenadine, cisapride, and ebastine at entry or within 24 hours before entry, or astemizole at entry or within 10 days before entry)
Subjects who are taking drugs known to lower the serum concentration/efficacy of posaconazole: cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, and isoniazid at entry or within 24 hours before entry
Patients may have untreated OPLs (i.e., hyperplasia, dysplasia, carcinoma in situ) at the time of study entry, provided the index OPL or HNSCC was definitively treated
Baseline mammogram performed within 90 days prior to study entry, done on a digital mammography machine, that are reported as normal or benign.
Study entry must be within 12 weeks of last surgery (breast or axilla) or last chemotherapy (if applicable)
Completion of first-line radiation at least 6 months prior to study entry.
Patients on aromatase inhibitors other than letrozole at study entry.
If receiving antiretroviral therapy:                \r\n* Receipt of antiretroviral therapy for at least 3 months prior to entry\r\n* No change in antiretroviral therapy within 30 days prior to entry
Prior RT is allowed and must have been completed more than 7 days before planned study entry\r\n* Note: For re-irradiation cases, standard departmental guidelines should be followed so as to not exceed normal tissue
The patient has a clinical negative node status at the time of study entry (i.e., Tis-4, N0, M0)
Subject who have received ferumoxytol within 3 weeks of study entry
Subject who have received ferumoxytol within 3 weeks of study entry
Subject who have received ferumoxytol within 4 weeks of study entry
After entry into the study, participants agree to be followed for up to 6 weeks after the final infusion of ferumoxytol
Baseline MRI studies for participants receiving ferumoxytol must be performed within 16 weeks of study entry
Patient must not have received craniospinal radiotherapy or involved field radiotherapy to the local tumor (and/or tumor designated as “measurable” for protocol purposes) =< 24 weeks prior to study entry; focal radiation to areas of symptomatic metastatic disease must not be given within 14 days of study entry
Radiation therapy (except palliative to relieve bone pain) within 7 days of study entry; palliative radiation (=< 10 fractions) must have been completed at least 48 hours prior to study entry; stereotactic or small field brain irradiation must have been completed at least 7 days prior to study entry; whole brain radiation must have been completed at least 2 weeks prior to study entry
Pre-imaging radiological scans/studies must be performed approximately 16 weeks prior to study entry; but not less than 24 hours prior
Prostate biopsy within 4 weeks prior to study entry
Replacement hormone therapy initiated before study entry is permitted
Replacement hormone therapy initiated before study entry is permitted
N0 and M0 at the time of study entry.
Patients with treated brain metastases are eligible if they are > 4 weeks from therapy completion (including radiation and/or surgery), are clinically stable at the time of study entry and are not receiving corticosteroid therapy at the time of study entry
has been diagnosed less than 3 months before study entry and/or