Patients may have received prior therapy for the treatment of MDS, including but not limited to: growth factor, transfusion support, immunomodulatory (IMID) therapy, DNA hypomethylating therapy, or cytotoxic chemotherapy prior to enrollment.
Radiopharmaceutical therapy (e.g., radiolabeled antibody,  iodine metaiodobenzylguanidine [I-MIBG]): >=  days after systemically administered radiopharmaceutical therapy
Subjects with certain mutations that have not been treated with a targeted therapy prior to enrollment
Hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration
CRITERIA FOR MAINTENANCE THERAPY-STEP : Patients must have resolved any serious infectious complications related to therapy
CRITERIA FOR MAINTENANCE THERAPY-STEP : Any significant medical complications related to therapy must have resolved
No prior taxane therapy =<  months, except as a radiosensitizer
Patients may receive up to a maximum of  days of pre-treatment with ATRA prior to administration of protocol therapy
No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC
Patients on antiretroviral therapy.
Patients receiving concurrent exogenous hormone therapy (topical vaginal estrogen therapy is allowable).
GCTs: no limit of prior therapy
Prior therapy - prior trastuzumab, lapatinib, pertuzumab, and trastuzumab emtansine (T-DM) are allowed; patients who have received prior therapy with taselisib (GDC-) or BYL- are excluded; there is no limit on the number of prior lines of therapy
Prior treatment with =< two prior cytotoxic regimens; prior therapy must have consisted of at least one of the following: cisplatin, carboplatin, paclitaxel, docetaxel or gemcitabine; if the only prior cytotoxic therapy was administered in the perioperative i.e. neoadjuvant or adjuvant settings, patient is eligible provided the interval from end of therapy to the diagnosis of metastatic disease is less than one year
Part B: More than  cycles of prior therapy with carboplatin
All patients receiving antifungal therapy voriconazole, posaconazole, or fluconazole must have sirolimus reduced according to the Standard Practice Antifungal Therapy Guidelines
Prior CAR T-cell or other genetically-modified T-cell therapy
Disease Characteristics and allowable prior therapy:
For Groups B or C patients must be off conventional therapy for at least  week prior to receiving treatment on this study
For prior cytotoxic therapy, treatment for  full cycle or less will not be considered as prior therapy unless the patient experienced progression of disease while on that therapy.
Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy. Prior therapy with weekly paclitaxel for recurrent disease, unless administered more than  years prior to enrollment, unless part of an upfront treatment strategy.
Completion of other cancer therapy (targeted therapy, chemotherapy, investigational therapy, immunotherapy, radiotherapy, surgery)  days prior to first dose of protocol therapy\r\n* For patients with breast cancer only:\r\n** May continue ongoing antiestrogen therapy (for example, aromatase inhibitor)\r\n** May continue ongoing human epidermal growth factor receptor (Her) directed therapy (for example, trastuzumab)
Prior cytoreductive therapy.
Prior therapy with abemaciclib
Prior radioisotope therapy
Any prior therapy targeted against PSMA
Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, topical therapy such as -fluorouracil or imiquimod, radiation therapy, surgery, or photodynamic therapy\r\n* For patients with multiple cutaneous BCCs at baseline that are not designated by the investigator as target lesions, treatment of these non-target BCCs with surgery may be permitted but must be discussed with data coordinator prior to any surgical procedure
If prior therapy consisted of palliative chemoradiation therapy, it will be considered one line of therapy.
Subjects must have recovered from all toxicity associated with previous chemotherapy, targeted therapy, experimental therapy, biological therapy, immuno-oncology therapy, surgery, radiotherapy, or other locoregional therapy. (Exception: Subjects may enter with continuing alopecia.) The following intervals must elapse between end of last treatment and receiving the first dose of SM:
Patients should have been off conventional therapy for at least  week prior to receiving treatment on this study
Patients may continue therapy with a targeted agent if CNS disease developed while receiving the agent, and for defined regimens that have been deemed safe when combined with anti-PD- therapy
Patients who are candidates for local salvage therapy must have had this option pursued or discussed; and the patient must have either declined salvage therapy or was deemed not to be a candidate for salvage therapy
Prior radiation therapy to the liver including Y , I based loco regional therapy. Prior loco regional therapy, including resection, based on other technology for ICC, if any, must have been completed at least  weeks prior to baseline imaging.
Patients must be receiving optimal therapy for their extracranial disease according to local practice at each center. Patients may continue on systemic therapy while receiving TTFields.
Duration of prior HMA therapy ?  months and/or total ?  cycles of prior HMA therapy in ?  months
Patients must be weaned off prednisone and be off therapy for >=  week prior to starting therapy
Note: HER mutation testing may be performed while the patient is receiving active systemic therapy for metastatic breast cancer so that the result can be used to determine eligibility for study drug therapy in the future
Having gotten prior PD therapy is allowed for, especially if they have previously progressed on it; progression may include extra-cranial as well as intra-cranial progression; after progressing on PD therapy, intervening chemotherapy and/or targeted therapy (BRAF inhibitors [BRAFi], etc) is allowed; if they are on intervening chemotherapy and/or targeted therapy (BRAFi, etc), they have to have progression intra-cranially and/or extra-cranially and must be off intervening therapy for at least  weeks
Participants who have had prior local regional therapy including radiation therapy, transarterial therapy, or ablative therapy
Receiving glucocorticoid therapy and calcineurin therapy or glucocorticoid therapy alone for cGVHD at study entry. Subjects on calcineurin therapy only, without glucocorticoid therapy, are not eligible. Subjects also receiving other therapies thought not to be immunosuppressive (such as extracorporeal photopheresis; ECP), will be considered for enrollment in this study on a case-by-case basis.
Prior infusion of a genetically modified therapy
At least  but no more than  prior lines of therapy for the treatment of de novo DLBCL and ineligible for (or failed) autologous or allogeneic stem cell transplant (SCT) (salvage therapy, conditioning therapy and maintenance with transplant will be considered one prior treatment). NOTE: For follicular lymphoma transformed to DLBCL (t-FL/DLBCL), single agent non-cytotoxic therapy will not be considered as a line of therapy.
Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy, retinoid therapy, or investigational agent) within  days or  half-lives of day 
Patients with NF will only be eligible if complete tumor resection is not considered to be feasible without substantial risk or morbidity, or if a patient with a surgical option refuses surgery\r\n* Since there is no standard effective chemotherapy for patients with NF and PN, patients may be treated on this trial without having received prior medical therapy directed at their PN\r\n* Since selumetinib is not expected to cause substantial myelosuppression, there will be no limit to number of prior myelosuppressive regimen for PN or other tumor manifestations associated with NF such as optic glioma\r\n* Patients who have received previous investigational agents or biologic therapy, such as tipifarnib, pirfenidone, Peg-Intron, sorafenib, or other VEGFR inhibitors are eligible for enrollment\r\n* Growth factors that support platelet or white cell number or function must not have been administered within the past  days and are not permitted while on the study\r\n* At least  weeks must have elapsed prior to enrollment since the patient received any prior radiation therapy, and no prior radiation therapy should have been directed at the target PN\r\n* At least  weeks must have elapsed since receiving medical therapy directed at the PN\r\n* At least  weeks must have elapsed since any surgeries, with evidence of completed wound healing\r\n* Patients who received prior medical therapy for their PN must have recovered from the acute toxic effects of all prior therapy to =< grade  Common Terminology Criteria for Adverse Events version  (CTCAE v) before entering this study
Must have completed and recovered from all prior definitive therapy (surgery, brachytherapy, cryotherapy or radiotherapy) for the primary tumor, or other definitive-intent local therapy
Prior therapy with afatinib
Prior therapy for the treatment of solitary plasmacytoma is permitted, but >  days should have elapsed from the last day of radiation; NOTE: prior therapy with clarithromycin, dehydroepiandrosterone (DHEA), anakinra, pamidronate or zoledronic acid is permitted; any additional agents not listed must be approved by the principal investigator
Prior treatment with an anti-CTLA- antibody treatment; the course of sipuleucel-T therapy (i.e. three treatments) leading up to this investigational trial must be the first course of therapy these patients have received
There is no waiting period for participants who relapse while receiving frontline therapy and are free from side effects attributable to such therapy
Patients receiving full dose anticoagulative therapy
No prior purine analog therapy except up to  prior course of either cladribine or pentostatin
No prior therapy for rectal cancer.
ALL patients refractory to liposomal vincristine as defined by progression while on therapy or relapse within  months of completion of therapy with liposomal vincristine
Prior immuno-oncology therapy
Must receive optimal therapy for extracranial disease and may continue on systemic therapy during TTF administration
Financial coverage for proton therapy
Prior therapy with LMB-
Recipient of CAR-T cell therapy outside of this protocol.
Failure to recover to grade  or baseline from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, immunotherapy, and/or experimental therapy, with the exception of: alopecia, grade =<  peripheral neuropathy, grade =<  cetuximab-related rash or other skin changes, hypomagnesemia (acceptable values detailed below), hypokalemia (acceptable values detailed below), and the acceptable hematologic values summarized above; a washout period of  weeks from prior cetuximab is required; a washout period of  weeks from any prior cytotoxic chemotherapy, targeted therapy, immunotherapy or investigational drug is required
Prior anti-ROR therapy within  weeks prior to the start of study therapy.
Prior anti-cancer therapy as specified below: At least  days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX agonists, -BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within  days prior to enrollment; Radiation therapy completed within  days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy.
No prior therapy for this disease
Chimeric Antigen Receptor (CAR)-T cell therapy.
At least  weeks away from any previous antineoplastic or investigational agent; patients may receive hydroxyurea or glucocorticoids for suppression of leukocytosis, but these must be stopped at least  hours (h) prior to initiation of therapy
(Arm B only): Subject must be relapsed or refractory to prior hypomethylating agent therapy, defined as prior receipt of  cycles of HMA therapy with failure to attain a response, or relapse after prior response to HMA therapy
Prior therapy with other HER targeted agents is not required, such as T-DM or pertuzumab
Hormone replacement therapy or vaginal estrogen therapy, DHEA, or biosynthetics within  weeks prior to enrollment
Use of finasteride within  days prior to therapy PSA should not be obtained prior to  days after stopping finasteride
Use of dutasteride within  days prior to therapy; PSA should not be obtained prior to  days after stopping dutasteride
Patients must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed
Prior therapy with a compound of the same mechanism as PF- (immunomodulation of -BB)
Prior therapy targeted to EGFRvIII
Candidate for potentially curative antibiotic therapy for gastric mucosa-associated lymphoid tissue (MALT); (gastric MALT lymphoma patients with stage I/II helicobacter [H.] pylori positive lymphoma must fail therapy with H.-pylori directed therapy before being considered for this study)
No prior genetically modified cell therapy that is still detectable >= % in the peripheral blood
Received at least one prior line of cancer therapy for the treatment of NSCLC; this should include at least one of the following: platinum (carboplatin or cisplatin) doublet chemotherapy (acceptable combinations include: paclitaxel, docetaxel, abraxane, pemetrexed, gemcitabine, vinorelbine, or etoposide), anti-PD/PDL therapy (pembrolizumab, nivolumab, or atezolizumab), or appropriate targeted therapy in patients with activating EGFR (osimertinib, erlotinib, gefitinib, or afatinib), ALK (alectinib, crizotinib, ceritinib, brigatinib, or loralatinib), or ROS- (crizotininb or entrectinib) alterations; therapy may be given as monotherapy or in combination with other cancer therapy (e.g. bevacizumab, ipilumimab)
No prior MM-directed therapy except for dexamethasone (up to  mg) and/or bortezomib (up to . mg/m^) and/or cyclophosphamide up to  mg/m^ administered for management of acute manifestations of MM (hypercalcemia, renal impairment, pain) for no longer than  weeks prior to enrollment. If subject received any prior therapy, pretreatment parameters necessary for disease characterization and response assessment must be available
I therapy <  months prior to initiation of therapy on this protocol; a diagnostic study using <  mCi of I is not considered I therapy
Prior anti-tumoral radionuclide therapy with unsealed sources; prior therapy with sealed radioactive sources such as brachytherapy will be allowed
Patients may be on somatostatin analogue therapy (e.g. but not only limited to sandostatin or lanreotide therapy); however, therapy with somatostatin analogues should not be initiated or altered within  months of study enrollment; patients on short term octreotide may have dose held for  hours prior to Lu--DOTATATE therapy; those on long acting octreotide therapy will receive treatment at  to  days prior to their next cold octreotide dose, in order to prevent competition for the receptor
Pregnant and nursing: female patients must have a negative serum pregnancy test within  hours prior to initiating protocol therapy and be practicing an effective form of contraception during protocol therapy and for at least  weeks following completion of protocol therapy
Has had prior therapy with indoleamine-pyrrole ,-dioxygenase (IDO)-inhibitors
Prior therapy wash-out period requirements\r\n* Participants must be at least  weeks from prior surgical procedures and surgical incisions must be healed\r\n* Participants must have had their last fraction of external beam radiation therapy at least  weeks prior to enrollment; participants with prior radiation therapy must be at least  weeks post therapy and have had progression of disease outside the radiation port\r\n* Participants must have had their last dose of cytotoxic chemotherapy at least  days prior to enrollment, their last dose of biological therapy, such as biological response modifiers (e.g., cytokines), immunomodulatory agents, vaccines, differentiating agents, used to treat their cancer at least  days prior to enrollment, their last dose of a monoclonal antibody at least  days prior to enrollment, and their last dose of any investigational agent at least  days prior to enrollment\r\n* Participants must have recovered from the acute toxic effects of prior therapy to a grade  (Common Terminology Criteria for Adverse Events [CTCAE] v..) level prior to enrollment (does not apply to alopecia)
Concomitant use of other anti-cancer therapy (chemotherapy, immunotherapy, hormonal therapy (hormone replacement therapy is acceptable), radiotherapy (except for palliative), biological therapy or other novel agent) or live virus and live bacterial vaccines while the patient is receiving study medication. Strong or moderate CYPA inhibitors and inducers should not be taken with study treatment; however, if no other suitable alternative concomitant medication is available, dose reductions may be allowed under careful monitoring
Patients must not have had leukemia therapy for  days prior to starting palbociclib. However, patients with rapidly proliferative disease may receive hydroxyurea as needed until  hours prior to starting therapy on this protocol and during the first cycle of study
Must have received at least one but not more than two prior anti-angiogenic therapy regimens (including, but not limited to, sunitinib, sorafenib, pazopanib, axitinib, tivozanib, and bevacizumab) in the advanced or metastatic RCC setting; prior cytokine therapy (eg, IL-, IFN-alpha), vaccine therapy, or treatment with cytotoxics is also allowed
No prior therapy, or limited prior therapy, including systemic glucocorticoids for one week or less, one dose of vincristine, emergency radiation therapy (e.g., to the mediastinum, head and neck, orbit, etc.) and one dose of intrathecal chemotherapy
Patients who have received previous investigational agents or biologic therapy, such as tipifarnib, pirfenidone, Peg-Intron, sorafenib, imatinib or other targeted therapies are eligible for enrollment; at least  weeks must have elapsed since receiving medical therapy directed at the plexiform neurofibromas (PN) and patients who received previous GIST-directed therapy must either demonstrate progression as defined by RECIST, or be unable to tolerate their previous therapy; patients who received prior medical therapy for their PN must have recovered from the acute toxic effects of all prior therapy to =< grade  before entering this study
Treatment with the following within the  weeks prior to the screening visit: radiotherapy, intralesional therapy; laser therapy surgery (other than biopsy) to the target area, local hyperthermia, levulinic acid, -fluorouracil, high potency corticosteroids (including systemic steroids), retinoids, diclofenac, hyaluronic acid, imiquimod;
>=  months since last therapy for HSIL
Prior or ongoing systemic therapy for prostate cancer including, but not limited to:\r\n* Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)\r\n* CYP- inhibitors (e.g. ketoconazole)\r\n* Antiandrogens (e.g. bicalutamide, nilutamide)\r\n* Second generation antiandrogens (e.g. enzalutamide, ARN-)\r\n* Immunotherapy (e.g. sipuleucel-T, ipilimumab)\r\n* Chemotherapy (e.g. docetaxel, cabazitaxel)\r\n* Note: may be enrolled if has recently initiated hormone therapy (<  days duration); in the event that hormone therapy was initiated prior to study enrollment, the clock for  year of androgen deprivation would begin at the time of therapy initiation, rather than at study enrollment
Patients receiving prior therapy with HCQ
Use of experimental drug therapy for myelofibrosis, or any other standard drug (eg, danazol, hydroxyurea, etc) with the exception of ruxolitinib within  months of starting study (combination) therapy and/or lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade  or better
Prior CAR T-cell or other genetically-modified T-cell therapy, with the exception of prior JCAR treatment in this protocol for subjects receiving retreatment
Completion of major surgery, chemotherapy, targeted therapy (such as everolimus or experimental agents or radiation within  days prior to starting investigational drug or has not recovered from major side effects; there is no required washout period from completion of prior anti-estrogen therapy (either scenario) or prior CDK / inhibitor (if scenario ) to initiation of ribociclib/placebo and anti-estrogen on trial
Previously untreated for myeloma or have received no more than one cycle of any treatment regimen; NOTE: Prior radiation therapy for the treatment of solitary plasmacytoma is permitted; prior therapy with clarithromycin, dehydroepiandrosterone (DHEA), anakinra, pamidronate or zoledronic acid is permitted; any additional agents not listed must be approved by the principal investigator
Any skin-directed therapy within  days prior to initiating protocol therapy
Chemotherapy/systemic therapy, radiotherapy, immunotherapy or surgery =<  days prior to registration or kinase inhibitor therapy =<  days prior to registration or failure to recover from toxicities (to grade  or below) from treatment; NOTE: concurrent therapy with octreotide is allowed providing that tumor progression on this therapy has been demonstrated; concurrent therapy with bisphosphonates (e.g. zoledronic acid) or denosumab is also allowed; NOTE: an unlimited number of prior chemotherapeutic or biologic therapies for malignant pheochromocytoma or paraganglioma is permitted; this includes prior anti-angiogenesis therapies such as tyrosine kinase inhibitors
Completion of local therapy, such as radiation, surgical resection, injectable immunebased therapy, or topical pro-inflammatory agent,  days prior to first dose of protocol therapy.
Tumor with mutation that is known to be sensitive to FDA approved targeted therapy but has not yet received such therapy
Prior antiestrogen therapy
Thrombocytopenia < x /ml, not resulting from therapy
Patients have a history of prior therapy with carboplatin
Prior conventional antitumor therapy, other than steroids, radiation therapy (RT) or TMZ therapy given for glioblastoma
Any number of prior therapies (including none) is permitted; the last dose of systemic therapy (include targeted therapies) must have been given at least  weeks prior to initiation of therapy; patients receiving carmustine (BCNU) or mitomycin C must have received their last dose of such therapy at least  weeks prior to initiation of therapy
No prior antineoplastic drug therapy for at least  days, with the exception of hydroxyurea, prior to starting OTS. Patients with rapidly proliferative disease may continue to receive hydroxyurea.
Patients with a diagnosis of advanced CML must have been treated with  prior TKIs, and the last therapy must have been discontinued  days prior to starting OTS.
No prior antineoplastic drug therapy for at least  days, with the exception of hydroxyurea, prior to starting OTS. Patients with rapidly proliferative disease may continue to receive hydroxyurea.
Patients with a diagnosis of advanced CML must have been treated with  prior TKIs, and the last therapy must have been discontinued  days prior to starting OTS.
Patients should have discontinued therapy with imatinib, dasatinib, nilotinib, ponatinib, omacetaxine or other anti-leukemia therapy (except hydroxyurea) >=  hours prior to start of study therapy and recovered from any toxicity due to these therapies to grade =< ; hydroxyurea may be received up to the time of enrollment and for the first  weeks of study treatment if necessary
Prior therapy with bosutinib or axitinib
Must have received at least one prior anti-angiogenic therapy (or inability to tolerate, as above) in the advanced or metastatic setting; prior cytokine therapy (eg, IL-, IFN-alpha), vaccine therapy, or treatment with cytotoxics is also allowed but not any other drug specifically targeting T-cell co-stimulation or checkpoint pathways
Not pregnant, or taking effective contraception before rapamycin therapy, during therapy and for  weeks after discontinuation of therapy
Chemotherapy (including oral agents and targeted agents) or immunotherapy given within  days of SRS; hormonal therapy is permitted; for Her+ breast cancer patients, anti-Her therapy cannot be given within  days of SRS; patients who are scheduled to receive trastuzumab emtansine after SRS cannot be enrolled
Prior therapy with lomustine
Prior systemic therapy for prostate cancer including, but not limited to:\r\n* Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)\r\n* CYP- inhibitors (e.g. ketoconazole)\r\n* Antiandrogens (e.g. bicalutamide, nilutamide)\r\n* Second generation antiandrogens (e.g. abiraterone, enzalutamide)\r\n* Immunotherapy (e.g. sipuleucel-T, ipilimumab)\r\n* Chemotherapy (e.g. docetaxel, cabazitaxel)\r\n* Note: may be enrolled if hormone therapy was recently initiated of any kind (<  days duration); in the event that hormone therapy was initiated prior to study enrollment, the clock for  year of androgen deprivation would begin at the time of therapy initiation, rather than at study enrollment
Prior therapy with ado-trastuzumab emtansine (patients who had prior trastuzumab or other HER targeted agents are eligible)
Prior frontline therapy for B-CLL must have been discontinued >=  days but =<  days prior to registration; NOTE: Patients on supportive care therapy due to use of specific induction regimen such as antibiotics may continue on those treatments at the discretion of the treating physician
Chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or any other anticancer therapy or investigational medicinal product (IMP) within  days of first trial drug intake for Phase Ia subjects, and any prior therapy for Phase Ib subjects. For subjects with rapidly growing tumors localized in the head and neck region or thorax where the treating physician cannot wait for  days, inclusion may take place if there is no residual toxicity from previous treatment (maximum CTCAE Grade )
Prior therapy with ceritinib
Prior therapy
Patients are eligible to participate within  months of completion of therapy for their breast cancer; this includes prior radiation therapy if needed
Completing SoC adjuvant therapy per NCCN guidelines to include chemotherapy, radiation therapy, and/or biologic therapy as clinically indicated. (Consent # should be signed as close to completion of SoC as possible but may overlap completion by up to one month.)
Prior CAR therapy or other genetically modified T cells
CAR-T infusion or other cellular therapy within  days
Unable to tolerate gastrointestinal prophylaxis therapy with sucralfate while on pre-phase and remission induction therapy; or severe pre-existing gastrointestinal (GI) disorder that requires peptidylprolyl isomerase (PPI) or histamine H (H) receptor antagonist therapy be uninterrupted
Chemotherapy, immunotherapy, biologically targeted therapy, other investigational agent, or radiation therapy within  weeks of initiation of enzalutamide therapy; for patients with objectively progressive disease on a Bruton tyrosine kinase (BTK)-targeting agent whom in the opinion of the investigator would not tolerate a  day washout period, a >  half-lives washout period will be allowed
For patients with type II diabetes receiving only oral anti-hyperglycemic therapy (patients receiving insulin are not eligible), the following are required at screening:\r\n* HbAc < . % or IFCC < . mmol/mol\r\n* Stable regimen of oral anti-hyperglycemic therapy without insulin usage for at least  weeks prior to first study treatment\r\n* Fasting plasma glucose levels =<  mg/dL (. mmol/L) and no hypoglycemia (blood sugar [BS] < ) during home monitoring for at least  week prior to study entry
Patients receiving prior therapy with RGF, VOR, and/or HCQ
No prior genetically modified cell therapy that is still detectable or prior virotherapy
Prior therapy with ceritinib
Persistent or recurrent adenovirus infection or disease despite at least  days of standard therapy or failure of therapy as described below or if unable to tolerate standard therapy. Standard therapy is defined as antiviral therapy with cidofovir or an alternative antiviral agent if patient will not tolerate cidofovir therapy because of poor renal function. i. Adenovirus infection: defined as the presence of adenoviral positivity as detected by polymerase chain reaction (PCR) or culture from ONE site, such as stool or blood or urine or nasopharynx. ii. Adenovirus disease: defined as the presence of adenoviral positivity as detected by PCR, Direct fluorescent assay (DFA) or culture from two or more sites such as stool or blood or urine or nasopharynx. iii. Failure of therapy: defined as a rise or a fall of less than % in viral load in peripheral blood or any site of disease as measured by PCR (or any other quantitative assay) after  days of antiviral therapy.
Patients must have had anti-HER based therapy for metastatic disease (which may include trastuzumab and pertuzumab either sequentially or in combination).
Newly-diagnosed chemo-naive or recurrent after curative-intent surgery\r\n* >=  months after completion of adjuvant therapy (including chemotherapy and/or radiotherapy)\r\n* No prior treatment with any targeted agent\r\n* Patients who have started first line mFOLFOX therapy (+/-trastuzumab for HER amplified tumors) may be considered for trial participation if they have received no more than  doses of therapy at the time of consent and screening\r\n** These patients will be required to meet next cycle parameters for eligibility before commencing treatment on trial rather than being required to meet parameters as indicated below which is for previously untreated metastatic/recurrent patients
Prior therapy with fenretinide and/or fenretinide + ketoconazole is allowed if no DLT's were experienced. Prior therapy with other retinoids
If newly diagnosed, prior therapy with hydrea and/or steroid and the use of a single or a two day dose of cytarabine (up to  g/m^), for emergency use up to  hours prior to start of study therapy is allowed
Cytoreduction therapy with plasmapheresis or hydroxyurea acceptable
Adenovirus: Treatment of persistent adenovirus infection or disease despite standard therapy; standard therapy is defined as antiviral therapy with cidofovir^ or an alternative antiviral agent if patient will not tolerate cidofovir therapy because of poor renal function\r\n* Adenovirus infection: defined as the presence of adenoviral positivity as detected by PCR or culture from ONE site such as stool or blood or urine or nasopharynx\r\n* Adenovirus disease: defined as the presence of adenoviral positivity as detected by PCR, direct fluorescent antibody (DFA) or culture from two or more sites such as stool or blood or urine or nasopharynx\r\n* Failure of therapy: defined as a rise or a fall of less than % in viral load in peripheral blood or any site of disease (as measured by PCR or any other quantitative assay) after  days of antiviral therapy
Patients who have a history of listeriosis prior ADXS- therapy
For Phase I and II: Patients must have been off chemotherapy for  weeks prior to entering this study, unless there is evidence of rapidly progressive disease, and must have recovered from the toxic effects of that therapy to at least grade . Use of hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy. The additional days of Hydrea after  is permitted as clinically indicated, on case by case basis after discussion with the PI. Other agents given transiently with the intention to control rapid proliferation such as - doses of single agent ara-C or few doses of sorafenib are also allowed.
INCLUSIONS FOR CAR-T CELL THERAPY
EXCLUSIONS FOR CAR-T CELL THERAPY
For cohort of patients that are already on ruxolitinib therapy: on therapy with ruxolitinib for at least for  months, and on stable dose for last  months, before starting therapy with sotatercept
Received systemic treatment for cancer, including immunotherapy, within one month prior to initiation of dosing within this protocol; however, cell harvesting by leukapheresis may be performed before one month from prior therapy if the study investigators consider that it will not have a detrimental impact on the generation of the two cell therapies in this protocol
Patients must have been off all prior therapy for CML for  weeks prior to start of study therapy and recovered from the toxic effects of that therapy; exceptions to these are hydroxyurea and TKIs (including but not limited to imatinib, nilotinib, and bosutinib) which should be discontinued >=  hours prior to the start of therapy; patients who are receiving dasatinib prior to enrollment do not have to discontinue this agent prior to start of study therapy
PHASE II: Patients may have had treatment for no more than  prior relapse (i.e. failed  lines of treatment-initial therapy and therapy for first relapse) at nd relapse, treatment per BTTC- is an option; relapse is defined as progression following initial therapy (i.e. radiation +/- chemo if that was used as initial therapy); the intent therefore is that patients had no more than  prior therapies (initial and treatment for  relapse); if the patient had a surgical resection for relapsed disease and no anti-cancer therapy was instituted for up to  weeks, and the patient undergoes another surgical resection, this is considered as  relapse; for patients who had prior therapy for a low-grade glioma, the surgical diagnosis of a high-grade glioma will be considered the first relapse
Patients must not have received prior whole brain radiation therapy; previous SRS/SRT done at least  weeks from the planned start of IPdR therapy is acceptable; SRS/SRT/fractionated boosts or neurosurgery can be performed once the dose limiting toxicity (DLT) assessment has been completed, if felt clinically necessary
Has been treated with Peptide receptor radionuclide therapy (PRRT) at any time prior to randomization
I therapy =<  months prior to registration; Note: I administered solely for diagnostic purposes is not considered I therapy
Prior therapy with romidepsin
Prior intrapleural therapy (except pleurodesis) or intrapleural therapy at the time of P/D (i.e.: intrapleural chemotherapy, photodynamic therapy, intrapleural betadine)
Patients must be at least  weeks past any prior surgery, cytotoxic, chemotherapy, other immunotherapy, hormonal therapy, or radiation therapy; patients having been treated with monoclonal antibodies may enter the trial after a specified period of time ( times the mean half-life of the agent); patients must have recovered from any toxicity of prior therapy prior to enrolling on study except for neuropathy where patients need to recover to less than grade 
Extensive prior therapy including >  months alkylator therapy or >  months alkylator therapy with extensive radiation
Prior treatment with a Mucin  (MUC)-targeted therapy
Radiopharmaceutical therapy (eg, radiolabeled antibody, I-metaiodobenzylguanidine): ? days after systemically administered radiopharmaceutical therapy.
Have documented evidence of progressive disease (PD) on or after their last regimen as defined by IMWG criteria. All participants must have received between  to  prior therapies for MM (a prior therapy is defined as  or more cycles of therapy given as a treatment plan for MM [eg, a single-agent or combination therapy or a sequence of planned treatments such as induction therapy followed by autologous stem cell transplant (SCT) and then consolidation and/or maintenance therapy]).
Subject has no prior anti-myeloma treatment therapy within  days prior to initiation of study treatment except for corticosteroids with a maximum allowed dosage equivalent to three pulses of dexamethasone (mg daily for  days equals one pulse). Patients may have received prior adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care, or radiation therapy as palliation for pain and/or spinal cord compression.
Prior TCN-PM therapy
Prior AQN therapy.
 Prior anti-cancer therapy as specified below: At least  half-lives from first dose of AMG  must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX agonists, -BB agonists, etc). Other targeted anti-cancer therapy (chemotherapy, antibody therapy,molecular targeted therapy, steroids) within  days or  half lives (which ever is longer) prior to first dose of AMG . Patients requiring continued treatment due to aggressive disease may only be included if there is agreement by both the investigator and the Amgen Medical Monitor. Radiation therapy completed within  days prior to first dose of AMG . Autologous HSCT within six weeks prior to start of AMG  treatment.
Patients must have had at least one prior platinum-based chemotherapeutic regimen for management of primary disease; unlimited prior hormonal therapy, targeted therapy or antiangiogenic therapy will be permitted
History of systemic anti-cancer therapy (e.g., chemotherapy, targeted therapy) for metastatic breast cancer (MBC) with the exception of administration of trastuzumab or lapatinib concurrently with radiation therapy for brain metastases; toxicities related to lapatinib should be =< grade , per the CTCAE version (v). and must have been completed at least  weeks prior to randomization
Subjects with proven or suspected persistent bacteremia despite  hours of both systemic antibiotic therapy and lock therapy to which the infecting organism is susceptible;
Symptomatic metastatic brain or meningeal tumors unless the patient is > months from definitive therapy, has no evidence of tumor growth on an imaging study and is clinically stable with respect to the tumor at the start of study treatment. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies).
The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anti-convulsant therapy at a stable dose is permitted.
Has received prior therapy with IL- or other investigational systemic cytokine therapy signaling through a common gamma-chain cytokine receptor including IL-, IL- or IL-
Prior use of aromatase inhibitor therapy apart from assisted reproduction
Fludarabine based therapy within  months of enrollment
Appropriate for single agent study drug therapy as prescribed by this protocol;
Patients who are not candidates for, or decline, intensive therapy
Any skin-directed therapy within  days prior to day  of protocol therapy
No prior targeted treatment (tx) or anti-angiogenic therapy; patients may have received one line of prior therapy with octreotide, locoregional therapy; continuation of concurrent octreotide is allowed; patients will be maintained on octreotide (sandostatin) for the duration of their treatment
Part  patients must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor infiltrating lymphocytes [TIL], lymphokine-activated killer [LAK] or gene therapy), or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed
Prior therapy with elotuzumab
Subjects must have completed their most recent drug therapy directed at multiple myeloma in the following timeframes:\r\n* Antitumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy, or investigational agent) at least  days prior to cycle  day  (CD) AMG  + KRd\r\n* Corticosteroids at least  weeks prior to starting AMG- + KRd, except for a dose equivalent to dexamethasone of =<  mg/day\r\n* Autologous stem cell transplantation at least  weeks prior to starting AMG- + KRd\r\n* Allogeneic stem cell transplantation at least  weeks prior to starting AMG- + KRd, and these subjects must also NOT have moderate to severe active acute or chronic graft versus host disease (GVHD)
Patients who have received prior anti-GD therapy, including chimeric antigen receptor (CAR) T cells directed against GD antigen
Patients must not have received prior radiation therapy (RT), chemotherapy, immunotherapy or therapy with a biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cells, or gene therapy), or hormonal therapy for their brain tumor; corticosteroid therapy is allowed
Subjects must have ended hormone replacement therapy (HRT) (e.g., conjugated estrogens tablets, USP, [Premarin]), at least  month ( days) prior to receiving the first dose of randomized therapy
Prior therapy with axitinib
Patients must not have had chemotherapy, molecular therapy with erlotinib, radiation therapy, or experimental biological or molecular therapy for at least  weeks prior to starting study medication; patients who received FOLFIRINOX must be  weeks from the last administration of therapy; patients must have recovered from any acute toxicity related to prior therapy or surgery, to a grade  or less unless specified
Concomitant chemotherapy, radiation therapy\r\n* For patients with hyperleukocytosis with > , blasts/uL; leukapheresis or hydroxyurea may be used prior to study drug administration for cytoreduction at the discretion of the treating physician; hydroxyurea must be stopped  hours prior to initiation of protocol defined therapy
Patients already using topical sirolimus therapy
Prior therapy with an angiogenesis inhibitor
Prior therapy with a hedgehog inhibitor
Prior therapy with vinorelbine (Navelbine) or vinca-containing compounds.
Has received previous high dose (>= , IU/kg) IL- therapy; other prior therapy (in the adjuvant or the metastatic setting) is allowed, including immunotherapy, targeted therapy, chemotherapy, or experimental therapy
Prior therapy for the treatment of solitary plasmacytoma is permitted, but >  days should have elapsed from the last day of radiation\r\n* NOTE: Prior therapy with clarithromycin, dehydroepiandrosterone (DHEA), anakinra, pamidronate, or zoledronic acid is permitted; any additional agents not listed must be approved by the principal investigator
Prior therapy requirements:\r\n* At least one prior therapy using an agent with the potential for prolonged remission (generally includes interleukin-, checkpoint-blocking antibodies, or adoptive cell therapy)\r\n* At least  weeks from last dose of prior chemotherapy or immunomodulator therapy with resolution of the acute toxicities; for patients coming off molecularly-targeted therapy, at least  weeks since last dose and recovery from laboratory and constitutional toxicities; patients must meet entry eligibility criteria\r\n* At least  weeks from completion of prior radiation therapy with no residual radiation toxicities\r\n* At least  weeks from last dose of prior investigational therapy with recovery to meet baseline eligibility criteria\r\n* Not receiving any current anticancer therapy\r\n* Note: any patient whose tumors carry a B-Raf proto-oncogene, serine/threonine kinase (BRAF) v mutation should either be excluded, or may be included after experiencing progression following treatment with BRAF inhibitor regimen or if they consent and agree to forgo Food and Drug Administration (FDA)-approved therapies that increase median survival
Subjects must not have had prior pazopanib therapy
For stage  (all patients) and dose expansion (stage ) endometrial and ovarian cancer cohorts, participants are allowed following unlimited prior therapy; for stage  GBM participants, no more than  prior relapses are allowed; for these patients, relapse is defined as progression following initial therapy (i.e. radiation +/- chemo if that was used as initial therapy) or a subsequent therapy; the intent therefore is that GBM patients enrolling onto stage  had no more than  prior therapies (initial and treatment for  relapses); if the patient had a surgical resection for relapsed disease and no anti-cancer therapy was instituted for up to  weeks, and the patient undergoes another surgical resection, this is considered to constitute  relapse\r\n* NOTE: for participants who had prior therapy for a low-grade glioma, the surgical diagnosis of glioblastoma will be considered the first relapse; therefore, these participants may have had more than  prior therapies
Prior therapy with another hedgehog inhibitor
Women diagnosed with osteoporosis may participate in this trial provided they are receiving appropriate therapy or if they have declined therapy
Prior therapy with trastuzumab
Prior therapy with LMB-
Prior Therapy Criteria:
Prior therapy with any antibody or drug targeting T-cell coregulatory proteins
Prior radio- or toxin-conjugated antibody therapy.
Prior treatment with any adoptive T cell therapy
Active tuberculosis (TB):\r\n* Patients who are undergoing first month of therapy (RIPE or equivalent) for active TB\r\n* Patients with TB immune reconstitution syndrome (IRIS) requiring corticosteroids\r\n** Note: patients who are receiving therapy beyond month one of initial therapy with no evidence of TB IRIS requiring corticosteroid therapy, or those receiving treatment for latent tuberculosis (INH or alternative) may be eligible after discussion with the protocol P.I.
Prior immune-oncology therapy
<  months between completion of prior RT and initiation of reirradiation using proton therapy
Patients must not have received any prior anti-cancer therapy (except for radical or partial nephrectomy noted above) for renal cell carcinoma, including systemic therapy in the adjuvant or neoadjuvant setting, immunotherapy, investigational therapy, surgical metastasectomy, or radiation therapy
Abnormal coagulation and current anticoagulant therapy. Patients whose anticoagulation therapy can be temporarily reversed within  days prior to treatment are eligible. Platelet inhibitors (ie: ASA) and heparin are not exclusion criteria.
Ongoing AE attributed to ibrutinib therapy
Recovery from the effects of previous chemotherapy, with a minimum of  days from initiation of last therapy; hydroxyurea or anagrelide may be used to manage elevated cell counts in patients up to the time they begin therapy under this protocol
Prior therapy containing MMAE
No prior therapy with IL- or IL- analog
CRLX or with any topoisomerase I therapy;
Subjects must have a histologically confirmed malignancy that is metastatic or unresectable for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit or they must be ineligible to receive such therapy and/or have declined all such therapy. In addition, subjects must have a tumor that is at least  cm in a single dimension and is radiographically apparent on CT or MRI.
All forms of prior local therapy are allowed as long as patients have either a target lesion, which has not been treated with local therapy and/or the target lesion(s) within the field of the local-regional therapy has shown an increase of ? % in size. Local-regional therapy must be completed at least  weeks prior to the baseline CT scan. Local therapies including chemoembolization do not count as prior systemic therapy.
Any systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy or biological therapy (including monoclonal antibodies), or experimental anti-cancer therapy) within  days prior to beginning study therapy. Note: Ongoing castrating therapy with a GnRH agonist or antagonist is mandatory to assure a castrate level of serum testosterone < ng/dL, except in patients who have undergone an orchiectomy. Bisphosphonates or denosumab continuation is permissible (i.e., no change for  days prior to Cycle  Day ). Patients who receive a dose of EC under another Endocyte protocol do not need a washout period for EC
Other ongoing anti-myeloma therapy. Patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids for symptom management and comorbid conditions. Doses of corticosteroid should be stable for at least  days prior to patient registration.
Patients must have newly diagnosed active multiple myeloma (MM); except where otherwise indicated below that assessment is required within  days, all tests for establishing baseline disease status must be completed within  days prior to registration for patients with no prior therapy, or within  days prior to initiation of first Induction course for patients with prior therapy
Patients in CRi must have evidence of hematologic recovery after prior therapy to at least: platelets >=  x ^/L
Stable dose of glucocorticoids pre-therapy. If patients are receiving glucocorticoids, the dose should not increase during the  hours prior to initiation of therapy.
No prior therapy with Avastin
With the exception of steroid pretreatment (defined below) or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL\r\n* Patients receiving prior steroid therapy may be eligible for AALL
Prior therapy with an IDO or arginase  inhibitor.
Patients who have received prior progestin or anti-estrogen therapy during the  months before the diagnosis of endometrioid adenocarcinoma of the uterine corpus is established; estrogen therapy alone is allowed
At least , prior line of VEGF-targeted therapy, but not more than  total prior lines of systemic therapy. Exposure to more than  line of VEGF-targeted therapy is acceptable. Participants may also have received prior therapies with interferon, interleukin  (IL-), anti-PD antibodies, cabozantinib or other experimental agents, but not prior therapy with any agent that targets phosphoinositide -kinase (PIK), serine/ threonine-specific protein kinase (AKT), or mechanistic (or mammalian) target of rapamycin (mTOR).
For patients with GIST, patients will have progressed on at least one prior tyrosine kinase inhibitor therapy or be intolerant. If documented to have SDH deficient or PDGFRA-DV GIST, no prior therapy is required for study entry. Other patients with KIT positive cancers will have progressed on at least one prior therapy.
Patients must discontinue treatment with H-blockers (cimetidine, ranitidine, etc.) prior to beginning protocol therapy
In the absence of rapidly progressing disease, the interval from prior treatment to time of initiation of -azacytidine and lirilumab will be at least  weeks OR at least  half-lives for cytotoxic/noncytotoxic agents; use of one dose of cytarabine (up to  g/m^) is allowed prior to the start of study therapy or hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and while the patient is on active study treatment, as needed, for clinical benefit and after discussion with the principal investigator (PI); concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted
For phase II, any receipt of cytotoxic, biologic, or immune therapy aimed to treat GIST except for adjuvant imatinib systemic therapy that concluded at least  days prior to registration; for phase I, patients are eligible regardless of prior therapy
Prior therapy for NHL
Adjuvant therapy (including radiation therapy) within  calendar weeks; toxicities from prior therapy for the malignancy should resolve to grade  or less
Phase : Clinically active cerebral melanoma metastases. Subjects with up to  cerebral metastases, and neurological performance status of  may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, or Gamma knife therapy, with no evidence of progression, and have not required steroids, for at least  months prior to enrollment.
History of any systemic or local therapy (e.g., chemotherapy, biologic or targeted therapy, hormonal therapy, or photodynamic therapy) for the treatment or prevention of melanoma, including interferon alpha-b and pegylated interferon alpha-b
History of limb perfusion therapy
Patients who have received any local therapy (radiotherapy, high-potency corticosteroids, intralesional therapy, laser therapy or surgery) other than biopsy to the target area within  weeks prior to first dosing of study agent
Prior therapy with hydroxyurea, all-trans retinoic acid (ATRA), corticosteroids (any route), and IT cytarabine given at diagnosis is allowed; hydroxyurea and ATRA must be discontinued prior to initiation of protocol therapy; patients who have previously received any other chemotherapy, radiation therapy or any other antileukemic therapy are not eligible for this protocol
Received systemic treatment for cancer, including immunotherapy, within one month prior to initiation of dosing within this protocol; however, cell harvesting by leukapheresis may be performed before one month from prior therapy if the study investigators consider that it will not have a detrimental impact on the generate of the two cell therapies in this protocol
Corticosteroids given with antineoplastic intent within  days, or chemotherapy given with antineoplastic intent, targeted therapy, or radiation therapy within  weeks, or antibody-based therapy within  weeks of the start of study drug
Prior therapy with ruxolitinib
The patient requires statin therapy. Patients who are taking a statin and are considered appropriate to discontinue treatment, must discontinue the statin at least  days prior to starting study therapy.
Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within  days before first BTCTA (Mosunetuzumab) administration
No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy [chemo], biologic, vaccine therapy or surgery) while on this protocol except at disease progression
Participants with prior therapy, other than therapy including systemic glucocorticoids for one week or less, one dose of vincristine, emergency radiation therapy to the mediastinum and one dose of intrathecal chemotherapy
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational; prior therapy with bisphosphonate is allowed; prior therapy for smoldering myeloma MM may not be an exclusion criterion, discussion with principal investigator must occur before enrolling patients with prior treatments; prior radiation therapy to a solitary plasmacytoma is allowed; patients who received prior therapy due to being incorrectly diagnosed as having overt multiple myeloma may not be excluded after discussion with the overall PI
No prior therapy with the exception of prior radiation therapy and/or prednisone alone, at the discretion of the investigator based on current diagnosis and clinical condition; this prednisone treatment will not count toward the  cycles of treatment given in the study
Prior history of any viral-based therapy
Any prior treatment with T-DM (trastuzumab emtansine) or any trastuzumab therapy
Focal therapy within the  days prior to randomization
Extended field therapy within the  days prior to randomization
Patients that are considered candidates for ipilimumab therapy
Symptomatic metastatic brain or meningeal tumors unless the patient is >  months from definitive therapy, has a negative imaging study within  weeks of randomization and is clinically stable with respect to the tumor at the time of randomization; note: patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
OR for subjects receiving warfarin or LMWH, the subjects must, in the investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for these subjects may exceed .  ULN if that is the goal of anticoagulant therapy.
Ineligible for cisplatin therapy
Prior therapy with everolimus or an aromatase inhibitor
Prior RRx- therapy
Multiple myeloma which has relapsed following primary therapy or is not responsive to primary therapy. For this study, stable disease following ASCT will be considered nonresponsive to primary therapy.
Intraocular retinoblastoma not previously treated with systemic chemotherapy, radiation therapy, or IA therapy; local retinal therapy such as laser photocoagulation and cryotherapy will be permitted
Patients who have previously been treated with chemotherapy (with the exception of local retinal therapy such as laser photocoagulation and cryotherapy) radiation therapy, or intra-arterial therapy
If not receiving myelofibrosis therapy, must remain off therapy for at least  weeks prior to screen date and through the screening period
Prior therapy with AA
History of prior therapy with trastuzumab and a taxane, separately or in combination. For patients in dose escalation and MTD expansion cohorts, prior therapy with trastuzumab and a taxane must have been for metastatic disease. For patients in CNS disease expansion cohorts, trastuzumab and taxane (together or separately) may have been given at any time prior to study enrollment as part of neoadjuvant therapy, adjuvant therapy, or therapy for metastatic disease.
Previous therapy with anthracyclines, taxanes, or HER-targeted therapy for any malignancy
Prior therapy restrictions:
Any prior therapy with irinotecan
No particle therapy such as but not limited to proton therapy is allowed
Disease Status and Prior Therapy:
Prior therapy with ibrutinib or venetoclax
Prior Therapy
Radiopharmaceutical therapy: ? days after systemically administered therapy.
Prior therapy with any antibody/drug targeting T cell co-regulatory proteins (immune checkpoints)
Prior therapy - prior trastuzumab, lapatinib, pertuzumab, and trastuzumab emtansine (T-DMI) are allowed; there is no limit on the number of prior lines of therapy
Prior treatment with four or more cycles of hypomethylator therapy
Prior therapy: there is no limit on the number of prior surgeries, radiation therapy treatments, radiosurgery treatments, or chemotherapy
Symptomatic metastatic brain or meningeal tumors unless the patient is >  months from definitive therapy, has a negative imaging study within  weeks of irinotecan initiation, and is clinically stable with respect to the tumor at the time of study entry; also, the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to day  [D] of treatment under this study)
Prior treatment with -azacytidine followed immediately by HiDAC and mitoxantrone as proposed in this study (NOTE: prior therapy with -azacytidine or decitabine or HiDAC or mitoxantrone would be allowed-in patients with relapsed/refractory disease- unless the prior therapy was identical to the schema/schedule proposed in this study)
Hypercalcemia >. mmol/L, unresponsive to standard therapy (e.g., I.V. hydration, diuretics, calcitonin and/or bisphosphate therapy).
Refractory to prior Bortezomib-containing therapy under the . mg/m dose twice weekly dosing schedule.
Prior taxane therapy for any indication
ONLY APPLIES TO PATIENTS IN GROUP B (COMBINATION THERAPY)
Prior nitrosurea therapy (including lomustine or Gliadel)
Peptide receptor radionuclide therapy (PRRT) at any time prior to randomization in the study.
One of the following subgroups of patients with HER overexpression as follows: \r\n* Histologically-confirmed breast cancer that is metastatic or locally recurrent (th Edition of the American Joint Committee on Cancer [AJCC] Tumor, Lymph Node, Metastasis [TNM] System) and measurable and/or evaluable or non-measurable by RECIST . criteria with HER/neu overexpression by immunohistochemistry (+,+) or fluorescent in situ hybridization (FISH)+ and progressive disease despite having received at least  prior Food and Drug Administration (FDA) approved HER targeted therapy (e.g. trastuzumab, trastuzumab plus pertuzumab, T-DM, or lapatinib) (determined by their physician); prior therapy has at least one of the following stipulations: \r\n** Patients may have received neoadjuvant or adjuvant treatment with prior trastuzumab or lapatinib treatment \r\n** Patients have received a trastuzumab, trastuzumab + pertuzumab, or T-DM-based therapy for locally advanced or metastatic disease for a minimum of  weeks duration; patients may have received more than  trastuzumab-based combination therapy\r\n** Patients have received a lapatinib-based therapy for locally advanced or metastatic disease for a minimum of  weeks duration; patients may have received more than  lapatinib-based combination therapy\r\n* Histologically-confirmed gastric, esophageal, or gastroesophageal adenocarcinoma that is metastatic or locally recurrent (th Edition of the AJCC TNM System) and measurable or non-measurable by RECIST . criteria with HER/neu overexpression by immunohistochemistry (+,+) or FISH+ and progressive disease despite having received at least  prior HER targeted therapy for a minimum of  weeks duration) (determined by their physician) or with previously documented HER over-expressing disease not being currently treated on a HER targeted therapy\r\n* Other histologically confirmed metastatic (stage IV) or locally recurrent (stage III) (th Edition of the AJCC TNM System) malignancy with HER/neu overexpression by immunohistochemistry (+,+) or FISH+; no prior HER directed therapy will be required for this subgroup; however, patients will been required to have at least  line of therapy with a known survival benefit for their malignancy
Received treatment with chemotherapy, radiation, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs  days prior to first dose of rucaparib and/or ongoing adverse effects from such treatment > NCI CTCAE Grade  (Grade  non-hematologic toxicity to most recent treatment may be permitted with prior advanced approval from Sponsor).
All patients may have had prior surgery, chemotherapy, and radiation therapy; prior biologic therapy is permitted only for bevacizumab-exposed patients (groups  and ); prior treatment with Gliadel is permitted for all groups
Subjects whose tumors overexpress ErbB are eligible provided that they have progressed following therapy which included trastuzumab and/or lapatinib:\r\n* Note for prior lapatinib: subjects must have completed therapy with lapatinib at least  days prior to the first dose of study drug\r\n* Note for prior trastuzumab: subjects who received thrice weekly (Q weekly), twice weekly (Q weekly) or once weekly (Q weekly) must have completed therapy with trastuzumab at least  weeks,  weeks or  week, respectively, prior to the first dose of study drug
Subjects must have discontinued hormone replacement therapy (HRT) (e.g., conjugated estrogens tablets, United States Pharmacopeia [USP] or premarin), at least  days prior to receiving the first dose of randomized therapy
Has had any major surgery within the last  days, or cytotoxic chemotherapy, biologic therapy, investigational agents, or radiotherapy within the last  days and/or has not recovered from prior therapy; patients who have just completed therapy with mitomycin C or nitrosourea will have to wait  days before starting therapy
One prior cytotoxic therapy for the treatment of metastatic disease is allowed. Unlimited regimens using biological agents (vaccines), immunotherapy, or targeted agents is permitted. For example, BRAF inhibitors and ipilimumab are permitted. Patients must have fully recovered from the acute toxicities related to any prior therapy. Prior therapy must be completed ? days before the first dose of cyclophosphamide.
Additional Exclusion Criteria for dabrafenib and trametinib combination therapy (Cohort B and C as well as subjects that crossover from monotherapy to combination therapy):
Symptomatic metastatic brain or meningeal tumors unless the patient is >  months from definitive therapy, has a negative imaging study within  weeks of FOLFIRI initiation, and is clinically stable with respect to the tumor at the time of study entry; also, the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
Patients with castrate resistant prostate cancer (CRPC) must have no standard options for therapy; prior to registration on the study, patients with CRPC must be at least  weeks from their last treatment, such as ketoconazole, abiraterone, low-dose dexamethasone, anti-androgens, or cytotoxic therapy, (excluding ongoing therapy to suppress testosterone, which must also be continued during this trial)
Concurrent therapy with any excluded medications that cannot be safely discontinued prior to initiation of combination therapy; discontinuation prior to enrollment is not required, but discontinuation prior to combination therapy must be possible
All patients receiving antifungal therapy voriconazole, posaconazole, or fluconazole and who are then randomized to ARM  must have sirolimus reduced according to the Standard Practice Antifungal Therapy Guidelines
Subjects must have active disease appropriate for therapy
Initial therapy must have included total/near-total thyroidectomy and RAI ablation therapy
Subjects who received less than four weeks of therapy and were unable to continue therapy due to toxicity will be allowed to participate
Participants who have discontinued prior palbociclib for toxicity, or have needed more than one dose or schedule reduction for toxicity from prior palbociclib therapy; if a participant required a single dose reduction during prior palbociclib therapy and tolerated it well, for example prior dosing at  mg qd  weeks on  week off schedule, than that dose may be selected for this trial
Endocrinopathies, unless on stable hormone replacement therapy;
Patients in this trial may receive ovarian estrogen +/- progestin replacement therapy as indicated at the lowest effective dose(s) for control of menopausal symptoms at any time, but not progestins for management of anorexia while on protocol directed therapy.
Prior therapy
Prior therapy with Dasatinib
Participation in any clinical study or having taken any investigational therapy for a disease other than CLL within  days prior to initiating maintenance therapy.
subjects with initial presentation of organ confined recurrent prostate cancer (Stages Tc and T only) who have been treated with EBRT (conventional, D conformal, or IMRT) or proton therapy, two or more years prior, and currently have biopsy proven local recurrence. Previous radiation therapy must be a documented therapeutic dose of  to Gy or GyE (gray equivalent) for proton therapy;
considered inappropriate for fludarabine-based therapy
Prior therapy with E Halichondrin analog (eribulin)
Patients who have had prior BMN (talazoparib) therapy
In the unlikely event that patients are still of childbearing potential, these patients must have a negative serum pregnancy test within  hours prior to initiating protocol therapy and be practicing an effective form of contraception during protocol therapy and for at least  weeks following completion of protocol therapy
Prior therapy:\r\n* There is no waiting period for participants who relapse while receiving therapy if they are free from side effects attributable to such therapy\r\n* Emergent radiation therapy, one dose of intrathecal chemotherapy and up to  days of steroids or hydroxyurea are permitted before start of treatment in participants who relapse after completion of frontline therapy; other circumstances must be cleared by principal investigator (PI) or medical designee\r\n* At least  days have elapsed since bone marrow transplant and participant is off immune suppression for >=  weeks, if applicable
Prior Therapy
Patients with a prior seizure disorder requiring anti-convulsant therapy are not eligible to receive nelarabine. For the purposes of this study, this includes any patient that has received anticonvulsant therapy to prevent/treat seizures in the prior two years.
Prior anti-tumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted therapy, retinoid therapy or hormonal therapy) within  weeks prior to CD.
In the absence of rapidly progressing disease and after discussion with the Principal Investigator (PI), the interval from prior treatment to time of IMGN administration will be at least  weeks or at least  half-lives for cytotoxic/noncytotoxic agents; for prior monoclonal antibody therapy the interval from prior monoclonal antibody treatment to time of IMGN administration will be at least  weeks; the use of chemotherapeutic or anti-leukemic agents other than hydroxyurea is not permitted during the study with the exception of intrathecal (IT) therapy for patients with controlled central nervous system (CNS) leukemia at the discretion of the PI; hydroxyurea is allowed prior to the initiation of IMGN and during the first  cycles, either prior to or concomitantly with IMGN administration initially to control leukocytosis
Prior therapy for DLBCL
History of prior therapy with belinostat or AZD
Prior therapy:
Patients must have been off all prior therapy for CML for  weeks prior to start of study therapy and recovered from the toxic effects of that therapy; exceptions to these are hydroxyurea and TKIs (including but not limited to imatinib, nilotinib, dasatinib, ponatinib and bosutinib), which should be discontinued  hours (hrs) prior to the start of therapy; patients who are receiving nilotinib prior to enrollment do not have to discontinue this agent prior to start of study therapy
Must have received at least  prior therapies, including a CD targeted therapy, alkylating agent or corticosteroid; subjects who are not eligible for high-dose chemotherapy and autologous stem cell transplantation (HD-ASCT) are eligible with exposure to at least  prior therapy. Waldstrom's Macroglobulinemia Dose Expansion Arm:
Patients who are actively receiving other cytotoxic or antibiologic chemotherapies; for patients with Her-/neu positive disease, trastuzumab (Herceptin) is NOT ALLOWED on this study, and should be withheld during the  weeks of therapy, and can be resumed no sooner than  days following completion of protocol therapy
Receipt of other cancer therapy, immunomodulatory drug therapy or immunosuppressive therapy within  weeks prior to st dose.
Evidence of continuing adverse effect of prior therapy
Prior therapy with an hypoxic cytotoxin
Meets the requirements for ipilimumab therapy per Institutional guidelines
Patients must be clinically suitable for cryoablation therapy
No documentation of prior cytotoxic or other therapy for malignancy if such therapy was previously received; Note: This does not apply to patients with synchronous metastases at initial diagnosis
Prior therapy with an IGF-R inhibitor.
Prior use of chemotherapy (targeted therapy such as erlotinib and crizotinib will be allowed; if a patient was receiving erlotinib and/ or crizotinib as targeted therapy before entering the study they should discontinue that medication  weeks before day  of the study)
Documented completion of at least  cycles of CHOP-based therapy:
Phase I:\r\n* Patients with prior therapy who do not have alternative treatment of higher priority will be eligible\r\nPhase II:\r\n* Patients should not have been previously treated with cytotoxic drugs or drugs included in IPI-biochemotherapy or regional therapy for metastatic malignant melanoma; prior adjuvant interferon is permitted; prior adjuvant Ipilimumab therapy is not permitted; prior therapy with targeted therapy including but not limited to v-raf murine sarcoma viral oncogene homolog B (B-RAF), mitogen-activated protein kinases (MAPK)/extracellular signal-regulated kinase (ERK) kinase (MEK) inhibitors etc. is allowed; at least three weeks should have passed since the last dose of prior adjuvant interferon therapy and prior targeted therapies and patient has fully recovered from toxicities of drugs; prior radiation therapy for metastatic melanoma is permitted provided the patient has unirradiated metastatic sites for response evaluation and has fully recovered from its toxicity
Prior cytotoxic therapy for at least  weeks before treatment on study; treatment within this  week window with corticosteroids is permitted as long as the dose is stable or decreasing; radiotherapy within this  week window is permitted as long as it is completed prior to initiating therapy and as long as there is assessable disease for response outside of the radiation field
Stage IIIc or IV histologically proven melanoma (confirmed by Vanderbilt pathologists), that is not curable by standard surgery, radiation therapy, or chemotherapy; no available effective therapy (i.e.; therapy known to be curative); non-biopsied (resected) tumor sites must be measurable for therapy
Patients receiving full dose anticoagulative therapy
Prior CAR therapy or other genetically modified T cell therapy
Thiazide (e.g HCTZ, Hydrochoirthiazide) or digoxin therapy (e.g Lanoxicaps, Lanoxin)
Patients who have received antiandrogens or progestational agents as therapy for prostate cancer must discontinue therapy and demonstrate a rising PSA >=  days following discontinuation (antiandrogen withdrawal- AAW) (>=  days for bicalutamide or nilutamide); patients who receive megestrol acetate as therapy for \hot flashes\ at a dose of =<  mg per day may continue this therapy during this trial; the dose of the megestrol acetate should not be changed during protocol treatment; patients undergoing androgen deprivation using LHRH analogues must continue such agents or undergo orchiectomy to maintain castrate levels of testosterone
Prior therapy with belinostat
Must have received at least  prior line of AML therapy given at standard doses and must have progressed after their most recent therapy. Prior therapy must have included: a hypomethylating agent with at least  cycles.
Prior treatment with MUC targeted therapy (e.g., oregovomab [OvaRex] or abagovomab) including DMUCA
Prior therapy with known risk for cardiovascular complications.
Less than three months since last taxane-containing therapy.
Participants must have received at least one prior chemotherapy regimen for AGC;\n             prior therapy does not need to have included HER-directed therapy.
First-line therapy for AGC, including adenocarcinoma of the GEJ, must have included a\n             combination of at least a platinum- and a fluoropyrimidine-based treatment given\n             concurrently; prior therapy does not need to have included a HER-directed therapy.
Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period, excluding CNS directed therapy upfront for AML patients and continuing for CNS positive patients as described in Section .. Cyto-reduction with hydroxyurea can be initiated and continued for up to  hours prior to the start or protocol therapy.
Prior therapy with idelalisib
For patients if they have a history of colitis or diarrhea during anti-CTLA monoclonal antibody therapy, it is recommended that they have a formal evaluation by a gastroenterologist and a colonoscopy/endoscopy should be considered to demonstrate the absence of active bowel inflammation before initiating IL- therapy on this protocol
Prior therapy with a conjugated or unconjugated auristatin derivative.
Patients with Her+ breast cancer receiving Her-directed therapy (e.g. trastuzumab) may continue on that therapy when enrolling into a dose level for which safety has been established
Patients must be on a stable dose of specific targeted therapy (erlotinib or crizotinib) for >=  days prior to initiation of ipilimumab/nivolumab
Patients can either have had no prior anticancer therapy, multiple lines of either prior chemotherapy/biologic therapy/experimental therapy or, if the patient has anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), prior crizotinib.
For participants with recurrent SCCHN, prior systemic therapy is allowed if it was given as part of induction or definitive therapy. If participants have received prior combined chemo-radiation therapy, they must be off therapy for at least  months
NOTE: prior therapy with decitabine, clofarabine, idarubicin (idarubicin hydrochloride), or cytarabine is allowed, unless the prior therapy is identical to the schema/schedule proposed in this study
Failure of at least one prior therapy
At least one prior therapy;
Males or non-pregnant, non-breastfeeding females  years-of-age or older with histologically confirmed non-Hodgkins lymphoma, without known or clinically suspected CNS involvement, that is refractory to available therapy or for which there is no available therapy.
Prior therapy: The subject's disease (i.e. cancer, neurofibromatosis type  [NF-] with plexiform neurofibroma [PN], or Langerhans cell histocytosis [LCH]) must have relapsed after or failed to respond to frontline curative therapy or there must not be other potentially curative treatment options available. Curative therapy may include surgery, radiation therapy, chemotherapy, or any combination of these modalities. All subjects must have recovered to grade <= from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment. Prior therapy includes; myelosuppressive chemotherapy, differentiating agents/ biologic response modifiers (small molecules, antibodies, viral therapies) (anti-cancer agent), non-myelosuppressive anticancer agents, investigational agent, radiation therapy, stem cell transplantation or infusion, number of prior treatment regimens, colony stimulating factors, corticosteroids.
Progressive disease under last palliative therapy with a history of prior ifosfamide, doxorubicin or taxane therapy for angiosarcoma; up to  prior therapies are allowed
Patients going on Arm  or combination dose cohort must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor infiltrating lymphocytes [TIL], lymphokine-activated killer [LAK] or gene therapy), or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed
CAR-T infusion or other cellular therapy within  days
Prior therapy with Velcade is allowed as long as the patient had at least a PR to prior Velcade therapy, was not removed from Velcade therapy due to toxicity, and will have at least a  month Velcade treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this  month Velcade treatment-free interval).
Previous cancer therapy for DLBCL other than anthracycline- or anthracenedione based chemoimmunotherapy, monotherapy rituximab prior to first line therapy and/or as a maintenance therapy, or limited field radiotherapy
Patients who have started protocol therapy prior to enrollment\r\n* Please note: patient may still enroll if IT therapy was given within  hours of study enrollment as part of the diagnostic lumbar procedure
A sufficient interval must have elapsed between the last dose of prior anti-cancer therapy (including cytotoxic and biological therapies and major surgery) and enrollment in this study, to allow the effects of prior therapy to have abated:
Patients must have completed standard frontline therapy for newly diagnosed metastatic disease; lung, bone, bone marrow or other metastases are sufficient to qualify as metastatic disease; standard frontline therapy is comprised of a regimen that includes (but is not limited to) multiple cycles of vincristine, adriamycin, ifosfamide, and etoposide; local therapy as dictated by the treating institutions; patients may have received autologous stem cell transplantation or other investigational agents as part of their primary therapy
Prior therapy with lapatinib or an ErbB inhibitor other than trastuzumab (including but not limited to trastuzumab-DM and neratinib) and capecitabine;
Anticoagulant drug therapy,
No prior radiation therapy to the liver including Y-, I-based loco-regional therapy. Prior loco-regional therapy based on other technology for HCC, if any, must have been completed at least  weeks prior to baseline imaging
For transplant-ineligible patients, salvage therapy just prior to MDV treatment must have resulted in a PR or stable disease;
Prior therapy with agents targeting immune coinhibitory receptors.
Have received between - prior cytotoxic treatments, not to include belinostat, RDHAP, or autologous or allogeneic stem cell transplant; radiation which was pre-planned to occur at the conclusion of systemic cytotoxic therapy will not be considered a separate prior therapy; radiation administered for potential recurrent or relapsed disease will be considered a separate prior therapy
Prior therapy for this cancer
Patients must not have received prior AI therapy with exemestane, letrozole, or anastrozole as preoperative/adjuvant therapy or for prevention of breast cancer; prior tamoxifen is allowed
Patients must have metastatic breast cancer and be initiating within  days of step  registration or continuing trastuzumabbased HER- targeted therapy without concurrent anthracyclines in first or second line setting; patients may have brain metastasis; there is no limit for number of doses of HER- targeted therapy prior to registration; examples of eligible HER- targeted therapy:\r\n* Trastuzumab\r\n* Trastuzumab + chemotherapy or hormonal therapy\r\n* Trastuzumab + other HER- targeted agent with or without chemotherapy (such as pertuzumab)\r\n* Ado-trastuzumab (Kadcyla)\r\n* NOTE: Patients on lapatinib without trastuzumab are not eligible; planned treatment with concurrent HER- targeted therapy and anthracyclines is not permitted
Not be receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for =<  days prior to registration or planned during protocol therapy (patients may have received prochloperazine and other phenothiazines as prior anti-emetic therapy)
Prior therapy with inhibitors of IGF- (example [ex]: AMG-, OSI-)
No therapy restrictions
Patients post-operative treatment must have included at least % of standard radiation and concomitant temozolomide; patients may not have received any other prior chemotherapy, immunotherapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor infiltrating lymphocytes [TIL], lymphokine-activated killer [LAK] or gene therapy), or hormonal therapy for their brain tumor; prior Gliadel wafers are allowed; glucocorticoid therapy is allowed
Patients being treated with antibacterial agents, other than any of the following:\r\n* Cotrimoxazole or other agents including dapsone, atovaquone, and pentamidine administered for Pneumocystitis jiroveci (PCP) prophylaxis\r\n* Topical antibiotics\r\n* Central venous catheter antibiotic lock therapy\r\n* Note: prophylactic antifungal therapy is NOT an exclusion criterion
Must be considering or currently receiving any kind of cancer treatment (any line), including but not limited to hormonal treatment, chemotherapy, monoclonal antibody therapy, or targeted therapy; patients who are considering therapy are eligible even if they ultimately choose not to be on therapy; patients with a history of any previous cancer treatment, including radiation and/or surgery are eligible; a patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and exclusion criteria are met
Subjects who will need conventional therapy during the course of the study
Pilot: Patients having been treated for stage III ovarian cancer, and received either intraperitoneal therapy/intravenous therapy or Intravenous therapy only
Patients who will be initiating therapy with any investigator-initiated mTOR inhibitor based therapy in the Department of Investigational Cancer Therapeutics (phase I program) or initiating radiation therapy to the esophagus
Patients who will receive cetuximab or other targeted therapy where physicians may use topical doxycycline to reduce the rash associated with therapy
Have a major contraindication to methylphenidate (MP) (e.g., allergy/hypersensitivity to study medications or their constituents), light therapy (e.g., currently receiving ultraviolet A [UVA]/ultraviolet B [UVB] therapy), cognitive behavioral therapy (e.g., schizophrenia), or conditions making adherence difficult as determined by the attending physician
Patients must not have received or implemented any other medical therapy, alternative therapy, or physical therapy for the treatment of joint pain/stiffness within  days prior to registration; therapeutic massage is allowed
No documentation of prior cytotoxic or other therapy for malignancy if such therapy was previously received; Note: This does not apply to patients with synchronous metastases at initial diagnosis
Prior therapy with romidepsin
ESA therapy within the  days prior to randomization.
Completion of two years monthly zoledronic acid therapy
Patients will be undergoing initial therapy for their disease or undergoing first salvage treatment, i.e. patients who fail therapy, or respond and relapse after initial therapy
Clinically suitable for cryoablation therapy
Need for intravenous therapy more frequently than every  weeks or inability to time intravenous therapy treatment before and after the study
Timing from prior therapy: Stratum : Enrollment no later than  days after completion of upfront therapy, (last dose of cis-retinoic acid) with a maximum of  cycles of cis-retinoic acid maintenance therapy. Stratum ,  and : Enrollment no later than  days from last dose of the most recent therapy.
No cancer therapy in the prior  months (excluding chemoprevention agents)
Receiving maintenance therapy with mesalamine for at least  months
Undergoing salvage therapy
Prior endoscopic therapy for BE
Prior therapy with anthracyclines
Patients must be willing to complete a bilateral mammogram at baseline with repeat exam after  cycles of protocol therapy; patients who have had a mammogram within  month prior to registration to protocol therapy will not need to repeat the exam
Hormone therapy, including vaginal estrogen creams
Prior trastuzumab therapy
If receiving antiretroviral therapy:                \r\n* Receipt of antiretroviral therapy for at least  months prior to entry\r\n* No change in antiretroviral therapy within  days prior to entry
If not receiving antiretroviral therapy:                \r\n* CD-cell count >=  cells/mm within  days prior to study entry\r\n* No plans to start antiretroviral therapy prior to week 
COHORT I: Initially treated with definitive local therapy (surgery and radiation therapy are the most common treatments, but other treatments are also eligible)
There will be no therapy restrictions
Patients should not have begun therapy, or, needed research imaging can be performed within - days of starting therapy
Prior treatment of prostate cancer including brachytherapy, radiation therapy, cryosurgery, high-intensity focused ultrasound (HIFU), or vaccine therapy
Subjects must have had no prior therapy for cancer of the rectum
Subjects must have had no prior therapy for cancer of the esophagus
Patient must not require a minor surgical procedure (i.e., Broviac line or infusaport placement) =<  days prior to beginning therapy, and the wound must be healed prior to initiation of therapy
Prior MAGE-A/A-targeting therapy
No prior therapy for IDC or ILC
Prior therapy is not a consideration for protocol entry and prior therapy is not an exclusion criteria
Being considered for salvage therapy
For CMML, participants must have been treated with at least one prior therapy (hydroxyurea or an hypomethylating agent [HMA]).
Undergoing salvage therapy
May continue ongoing trastuzumab therapy
Prior therapy with crizotinib.
No prior therapy for disease under study
Prior chemotherapy, radiotherapy, biological cancer therapy, targeted therapy, or major surgery within  days prior to enrollment or has not recovered to CTCAE grade  or better from adverse event due to cancer therapy administered more than  days prior to enrollment.
Prior CAR therapy or other genetically modified T cell therapy
Prior treatment with any therapy targeting mutant IDH (including BAY)
Prior therapy with CD- or IL-R-directed immunotherapies, including monospecific and bsAbs, immunoconjugates, or chimeric antigen receptor- modified T-cell therapy
Patients must have been receiving single agent ibrutinib therapy at the time of disease progression; patient may have received other therapy in combination with ibrutinib earlier in their treatment course; prior obinutuzumab therapy is also permitted