Patients with refractory or relapsed JMML must have had at least one cycle of intensive frontline therapy or at least 2 cycles of a deoxyribonucleic acid (DNA) demethylating agent with persistence of disease, defined by clinical symptoms or the presence of a clonal abnormality; frontline therapy is defined as one cycle of intravenous chemotherapy that includes of any of the following agents: fludarabine, cytarabine, or any anthracycline but specifically excludes oral 6-mercaptopurine; frontline therapy will also include any conditioning regimen as part of a stem cell transplant; patients who transform to acute myeloid leukemia (AML) with more than 20% blasts at relapse are not eligible for this trial
Have at least one evaluable and measurable lesion as defined by RECIST v1.1. Subjects who have received prior local therapy (including but not limited to embolization, chemoembolization, radiofrequency ablation, or radiation therapy) are eligible provided measurable disease falls outside of the treatment field or within the field and has shown ?20% growth in size since post-treatment assessment.
Underwent hepatic radiation, chemoembolization, and radiofrequency ablation <4 weeks prior to Day 1.
Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131 iodine metaiodobenzylguanidine [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy
Hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration
Patients with tumors with the following molecular alterations must submit testing results via Medidata Rave to determine eligibility to Arm T; the study chair, co-chair, biology co-chair, or a delegate must review the molecular testing and agree that the testing meets eligibility outlined below:\r\n* ROS1 gene rearrangement by fluorescence in situ hybridization (FISH) or deoxyribonucleic acid (DNA) analysis (may have progressed on prior crizotinib therapy)\r\n* MET exon 14 splice mutations on DNA analysis (may have progressed on prior crizotinib therapy)\r\n* MET high amplification by FISH or DNA analysis or other MET mutations predicted to be sensitive to MET inhibitor (no prior targeted therapy allowed)\r\n* RET gene rearrangement by FISH or DNA analysis (no prior targeted therapy allowed)\r\n** Institutions will be notified of the patient’s eligibility status for Arm T within two (2) business days of submission of the molecular testing reports\r\n** If patients do not have tumors with the above molecular alterations noted proceed directly to step 1
Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound [HIFU]) for prostate cancer is allowed; prior focal HIFU or treatment for benign prostatic hypertrophy is allowed
No waiting period for patients who relapse while receiving standard maintenance therapy
With the exception of intrathecal chemotherapy (methotrexate strongly preferred; cytarabine is permissible) administered at the time of the required diagnostic lumbar puncture to establish baseline CNS status, patient has not received prior relapse-directed therapy (i.e., this protocol is intended as the INITIAL treatment of first relapse)
Treatment with hydroxyurea, corticosteroids (any route) and intrathecal cytarabine prior to beginning protocol directed therapy is allowed; however, it should be noted that lumbar puncture and intrathecal therapy at initial diagnosis of APL is not recommended
With the exception of steroid pretreatment or the administration of intrathecal methotrexate or intrathecal cytarabine, receipt of any other prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL15P1
Prior therapy\r\n* Patients =< 30 days from the last dose of cytarabine used for treatment of TMD
Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound [HIFU]) for prostate cancer is not allowed
No prior therapy for ALL except for limited treatment (=< 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine; however, patients who are being treated with chronic steroids for other reasons (for example, to treat asthma, autoimmune disorders, lupus, etc.) are eligible
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
Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience; systemic chemotherapy must begin within 72 hours of this intrathecal therapy
Patients receiving concurrent exogenous hormone therapy (topical vaginal estrogen therapy is allowable).
Prior chemotherapy or tumor directed therapy (i.e. radiation therapy, biologic agents, local therapy (embolization, radiofrequency ablation, and laser); therefore, patients with a pre-disposition syndrome who have a prior malignancy are not eligible
Part B: More than 6 cycles of prior therapy with carboplatin
Parts B1, B3, and C: During prior platinum therapy, requirement for dose reduction or discontinuation of carboplatin or cisplatin for toxicity or lack of tolerability
No prior chemotherapy, radiation therapy, or surgery for this malignancy will be allowed; prior endoscopic procedures for superficial disease (endoscopic mucosal resection, cryotherapy, photodynamic therapy, etc.) will not exclude a patient; prior dilatation is also allowed
Corticosteroid therapy and endocrine replacement therapy (L-thyroxine, testosterone, estrogen, desmopressin acetate [DDAVP]) are permissible; any patient already receiving human growth replacement therapy should discontinue this prior to commencing chemotherapy, and should not restart until 3 years from diagnosis
Prior therapy with a toll-like receptor (TLR) agonist, excluding topical agents.
Prior CAR T-cell or other genetically-modified T-cell therapy
Disease Characteristics and allowable prior therapy:
Prior medical therapy is allowed but not required
Refractory/relapsed disease following DNMTi failure; refractory disease defined as either 1) failure to achieve an objective response after at least 4 cycles of DNMTi therapy, or 2) failure to achieve an objective response with clear progressive disease on bone marrow biopsy after at least 2 cycles of DNMTi therapy; relapsed disease is defined as having progressive disease after achieving an objective response after at least 2 cycles of DNMTi therapy; previous DNMTi therapy may include 5’azacitidine, decitabine, or DNMTi therapy currently in clinical trials (e.g. SGI-110 [guadecitabine], ASTX727 or CC-486); to be considered DNMTi treatment failure, during each prior treatment cycle, patients must have received minimum dosing of:\r\n* Decitabine 15 mg/m^2 daily x 5 days, or\r\n* 5’azacitidine 50 mg/m^2 IV/SC daily x 5 days,\r\n* SGI-110 (guadecitabine) 60 mg/m^2 SC daily x 5 days, or\r\n* Oral DNMTi therapy with ASTX727 20/100 mg daily x 5 days, or\r\n* Oral DNMTi therapy with CC-486 200 mg daily x 14 days
For prior cytotoxic therapy, treatment for 1 full cycle or less will not be considered as prior therapy unless the patient experienced progression of disease while on that therapy.
Received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days (or have not yet recovered from any actual toxicities of the most recent therapy) prior to the first scheduled dose of MM-310
All hematologic, gastrointestinal, and genitourinary chemotherapy toxicities must be less than Grade 2 at the time study therapy is to begin. (Note: Transfusions may be used to correct hemoglobin for patients experiencing anemia from therapy who otherwise would be eligible for the study.
Cutaneous, subcutaneous soft tissue, or superficial lymphatic metastasis that is amenable to injection and irradiation and > 10 mm in longest dimension\r\n* Cutaneous metastasis in a region of previous radiation therapy is amenable to radiation therapy as part of this protocol if at least 6 months has elapsed since prior radiotherapy and the dose of radiotherapy previously administered did not exceed an equivalent dose of 60 Gy in 2 Gy equivalent fractions at the skin surface (using linear-quadratic modeling with alpha/beta = 11.5)
Prior cytoreductive therapy.
Patients who progressed after initial therapy\r\n* Subjects whose therapy changed due to suboptimal response, intolerance, etc., remain eligible, provided they do not meet criteria for progression\r\n* No more than two regimens will be allowed excluding dexamethasone alone
Prior therapy with abemaciclib
Prior radioisotope therapy
Patients must not have received prior systemic therapy for PTCL (except for corticosteroids for 10 or fewer days at any dose, no washout period required as long as they discontinue prior to starting study therapy); NOTE: topical treatment may have been given for prior existence of cutaneous lymphoma that has since become systemic PTCL; however, these topical therapies should be stopped at time of registration
For Part E (LY2835219 + exemestane + everolimus): The participant must have received prior systemic endocrine therapy with at least one nonsteroidal aromatase inhibitor (anastrozole, letrozole) for metastatic disease and may be receiving ongoing therapy with either exemestane or exemestane + everolimus.
Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, topical therapy such as 5-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
For patients with LABC, no prior therapy is allowed
Glucocorticoid therapy allowed.
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 SM08502:
Require concomitant chemotherapy, radiation therapy, or immunotherapy. Hydroxyurea is allowed up to the evening before starting (but not within 12 hours) of starting Induction therapy.
At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy, which requires 5 half-lives\r\n* Exceptions:\r\n** There is no time restriction with regard to prior intrathecal chemotherapy (including [incl.] steroids) provided there is complete recovery from any acute toxic effects of such\r\n** Subjects receiving hydroxyurea may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis\r\n** Subjects who are on standard ALL maintenance type chemotherapy (vincristine, 6-mercaptopurine or oral methotrexate) may be enrolled provided that chemotherapy is discontinued at least 1 week prior to apheresis\r\n** Subjects receiving steroid therapy at physiologic replacement doses (=< 5 mg/day of prednisone or equivalent doses of other corticosteroids) only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis\r\n** For radiation therapy: radiation therapy must have been completed at least 3 weeks prior to enrollment, with the exception that there is no time restriction if the volume of bone marrow treated is less than 10% and also the subject has measurable/evaluable disease outside the radiation port
more than one sequential second generation AR-directed therapy
No prior Y90 radioembolization for HCC is permitted; therapies below are allowed but must be completed 4 weeks prior to baseline scan:\r\n* Prior transarterial embolization (TAE) or transarterial chemoembolization (TACE)\r\n* One treatment of stereotactic body radiation therapy (SBRT)\r\n* Liver resection\r\n* Ablation 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 90Y , I131 based loco regional therapy. Prior loco regional therapy, including resection, based on other technology for ICC, if any, must have been completed at least 4 weeks prior to baseline imaging.
Prior isotope therapy with strontium-89, samarium or RAD223
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 ? 9 months and/or total ? 9 cycles of prior HMA therapy in ? 12 months
Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy
Patients must be weaned off prednisone and be off therapy for >= 1 week prior to starting therapy
Any therapy including chemotherapy (e.g., docetaxel) or biological therapy (e.g., vaccine, immunotherapy) for the treatment of castration-resistant prostate cancer. Previous treatment with flutamide, steroidal anti-androgens, androgens, estrogens, bicalutamide, nilutamide, or 5-? reductase inhibitor is permitted.
Subject must be non-refractory to bortezomib (Refractory is defined: progression of disease while receiving bortezomib therapy or within 60 days of ending bortezomib therapy).
Failed at least one trial of immunosuppressive therapy (IST) by being refractory or having relapsed. IST could have included ATG based regimens, calcineurin inhibitors and/or other higher dose therapy directed at the treatment of primary SAA.
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.
For patients who have received prior radiation, cryotherapy, radiofrequency ablation, TheraSphere, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, the following criteria must be met:\r\n* 28 days have elapsed since that therapy\r\n* Lesions that have not been treated with local therapy must be present and measureable
Prior infusion of a genetically modified therapy
Prior MRI results dated within 120 days prior to ablation.
Prior therapy with afatinib
Biopsy-proven, measurable, stage IB-IVB relapsed or refractory cutaneous T-cell lymphoma after 2 lines of skin-directed therapy or one prior line of systemic therapy (Note: extracorporeal photopheresis will be considered a systemic therapy for this study)
Prior therapy for the treatment of solitary plasmacytoma is permitted, but > 14 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
There is no waiting period for participants who relapse while receiving frontline therapy and are free from side effects attributable to such therapy
Prior anti-angiogenic therapy, including thalidomide and oral cyclophosphamide, is permitted
Patients receiving full dose anticoagulative therapy
Prior radiation therapy is allowed but there should not be overlap with the prior high dose regions unless approved by the protocol directors
No prior purine analog therapy except up to 1 prior course of either cladribine or pentostatin
ALL patients refractory to liposomal vincristine as defined by progression while on therapy or relapse within 3 months of completion of therapy with liposomal vincristine
Prior immuno-oncology therapy
Prior systemic therapy is allowed after diagnosis of brain metastases provided that restaging MRI shows measurable intracranial disease
Must receive optimal therapy for extracranial disease and may continue on systemic therapy during TTF administration
Prior therapy with etoposide and cyclophosphamide is allowed
Prior therapy with LMB-100
Recipient of CAR-T cell therapy outside of this protocol.
Failure to recover to grade 1 or baseline from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, immunotherapy, and/or experimental therapy, with the exception of: alopecia, grade =< 2 peripheral neuropathy, grade =< 2 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 2 weeks from prior cetuximab is required; a washout period of 3 weeks from any prior cytotoxic chemotherapy, targeted therapy, immunotherapy or investigational drug is required
Hepatic intra-arterial embolization or peptide receptor radionuclide therapy (PRRT) within 4-8 weeks; cryoablation, radiofrequency ablation or trans-arterial chemoembolization of hepatic metastases within ? 4 weeks of study enrollment
Biopsy-proven, measurable, stage IB-IVB relapsed or refractory cutaneous T-cell lymphoma after 2 lines of skin-directed therapy or one prior line of systemic therapy\r\n* Note: extracorporeal photopheresis will be considered a systemic therapy for this study
Patients with high-risk MDS, and chronic myelomonocytic leukemia (CMML) with bone marrow blasts between 10% and 20%, relapsed or refractory to prior hypomethylating agent (HMA) therapy, defined as prior receipt of 4 cycles of HMA therapy with failure to attain a response, or relapse after prior response to HMA therapy
Subjects receiving systemic steroids, nitrogen mustard, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment.
There is no limitation of amount or the type of prior therapy or drugs
Chimeric Antigen Receptor (CAR)-T cell therapy.
At least 4 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 24 hours (h) prior to initiation of therapy
No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed
(Arm B only): Subject must be relapsed or refractory to prior hypomethylating agent therapy, defined as prior receipt of 6 cycles of HMA therapy with failure to attain a response, or relapse after prior response to HMA therapy
No prior genetically modified cell therapy that is still detectable or virotherapy allowed
Hormone replacement therapy or vaginal estrogen therapy, DHEA, or biosynthetics within 6 weeks prior to enrollment
Receiving, or previously received, any systemic chemotherapy, or investigational agent for HCC\r\n* Note: prior surgical resection with recurrence, or palliative local therapy (including transcatheter arterial chemoembolization [TACE], Y-90 resin microspheres, etc.) would not exclude trial participation, but must have been performed at least 6 months prior to enrollment
Prior therapy with a compound of the same mechanism as PF-05082566 (immunomodulation of 4-1BB)
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 >= 5% in the peripheral blood
No prior virotherapy allowed
At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy, which requires 5 half-lives\r\n* Exceptions:\r\n** There is no time restriction with regard to prior intrathecal chemotherapy (including [incl.] steroids) provided there is complete recovery from any acute toxic effects\r\n** Subjects receiving hydroxyurea may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis\r\n** Subjects who are on standard ALL maintenance type chemotherapy (vincristine, 6-mercaptopurine or oral methotrexate) may be enrolled provided that chemotherapy is discontinued at least 1 week prior to apheresis\r\n** Subjects receiving steroid therapy at physiologic replacement doses (>= 5 mg/day of prednisone or equivalent doses of other corticosteroids) only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis\r\n** For radiation therapy: Radiation therapy must have been completed at least 3 weeks prior to enrollment, with the exception that there is no time restriction if the volume of bone marrow treated is less than 10% and also the subject has measurable/evaluable disease outside the radiation port
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-PD1/PDL1 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-1 (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 160 mg) and/or bortezomib (up to 5.2 mg/m^2) and/or cyclophosphamide up to 1000 mg/m^2 administered for management of acute manifestations of MM (hypercalcemia, renal impairment, pain) for no longer than 4 weeks prior to enrollment. If subject received any prior therapy, pretreatment parameters necessary for disease characterization and response assessment must be available
Participants may have had prior chemotherapy, targeted biological therapy (i.e. sorafenib), surgery, transarterial chemoembolization (TACE), radiofrequency ablation, or cryosurgery for their disease as long as the prior therapy occurred more than 3 weeks before the first radiation treatment; patients may not have had prior liver directed radiation, including radioembolization
131I therapy < 6 months prior to initiation of therapy on this protocol; a diagnostic study using < 10 mCi of 131I is not considered 131I therapy
Currently on therapy for active chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria); prophylactic therapy is allowed
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 3 months of study enrollment; patients on short term octreotide may have dose held for 24 hours prior to Lu-177-DOTATATE therapy; those on long acting octreotide therapy will receive treatment at 1 to 5 days prior to their next cold octreotide dose, in order to prevent competition for the receptor
Allowed prior therapy:\r\n* Newly diagnosed DLBCL and low grade B cell lymphoma: No prior therapy is allowed except steroids equivalent to maximum of prednisone 20 mg once daily for maximum of seven days prior to registration\r\n* Relapsed/refractory low grade B cell lymphoma (only allowed in phase I): A minimum and maximum of one line of prior non-anthracycline containing therapy is allowed; prior localized radiation therapy is not considered a line\r\n* For patients who have had prior chemotherapy or immunotherapy, at least 2 weeks must have elapsed between last dose and initial dose of RCHOP-selinexor; for patients treated with radio-immunotherapy, at least 12 weeks
Patients must not have had leukemia therapy for 14 days prior to starting palbociclib. However, patients with rapidly proliferative disease may receive hydroxyurea as needed until 24 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-2, 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 with prior known toxicity attributed to PD-1 or PDL-1 directed therapy, which led to discontinuation of these agents, will be excluded from the PDR001 containing arms of the study.
Patients with prior known toxicity from IL-17A directed therapy, which led to discontinuation of the study treatment, will be excluded from CJM112 containing arms of the study.
Patients with plans to receive other concomitant local therapy (including standard fractionated radiotherapy and surgery) or other systemic therapy (including chemotherapy, target therapy and other type of immunotherapy or investigative agents) while on this protocol, except at disease progression, are not eligible
Treatment with the following within the 4 weeks prior to the screening visit: radiotherapy, intralesional therapy; laser therapy surgery (other than biopsy) to the target area, local hyperthermia, levulinic acid, 5-fluorouracil, high potency corticosteroids (including systemic steroids), retinoids, diclofenac, hyaluronic acid, imiquimod;
>= 2 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-17 inhibitors (e.g. ketoconazole)\r\n* Antiandrogens (e.g. bicalutamide, nilutamide)\r\n* Second generation antiandrogens (e.g. enzalutamide, ARN-509)\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 (< 90 days duration); in the event that hormone therapy was initiated prior to study enrollment, the clock for 1 year of androgen deprivation would begin at the time of therapy initiation, rather than at study enrollment
Non-resectable, recurrent, or metastatic well- or moderately-differentiated gastroenteropancreatic neuroendocrine tumor (GEP-NETs) with disease progression within the last 12 months; (patients who have received prior local therapy, including but not limited to embolization, chemoembolization, radiofrequency ablation, radiation therapy, are eligible provided that measurable disease falls outside the treatment field or within the field but has shown an increase of > 20% in the size; prior local therapy must be completed at least 4 weeks prior to the baseline scan)
Patients receiving prior therapy with HCQ
Patients must have failed at least one regimen of chemo or radiation therapy; NOTE: There is no limit to the number or types of prior therapy
Use of experimental drug therapy for myelofibrosis, or any other standard drug (eg, danazol, hydroxyurea, etc) with the exception of ruxolitinib within 6 months of starting study (combination) therapy and/or lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better
Prior CAR T-cell or other genetically-modified T-cell therapy, with the exception of prior JCAR017 treatment in this protocol for subjects receiving retreatment
Patients must discontinue antiandrogen therapy (i.e., flutamide, bicalutamide, nilutamide) for at least 4 weeks prior to registration with no evidence of a falling PSA after washout
Completion of major surgery, chemotherapy, targeted therapy (such as everolimus or experimental agents or radiation within 14 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 4/6 inhibitor (if scenario 2) to initiation of ribociclib/placebo and anti-estrogen on trial
Prior treatment\r\n* Phase I: exposure to 2-3 prior lines of therapy or no therapeutic options\r\n* Phase II: previously untreated for symptomatic MM\r\n* EXCEPTION: =< 7 days with pulse steroids or localized radiation therapy, without curative intent, for a myeloma-related complication prior to registration is allowed, as considered necessary by the treating physician
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
Chemotherapy/systemic therapy, radiotherapy, immunotherapy or surgery =< 21 days prior to registration or kinase inhibitor therapy =< 14 days prior to registration or failure to recover from toxicities (to grade 1 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, 21 days prior to first dose of protocol therapy.
Prior interferon or interleukin-2 therapy is NOT allowed
Must have completed any systemic therapy at least one week prior to planned start of SBRT (two weeks preferred), and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred)
Time interval for last local therapy (radiofrequency ablation, percutaneous ethanol injection, radiotherapy, transarterial chemoembolization) more than 4 weeks prior to registration
Prior antiestrogen therapy
Patient must have failed at least one prior therapy
Patients are excluded if they have had prior hepatic arterial embolization therapy
Patients must have either:\r\n* Symptomatic multiple myeloma who have responded to prior induction or salvage chemotherapy (i.e. chemosensitive disease): patients who are receiving high-dose melphalan and AHCT as part of their initial therapy require at least a partial response (PR) as defined by the International Myeloma Working Group uniform response criteria for MM; patients who are receiving high-dose melphalan and AHCT as part of salvage therapy require at least a minor response to their last line of therapy to document chemosensitive disease; there is no limit on the number of prior regimens received by the patient; OR\r\n* Light chain (AL) amyloidosis who may be newly diagnosed or previously treated
Prior thermal ablative therapy for prostate cancer (e.g. high-intensity focused ultrasound [HIFU] or cryoablation)
Patients receiving cytotoxic agent as immunomodulatory therapy for a non neoplastic indication (e.g. methotrexate for rheumatoid arthritis) and who are unable to discontinue such agents within 2 weeks prior to starting treatment
Need or plans for concomitant antineoplastic therapy (including surgery, cryotherapy, radiofrequency ablation, chemo-embolization, conventionally fractionated radiotherapy, stereotactic body radiation therapy, and hepatic artery chemotherapy) for the protocol treated lesions except at progression; adjuvant systemic therapy before and after the protocol therapy, and surgery or other ablative therapy is allowed for lesions appearing after enrollment to this protocol is allowed; at least 4 weeks must have passed since the last directed intervention to the protocol-treated lesion
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
Prior or ongoing systemic therapy for prostate cancer including, but not limited to:\r\n* Hormonal therapy (for example [e.g.] leuprolide, goserelin, triptorelin, degarelix)\r\n* Cytochrome P450 (CYP)-17 inhibitors (e.g. ketoconazole)\r\n* Antiandrogens (e.g. bicalutamide, nilutamide)\r\n* Second generation antiandrogens (e.g. enzalutamide, apalutamide)\r\n* Immunotherapy (e.g. sipuleucel-T, ipilimumab)\r\n* Chemotherapy (e.g. docetaxel, cabazitaxel)
Any of the disease stages listed below\r\n* Stage IB disease that meets ALL of the following criteria:\r\n** Plaque disease (ie,T2b staging)\r\n** Diffuse skin involvement with indication for TSEB (plaque disease with or without patches)\r\n** Not appropriate for treatment with focal therapies\r\n** One prior course of low-dose TSEB or one prior course of systemic chemotherapy regimens (excluding brentuximab)\r\n* Stage IIA, IIB, or IIIA that meets ONE or BOTH of the following criteria:\r\n** Patient is a candidate for treatment with low-dose TSEB\r\n** Patient is a candidate for systemic therapy\r\n* IIIB or IVA disease requiring systemic therapy\r\n* Transformed cutaneous T-cell lymphoma (CTCL)
No prior antineoplastic drug therapy for at least 14 days, with the exception of hydroxyurea, prior to starting OTS167. Patients with rapidly proliferative disease may continue to receive hydroxyurea.
No prior antineoplastic drug therapy for at least 14 days, with the exception of hydroxyurea, prior to starting OTS167. Patients with rapidly proliferative disease may continue to receive hydroxyurea.
Patients should have discontinued therapy with imatinib, dasatinib, nilotinib, ponatinib, omacetaxine or other anti-leukemia therapy (except hydroxyurea) >= 48 hours prior to start of study therapy and recovered from any toxicity due to these therapies to grade =< 1; hydroxyurea may be received up to the time of enrollment and for the first 6 weeks of study treatment if necessary
Receipt of any anti-cancer therapy within 14 days prior to C1D1, with the exception of hydroxyurea or anagrelide (within 24 hours), TKI (within 1days), or a single dose of cytarabine (for proliferative disease)
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-2, 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 12 weeks after discontinuation of therapy
Patients having prior therapy with Laser Induced Thermal Therapy (LITT) is allowed, but at least 21 days must have elapsed from last LITT, with recovery from all LITT-related toxicities to Grade 1 or less and subsequent histologic documentation of recurrence
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-17 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 (< 90 days duration); in the event that hormone therapy was initiated prior to study enrollment, the clock for 1 year of androgen deprivation would begin at the time of therapy initiation, rather than at study enrollment
Subjects must be willing to refrain from blood donations during study drug therapy and for 8 weeks after therapy
For patients who have received prior radiation, cryotherapy, radiofrequency ablation, therasphere, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, the following criteria must be met:\r\n* 28 days have elapsed since that therapy\r\n* Lesions that have not been treated with local therapy must be present and measurable
Prior therapy with TAS-102
Any prior arterial liver-directed therapy, including transarterial chemoembolization (TACE), arterial embolization (TAE), and 90Y radioembolization
Patients with malignant solid tumors must have relapsed after or failed to respond to frontline therapy and there must be no other known curative therapies available. Patients with desmoid fibromatosis must have relapsed after or failed to respond to at least one prior line of therapy, and in the opinion of the treating physician surgical resection of the tumor must not be possible without an amputation or other surgery predicted to result in an unacceptable functional deficit.
Chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or any other anticancer therapy or investigational medicinal product (IMP) within 28 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 28 days, inclusion may take place if there is no residual toxicity from previous treatment (maximum CTCAE Grade 1)
Completing SoC adjuvant therapy per NCCN guidelines to include chemotherapy, radiation therapy, and/or biologic therapy as clinically indicated. (Consent #2 should be signed as close to completion of SoC as possible but may overlap completion by up to one month.)
Maintenance therapy during the first platinum-free interval is allowed; however, the last dose must have been at least 21 days prior to Randomization. No cancer vaccine therapy is allowed.
Prior CAR therapy or other genetically modified T cells
CAR-T infusion or other cellular therapy within 30 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 H2 (H2) receptor antagonist therapy be uninterrupted
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* HbA1c < 8.5 % or IFCC < 69.4 mmol/mol\r\n* Stable regimen of oral anti-hyperglycemic therapy without insulin usage for at least 3 weeks prior to first study treatment\r\n* Fasting plasma glucose levels =< 160 mg/dL (8.88 mmol/L) and no hypoglycemia (blood sugar [BS] < 60) during home monitoring for at least 1 week prior to study entry
ARM 1 AND 2 FRONT LINE OLDER COHORT: Patients age 65 years and above with previously untreated AML (>= 20% blasts) who are unfit for or decline standard induction therapy; prior therapy with hydroxyurea, biological or targeted therapy (e.g. FLT3 inhibitors, other kinase inhibitors), or hematopoietic growth factors is allowed, however prior therapy with chemotherapy agents for the disease under study is not allowed; patients may have received one dose of cytarabine (up to 2 g/m2 administered at presentation for control) of hyperleucocytosis; the frontline cohort of vidaza+nivolumab+ipilimumab and vidaza+nivolumab will be open simultaneously and we will enroll alternately to these two frontline protocols with close monitoring for futility and as specified in the predefined statistical futility and toxicity stopping rules
Patients for whom busulfan/melphalan consolidation therapy following treatment with 131I-MIBG is planned
Patients for who CEM (carboplatin, etoposide, melphalan) therapy is administered within 30 days prior to 131I-MIBG therapy or for whom this therapy is planned within 30 days following administration of 131I-MIBG
Prior treatment of B-NHL with radiation therapy, non-standard systemic therapy, or antibiotics (in cases of MZL) within 21 days of the first dose of ixazomib
Patients receiving prior therapy with RGF, VOR, and/or HCQ
No prior genetically modified cell therapy that is still detectable or prior virotherapy
Prior local therapy, such as surgery, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation is allowed if the index lesion(s) remains outside of the treatment field or has progressed since prior treatment; local therapy must have been completed at least 4 weeks prior to the baseline scan
Persistent or recurrent adenovirus infection or disease despite at least 7 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 50% in viral load in peripheral blood or any site of disease as measured by PCR (or any other quantitative assay) after 7 days of antiviral therapy.
Therapy with myelosuppressive chemotherapy or biologic therapy < 21 days prior to registration unless the patient has recovered from the nadir of the previous treatment to a level that meets the inclusion eligibility criteria of this protocol
Prior therapy with neural stem cells
Prior treatment with fractionated radiation therapy (up to 60 Gy) is an eligibility criterion, however there should not have been a second course of fractionated radiotherapy to the supratentorial area
Persistent disease after at least a partial response to frontline therapy (i.e. patient has had at least a partial response to frontline therapy but still has residual disease by MIBG, CT/MRI, or bone marrow)
Prior therapy with fenretinide and/or fenretinide + ketoconazole is allowed if no DLT's were experienced. Prior therapy with other retinoids
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^13 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 50% in viral load in peripheral blood or any site of disease (as measured by PCR or any other quantitative assay) after 7 days of antiviral therapy
PHASE I and II -- Administration of any antineoplastic therapy within at least 4 weeks (cytotoxic chemotherapy) or 2 weeks (biological and targeted therapy; hypomethylating agents are considered to be biological therapy) of that therapy of the first MEK 162/MEK 162 dose; except the use of hydroxyurea which can be administered up to 5 g/day up to 24 hours before the initiation of the study drug
Inclusion Criteria\n\n        -Male or female patients ?18 years of age who present with one of the following:\n\n        LGH447 monotherapy arm\n\n          -  Refractory/Relapsed AML following no more than 2 prior therapies, or in previously\n             untreated AML patients who are not candidates for standard therapy.\n\n          -  High and very high risk MDS according to the revised International Prognostic Scoring\n             System (rIPSS) who have failed prior therapies, such as azacitidine and decitabine\n\n          -  Patients with rIPSS score of > 4.5\n\n        LGH447 and midostaurin combination arm\n\n          -  Refractory/Relapsed AML following no more than 2 prior therapies, or in previously\n             untreated AML patients who are not candidates for standard therapy. AML patients may\n             have either FLT3 wild type or FLT3-ITD/TKD mutant disease, and FLT3 mutation status\n             needs to be defined at study entry.\n\n               -  For AML patients, peripheral blast counts < 50,000 blasts/mm3\n\n               -  For MDS patients;\n\n          -  Platelet count > 25,000/mm3\n\n          -  Neutrophils > 500/mm3\n\n          -  Blood transfusions are allowed to maintain clinically adequate hemoglobin and\n             hematocrit levels\n\n               -  Patients with active central nervous system (CNS) disease are eligible to\n                  participate and may be treated concurrently with intrathecal (or intra Ommaya)\n                  chemotherapy\n\n               -  Patients who are maintained on prophylactic antibiotics are eligible to\n                  participate as long as agents comply with the list of approved concomitant\n                  medications\n\n               -  Performance status ? 2\n\n               -  Meet other lab criteria\n\n        Exclusion Criteria\n\n          -  Systemic antineoplastic therapy (including unconjugated therapeutic antibodies and\n             toxin immunoconjugates) or any experimental therapy within 7 days or 5 half-lives,\n             whichever is longer, before the first dose of LGH447 monotherapy or LGH447 in\n             combination with midostaurin\n\n          -  Radiotherapy with a wide field of radiation within 28 days or radiotherapy with a\n             limited field of radiation for palliation within 7 days of the first dose of LGH447\n             monotherapy or LGH447 in combination with midostaurin\n\n          -  Patients who received CNS irradiation for meningeal leukemia, except if radiotherapy\n             occurred > 3 months previously\n\n          -  Major surgery within 4 weeks before the first dose of LGH447 monotherapy or LGH447 in\n             combination with midostaurin\n\n          -  Ongoing therapy with corticosteroids greater than 10 mg of prednisone or its\n             equivalent per day. Inhaled and topical steroids are permitted\n\n          -  Patients who are currently receiving hydroxyurea to control peripheral blood leukemic\n             blasts and cannot be discontinued for at least 48 hours prior to obtaining PD\n             biomarkers at screening/baseline and during the study\n\n          -  Patients who are currently receiving treatment with prohibited medication and that\n             cannot be discontinued at least one week prior to the start of treatment with LGH447\n             monotherapy or LGH447 in combination with midostaurin\n\n          -  Active infection requiring systemic therapy or other severe infection, including\n             pneumonia, within 2 weeks before the first dose of LGH447 monotherapy or LGH447 in\n             combination with midostaurin\n\n          -  Known human immunodeficiency virus (HIV) positive\n\n          -  Corrected QT interval (QTc) of > 450 milliseconds (ms) in males and > 470 milliseconds\n             (ms) in females on baseline electrocardiogram (ECG) (using corrected QT interval using\n             Fridericia [QTcF] or local standards).\n\n          -  Uncontrolled cardiovascular condition, including ongoing cardiac arrhythmias,\n             congestive heart failure, angina, or myocardial infarction within the past 6 months\n\n          -  Pregnant or nursing
Receipt of Gliadel therapy
Patients who have a history of listeriosis prior ADXS11-001 therapy
If prior therapy with gamma knife or other focal high-dose radiation, must have subsequent histologic documentation of local relapse, or relapse with new lesion outside the irradiated field
All prior therapy must have been completed at least 21 days prior to enrollment; no concomitant anti lymphoma therapy, including systemic corticosteroids for the purpose of treatment of lymphoma are allowed; topical steroids are allowed
RANDOMIZED PHASE II (ARMS K AND L): All prior therapy must have been completed at least 21 days prior to enrollment (6 weeks for nitrosoureas or mitomycin C); no concomitant anti lymphoma therapy, including systemic corticosteroids for the purpose of treatment of lymphoma are allowed; topical steroids are allowed
For Phase I and II: Patients must have been off chemotherapy for 2 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 1. 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 28 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 1-2 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
Patients with previously untreated AML (by the World Health Organization [WHO] criteria, i.e. >= 20% blasts); prior biologic therapies (such as growth factors) and targeted therapies administered for the treatment of prior myelodysplastic syndrome are allowed, with the exception of hypomethylating agents 5-azacytidine or decitabine; patients must have been off such therapy for 1 week prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease; hydroxyurea, and a single dose of cytarabine up to 3 g/m^2, is permitted for control of counts prior to treatment
Stage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin [IL]-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen)
For cohort of patients that are already on ruxolitinib therapy: on therapy with ruxolitinib for at least for 6 months, and on stable dose for last 2 months, before starting therapy with sotatercept
Prior therapy with any hypoxic cytotoxin (hypoxia-targeting drugs).
PHASE I: Patients may have had treatment for any number of prior relapses; relapse is defined as progression following initial therapy (i.e. surgery and radiation +/- chemotherapy [chemo] if that was used as initial therapy)
PHASE II: Patients may have had treatment for no more than 1 prior relapse (i.e. failed 2 lines of treatment-initial therapy and therapy for first relapse) at 2nd relapse, treatment per BTTC09-01 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 2 prior therapies (initial and treatment for 1 relapse); if the patient had a surgical resection for relapsed disease and no anti-cancer therapy was instituted for up to 12 weeks, and the patient undergoes another surgical resection, this is considered as 1 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
Recent prior therapy: systematic chemotherapy less than 2 weeks prior to infusion; exceptions:\r\n* There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such\r\n* Subjects receiving hydroxyurea or oral maintenance chemotherapy may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis or treatment\r\n* Subjects receiving steroid therapy at physiological replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to subject starting apheresis or treatment\r\n* Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met; cytopenias deemed to be disease-related and not therapy-related are exempt from this exclusion
Phase II IMT naive cohorts: Patients have not received systemic cytotoxic or immune-based therapy for advanced melanoma. BRAF and/or MEK inhibition therapy is acceptable before immunotherapy where clinically indicated. Other systemic cytotoxic or targeted therapy in the advanced setting is not permitted in this subset
RAI-avid lesion on a radioiodine scan (a diagnostic, post-therapy, or post-ablation scans) performed =< 24 months prior to registration, which suggests that therapy with 131I is justifiable in the judgment of the investigator
131I therapy =< 6 months prior to registration; Note: 131I administered solely for diagnostic purposes is not considered 131I 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)
Previous systemic chemotherapy or non-radiation local therapy (such as surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation) is allowed; the lesion must however have shown criteria of progression based on RECIST; local therapy must be completed at least 4 weeks prior to the baseline scan; this is to create a safer treatment environment and to help determine the effect of treatment by SBRT alone; patients will be allowed to go onto appropriate systemic therapy, as determined by their medical oncologist, 2 weeks following delivery of SBRT
Patients can have extra-hepatic disease, provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with surgery, ablative radiation therapy, or United States (US) Food and Drug Administration–approved first- or second-line systemic therapy regimens
Corticosteroid therapy and endocrine replacement therapy (L-thyroxine, testosterone, estrogen, desmopressin acetate [DDAVP]) are permissible; any patient already receiving human growth replacement therapy should discontinue this prior to commencing chemotherapy, and should not restart until 3 years from diagnosis
Extensive prior therapy including > 12 months alkylator therapy or > 6 months alkylator therapy with extensive radiation
Radiopharmaceutical therapy (eg, radiolabeled antibody, 131I-metaiodobenzylguanidine): ?42 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 1 to 3 prior therapies for MM (a prior therapy is defined as 2 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]).
Patients with intermediate-1 or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.
Plans for the patient to receive other concomitant antineoplastic therapy (including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and surgery) while on this protocol except at disease progression
Oral treatment with anti-infective therapy that has been administered less than one week prior to first dose in this trial.
Prophylactic anti-infective therapy, which is given without clinical symptoms is allowed.
thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy;
are in relapse following an initial response and no more than 1 prior salvage therapy
failed primary induction therapy with no complete remission and for whom no other approved therapy is available, and no more than 1 prior salvage therapy
Subject has no prior anti-myeloma treatment therapy within 14 days prior to initiation of study treatment except for corticosteroids with a maximum allowed dosage equivalent to three pulses of dexamethasone (40mg daily for 4 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.
Patients with MF/SS must have failed at least 1 prior topical therapy (including steroids, nitrogen mustard, retinoids, phototherapy, photochemotherapy, radiation, and total skin electron beam); there is no upper limit for prior therapies
Prior TCN-PM therapy
Currently benefiting from the treatment with ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone, as determined by the investigator.
Able to access ruxolitinib and/or background cancer therapy outside of the clinical study.
202 Prior anti-cancer therapy as specified below: At least 3 half-lives from first dose of AMG 562 must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Other targeted anti-cancer therapy (chemotherapy, antibody therapy,molecular targeted therapy, steroids) within 14 days or 5 half lives (which ever is longer) prior to first dose of AMG 562. 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 28 days prior to first dose of AMG 562. Autologous HSCT within six weeks prior to start of AMG 562 treatment.
207 Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy. Patient may be included if the treatment is discontinued more than 3 months prior to the first dose of AMG 562 at a low likelihood of relapse AND if there is agreement by both the investigator and the Amgen Medical Monitor.
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
Any local or loco-regional therapy of intrahepatic tumor lesions (e.g. surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed ? 4 weeks before first dose of study medication. Note: patients who received sole intrahepatic intra-arterial chemotherapy, without lipiodol or embolizing agents are not eligible.
Subjects with proven or suspected persistent bacteremia despite 72 hours of both systemic antibiotic therapy and lock therapy to which the infecting organism is susceptible;
Cancer-directed therapy within 2 weeks prior to starting treatment, with the exception of hydroxyurea, which is allowed to control white blood cell count. Hydroxyurea will be weaned as soon as clinically feasible.
Symptomatic metastatic brain or meningeal tumors unless the patient is >6 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).
Prior anti-GD2 therapy is not otherwise an exclusionary criteria unless it was given in combination with therapeutic 131I-MIBG.
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-2 or other investigational systemic cytokine therapy signaling through a common gamma-chain cytokine receptor including IL-7, IL-15 or IL-21
Prior 131 I-MIBG therapy is excluded
Patients must be co-enrolled on the companion protocol HCC 17-220 (Cell Harvest and Preparation to Support Adoptive Cell Therapy Clinical Protocols and Pre-Clinical Studies) and have available TIL cultures for therapy
Patients who have received at least two cycles of initial systemic therapy and are within 2 to 12 months of the first dose. Mobilization therapy is not considered initial therapy.
Any skin-directed therapy within 14 days prior to day 1 of protocol therapy
Patients must not have received chemotherapy within 14 days of enrollment, with the two following exceptions: \r\n* Routine systemic maintenance therapy (e.g., Abelson murine leukemia viral oncogene homolog 1 [ABL] kinase inhibitor, methotrexate, 6-mercaptopurine, vincristine, etc.) and intrathecal/intraventricular therapy\r\n* Systemic therapy for the acute management of hyperleukocytosis or acute symptoms (e.g., corticosteroids, cytarabine, etc.)
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
No prior therapy for this malignancy except for one dose of intrathecal therapy and the use of hydroxyurea or low-dose cytarabine (100-200 mg/m^2 per day for one week or less for hyperleukocytosis), and
To be performed within 28 days prior to day 1 of protocol therapy: Normal eye examination
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 21 days prior to cycle 1 day 1 (C1D1) AMG 232 + KRd\r\n* Corticosteroids at least 3 weeks prior to starting AMG-232 + KRd, except for a dose equivalent to dexamethasone of =< 4 mg/day\r\n* Autologous stem cell transplantation at least 12 weeks prior to starting AMG-232 + KRd\r\n* Allogeneic stem cell transplantation at least 24 weeks prior to starting AMG-232 + 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-GD2 therapy, including chimeric antigen receptor (CAR) T cells directed against GD2 antigen
Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of T-ALL, T-L-Ly or for any cancer diagnosis prior to the initiation of protocol therapy on AALL1231, with the exception of:\r\n* Steroid pretreatment: prednisone or methylprednisolone for =< 120 hours (5 days) in the 7 days prior to initiating induction chemotherapy or for =< 336 hours (14 days) in the 28 days prior to initiating induction chemotherapy; prior exposure to ANY steroids that occurred > 28 days before the initiation of protocol therapy does not affect eligibility; the dose of prednisone or methylprednisolone does not affect eligibility\r\n* Intrathecal cytarabine (the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment) system chemotherapy must begin with 72 hours of this IT therapy; or\r\n* 600 cGy of chest irradiation, if medically necessary\r\n** Pre-treatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone use during sedation to prevent or treat airway edema; inhalation steroids and topical steroids are not considered pretreatment
Subjects must have ended hormone replacement therapy (HRT) (e.g., conjugated estrogens tablets, USP, [Premarin]), at least 1 month (30 days) prior to receiving the first dose of randomized therapy
Concomitant chemotherapy, radiation therapy\r\n* For patients with hyperleukocytosis with > 50,000 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 24 hours prior to initiation of protocol defined therapy
Intrathecal cytotoxic therapy:\r\n* No waiting period is required for patients having received intrathecal cytarabine, methotrexate, and/or hydrocortisone\r\n* At least 14 days must have elapsed since receiving liposomal cytarabine (DepoCyte) by intrathecal injection
Patients must have recovered from the acute effects of prior liver-directed therapy (e.g. RT, radiofrequency ablation [RFA], or transarterial chemoembolization [TACE]), and a minimum of 4 weeks must have passed since the last procedure and protocol therapy
Patients already using topical sirolimus therapy
Therapy with myelosuppressive chemotherapy or biologic therapy < 21 days prior to registration; NOTE: patients who have recovered from cytopenia related to previous treatment and meet criteria of this protocol will be eligible
Prior therapy for the treatment of solitary plasmacytoma is permitted, but > 7 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-2, checkpoint-blocking antibodies, or adoptive cell therapy)\r\n* At least 4 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 2 weeks since last dose and recovery from laboratory and constitutional toxicities; patients must meet entry eligibility criteria\r\n* At least 2 weeks from completion of prior radiation therapy with no residual radiation toxicities\r\n* At least 4 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) v600 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
Liver-directed therapy (chemoembolization, radioembolization, bland embolization, ablative therapy) within 4 weeks of DEB-TACE
For stage 1 (all patients) and dose expansion (stage 2) endometrial and ovarian cancer cohorts, participants are allowed following unlimited prior therapy; for stage 2 GBM participants, no more than 2 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 2 had no more than 3 prior therapies (initial and treatment for 2 relapses); if the patient had a surgical resection for relapsed disease and no anti-cancer therapy was instituted for up to 12 weeks, and the patient undergoes another surgical resection, this is considered to constitute 1 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 3 prior therapies
Patient may have had any prior topical or systemic therapy except for total electron beam irradiation; patients must be a minimum of 2 weeks from topical therapy and 3 weeks from systemic therapies, phototherapy, or local radiation therapy before initiating protocol specific therapy except for HDACI if they are in Arm B; patients are allowed to take weak potency topical corticosteroids if patient has been on a stable dose for more than a month
Prior therapy with other human or humanized monoclonal antibodies, unless HAHA tested\n             and negative
Women diagnosed with osteoporosis may participate in this trial provided they are receiving appropriate therapy or if they have declined therapy
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy:\r\n* Myelosuppressive chemotherapy:\r\n** Solid tumors: Patients with solid tumors must not have received chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)\r\n** Lymphoma: Patients with lymphoma who relapse during standard maintenance therapy are eligible at time of relapse; for patients with ALCL who relapse while they are receiving cytotoxic therapy, at least 14 days must have elapsed since the completion of cytotoxic therapy; Note: cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of PF-02341066
Prior therapy with LMB-2
Participant treated with any prior systemic therapy for myeloma; treatment by localized radiotherapy is not an exclusion criterion if an interval of at least 7 days between the end of radiotherapy and initiation of protocol therapy is observed; intervals of less than 7 days between radiotherapy and initiation of protocol therapy will be considered on a case by case basis with the lead principal investigator (PI), provided toxicity is not a concern; similarly, the dose of corticosteroids received by the participant as part of initial therapy for myeloma should not exceed the equivalent of 160 mg of dexamethasone over a two-week period before initiation of protocol therapy
Has received locoregional therapy to liver (transcatheter chemoembolization [TACE], transcatheter embolization [TAE], hepatic arterial infusion [HAI], radiation, radioembolization, or ablation) within 4 weeks prior to the first dose of study drug.
Patients must have relapsed neuroblastoma, refractory neuroblastoma that had less than a partial response to standard treatment or persistent neuroblastoma that had at least a partial response to frontline therapy frontline therapy with > 3 residual lesions on end-induction MIBG scan.
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
Prior intra-arterial liver directed therapy, including transcatheter arterial chemoembolization (TACE) or Y-90 microsphere therapy
< 6 months between completion of prior RT and initiation of reirradiation using proton therapy
Prior therapy criteria must be met
Recovery from the effects of previous chemotherapy, with a minimum of 21 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
No prior therapy with IL-15 or IL-15 analog
Hepatic artery embolization or ablation of hepatic metastasis within 3 months of enrollment, prior peptide receptor radionuclide therapy (PRRT) within 4 months or any other cancer therapy within 4 weeks (as long as all toxicities are resolved)
CRLX101 or with any topoisomerase I therapy;
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 ? 20% in size. Local-regional therapy must be completed at least 4 weeks prior to the baseline CT scan. Local therapies including chemoembolization do not count as prior systemic therapy.
Contraception is recommended for 28 days prior to starting therapy, while participating in this study, during dose interruptions, and for at least 3 days after discontinuation of ibrutinib, 28 days after discontinuation of lenalidomide, and 12 months after discontinuation of rituximab
EXCLUSION FOR TREATMENT: Recent prior therapy: systemic chemotherapy less than 2 weeks prior to infusion or apheresis (6 weeks for clofarabine or nitrosoureas for apheresis) or radiation therapy less than or equal to 3 weeks prior to apheresis; exceptions:\r\n* There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such\r\n* Subjects receiving hydroxyurea or oral maintenance chemotherapy may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis or treatment\r\n* Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis or treatment\r\n* Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met; cytopenias deemed to be disease-related and not therapy-related are exempt from this exclusion
Must not have received systemic antineoplastic therapy, including radiotherapy within 7 days of study treatment, with the exception of hydroxyurea or 6-mercaptopurine for the purposes of cytoreduction
Patients must have newly diagnosed active multiple myeloma (MM); except where otherwise indicated below that assessment is required within 14 days, all tests for establishing baseline disease status must be completed within 28 days prior to registration for patients with no prior therapy, or within 28 days prior to initiation of first Induction course for patients with prior therapy
Patients must have been treated with 1-2 courses of therapy as first therapy for AML, commonly described as remission induction; examples include, but are not limited to:\r\n* Anthracycline containing regimens\r\n* Nucleoside analogs as monotherapy or in combination\r\n* Deoxyribonucleic acid (DNA) methyltransferase inhibitors
Limited prior therapy, including systemic glucocorticoids for 1 week or less, 1 dose of vincristine, emergency radiation therapy to the mediastinum, and 1 dose of IT chemotherapy; other circumstances must be cleared by principal investigator (PI) or co-PI
Stable dose of glucocorticoids pre-therapy. If patients are receiving glucocorticoids, the dose should not increase during the 96 hours prior to initiation of therapy.
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 AALL0932\r\n* Patients receiving prior steroid therapy may be eligible for AALL0932
Patients who have received prior progestin or anti-estrogen therapy during the 3 months before the diagnosis of endometrioid adenocarcinoma of the uterine corpus is established; estrogen therapy alone is allowed
Participant must have received prior treatment with at least one, but no more than three, prior lines of therapy for multiple myeloma. A line of therapy consists of greater than or equal to 1 complete cycle of a single agent, a regimen consisting of combination of several drugs, or a planned sequential therapy of various regimens.
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-D842V GIST, no prior therapy is required for study entry. Other patients with KIT positive cancers will have progressed on at least one prior therapy.
Any medical contraindications or previous therapy that would preclude treatment with either IRX 2 Regimen 1 or 2 or the surgery, reconstruction or adjuvant therapy required to treat the oral tumor appropriately
Patients must discontinue treatment with H2-blockers (cimetidine, ranitidine, etc.) prior to beginning protocol therapy
Prior systemic antitumour therapy within 28 days before Screening Visit. However, local radiation therapy to any area except for the abdominal/retroperitoneal area including the kidney tumour is allowed
In the absence of rapidly progressing disease, the interval from prior treatment to time of initiation of 5-azacytidine and lirilumab will be at least 2 weeks OR at least 5 half-lives for cytotoxic/noncytotoxic agents; use of one dose of cytarabine (up to 2 g/m^2) 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 90 days prior to registration; for phase I, patients are eligible regardless of prior therapy
Patients must have been off therapy for MDS for 2 weeks prior to entering this study, and must have recovered from the toxic effects of that therapy to at least grade 1, unless there is evidence of rapidly progressive disease; use of hydroxyurea (any dose) or cytarabine (ara-C) (up to 1 g/m^2 x 2 doses) for patients with rapidly proliferative disease is allowed before the start of study therapy; these should be stopped for 24 hours prior to the initiation of azacitidine and sorafenib
Prior therapy for NHL
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 4 weeks prior to first dosing of study agent
Who have received at least two cycles of initial systemic therapy and are within 2 to 12 months of the first dose; mobilization therapy is not considered initial therapy
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
Patients that have been previously treated with chemotherapy for hepatoblastoma or other hepatoblastoma-directed therapy (eg, radiation therapy, biologic agents, local therapy [embolization, radiofrequency ablation, laser]) are not eligible
Corticosteroids given with antineoplastic intent within 7 days, or chemotherapy given with antineoplastic intent, targeted therapy, or radiation therapy within 3 weeks, or antibody-based therapy within 4 weeks of the start of study drug
Prior therapy with ruxolitinib
Hormone replacement therapies (estrogens, megestrol acetate) within 14 days prior to day 1 of protocol therapy
If considered for combination therapy:
Hormone replacement therapy of any type, megestrol acetate, or raloxifene within four weeks prior to first study treatment
Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days before first BTCT4465A (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
Limited prior 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 circumstances must be cleared by principal investigator (PI) or co-PI
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
Prior systemic fluoropyrimidine therapy (unless given in an adjuvant setting and at least six months earlier); prior topical fluoropyrimidine use is allowed
Prior therapy with Laser-Induced Thermal Therapy (LITT) is allowed but at least 21 days must have elapsed from last LITT, with recovery from all LITT-related toxicities to Grade 1 or less and subsequent histologic documentation of recurrence.
Patients with chronic myeloid leukemia (CML) in chronic phase who have resistance and/or intolerance to frontline TKI therapy; resistance is defined as lack (lack defined as response not achieved or lost by the given dates mentioned hereafter) of CHR (complete hematologic response) within 3 months, lack of major cytogenetic response (MCyR) within 6 months, and lack of CCyR within 12 months of therapy with frontline TKIs; in addition, loss of MCyR, CCyR or MMR at any time during the course of therapy is also considered resistance to therapy; intolerance is defined as persistent or severe toxicity that is unacceptable to the patient
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
Completed any systemic therapy (excluding endocrine therapy, which may be ongoing) at least one week prior to planned start of SBRT (two weeks preferred) and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred)
Allowed prior therapies include:\r\n* Surgery (major surgery at least more than four weeks prior to baseline assessment)\r\n* Locoregional therapy such as: chemoembolization, radio-embolization, radiofrequency ablation, radiotherapy as long as there is progressive measurable disease outside the area of locoregional therapy or there is progression in the previously treated areas\r\n* Any number of previous lines of systemic therapy; last treatment before enrollment must have occurred more than 4 weeks for chemotherapy, 6 weeks for antibodies or more than 5 half-lives of prior tyrosine kinase inhibitors (TKIs) or small molecules
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 6 cycles of treatment given in the study
Subject had previous local therapy (e.g., surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation) within 14 days prior to Day 1, has not recovered from toxicities from prior local therapy or may require major surgical procedure during the course of the study.
Prior history of any viral-based therapy
For patients who have received prior cryotherapy, radiofrequency ablation, radioembolization, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, at least 28 days must have elapsed since that therapy, and lesions that have not been treated with local therapy must be present and measurable.
Ineligible for cisplatin therapy
Failure to recover to grade 1 or baseline from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, and/or experimental therapy, with the exception of: alopecia, grade =< 2 peripheral neuropathy, grade =< 2 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 2 weeks from prior cetuximab is required; a washout period of 3 weeks from any prior cytotoxic chemotherapy or investigational drug is required
Prior therapy with all choices of active comparator
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
For unilateral retinoblastoma\r\n* Group A eye that has failed local therapy\r\n* Group B eye that has failed local therapy\r\n* Group C eye that has failed local therapy\r\n* Group D eye\r\n* Group E eye that is not buphthalmic, is not planned for enucleation after first cycle of chemotherapy, and is in a child less than 1 year of age
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
For patients who have received prior cryotherapy, radiofrequency ablation, Therasphere, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, the following criteria must be met: 28 days have elapsed since that therapy (lesions that have not been treated with local therapy must be present and measurable)
Treatment with any of the following medications or interventions concomitantly or within 28 days of starting ipilimumab: a) systemic corticosteroids; use of inhaled, intranasal, intra-articular and topical steroids is acceptable, as is a short course (i.e. =< 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans; b) external beam radiation therapy or major surgery requiring general anesthetic; c) any systemic therapy for prostate cancer (with the exception of bisphosphonates and receptor activator of nuclear factor kappa [RANK]-ligand inhibitors for bone metastases which are allowed) including chemotherapy, secondary hormonal therapies, (such as megestrol acetate, diethylstilbestrol, ketoconazole, abiraterone, enzalutamide) and non-steroidal anti-androgens (such as bicalutamide, flutamide or nilutamide); d) immune modulators, cytokines or vaccines for the management of cancer or non-cancer-related illnesses; e) any non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month before any dose of ipilimumab); f) any other investigational product
If not receiving myelofibrosis therapy, must remain off therapy for at least 2 weeks prior to screen date and through the screening period
Histologically confirmed prostate adenocarcinoma with metastasis either starting or recently started on LHRH analogue therapy; (late induction permitted within 3 months of starting LHRH analogue therapy or antiandrogen); no minimum PSA requirement for patients with measurable disease
Prior therapy with AA
Prior therapy restrictions:
No particle therapy such as but not limited to proton therapy is allowed
Radiopharmaceutical therapy: ?42 days after systemically administered therapy.
Prior treatment with four or more cycles of hypomethylator therapy
The target lesion(s) has not been previously treated with local therapy (such as surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation)
Patients who have received local therapy, such as surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible if the previously treated lesions have progressed or recurred can be identified as target lesions; local therapy must have been completed at least 4 weeks prior to the baseline scan
Symptomatic metastatic brain or meningeal tumors unless the patient is > 3 months from definitive therapy, has a negative imaging study within 4 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 1 [D1] of treatment under this study)
Patients may have been treated with locoregional liver directed therapies such as embolization, chemo-embolization including drug-eluting beads doxorubicin chemoembolization (prior non drug eluting beads chemoembolization with doxorubicin is excluded), radiation, radioactive microspheres, etc., provided that they either have a target lesion that has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of >= 25% in the size since last treatment; such therapy must be completed at least 4 weeks prior to treatment initiation; patients that have received palliative radiation therapy to the bone need not wait 4 weeks to begin protocol therapy
Prior loco-regional therapy including drug-eluting beads doxorubicin chemoembolization (prior non drug eluting beads chemoembolization with doxorubicin is excluded) is allowed
Prior treatment with 5-azacytidine followed immediately by HiDAC and mitoxantrone as proposed in this study (NOTE: prior therapy with 5-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)
Patients who have had any prior line of systemic therapy including cytotoxic agents or molecularly targeted agents for advanced/unresectable disease; any number of prior regional therapies with transarterial chemoembolization (TACE), brachytherapy with yttrium-90 microsphere, intra-arterial chemotherapy, surgery, or ablative therapy are allowed
Patients who have received prior local therapy, including but not limited to embolization, chemoembolization, radiofrequency ablation, radiation therapy, are eligible provided that measurable disease falls outside the treatment field or within the field but has shown an increase of >= 20% in the size; prior local therapy must be completed at least 4 weeks prior to the baseline scan
Patients with a prior history of liver directed therapy for their HCC (chemoembolization, radioembolization, bland embolization, radiation therapy, radiofrequency ablation, microwave ablation) can participate in the study if the liver-directed therapy was performed more than 4 weeks prior to their first dose of sorafenib and measurable lesions present outside of previously treated field
Hypercalcemia >2.9 mmol/L, unresponsive to standard therapy (e.g., I.V. hydration, diuretics, calcitonin and/or bisphosphate therapy).
Liver function status Child-Pugh Class A. Child Pugh status should be calculated based on clinical findings and laboratory results during the screening period. Local or loco-regional therapy of intrahepatic tumor lesions (e.g. surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed >/=4 weeks before first dose of study medication. Note: patients who received sole intrahepatic intraarterial chemotherapy, without lipiodol or embolizing agents are not eligible.
Refractory to prior Bortezomib-containing therapy under the 1.3 mg/m2 dose twice weekly dosing schedule.
ONLY APPLIES TO PATIENTS IN GROUP B (COMBINATION THERAPY)
Prior ADT is allowed if it was an adjunct to definite local therapy, was given for =< 1 year, and was completed at least 12 months before initiating therapy for metastatic disease
Malignancy has failed curative therapy and has no reasonable expectation of cure with available alternative salvage therapy
Prior nitrosurea therapy (including lomustine or Gliadel)
Achieved at least a PR (and not progressed) after ABVD therapy
Patients who have received any systemic corticosteroid therapy within 3 weeks prior to the start of therapy with the exception of physiological replacement doses of cortisone acetate or equivalent
Patients on continuous steroid therapy for at least 72 hours (hrs) (or other continuous immunosuppressives such as azathioprine or cyclosporine A) are excluded on the basis of potential immune suppression; patients must have had 6 weeks of discontinuation of any continuous steroid therapy (taken for at least 72hrs duration) prior to enrollment (except steroids used for allergic reactions or as anti-emetics for systemic chemotherapy which are permitted)
No prior therapy for recurrent ALL is allowed prior to study entry with the exception of intrathecal (IT) chemotherapy; participants who have relapsed while receiving up-front therapy are eligible, but must have recovered from adverse effects from any previously administered agents
Received treatment with chemotherapy, radiation, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs 14 days prior to first dose of rucaparib and/or ongoing adverse effects from such treatment > NCI CTCAE Grade 1 (Grade 2 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 2 and 4); prior treatment with Gliadel is permitted for all groups
Subjects must have discontinued hormone replacement therapy (HRT) (e.g., conjugated estrogens tablets, United States Pharmacopeia [USP] or premarin), at least 28 days prior to receiving the first dose of randomized therapy
pc-ALCL and MF patients must have progressed or relapsed after treatment with local radiation therapy, phototherapy, topical chemotherapy, or have failed systemic therapy of at least one single agent (e.g., methotrexate or bexarotene or other non-CD30 antibody) or one multi-agent chemotherapy (e.g. CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone); pc-ALCL classified patients are required to have one or more cutaneous tumors that by history have been present for at least 3 months
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 ?28 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 > 6 months from definitive therapy, has a negative imaging study within 4 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 3 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
Baseline studies must be performed 8 weeks prior to the start of systemic therapy, and must document the extent of disease in the breast; the specifics of this are at physician discretion, but must address clinical signs and symptoms; if pre-therapy scans were not performed, scans performed within the first 4 weeks of systemic therapy, but prior to registration, will be accepted; radiology reports documenting status of disease must be available
Patients must have completed at least 16 weeks of optimal systemic therapy (appropriate to the tumor biological profile and the patient’s age and menopausal status)\r\n* NOTE: The patient will be considered eligible if the last day of the treatment cycle meets the 16 weeks criteria\r\n* If systemic therapy is discontinued for toxicity, there is no distant progression and at least 12 weeks of therapy have been delivered, then the patient remains eligible; if systemic therapy is changed for reasons other than progression of disease (e.g. from chemotherapy to endocrine therapy), the patient remains eligible
Initial therapy must have included total/near-total thyroidectomy and RAI ablation therapy
Have not received anti-cancer therapy for at least 2 weeks prior to study entry, with the exception of low dose ara-C (LDAC) given as subcutaneous injections (no less than 15 days prior), hydroxyurea or anagrelide (no less than 24 hours prior), TKI (no less than 5 days prior), and interferon (no less than 2 weeks prior)
Subjects who received less than four weeks of therapy and were unable to continue therapy due to toxicity will be allowed to participate
The participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate).
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.
Any prior therapies such as surgery, chemoembolization, radiofrequency ablation, and alcohol injection are allowed as long as toxicity from such prior therapy is =< grade 1
Prior therapy with Dasatinib
subjects with initial presentation of organ confined recurrent prostate cancer (Stages T1c and T2 only) who have been treated with EBRT (conventional, 3D 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 60 to 81Gy or GyE (gray equivalent) for proton therapy;
No prior therapy for this malignancy except for one dose of intrathecal therapy and the use of hydroxyurea or low-dose cytarabine (100-200 mg/m^2 per day for one week or less) for hyperleukocytosis
Prior therapy with E7389 Halichondrin analog (eribulin)
Prior therapy with modulators of monocyte or TAM function.
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 7 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 90 days have elapsed since bone marrow transplant and participant is off immune suppression for >= 2 weeks, if applicable
Prior therapy with pemetrexed
Patients may be enrolled on study regardless of the timing of prior Intrathecal therapy; however, they MAY NOT BEGIN TREATMENT ON THIS PROTOCOL UNTIL A MINIMUM OF 7 DAYS HAS ELAPSED SINCE PRIOR INTRATHECAL THERAPY.
Patients should have finished their prior systemic therapy or radiation therapy, at least 3 weeks before cyclophosphamide or granulocyte colony-stimulating factor (G-CSF)/plerixafor mobilization, and should have finished dexamethasone at least 7 days prior to Plerixafor priming; administration of bisphosphonates needs to be completed at least 2 weeks before cyclophosphamide priming; bisphosphonates can be resumed or started after day 30
Naïve to targeted therapy (e.g., BRAFi, MEKi) for advanced disease; prior immune-based therapy in the adjuvant setting or for advanced disease (e.g. interferon alfa, ipilimumab, anti-programmed cell death protein 1 [PD-1], vaccine) will be allowed if > 2 weeks from study entry; prior adjuvant treatment with BRAFi or MEKi will not be allowed
Intrathecal therapy with cytarabine is allowed prior to registration for patient convenience; systemic chemotherapy must begin within 72 hours of the first intrathecal treatment
History of prior therapy with belinostat or AZD1775
Patients who are actively receiving other cytotoxic or antibiologic chemotherapies; for patients with Her-2/neu positive disease, trastuzumab (Herceptin) is NOT ALLOWED on this study, and should be withheld during the 8 weeks of therapy, and can be resumed no sooner than 14 days following completion of protocol therapy
At least 1-4 weeks since prior myelofibrosis therapy, including any erythropoietic or thrombopoietic agent
Receipt of other cancer therapy, immunomodulatory drug therapy or immunosuppressive therapy within 4 weeks prior to 1st dose.
Subject has attempted \best\ medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classes
Evidence of continuing adverse effect of prior therapy
Meets the requirements for HD IL-2 therapy per Institutional guidelines
Meets the requirements for ipilimumab therapy per Institutional guidelines
The last dose of previous therapy targeting RET kinase must be given at least 4 weeks prior to the first dose of ponatinib
Patients must be clinically suitable for cryoablation therapy
Because patients with immune deficiency are at increased risk of lethal infections when treated with bone marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with bevacizumab, vemurafenib and cobimetinib.
Documented completion of at least 6 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 B1 (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 4 weeks before treatment on study; treatment within this 4 week window with corticosteroids is permitted as long as the dose is stable or decreasing; radiotherapy within this 4 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
Willingness to discontinue LHRH analogue therapy and for the duration of the study
Patients receiving full dose anticoagulative therapy
No response to last line of therapy i. PD as best response to most recent therapy regimen ii. SD as best response to most recent therapy with duration no longer than 6 month from last dose of therapy OR
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 >= 28 days following discontinuation (antiandrogen withdrawal- AAW) (>= 42 days for bicalutamide or nilutamide); patients who receive megestrol acetate as therapy for \hot flashes\ at a dose of =< 40 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
The study will be limited to patients who are chemotherapy naive; patients may have received prior systemic or liver-directed local therapies for advanced uveal melanoma as long as those treatments do not involve chemotherapy; this includes, but is not limited to: immunotherapy, targeted therapy, transarterial embolization, radiofrequency ablation, or cryoablation; treatment must be completed at least 28 days prior to initiation of study therapy; radiation therapy is also allowed and must be completed at least 28 days prior to initiation of study therapy; lesions treated via radiation or liver-directed therapy may not be used as target lesions unless they demonstrate growth over a minimum of 3 months on subsequent imaging
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 HER2-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 4.1. Cyto-reduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start or protocol therapy.
Prior therapy with a conjugated or unconjugated auristatin derivative.
Concurrent chemotherapy, or targeted anti-cancer agents, other than hydroxyurea, low-dose cytarabine, intrathecal therapy and/or low dose maintenance therapy such as vincristine, mercaptopurine, methotrexate or glucocorticoids
Must have completed any systemic therapy at least one week prior to planned start of SBRT (two weeks preferred), and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred)
Prior therapy with radium-223 is allowed
At least 21 days since receipt of chimeric antigen receptor therapy or other modified T cell therapy
Measurable disease using RECIST 1.1 criteria (Appendix A). At least 1 measurable lesion must be present. Subjects who have received local-regional therapy such as (but not limited to) chemoembolization, embolization, cryoablation, hepatic artery therapy, percutaneous ethanol injection, radiation therapy, radiofrequency ablation or surgery are eligible, provided that they 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 ? 20% in size. Local-regional therapy must be completed at least 4 weeks prior to the baseline CT scan. Local therapies including chemoembolization do not count as prior systemic therapy.
Radiation therapy, local therapy (except for surgical re-resection), or systemic therapy following first recurrence/progressive disease. Excluded local therapies include stereotactic radiation boost, implantation of carmustine biodegradable wafers (Gliadel), intratumoral or convection-enhanced delivery administered agents, etc.
Hepatic radiation, chemoembolization, and radiofrequency ablation < 4 weeks prior to study day 1.
Last received ONT-10 a maximum of 6 months (unless approved by the medical monitor) prior to receiving the first dose of maintenance or retreatment cohort therapy
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.
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
Local or loco-regional therapy (i.e., surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed >= 4 weeks prior to randomization
No prior systemic therapy, immunotherapy, investigational agent, chemoembolization, radioembolization or radiation therapy within the last 4 weeks.
Prior unanticipated severe reaction to fluoropyrimidine therapy
Progressive disease under last palliative therapy with a history of prior ifosfamide, doxorubicin or taxane therapy for angiosarcoma; up to 4 prior therapies are allowed
Patients may have failed ablative therapy
Patients cannot be receiving HAART (highly active anti-retroviral therapy) therapy
CAR-T infusion or other cellular therapy within 30 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 6 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 6 month Velcade treatment-free interval).
The participant’s target lesion must be limited to a single biopsy-confirmed tumor; presence of other pulmonary nodules, which may represent synchronous early lung cancer, is allowed as long as no additional therapy is anticipated within 3 months following protocol therapy
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
No prior bortezomib is allowed
b. ?1 prior therapy and one of the following abnormalities: 17p del, p53, 1q amp, 1p del, t(4;14)
Patients must not have received any systemic corticosteroid therapy for 3 weeks prior to the start of therapy with the exception of physiological replacement doses of cortisone acetate or equivalent
Subject must have progressive disease after therapy consisting of one of the Food and Drug Administration (FDA)-approved agents for therapy of metastatic renal cell carcinoma, including but not limited to: sorafenib, sunitinib, or temsirolimus
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
At the time of enrollment, at least 3 weeks and no more than 8 weeks should have elapsed since the last cycle of cytotoxic therapy or since the last dose of radiation therapy, and patients should have recovered from toxic side effects of previous therapy to a grade 1 or less, with the exception of the following:\r\n* Hematological toxicity: recovery to required levels\r\n* Low electrolyte levels (such individuals should receive appropriate supplementation)\r\n* For patients on anticoagulant therapy or with pre-existing coagulation abnormalities, PT, PTT must return to baseline\r\n* Liver function tests must resolve to required values\r\n* Grade 3 hypoalbuminemia is permitted\r\n* Alopecia is permitted\r\n* Sterility is permitted
No prior radiation therapy to the liver including Y90-, I131-based loco-regional therapy. Prior loco-regional therapy based on other technology for HCC, if any, must have been completed at least 4 weeks prior to baseline imaging
Patients must have recovered from the acute effects of prior liver-directed therapy (e.g., radiation therapy [RT], radiofrequency ablation [RFA], MWA or transarterial chemoembolization [TACE]) and a minimum of 4 weeks must have passed since the last procedure and protocol therapy
Corticosteroids should not be used as anti-emetic therapy; corticosteroid therapy is not permissible except for the following indications: \r\n* As treatment or prophylaxis for anaphylactic reactions\r\n* As a treatment for symptoms of cytarabine (Ara-C) syndrome (including fever, rash, or conjunctivitis)\r\n* Physiologic replacement stress-dosing as indicated for suspected or confirmed adrenal insufficiency
For transplant-ineligible patients, salvage therapy just prior to MDV9300 treatment must have resulted in a PR or stable disease;
Have received between 1-2 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
Liver-directed therapy (hepatic artery chemoembolization [HACE], hepatic artery embolization [HAE], selective internal radiation therapy [SIRT]) or peptide receptor radionuclide therapy (PRRT) =< 56 days of first dose of study drug
Has the ability to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post procedure,
Oral or transdermal estrogen therapy is not allowed
Not be receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for =< 30 days prior to registration or planned during protocol therapy (patients may have received prochloperazine and other phenothiazines as prior anti-emetic therapy)
A self-reported current practice of yoga or any other mind-body therapy, including but not limited to meditation or hypnosis therapy in the past 30 days prior to study enrollment
Prior hepatic arterial therapy or hepatic radiation therapy; prior surgical resection or ablation of liver metastases is acceptable; patients must be at least one month beyond prior radiotherapy or surgery, and 6 months beyond chemotherapy and have recovered from all therapy-associated toxicities
No therapy restrictions
Patients’ post-operative treatment must have included at least 80% 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
Patients on hormone-replacement therapy (HRT) =< 4 weeks prior to registration; this includes the use of vaginal estrogen therapy
Participants must be receiving systemic glucocorticoid therapy for cGVHD; all immunosuppressive therapy may include but not be limited to tacrolimus, sirolimus, CellCept, cyclosporine, and systemic corticosteroid must be at stable doses for 28 days prior to the first cell infusion
The following patient-related situations are allowed: prior surgery, concurrent treatment, homecare, residing in assisted living or a skilled nursing facility, and hospitalization during radiation therapy
Pilot: Patients having been treated for stage III ovarian cancer, and received either intraperitoneal therapy/intravenous therapy or Intravenous therapy only
Abnormal global longitudinal strain (< 19%, or a % decrease of >= 11% from baseline) prior to initiation of planned anti-HER2 therapy
Patients must not have received prior regional therapy such as ablation, embolization, or radiation therapy for at least 2 weeks prior to the first dose of study treatment; patients who receive such therapy should have evidence of radiologic progression at this site or other progressing measurable disease
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 28 days prior to registration; therapeutic massage is allowed
Prior therapy with romidepsin
No limitations exist for type or amount of prior therapy
Patients who have never utilized art therapy at Maroone Cancer Center
Clinically suitable for cryoablation therapy
Need for intravenous therapy more frequently than every 3 weeks or inability to time intravenous therapy treatment before and after the study
Any prior therapy with radium-223, samarium, or strontium
Receipt of intravenous immunoglobulin therapy (IVIG) < 27 days prior to calendar day of vaccination
Timing from prior therapy: Stratum 1: Enrollment no later than 60 days after completion of upfront therapy, (last dose of cis-retinoic acid) with a maximum of 6 cycles of cis-retinoic acid maintenance therapy. Stratum 2, 3 and 4: Enrollment no later than 60 days from last dose of the most recent therapy.
Receipt of intravenous immunoglobulin therapy (IVIG) < 27 days prior to vaccination
No cancer therapy in the prior 3 months (excluding chemoprevention agents)
No future cancer therapy planned
Receipt of locoregional therapy (LRT) with verification of complete response at least 30 days following treatment
Receiving maintenance therapy with mesalamine for at least 3 months
Prior endoscopic therapy for BE
Prior therapy with anthracyclines
No prior systemic therapy EXCEPT patients may be consented and enrolled if they have already started mFOLFIRINOX for up to four cycles
Patients must be willing to complete a bilateral mammogram at baseline with repeat exam after 12 cycles of protocol therapy; patients who have had a mammogram within 1 month prior to registration to protocol therapy will not need to repeat the exam
Hormone therapy, including vaginal estrogen creams
If not receiving antiretroviral therapy:                \r\n* CD4-cell count >= 350 cells/mm³ within 90 days prior to study entry\r\n* No plans to start antiretroviral therapy prior to week 28
Individuals can have a prior history of cancer; these individuals must be in stable remission and at least 6 months out from the completion of surgery/radiation therapy/chemotherapy; individual cases can be reviewed with the institutional principal investigator
Individuals can have a prior history of cancer; these individuals must be in stable remission and at least 6 months out from the completion of surgery/ radiation therapy/ chemotherapy; individual cases can be reviewed with the institutional principal investigator
Has a plan for cystoscopic surveillance (adjuvant intravesical therapy allowed)
There will be no therapy restrictions
Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (high-intensity focused ultrasound ablation [HiFu])
Any surgical therapy in the area of the oral cavity or pharynx within the last 2 weeks
Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy\r\n* Including focal ablation techniques (high-intensity focused ultrasound therapy [HiFu])
Patients should not have begun therapy, or, needed research imaging can be performed within 2-5 days of starting therapy
Any types and amounts of prior therapy will be allowed for this study
Surgical resection, chemotherapy, radiation therapy, or biologic therapy since last Octreoscan + CT; continuation of the same dose of Sandostatin-LAR or subcutaneous Sandostatin is allowed
Patients are deemed suitable for therapy with ADT and EBRT
Prior MAGE-A3/A6-targeting therapy
Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
Residual side effects to previous therapy over specific grade prior to initiation of therapy
Any types and amounts of prior therapy will be allowed for this study
Prior therapy is not a consideration for protocol entry and prior therapy is not an exclusion criteria
Being considered for salvage therapy
Documented normal LVEF for at least 6 months after the initiation of recommended HF therapy
Received any systemic therapy within 21 days prior to planned B-WARM therapy\r\n* Patients may be enrolled on study but at least 21 days should elapse prior to date of B-WARM therapy
Prior therapy with crizotinib.
Prior CAR therapy or other genetically modified T cell therapy
Prior treatment with any therapy targeting mutant IDH1 (including BAY1436032)
Prior therapy with CD123- or IL-3R-directed immunotherapies, including monospecific and bsAbs, immunoconjugates, or chimeric antigen receptor- modified T-cell therapy