Prior therapy for metastatic disease permitted; at least 4 weeks must have elapsed since prior chemotherapy or biological therapy, 6 weeks if the regimen included carmustine (BCNU) or mitomycin C; radiotherapy must be completed at least 4 weeks prior to registration
Patients must be at least 2 weeks and within 12 weeks from documented progressive disease (PD) on Step 1 of current study; all sites of disease must be evaluated within 4 weeks prior to registration
Patient should be randomized in the trial ideally within a maximum of 8 weeks of completion of their last treatment (surgery, chemotherapy or radiotherapy), but in no case longer than 12 weeks
Patient has received any of the following treatments within the specified timeframes: a. Surgery, radiotherapy, chemotherapy (including molecular-targeted drugs): 4 weeks (28 days), b. Immunosuppressants or cytokine formulations (excluding G-CSF): 4 weeks (28 days), c. Endocrine therapy or immunotherapy (including biological response modifier therapy): 2 weeks (14 days)
Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, 4 weeks washout period. For patients receiving anticancer immunotherapies such as CTLA-4 antagonists, 6 weeks is indicated as the washout period.
Radio- or toxin-immunoconjugates within 10 weeks
Nitrosourea or mitomycin C within 6 weeks
Treatment with any of the following:\r\n* Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment\r\n* Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks or 5 half lives, whichever is shorter, of the first dose of study treatment, except fulvestrant, enzalutamide or hormonal therapy with LHRH analogues for medical castration in patients with breast or prostate cancer, which are permitted\r\n* Potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John's wort)\r\n* Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment\r\n* Radiotherapy with a wide field of radiation within 4 weeks of the first dose of study treatment\r\n* AKT inhibitors
Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment; for cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, 4 weeks is indicated as washout period; for patients receiving anticancer immunotherapies such as CTLA-4 antagonists, 3 weeks is indicated as the washout period
Carmustine (BCNU): 42 days/6 weeks
Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\r\n* 12 weeks from the completion of radiation\r\n* 6 weeks from a nitrosourea chemotherapy\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents \r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., erlotinib, hydroxychloroquine, etc.)
Any of the following therapies prior to registration:\r\n* Chemotherapy =< 3 weeks\r\n* Immunotherapy =< 3 weeks\r\n* Biologic therapy =< 3 weeks\r\n* Hormonal therapy =< 2 weeks\r\n* Monoclonal antibodies =< 3 weeks\r\n* Radiation therapy =< 2 weeks\r\n* CDK 4/6 inhibitors =< 4 weeks\r\n* mTOR inhibitors =< 4 weeks
Cytotoxic chemotherapy, surgery, immunotherapy, radiotherapy or other targeted therapies within 4 weeks (6 weeks in cases of ramucirumab, mitomycin C, nitrosourea, lomustine; 2 weeks in case of biopsy) prior to randomization (Adjuvant radiotherapy given to local area for non-curative symptom relief is allowed until 2 weeks before randomization.).
Minimum interval since last drug therapy:\r\n* 3 weeks since last non-cytotoxic therapy\r\n* 3 weeks must have elapsed since the completion of non-nitrosourea-containing chemotherapy regimen\r\n* 6 weeks since the completion of a nitrosourea-containing therapy regimen
Concurrent administration of any other anti-cancer therapy\r\n* Bisphosphonates and denosumab for bone metastases are allowed as long as these were started at least 4 weeks prior to treatment with study drug\r\n* Octreotide is allowed if dose is stable for > 3 months with no worsening of carcinoid syndrome\r\n* Hormonal therapy with luteinizing hormone-releasing hormone (LHRH) analogues for medical castration in patients with castrate-resistant prostate cancer is permitted\r\n* Most recent chemotherapy within 3 weeks prior to entering the study\r\n* Therapeutic radiotherapy within the previous 3 weeks if =< 5% of their total marrow volume or 4 weeks if > 5% of their total marrow volume, or unresolved acute or subacute toxicities from prior radiotherapy\r\n* Most recent experimental (non-FDA approved) anti-cancer therapy or immunotherapies =< 30 days or five half-lives of the drug (whichever is less)\r\n* Patients who have not recovered to =< Common Terminology Criteria for Adverse Events (CTCAE) grade 1 toxicities related to prior therapy (administered more than 3 weeks earlier) or incomplete recovery from previous surgery, unless agreed by the principal investigator (PI) and documented are not eligible to participate in this study with the exception of grade 2 peripheral neuropathy if it has been stable, and not worsening, for at least 28 days, and grade 2 alopecia
The following time periods must have elapsed prior to the planned start date of study treatment:\r\n* >= 2 weeks or 6 half-lives from any approved tyrosine kinase inhibitors (TKIs) or investigational agent, whichever is shorter\r\n* >= 4 weeks from prior cytotoxic therapy, except >= 3 weeks from last dose of temozolomide and >= 6 weeks from nitrosoureas or mitomycin C\r\n* >= 2 weeks from non-cytotoxic agents\r\n* >= 3 weeks from bevacizumab
Had systemic treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 3 weeks before study drug treatment; or treatment with nitrosoureas or mitomycin C within 6 weeks before study drug treatment; or treatment with small-molecule targeted agents within 2 weeks before study drug treatment. Previous and concurrent use of hormone replacement therapy, the use of gonadotropin releasing hormone modulators for prostate cancer, and the use of somatostatin analogs for neuroendocrine tumors are permitted if such therapy has not been changed within 8 weeks before study drug treatment.
Mitomycin C or a nitrosourea: 6 weeks
Time since the last prior therapy to treat underlying malignancy to start of drug:\r\n* Cytotoxic chemotherapy: greater than the duration of the most recent cycle of the previous regimen (with a minimum of two weeks for all)\r\n* Biologic therapy (e.g., antibodies): >= four weeks\r\n* >= 5 x t1/2 of a small molecule therapeutic, not otherwise defined above, with a minimum of 2 weeks (including aromatase inhibitors and tamoxifen)
Patients with HGG: Have received anticancer therapies including: radiation therapy to current site of disease within 12 weeks of dose assignment, targeted agent therapy within 2 weeks of dose assignment, nitrosoureas within 6 weeks of dose assignment, procarbazine within 3 weeks of dose assignment, or other cytotoxic agents within 4 weeks of dose assignment
Nitrosourea or mitomycin C within 6 weeks of the first dose
Small pox vaccination for 4 weeks before study therapy and during study treatment
Intravesical chemo- or biologic therapy within 6 weeks of first treatment
Biologic therapy (eg, antibodies), other than ADCs: ?4 weeks
Patients who are currently receiving systemic cytotoxic chemotherapy, radiation, targeted molecular therapy (e.g. vemurafenib, other inhibitor of mutant BRAF, MEK, or cKit), or other experimental therapy, or who have received this therapy within the preceding 4 weeks (except as specified). Gamma knife or stereotactic radiosurgery may be administered within the prior 4 weeks, but must not be administered less than one week prior to study registration. Patients who are currently receiving nitrosoureas or who have received this therapy within the preceding 6 weeks are excluded.
A minimum of 4 weeks from prior systemic anti-cancer therapies or 3 weeks for radiation treatment prior to enrollment is required
Minimum interval since last drug therapy:\r\n* 3 weeks since last non-cytotoxic therapy\r\n* 3 weeks must have elapsed since the completion of a non-nitrosourea-containing chemotherapy regimen\r\n* 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen
Treatment must begin at a minimum of 4 weeks after, but no later than 14 weeks after, the date of completion of radiotherapy.
Patients who have received antiandrogens such as flutamide, bicalutamide, or nilutamide for > 6 months immediately before enrollment on this study must be off treatment for 4 weeks (6 weeks for bicalutamide) and demonstrate a continued rise in PSA. Patients on antiandrogens for < 6 months must be off medication for 2 weeks.
Prior therapeutic intervention with any of the following:\r\n* Nitrosoureas or mitomycin C within 6 weeks\r\n* Therapeutic anticancer antibodies (including rituximab) within 4 weeks\r\n* Radio- or toxin-immunoconjugates within 10 weeks\r\n* All other chemotherapy, radiation therapy within 3 weeks prior to initiation of therapy
For cohort 4, patients must be at least 4 weeks from radiation therapy; additionally, patients must be at least 6 weeks from nitrosoureas, 4 weeks from temozolomide, 3 weeks from procarbazine, 2 weeks from vincristine and 4 weeks from last bevacizumab administration; patients must be at least 4 weeks from other cytotoxic therapies not listed above and 2 weeks for non-cytotoxic agents (e.g., interferon) including investigative agents
Wash-out requirements (standard or investigational):\r\n* At least 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen; and\r\n* At least 23 days must have passed since the completion of Temodar and/or 4 weeks for any other non-nitrosourea-containing cytotoxic chemotherapy regimen; if a participant’s most recent treatment was with a targeted agent only, and s/he has recovered from any toxicity of this targeted agent, then a waiting period of only 2 weeks is needed from the last dose and the start of CAR T cell infusion with the exception of bevacizumab where a wash out period of at least 4 weeks is required before starting CAR T cell therapy
Concurrent or recent chemotherapy, radiotherapy, or general anesthesia/major surgery within 3 weeks. Patients must have recovered from all known or expected toxicities from previous treatment and passed a treatment-free \washout\ period of 3 weeks before starting this program (8 weeks for persons receiving nitrosourea or mitomycin).
Patients must be off cancer-directed therapy for at least 3 weeks (2 weeks for oral agents) prior to day 1 of the study
At least 2 weeks (or 5 half-lives, whichever is longer) wash-out since the end of previously administered experimental therapy (6 weeks if previous nitrosourea containing regimen) or 2 weeks for standard-of-care regimens. Concurrent corticosteroids are allowed provided they are administered at an equivalent prednisone dose of ? 10 mg/day, as prediction or blood products only;
Previous cytotoxic therapies, including cytotoxic investigational agents, within 3 weeks (6 weeks nitrosoureas) prior to start of study treatment; previous corticosteroids used with intent to treat amyloidosis within three weeks; (prednisone up to but no more than 10 mg orally once a day [q.d.] or its equivalent for symptom management of comorbid conditions is permitted but dose should be stable for at least 7 days prior to study treatment)
Pegvisomant, within 24 weeks
Dopamine agonists, within 12 weeks
Pasireotide, within 24 weeks
Patients must discontinue antiandrogen therapy (i.e. bicalutamide, flutamide, nilutamide) at least 4-6 weeks prior to registration with no evidence of PSA decline after washout\r\n* Bicalutamide: Washout period at least 6 weeks\r\n* Flutamide and nilutamide: Washout period at least 4 weeks
Planning to relocate within the next 4-5 weeks
Life expectance of >= 12 weeks
131I therapy not allowed within 24 weeks before entry (4 weeks if negative post-treatment scan)
131I therapy within 24 weeks before entry (4 weeks if negative post-treatment scan)
Treatment must begin at a minimum of 4 weeks after, but no later than 14 weeks after, the date of the completion of radiotherapy
Prohibited treatments and or therapies\r\n* Autologous stem cell transplant (ASCT) =< 12 weeks prior to first dose of the study drug\r\n* Prior treatments (window prior to registration): \r\n** Chemotherapy =< 2 weeks\r\n** Nitrosureas =< 6 weeks\r\n** Therapeutic anticancer antibodies =< 4 weeks\r\n** Radio- or toxin immunoconjugates =< 10 weeks\r\n** Radiation therapy =< 3 weeks\r\n** Or major surgery =< 2 weeks\r\n* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways\r\n* Prior allogeneic stem cell transplant (SCT)\r\n* Chest radiation =< 24 weeks prior to registration
Concurrent or recent chemotherapy (within 3 weeks), XRT within 3 weeks, may have had immunotherapy in the past (off within 3 weeks), or general anesthesia/major surgery (within 3 weeks). Patients must have recovered from all known or expected toxicities from previous treatment and passed a treatment-free \washout\ period of 3 weeks before starting this program (8 weeks for persons receiving nitrosourea or mitomycin).
Patients must not be receiving concurrent anti-tumor treatment and must have recovered from toxicity of prior treatment. Minimum interval required: 1) > 6 weeks following nitrosourea chemotherapy; 2) > 4 weeks after recovering from any non-nitrosourea drug or systemic investigational agent; 3) > 2 weeks after receiving any non-cytotoxic anti-tumor drug; 4) > 4 weeks after receiving radiation therapy (> 12 weeks following upfront concurrent chemoradiation); 5) > 2 weeks following Optune device use.
For MM patients only:\r\n* Prior radiotherapy within 2 weeks prior to the administration of study drug\r\n* Surgery within 4 weeks\r\n* Chemotherapy (Chemo) within 3 weeks (6 weeks for melphalan, or monoclonal antibodies)
LYMPHODEPLETION: Treatment with any investigational drug within 14 days (ie, two weeks) prior to lymphodepletion or has received any tumor vaccines within the previous five weeks prior to lymphodepletion
Within 4 weeks since any plasmapheresis
At the time of registration, subject must be removed from prior therapy as follows:\r\n* >= 28 days from any investigational agent,\r\n* >= 4 weeks (28 days) from prior cytotoxic therapy,\r\n* >= 2 weeks (14 days) from vincristine,\r\n* >= 6 weeks (42 days) from nitrosoureas,\r\n* >= 3 weeks (21 days) from procarbazine administration,\r\n* >= 1 week (7 days) for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count)
Washout of 2 weeks is required for aromatase inhibitors; washout of 4 weeks is required for CDK 4/6 inhibitor, everolimus or other biological agent
Discontinuation of bicalutamide or nilutamide less than 6 weeks, and other antiandrogens less than 4 weeks, abiraterone less than 3 weeks, prior to the start of study medication.
Administration of any of the following within the specified timeframe prior to the first dose of study drug:\r\n* 4 weeks from TMZ\r\n* 6 weeks from a nitrosoureas\r\n* 3 weeks from a biologic or targeted agent (i.e. small molecule)\r\n* 4 weeks for a VEGF inhibitor (i.e. bevacizumab)
Patients must have the following minimum intervals from prior treatments:\r\n* Surgery – 4 weeks\r\n* Nitrosoureas – 6 weeks\r\n* Cytotoxic chemotherapy – standard intervals depending on the most recent regimen. i.e., for temozolomide 5 of 28, 23 days after most recent temozolomide; for temozolomide 21 of 28 days, 7 days after most recent dose; etoposide 14 of 21 days, 7 days after last dose; for drugs not listed, the research nurse, treating investigator, and principal investigator will determine the appropriate interval\r\n* Investigational therapy or non cytotoxic therapy – 2 weeks
More than 12 weeks from completion of chemoradiation, unless RANO criteria for early progression within 12 weeks of chemoradiation are met (See 18.1)
4 weeks from prior chemotherapy ( 6 weeks for mitomycin C and nitrosourea) , immunotherapy, investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
Phototherapy (PUVA): 4 weeks
Retinoids: 4 weeks
Interferons: 4 weeks
Low dose methotrexate: 4 weeks
2 weeks or more since end of previous systemic or radiation treatment (4 weeks or more for bevacizumab plus interferon-alfa)
Washout of 3 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas; 4 weeks for definitive radiotherapy, and 2 weeks for palliative radiotherapy; 3 months from high-dose chemotherapy and stem cell rescue; 3 weeks from major surgery. Participants must have recovered from the acute toxic effects of all prior anticancer therapy before enrollment into the study.
Patients with lymphoma must ideally have at least stable disease from last therapy, however if the PI or LAI believes there is a high likelihood of response to induction chemotherapy (etoposide, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride-fludarabine phosphate+/-rituximab [EPOCH-F+/-R]), then the patient may be enrolled on the induction phase arm; for enrollment on the research phase arm, the patient must have at least stable disease which is defined as:\r\n* Absence of disease progression for at least 8 weeks after previous therapy or 12 weeks after autologous transplantation\r\n* Patients who are less than 8 weeks from previous therapy or 12 weeks from autologous transplantation may participate in the study at the discretion of the PI or LAI as long as they do not have progressive disease
Must be at least 4 weeks post-operative
Wash-out requirements (standard or investigational):\r\n* At least 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen\r\n* At least 23 days since the completion of Temodar and/or 4 weeks for any other non-nitrosourea-containing cytotoxic chemotherapy regimen; if a patient’s most recent treatment was with a targeted agent only, and s/he has recovered from any toxicity of this targeted agent, then a waiting period of only 2 weeks is needed from the last dose and the start of study treatment, with the exception of bevacizumab where a wash out period of at least 4 weeks is required before starting study treatment
Any number of prior therapies is permitted; from the start of study treatment, the following time periods must have elapsed: 6 weeks from nitrosourea-containing chemotherapy, 4 weeks from non-nitrosourea-containing cytotoxic chemotherapy (except 23 days from last daily dose of temozolomide taken in a 5 of 28 day regimen), and 2 weeks from last dose of a targeted agent (except 4 weeks for bevacizumab); there is no time period requirement for prior radiation therapy
Minimum of six weeks is required following prior therapeutic doses of MIBG.
Patients must be ?4 weeks since major surgery, radiotherapy, chemotherapy (6 weeks if they were treated with nitrosureas) or biotherapy/targeted therapies.
Required wash out periods for prior therapy (for cohort B):\r\n* Topical therapy: 2 weeks \r\n* Chemotherapy: 4 weeks\r\n* Radiotherapy: 4 weeks\r\n* Other investigational therapy: 4 weeks\r\n* Rituximab: 12 weeks
Patients must be entered no more than 12 weeks post operatively
Have received radiotherapy, chemotherapy, biological therapy or investigational treatment less than four weeks (six weeks for nitrosourea or mitomycin C) prior to first dose of study medication or have not recovered from all acute toxicities from prior treatments.
Minimum interval since last investigational agent and/or prior cytotoxic drug therapy (patient must have also recovered from the toxic effects of any prior therapy):\r\n* 3 weeks since last non-cytotoxic therapy\r\n* 3 weeks must have elapsed since the completion of a non-nitrosourea-containing chemotherapy regimen\r\n* 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen
Patients on alemtuzumab within 6 weeks prior to consenting
Relapsed/refractory MCL: Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, major surgery within 4 weeks or vaccination with live attenuated vaccines within 4 weeks of the first dose of study drug
Radioimmunotherapy within 12 weeks
Specific KS therapy, including cytotoxic chemotherapy but not including HAART, within the past 4 weeks (6 weeks if the therapy was bevacizumab)
Patients must be at least 4 weeks from radiation therapy; additionally, patients must be at least 6 weeks from nitrosoureas, 4 weeks from temozolomide, 3 weeks from procarbazine, 2 weeks from vincristine and 4 weeks from last bevacizumab administration; patients must be at least 4 weeks from other cytotoxic therapies not listed above and 2 weeks for non-cytotoxic agents (e.g., interferon, tamoxifen) including investigative agents; all toxicities from prior therapies should be resolved to Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 (except for toxicities such as alopecia, or vitiligo)
History of tocilizumab therapy within prior 6 weeks
Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity and any prior immunotherapy approach, 4 weeks is indicated as washout period
Prior T-cell or other cell-based therapies within 12 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)
Patients must be entered no more than 12 weeks post operatively
Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to study treatment.
Intravenous treatment with anti-infective therapy that has been administered less than two weeks prior to first dose in this trial, or
Able to begin study therapy within 3 weeks (+/- 1 week) of final IV/IP chemotherapy
?4 weeks for monoclonal antibodies (?8 weeks for alemtuzumab),
?3 weeks for phototherapy
Patients who have had chemotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C), anticancer antibodies within 4 weeks, radio or toxin immunoconjugates within 2 weeks, radiation therapy within 3 weeks or major surgery within 2 weeks prior to entering the study\r\n* Palliative (limited-field) radiation therapy is permitted if the patient has additional measurable lesions to assess response of therapy
Use of systemic anti-cancer therapy ? 4 weeks, or six weeks if the systemic therapy contains a nitrosourea or mitomycin C.
Subjects must be >= 4 weeks beyond treatment with any chemotherapy or other investigational therapy to include hormonal, biological, or targeted agents (>= 8 weeks from previous bevacizumab treatment) at the time of first dose of study drug(s)
Prior therapeutic intervention with any of the following:\r\n* Therapeutic anticancer antibodies (rituximab, obinutuzumab) within 4 weeks\r\n* Radio- or toxin-immunoconjugates within 10 weeks\r\n* Inhibitors of PI3K (idelalisib), ibrutinib, BH3-mimetic venetoclax, lenalidomide, and other “targeted” therapy (including investigational BTK inhibitors and other investigational therapy) – within 6 half-lives\r\n* All other chemotherapy, radiation therapy within 3 weeks prior to initiation of therapy
Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, major surgery within 4 weeks or vaccination with live attenuated vaccines within 4 weeks of the first dose of study drug.
A minimum of two weeks of VMS diary recording prior to SGB
Part 1 patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\r\n* 12 weeks from the completion of radiation \r\n* 6 weeks from a nitrosourea chemotherapy or mitomycin C\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents \r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent, except bevacizumab/ vascular endothelial growth factor receptor (VEGFR) inhibitors (e.g., erlotinib, hydroxychloroquine, etc.)\r\n* 6 weeks from bevacizumab/VEGFR inhibitors
Any of the following therapies prior to pre-registration:\r\n* Chemotherapy =< 4 weeks\r\n* Immunotherapy =< 4 weeks\r\n* Biologic therapy =< 4 weeks; Note exception: prior viral and/or gene therapy are exclusion criteria\r\n* Radiotherapy =< 4 weeks
3 weeks from procarbazine
The subject has received systemic chemotherapy (including investigational agents) within 4 weeks, or biological agents (antibodies, immune modulators, cytokines, or vaccines) within 6 weeks, or hormonal anticancer therapy within 2 weeks before the first dose of study treatment (within 4 weeks in the case of fulvestrant) (vaccines, such as flu shot or, pneumovax are not exclusions)
Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\r\n* 12 weeks from the completion of radiation \r\n* 6 weeks from a nitrosourea chemotherapy\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents \r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., erlotinib, hydroxychloroquine, etc.)
Patients who have received oral or IV chemotherapy or targeted anticancer therapy =< 2 weeks (4 weeks for nitrosourea, antibodies or mitomycin-C) prior to study enrollment; steroids used for anti-cancer properties must be tapered to 10 mg or less of prednisone (or equivalent) for at least 2 weeks prior to initiating therapy
Therapy must begin between 21 days (3 weeks) and 42 days (6 weeks) after the most recent brain tumor surgery (resection or biopsy)
Patients must be at least 3 weeks from prior thoracotomy (if performed)
Patient has not recovered from any toxicity of prior therapies; an interval of \r\n* At least 6 weeks must have elapsed since taking a nitrosourea-containing chemotherapy regimen\r\n* At least 4 weeks since completing a non-nitrosourea-containing cytotoxic chemotherapy regimen (except temozolomide: only an interval of 23 days is required from the last does administered when patient has been recently treated with the standard temozolomide regimen of daily for 5 days, repeated every 28 days)\r\n* At least 2 weeks from taking the last dose of targeted agent\r\n* At least 4 weeks from the last dose of bevacizumab
Intravesical therapy within 8 weeks prior to beginning study treatment with the exception of:
Patients must be enrolled within 6 weeks of primary surgery or within 6 weeks after diagnosis of recurrent disease
Anticancer treatment within 4 weeks of study drug or 2 weeks if patient experienced disease progression on prior treatment
Cohort 3: Subjects with high-grade Ta or any grade T1 papillary disease (without CIS) whose disease is determined to be refractory or relapsed within 6 months of the last dose of adequate BCG treatment. For eligibility and cohort assignment, 6 months is defined as 30 weeks i.e., 26 weeks (6 months) plus an additional 4 weeks to accommodate scheduling variations and for diagnostic work-up and 11 months is defined as 50 weeks i.e., 48 weeks (11 months) plus an additional 2 weeks to accommodate scheduling variations and for diagnostic work-up. For subjects enrolling in Cohort 2: The investigator documents he/she would not treat the subject with additional BCG at the time of study entry.
Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of study treatment.
Peripheral edema requiring medical intervention within 2 weeks prior to study day 1.
Investigational therapy within 4 weeks prior to CMB305 dosing
Investigational therapy within 3 weeks prior to CMB305 dosing
Participant must have received ruxolitinib therapy for at least 24 weeks and be currently on a stable dose of >= 10 mg BID of ruxolitinib for >= 8 weeks prior to the 1st dose of navitoclax, ECOG of 0,1, or 2.
Investigational therapy within 3 weeks prior to LV305 dosing.
Wash out periods prior to Day 1 of Cycle 1: At least three weeks since the last chemotherapy (six weeks in some particular cases) and At least four weeks since the last radiotherapy (RT) > 30 Gy) and At least one week since the last hormonal therapy and At least two weeks since the last biological/investigational therapy
Investigational therapy within 4 weeks prior to G100 dosing
None of the following therapies are allowed prior to registration:\r\n* Chemotherapy =< 2 weeks\r\n* Immunotherapy =< 2 weeks\r\n* Biologic therapy =< 2 weeks\r\n* Hormonal therapy =< 2 weeks\r\n* Monoclonal antibodies =< 2 weeks\r\n* Radiation therapy =< 2 weeks\r\n* Anti-Her-2 or other “targeted” (e.g. mammalian target of rapamycin [mTOR]) therapy =< 2 weeks\r\n** NOTE : Any toxicities derived from these therapies must be =< grade 2 prior to starting study therapy
SUB-PROTOCOL AIM A: Any of the following treatments:\r\n* Chemotherapy within 4 weeks before treatment with nab-rapamycin\r\n* Hormonal therapy within 4 weeks before treatment with nab-rapamycin (with the exception of leuprolide, degarelix, or goserelin)\r\n* Immunotherapy within 4 weeks before treatment with nab-rapamycin\r\n* Radiotherapy within 4 weeks before treatment with nab-rapamycin \r\n* Treatment with nitrosoureas, mitomycin, or extensive radiotherapy within 6 weeks before treatment with nab-rapamycin\r\n* Immunosuppressive agents within 3 weeks before treatment with nab-rapamycin (except corticosteroids used as antiemetics)\r\n* Use of prior mTOR pathway inhibitor therapy
Prior treatment will be permitted including surgery (>= 4 weeks), cytotoxic chemotherapy (maximum of 2 prior regimens); radiation, interferon, targeted growth factors (>= 4 weeks); and prior treatment with octreotide, will be allowed
At least 4 weeks from surgical resection and 12 weeks from end of radiotherapy prior to enrollment in this study, unless relapse is confirmed by tumor biopsy or new lesion outside of radiation field, or if there are two MRIs confirming progressive disease that are 8 weeks apart.
No prior systemic therapy for CLL or SLL including chemotherapy or immunotherapy (e.g., monoclonal antibody-based therapy), radiation therapy, within 4 weeks of enrollment; no prior carmustine (BCNU) or mitomycin C within 6 weeks of enrollment; no radioimmunotherapy within a year of enrollment; no corticosteroids administered within 2 weeks prior to study entry, except for maintenance therapy (=< prednisone 20 mg daily or equivalent) for a non-malignant disease
Prohibited treatments and/or therapies\r\n* Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses); however, use of corticosteroids is allowed for the treatment of immune related adverse events (irAEs), or adrenal insufficiency\r\n* Any non-oncology vaccine therapy used for prevention of infectious diseases within 4 weeks prior to first dose of ipilimumab/nivolumab\r\n* Prior treatment with a CD137 agonist, ipilimumab or other CTLA4 inhibitor\r\n* Prior investigational agents within 2 weeks prior to first dose of ipilimumab/nivolumab\r\n* Prior therapy with any anti-cancer agents including chemotherapy, adjuvant chemotherapy, immunosuppressive agents, surgery or radiotherapy within 2 weeks prior to first dose of ipilimumab/nivolumab
Inactivated vaccines should precede the initiation of any study regimen and/or standard adjuvant therapy by at least 2 weeks, but preferably 4 weeks or longer
Was treated for at least 24 weeks with MK-3475 before discontinuing therapy
Has discontinued antiandrogens (bicalutamide, nilutamide) >6 weeks and enzalutamide >4 weeks prior to Day 1 of trial treatment
Patients must be > 4 weeks and < 12 weeks post-surgery at time of study registration
No chemotherapy, radiation, biologics or immunotherapy within 2 weeks prior to registration (6 weeks if last received carmustine [BCNU] or mitomycin C)
The patient must not have required a paracentesis within the preceding 4 weeks nor be projected to require a paracentesis within the next 8 weeks.
Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity and washout period is 6 weeks; prior immunotherapy - washout is 4 weeks
Patients must be >= 2 weeks (minimum) to 4 weeks (preferred) from prior myelosuppressive chemotherapy (primarily lenalidomide) to facilitate mobilization
Platelets ?100,000/?L (?150,000/?L, if within 12 weeks of prior nitrosourea treatment).
At the time of enrollment, patients must be ? 4 weeks since all of the following treatments (and recovered from the toxicity of prior treatment to <= Grade 1, exclusive of alopecia): major surgery; radiotherapy; chemotherapy (note: must be ? 6 weeks since therapy if treated with a nitrosourea, mitomycin, or monoclonal antibodies such as bevacizumab); immunotherapy; Biotherapy/targeted therapies.
Last dose of chemotherapy or experimental therapy more than 4 weeks (6 weeks in the case of nitrosourea) prior to enrollment date; 2 weeks if the last therapy was received as part of a “phase 0” or “exploratory investigational new drug (IND)” trial; last surgery more than 4 weeks prior to enrollment; core biopsies or fine need aspiration (FNA) will not require any waiting period
Patients must be at least 4 weeks from last radiation dose; patients must be at least 4 weeks from last chemotherapy, targeted therapy, or biologic therapy (exception allowed for a 2 week washout for patients who were on chemotherapy at less than a standard of care dose, as long as all other eligibility criteria are met); patients must be at least 4 weeks from last surgical procedure and recovered from all post-operative complications
Participants may not have had other anti-neoplastic therapies within the following timelines:\r\n* Radiation within 2 weeks\r\n* Cytotoxic chemotherapy or monoclonal antibodies within 2 weeks, if all treatment-related toxicities have resolved to =< grade 1 prior to starting study treatment\r\n* EGFR tyrosine kinase inhibitor within 2 weeks\r\n* Any other small molecule inhibitor within 2 weeks or 5 half-lives of the compound, whichever is shorter\r\n* Experimental treatment of any type within 30 days
At the time of registration, patient must be at least 2 weeks from prior vincristine, 3 weeks from prior procarbazine, and 4 weeks from other prior cytotoxic chemotherapy
Patients must be ? 4 weeks since major surgery, chemotherapy (6-weeks if they were treated with a nitrosourea or mitomycin) or biotherapy/target therapies and ? 2 weeks since radiotherapy.
Completion of preoperative systemic chemotherapy and HER2-directed treatment consisting of at least 6 cycles of chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy
Cohort 3: Patients with recurrent WHO grade 2 glioma may have received prior external beam radiotherapy and/or chemotherapy; patients with stable WHO grade 2 glioma must have had prior chemotherapy (at least one cycle of temozolomide or procarbazine, lomustine, and vincristine [PCV]-based chemotherapy); with regard to the prior therapy in Cohort 3, patients may have had treatment for no more than 2 prior relapses; relapse is defined as progression following initial therapy (i.e. radiation +/- chemo if that was used as initial therapy) or observation of stable disease; the intent therefore is that patients may have had 3 prior therapies (initial therapy 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 as 1 relapse\r\n* In Cohort 3 with recurrence, tumor recurrence is defined by the increase of maximum tumor diameter, based on the axial and/or coronal T2 or FLAIR MR images; increase of tumor size can be based on comparison with previous scans performed up to prior 3 years to allow assessment of slow-growth of the tumor\r\n* In Cohort 3, patients must have recovered from the toxic effects of prior therapy: 4 weeks from any investigational agent, 4 weeks from prior cytotoxic therapy and/or at least two weeks from vincristine, 4 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count); any questions related to the definition of non-cytotoxic agents should be directed to the Principal Investigator; with regard to previous RT, there must be at least 6 months from the completion of RT (or radiosurgery)
Interval >= 4 weeks and =< 8 weeks from the completion of radiochemotherapy
Brain metastases (except if all known lesions were previously treated with surgery or stereotactic radiosurgery and lesions, if still present, are confirmed stable for >= 12 weeks prior to randomisation or if no longer present are confirmed no evidence of disease for >= 12 weeks, and are asymptomatic with no corticosteroid requirements for >= 4 weeks prior to randomisation, and no enzyme inducing anticonvulsants for >= 4 weeks prior to randomisation
Patients in cohort 1 may not receive chemotherapy, monoclonal antibodies (other than RANK-ligand inhibitors being used for bone protection), HER2 targeted therapy such as lapatinib, or radiation therapy in the 3 weeks before the first injection, during the injection period or for at least 2 weeks after the last injection; in cohort 2, patients may not receive cytotoxic chemotherapy or radiation therapy in the 3 weeks before the first injection, during the injection period or for at least 2 weeks after the last injection; patients may have received prior radiation including for brain metastases
Prior sunitinib and everolimus will be permitted; a wash-out period of 2 weeks is required prior to first dose on this study
Nitrosurea: ? 6 weeks
Biologic therapy: ? 4 weeks
Patients must have the following minimum wash-out from previous treatments: a) >= 4 weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment with other anticancer investigational agents; b) > 2 weeks for oral methotrexate, retinoids or biological response modifiers therapy for any indication, or topical prescription or topical therapy; c) >= 12 weeks for any immunotherapy (e.g., monoclonal antibody); patients with rapidly progressive disease may be treated earlier than the required washout period; patients should have recovered from prior treatment-related toxicities
Time since the last dose of prior therapy to treat underlying malignancy:\r\n* Cytotoxic chemotherapy or endocrine therapy: >= the duration of the most recent cycle of the previous regimen (with a minimum of 3 weeks for all, except 6 weeks for nitrosourea, mitomycin-C)\r\n*Biologic therapy (e.g., antibodies): >= 4 weeks\r\n* >= 5 X half-life of a small molecule therapeutic\r\n* >= 4 weeks interval between whole brain radiation therapy and initiation of protocol-based therapy for ARM C or D patient with stable brain metastases\r\n* >= 2 weeks interval between stereotactic radiosurgery (SRS) or gamma knife (or equivalent) and initiation of protocol-based therapy for ARM C or D patient with stable brain metastases\r\n* Patients enrolled in ARM C may remain on trastuzumab without a washout period\r\n* Patients enrolled in ARM D may remain on lapatinib without a washout period
At least 4 weeks since the last dose of chemotherapy, immunotherapy, surgery, or radiation therapy (exception: patients may have received palliative low dose radiation therapy one week before treatment provided it is not given to the only targeted lesions); at least 6 weeks for therapy which is known to have delayed toxicity (nitrosoureas, mitomycin-C, and liposomal doxorubicin); at least 4 weeks (or 5 half-lives, whichever is shorter) since treatment with biologic/targeted therapies; at least 2 weeks since last hormonal therapy
Patients must begin temozolomide chemotherapy no sooner than 2 weeks and no later than 6 weeks from the diagnostic surgery; patients must begin bevacizumab no sooner than 4 weeks and no later than 6 weeks from the surgery
KS therapy other than HAART within 3 weeks
Cytotoxic chemotherapy =< 3 weeks, or biologic or novel targeted therapies =< 2 weeks, or corticosteroids =< 2 weeks, prior to registration; patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma
Patients must have recovered from the toxic effects of prior therapy to < grade 2 non hematological or grade 2 or lesser hematological toxicity per CTC ver 4 (except deep vein thrombosis): 4 weeks from prior cytotoxic therapy and/or at least two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, cis-retinoic acid, etc. (radiosensitizer does not count). Patients who receive anticancer agents for non-therapeutic purposes unrelated to this study
Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of study treatment.
Discontinuation of all cytotoxic chemotherapy and anti-CD20 antibody therapy for ? 4 weeks, alemtuzumab for ? 8 weeks, targeted therapy for ? 2 weeks, and investigational therapy for ? 3 weeks before enrollment (Phase 1b) or randomization (Phase 2). For individuals with relapsed CLL most recently treated with B-cell receptor (BCR) pathway inhibitors who, in the opinion of the investigator, will not tolerate waiting 3 weeks, a washout period of > 5 half-lives is allowed. If on a systemic corticosteroid, the dose must be stable for the previous 4 weeks.
Prior anti-tumor therapy including (all times measured prior to start of study drug): nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 2 weeks, investigational agents within 3 weeks, unless antibody this should be within 4 weeks
Patients must be >= 4 weeks from cytotoxic chemotherapy, except >= 6 weeks for mitomycin C or nitrosoureas, and >= 8 weeks from prior 7-hydroxystaurosporine (UCN01); >= 4 weeks from monoclonal antibody therapy (cetuximab, bevacizumab); >= 4 weeks from prior experimental therapy; >= 2 weeks from radiation or hormonal therapy; >= 2 weeks from sorafenib, sunitinib or temsirolimus treatment; patients with prostate cancer may continue ongoing luteinizing hormone-releasing hormone (LhRH) agonist therapy; patients with bone metastases or hypercalcemia who began intravenous bisphosphonate treatment prior to study entry may continue this treatment while on study
Biologic therapy (e.g., antibodies): ?4 weeks
Minimum of 12 weeks from the first dose of antiCTLA-4 and 6 weeks from the last dose
Monoclonal based therapies within 4 weeks and all other immunotherapy within 2 weeks prior to first dose of study treatment.
Systemic radiation therapy within 4 weeks, focal radiotherapy within 2 weeks and radiopharmaceuticals (strontium, samarium) within 8 weeks prior to first dose of study treatment.
Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of study treatment.
Prior chemotherapy within 3 weeks, nitrosoureas (carmustine) within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 3 weeks, or major surgery within 2 weeks of first dose of study drug
Prior local therapy within 2 weeks (for both phases I and II) or prior systemic therapy within 4 weeks of starting protocol treatment
Patients who receive other chemotherapy; patients must have been off previous therapy for >= 2 weeks and must have recovered from clinically significant toxicity (to grade 1 or less) of all previous therapy prior to enrollment (consent signing) with the following exceptions: steroids, hydroxyurea, oral mercaptopurine, methotrexate, vincristine (including prophylactic intrathecal medication), thioguanine, and tyrosine kinase inhibitors are permitted within 2 weeks of randomization as maintenance or to reduce the peripheral blood blast counts; during ibrutinib therapy, only steroids and hydroxyurea are permitted to reduce peripheral blood blast counts; patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier
Receiving any cancer therapy within 2 weeks of first dose (including surgery, and/or tumor embolization) Note: the following are allowed: Corticosteroids to control systemic or local symptoms, up to a dose of 10 mg prednisone or equivalent daily and stable for at least 7 days prior to enrollment. Subjects with prostate cancer may remain on GnRH agonists. Other hormonal therapies (e.g., bicalutamide, abiraterone and enzlutimide) for prostate cancer must be stopped 4 weeks prior to enrolment. Note: the following are NOT allowed: Chemotherapy regimens with delayed toxicity within the last 3 weeks. Nitrogen mustards, Melphalan, Monoclonal antibody or Nitrosourea within the last 6 weeks.
3 weeks from procarbazine
Patients must have recovered and healed from the effects of any prior surgery, must have received prior chemotherapy at least 2 weeks prior to dosing with adequate recovery of white blood cell (WBC) and platelet counts, and at least 12 weeks must have elapsed from the completion of radiotherapy, unless there are new lesions appearing on imaging within this 12 weeks frame
Completed prior chemotherapy a minimum of 4 weeks previously (6 weeks for BCNU and/or mitomycin C), 4 weeks for prior immune therapy, 6 weeks for antibodies to checkpoints CTLA4, PD1, PDL1, etc, and 2 weeks for targeted agents (i.e. inhibitors of MEK, BRAF, Akt, PI3K, mTORC1/2) or localized radiation therapy; all treatment related toxicity must have resolved to grade 2 or less or to a baseline level as well
Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\r\n* 12 weeks from the completion of radiation\r\n* 6 weeks from a nitrosourea chemotherapy\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents \r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., erlotinib, hydroxychloroquine, etc.)\r\n* 4 weeks from prior antiangiogenesis therapy (approved or investigational) (e.g., bevacizumab, aflibercept, ramucirumab, cediranib, cabozantinib, etc.)
Patients must have recovered from the toxic effects of prior therapy: 4 weeks from prior cytotoxic therapy and/or at least two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count). Any questions related to the definition of non-cytotoxic agents should be directed to the Study Chair.
Less than 4 weeks since prior treatment; or 2 weeks if patient experienced disease progression on the prior treatment
Schedule can accommodate both of the following: 2 doses of mirvetuximab soravtansine administered 3 weeks apart and surgery within 9 weeks of last dose of NAC
Oral treatment with antimicrobial therapy starting less than two weeks prior to first dose.
Has received treatment with focal radiotherapy within 2 weeks, or radiopharmaceuticals (e.g., strontium, samarium) within 8 weeks of receiving cyclophosphamide on Day -3
Subjects must have the following minimum wash-out and adverse event (AE) recovery period from previous treatments without treatment between documentation of relapse/progression and enrollment of specifically:\r\n* >= 2 weeks for local radiation therapy\r\n* >= 4 weeks for systemic cytotoxic anticancer agents, anticancer investigational agents that are not defined as immunotherapy, or for tumor-targeting monoclonal antibodies (mAbs) with the exception of alemtuzumab for which the washout is at least 8 weeks\r\n* >= 15 weeks for anti-cluster of differentiation (CD)137 or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)\r\n* >= 2 weeks from resolution (i.e., =< grade 1 or at baseline) from AEs due to procedures performed or therapeutic agents administered\r\n* >= 2 weeks for retinoids, interferons, vorinostat, romidepsin, denileukin diftitox, and therapeutic doses of oral corticosteroids (physiologic replacement doses of oral corticosteroids are allowed, topical corticosteroids are allowed)\r\n* >= 2 weeks for phototherapy\r\n* >= 1 week for topical therapy (including retinoid, nitrogen mustard, or imiquimod)
Able to initiate study treatment at least 2 weeks but no more than 4 weeks after completion of salvage therapy
Local-regional therapy within 4 weeks before Day 1
Following treatment-free period prior to enrollment to the study: i)Surgery: 4 weeks for major surgery (e.g., laparotomy and thoracotomy); 2 weeks for less extensive surgery (e.g., colostomy) ii)Radiation: 4 weeks (2 weeks for palliative irradiation to bone metastases [except for pelvic irradiation], and brain metastasis) iii) Chemotherapy (including systemic treatment with anticancer therapy and retinoid therapy): 3 weeks (6 weeks for nitrosourea antineoplastic agent and mitomycin C) iv) Antibody-based therapy: 4 weeks v) Small molecule targeted agents: If myelosuppression is not expected, 2 weeks or 5 half-lives, whichever is longer; otherwise, 3 weeks vi) Hormonal treatment: 3 weeks. Previous and concurrent use of hormone replacement therapy, the use of gonadotropin-releasing hormone modulators for prostate cancer, and the use of somatostatin analogs for neuroendocrine tumors are permitted if such therapy has not been changed within 8 weeks before study drug treatment. vii) Pleurodesis: 2 weeks
Interferon therapy < 4 weeks prior to study day 1.
within 3 weeks prior to the first dose of KTN3379, or
Adequate recovery from prior systemic or local melanoma therapy; no systemic anticancer therapy in the 4 weeks and no ipilimumab in the 6 weeks from planned vemurafenib administration; no radiation therapy in 2 weeks prior to date plan to initiate vemurafenib treatment and no surgery in 3 weeks prior to date of planned vemurafenib administration
Receipt of any biological therapy within 6 weeks of the first dose of GSK3052230
Systemic anticancer treatment (including biologic therapy/antibodies) within 2 weeks before first dose of study treatment (6 weeks for nitrosourea, mitomycin, and monoclonal antibodies).
Prior treatment with a Smoothened inhibitor Systemic anticancer treatment within 2 weeks before first dose of study treatment (6 weeks for nitrosourea, mitomycin, and monoclonal antibodies).
Radiation therapy within 3 weeks (if single fraction of radiotherapy within 2 weeks) of Day 1 visit, or radionuclide therapy within 8 weeks of Day 1
Recovery from effects of recent surgery, radiotherapy, or chemotherapy\r\n* At least 4 weeks out from their last dose of radiation therapy\r\n* At least 4 weeks post-operative (op) from any major surgical procedure\r\n* At least 3 weeks out from their last dose of chemotherapy and/or biologic/targeted therapy
Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\r\n* 12 weeks from the completion of radiation \r\n* 6 weeks from a nitrosourea chemotherapy\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents \r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., Tarceva, hydroxychloroquine, bevacizumab, etc.)
Have had their last administration of study treatment (siltuximab or placebo) less than 6 weeks (window of plus 2 weeks) prior to first dose
Treatment with anti CD 20 therapy within 4 weeks, or alemtuzumab within 8 weeks, or any cytotoxic antileukemia therapy within 2 weeks, Ibrutinib or Idelalisib within 1 week prior to the first administration of the trial drug.
4-12 weeks since completion of combined modality therapy
Last dose of chemotherapy or experimental therapy more than 4 weeks (6 weeks in the case of nitrosourea) prior to enrollment date; unless the last therapy consisted of an oral agent whose average half life is known to be less than 48 hours in which case only 2 weeks need to have elapsed; regardless of the therapy, any toxicity greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 from previous anti-cancer therapy must have been resolved
Biologic therapy (e.g., antibodies): ? 4 weeks.
cytotoxic therapy within the past 4 weeks (6 weeks for BCNU/CCNU)
Any prior chemotherapy therapy is allowed in this protocol; no more than 2 prior cytotoxic chemotherapy regimens are allowed for eligibility; non-myelotoxic therapies such as sunitinib and sorafenib or everolimus are not considered \cytotoxic chemotherapies\; patients must be >= 4 weeks from prior radiation or cytotoxic chemotherapy, except >= 6 weeks for mitomycin C and nitrosoureas; >= 2 weeks from hormonal therapy; >= 4 weeks from prior experimental therapy; >= 4 weeks from monoclonal antibody therapy (cetuximab, bevacizumab), >= 2 weeks from sorafenib, sunitinib or temsirolimus and >= 8 weeks from prior 7-hydroxystaurosporine (UCN01) treatment; patients with prostate cancer may continue ongoing luteinizing hormone-releasing hormone (LHRH) agonist therapy; patients with bone metastases or hypercalcemia who began intravenous bisphosphonate treatment prior to study entry may continue this treatment
Patients must have recovered from the toxic effects of prior therapy: 4 weeks from prior cytotoxic therapy and/or at least 2 weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count), 4 weeks for experimental biologic agents (epidermal growth factor receptor [EGFR] inhibitors, etc) and 7 weeks from Gliadel implantation
Patients must have recovered from the toxic effects of prior therapy:\r\n - 4 weeks from any investigational agent\r\n - 4 weeks from prior cytotoxic therapy (except 6 weeks from nitrosoureas, 3 weeks from procarbazine, 3 weeks from vincristine)\r\n - 3 weeks for non-cytotoxic or biologic agents e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, tarceva, etc; note a 3-week washout is required for prior treatment with bevacizumab
Intravesical chemo- or biologic therapy within 6 weeks of first treatment
Patients who received anti-cancer therapy prior to the first dose of WNT974 within the following time frames:\r\n* Biological therapy with a prolonged half-life (e.g., monoclonal antibodies) within 4 weeks\r\n* Cytotoxic agents associated with delayed hematologic recovery (e.g., nitrosourea or mitomycin-C) within 6 weeks\r\n* Other systemic anti-cancer agents within 3 weeks\r\n* Radiotherapy within 2 weeks
Systemic anticancer treatments (including chemotherapy and biologics) less than 3 weeks prior to T cell therapy; locally directed therapy (e.g. radiation) 2 weeks prior to cell infusion
Previous anti-cancer chemotherapy, immunotherapy or investigational agents < 4 weeks, or palliative radiation < 2 weeks prior to the first day of study treatment, or who have not recovered to grade 1 or better from related side effects of such therapy (except alopecia); patients who receive gamma knife radiosurgery for brain metastases are eligible if procedure was performed > 2 weeks before treatment is started, is clinically stable and has been on stable low dose corticosteroid treatment (e.g., dexamethasone 2 mg/day, prednisolone 12 mg/day for at least 14 days before start of study treatment are eligible); ongoing hormonal therapies (luteinizing hormone-releasing hormone [LHRH] antagonists, megestrol) are allowed
Histologically confirmed breast cancer for which chemotherapy with AC (doxorubicin plus cyclophosphamide) is being utilized in the neoadjuvant or adjuvant setting (AC may be administered every 2 or 3 weeks, and may be preceded by or followed by paclitaxel planned to be given at 80 mg/m^2 weekly or 175 mg/m^2 every 2-3 weeks, per standard treatment plan) OR metastatic prostate adenocarcinoma for which docetaxel will be administered (between 60 mg/m^2 to 75 mg/m^2 every 3 weeks)
Subjects must have the following minimum wash-out from previous treatments and without treatment between documentation of relapse/progression and enrollment:\r\n* >= 2 weeks for local radiation therapy\r\n* >= 8 weeks for low dose (12 Gy or less) total skin electron beam therapy (TSEBT)\r\n* >= 4 weeks for systemic cytotoxic anticancer agents, anticancer investigational agents that are not defined as immunotherapy, or for tumor-targeting monoclonal antibodies (mAbs) with the exception of alemtuzumab for which the washout is at least 16 weeks\r\n* >= 15 weeks for anti-CD137 or anti-CTLA-4 (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)\r\n* >= 2 weeks from resolution (i.e., < grade 1 or at baseline) from adverse event (AE)s due to procedures performed or therapeutic agents administered\r\n* >= 2 weeks for retinoids, interferons, vorinostat, romidepsin and denileukin diftitox\r\n* >= 4 weeks for doses of systemic corticosteroidsgreater than 10 mg/day of prednisone or equivalent; patients who are on physiologic doses of corticosteroids (prednisone equivalent 10 mg/day or less) may participate, however, they must be on a stable dose for at least 4 weeks before enrollment; patients who are on low or moderate potency topical corticosteroids may participate if they are on a stable dose for at least 4 weeks before enrollment; inhaled corticosteroids are acceptable; local injections of corticosteroids are acceptable; all corticosteroids will be reported as concomitant medications\r\n* >= 2 weeks for phototherapy\r\n* >= 1 week for topical therapy (including retinoid, nitrogen mustard, or imiquimod)
The presence of fatigue for at least 2 weeks
On AI therapy for at least 4 weeks
Patients who have had chemotherapy within three (3) weeks or radiation within four (4) weeks; patients may not receive additional chemotherapeutic agents while on this study
Patients should describe fatigue as being present for a minimum of 2 weeks
Patients who have been on opioid therapy for the last 4 weeks or more
Low-dose IL-2 therapy in the 4 weeks prior
Patients who do not have at least 10 weeks before receiving local control
Stable hormone status for 8 weeks prior to aspiration and willing to maintain same status while on study; this means no change in an oral or non-oral hormonal contraceptive within the past 8 weeks prior to RPFNA
At least 4 weeks since the last dose of chemotherapy, immunotherapy, surgery, or radiation therapy (exception: patients may have received palliative low dose radiation therapy one week before treatment provided it is not given to the only targeted lesions); at least 6 weeks for therapy which is known to have delayed toxicity (nitrosoureas, mitomycin-C, and liposomal doxorubicin); at least 4 weeks (or 5 half-lives, whichever is shorter) since treatment with biologic/targeted therapies; at least 2 weeks since last hormonal therapy
Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\r\n* 12 weeks from the completion of radiation \r\n* 6 weeks from a nitrosourea chemotherapy or mitomycin C\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents \r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent except bevacizumab/vascular endothelial growth factor receptor (VEGFR) inhibitors (e.g., erlotinib, hydroxychloroquine, etc.)\r\n* 6 weeks from bevacizumab/VEGFR inhibitors
Completed definitive local therapy and have scans, 10?12 weeks after completion of definitive local therapy confirming either Complete Response (CR), Partial Response (PR), or Stable Disease (SD). If salvage neck dissection or salvage laryngectomy is not performed, patients must initiate study treatment within 4 weeks of the screening scans and within 16 weeks after completion of the definitive local therapy. If salvage neck dissection or salvage laryngectomy is performed, patients must initiate study treatment within 4 weeks of screening scans and within 20 weeks after completion of definitive local therapy.
Cranio-spinal radiation ? 12 weeks NOTE: Subjects in Arm 2 (ie, with DIPG) must be ? 2 weeks and ? 10 weeks after standard focal radiotherapy (dose of 5400 to 5960 cGy and maximum dexamethasone of 1 mg/m2/day)
Prior radiation therapy or chemotherapy within 2 weeks prior to study radiotracer administration (washout is one half-life of the drug or 2 weeks, whichever is longest)
Use of tamoxifen, Faslodex, diethylstilbestrol (DES) or any other ER blocking agent < 6 weeks or chemotherapy < 3 weeks prior to imaging scan
Need to be able to undergo atorvastatin treatment for a minimum of 2 weeks but no more than a maximum of 4 weeks prior to surgical staging
Willing to be seen at baseline, 6 weeks, 12 weeks, and 16 weeks for the study time points
Wash-out periods: at least three weeks since the last anticancer therapy, including radiation therapy (RT) in more than 35% of the bone marrow; at least three weeks since the last biological/investigational therapy [excluding monoclonal antibodies (MAbs)]; at least four weeks since the last MAb-containing therapy; and at least six weeks since nitrosoureas and mitomycin C (systemic). In the case of hormonesensitive breast cancer progressing while on hormone therapy, the latter must be either stopped up to one week before or continued without changes during the trial.
No chemotherapy within 2 weeks of first dose of SGI-110 (minimum of 6 weeks for nitrosoureas and 8 weeks for bone marrow transplantation) with the exception of hydroxyurea which will be allowed during course 1 of treatment.