With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131
Cytotoxic therapy: at least 14 days since the completion of cytotoxic therapy with the exception of hydroxyurea, which is permitted up to 24 hours prior to the start of protocol therapy, or maintenance chemotherapy, or intrathecal chemotherapy (methotrexate strongly preferred) administered at the time of the required diagnostic lumbar puncture to establish baseline CNS status
Patients who have received treatment with any other cytotoxic chemotherapy prior to beginning protocol therapy (other than allowed in above criteria) are excluded
Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of ALCL or any cancer diagnosed previously are not eligible
ALL developing after a previous cancer treated with cytotoxic chemotherapy
Patients who have received any prior cytotoxic chemotherapy or biologics for sex cord-stromal tumors (SCSTs)
Subjects who have received any cytotoxic chemotherapy within the last 7 days prior to biopsy
Patients with AML must be unlikely to benefit from cytotoxic chemotherapy defined by any one of the following criteria:
At the time of registration: patients must have recovered from the toxic effects of prior therapy: >= 28 days from any investigational agent, >= 28 days from prior cytotoxic therapy, >= 14 days from vincristine, >= 42 days from nitrosoureas, >= 21 days from procarbazine administration, and >= 7 days 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
Must not have received cytotoxic chemotherapy within 14 days of entry on to this study
Cytotoxic chemotherapy -2 weeks
Patients must be willing to forego other cytotoxic and non-cytotoxic therapies against the tumor while being treated on this protocol
Patients who have received prior cytotoxic, non-cytotoxic or experimental drug therapies for brain tumor are excluded
Cytotoxic chemotherapy or immunotherapy within 3 weeks of study entry
Prior cytotoxic chemotherapy is allowed.
Any cytotoxic chemotherapy within 21 days prior to initiation of study drug.
Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment
Treatment with cytotoxic or targeted antineoplastics within 3 weeks of initiation of study treatment. For cytotoxic agents that have major delayed toxicity a washout period of one cycle is indicated (examples are nitrosoureas and mitomycin C which typically require a 6 week washout). Prior antibodies or immunotherapies require a 6 week washout.
>= 2 weeks off cytotoxic chemotherapy
Received any other investigational agent or systemic cytotoxic chemotherapy within the preceding 2 weeks
Chemotherapy: at least 2 weeks since prior cytotoxic chemotherapy
Patients must be willing to forego other cytotoxic and non-cytotoxic therapies against the tumor while being treated on this protocol
Patients who have received prior cytotoxic, non-cytotoxic or experimental drug therapies for brain tumor are excluded
In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 7 days for cytotoxic or non-cytotoxic (immunotherapy) agents.
Prior cytotoxic chemotherapy or biologic therapy for prostate cancer
Any cytotoxic chemotherapy or other anticancer drugs from previous treatment regimen or clinical study within 14 days of first dose of study drug
Treatment with cytotoxic chemotherapy within 3 months prior to enrollment
Previous or concurrent cytotoxic chemotherapy for prostate cancer
Patients may have received one additional non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition: non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) hormones, monoclonal antibodies, cytokines, and small molecule inhibitors of signal transduction
Has received cytotoxic chemotherapy for post-transplant relapse prior to study entry
Any prior myeloma-directed therapy including cytotoxic chemotherapy, biologic therapy, or radiotherapy within 2 weeks of enrollment
Prior therapy requirements:\r\n* Wt-GIST: previously untreated participants are eligible\r\n* PHEO/PGL with germline SDH subunit mutation: 131I-methyl-iodobenzylguanine (MIBG) in patients with MIBG avid tumors or cytotoxic chemotherapy (cyclophosphamide, vincristine, and dacarbazine [CVD] or temozolomide) is required prior to enrollment on this trial; however, patients who have refused cytotoxic chemotherapy or for whom treatment on this protocol prior to receiving cytotoxic chemotherapy is felt to be in the best interest for the patient by the local investigator will also be eligible\r\n* HLRCC-associated renal cell cancer: previously untreated participants are eligible
Subjects receiving cytotoxic chemotherapy
No previous cancer treatment with any cytotoxic agent for this malignancy
Be at least 28 days from last administration of cytotoxic chemotherapy or other investigational agent
Prior cytotoxic chemotherapy or radiotherapy for this lymphoma
Patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast cancer surgical procedure or administration of the last cycle of cytotoxic chemotherapy
PHASE 2 ONLY: Patient participants previously untreated for AML who are considered unfit for cytotoxic chemotherapy by virtue of performance status, comorbidities, advanced age and/or low likelihood of response based on disease characteristics, or who decline cytotoxic induction chemotherapy
Patients must have been previously treated, as defined by treatment with at least one prior cytotoxic chemotherapy regimen or agent; patients may have received any number of prior cytotoxic agents
Prior systemic chemotherapy or radiation therapy for urothelial carcinoma or cytotoxic chemotherapy for another malignancy within 1 year of study entry are ineligible
Patients must be >= 14 days from previous cytotoxic treatment
Cytotoxic chemotherapy within 21 days prior to enrollment
Chemotherapy: cytotoxic (At least 21 days since last dose of chemotherapy prior to first dose of tazemetostat)
Chemotherapy: non-cytotoxic (e.g., small molecule inhibitor) (At least 14 days since last dose of non-cytotoxic chemotherapy prior to first dose of tazemetostat)
At the time of registration, patient must be at least 4 weeks from other prior cytotoxic chemotherapy
May not have received cytotoxic chemotherapy, targeted therapies, biologic response modifiers, chemotherapy, and hormonal therapy within the last 3 weeks, or nitrosureas within the last 6 weeks prior to study treatment.
No intention to use cytotoxic chemotherapy within the next 6 months
Treatment with cytotoxic chemotherapy within previous 28 days, or failure to recover from adverse events (AEs) due to cytotoxic chemotherapy administered more than 28 days previous (however, ongoing neuropathy is permitted)
Previous or concurrent cytotoxic chemotherapy for prostate cancer
At the time of treatment on protocol patients must have recovered from the toxic effects of prior therapy: > 10 days from any noncytotoxic investigational agent, > 28 days from prior cytotoxic therapy or Avastin, > 14 days from vincristine, > 42 days from nitrosoureas, > 21 days from procarbazine administration, and > 7 days 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
Ongoing treatment with cytotoxic therapy
Patients with active cytotoxic chemotherapy or radiation therapy are excluded
Cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) within 3 weeks before the first dose of study treatment
Cohort A: patients who have received prior cytotoxic chemotherapy, such as anthracyclines and cytarabine not permitted; but prior treatment with demethylating agents (azacytidine or decitabine), lenalidomide etc ALLOWED
Patients must have recovered from the toxic effects of prior therapy and be at least 3 weeks from the last dose of standard cytotoxic chemotherapy or myelosuppressive biological therapy and at least 1 week from the last dose of non-myelosuppressive biologic therapy; any questions related to the definition of non-cytotoxic agents should be directed to the principal investigators; for those who have received radiation, 4 weeks must have elapsed before beginning vaccination
Patients must have recovered from the toxic effects of prior therapy: > 3 weeks for biologic therapies or non-cytotoxic therapies, > 4 weeks for cytotoxic therapies, and > 6 weeks for nitrosoureas; any questions related to the definition of non-cytotoxic agents should be directed to the study chair\r\n* NOTE: 13 cis-retinoic acid (Accutane) as biologic therapy has a washout period of 14 days
Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC; Note: sipulecel-T is permitted with a 2-week washout
Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy (prior taxane chemotherapy allowed).
Must not have received cytotoxic chemotherapy within 14 days of entry on to this study
Patients on Strata C and D must have recovered from the toxic effects of prior therapy to grade 1 or better; patients must be at least 3 weeks form the last dose of standard cytotoxic chemotherapy or myelosuppressive biological therapy, at least 1 week from the last dose of non-myelosuppressive biologic therapy and at least 6 months from placement of bis-chloroethylnitrosourea (BCNU) wafers; any questions related to the definition of non-cytotoxic agents should be directed to the principal investigator
Has had prior systemic cancer cytotoxic chemotherapy within the past four weeks at the time of the start of the lymphodepletion regimen
Prior treatment with cytotoxic chemotherapy for advanced NSCLC
1 week from non-cytotoxic agents
Patients must be willing to forego other cytotoxic and non-cytotoxic drug or radiation therapy against the tumor while enrolled in the study.
Have received more than 2 previous lines of cytotoxic chemotherapy (if receiving cisplatin, 5-FU or pemetrexed)
Last cytotoxic chemotherapy 28 or more days or biologic therapy treatment 14 or more days before study start (greater than or equal to 42 days if nitrosourea was administered)
Previous cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy directed against the brain tumor. Subjects who received Gliadel wafers will be excluded.
Nitrosourea cytotoxic drug ? 6 weeks
Not eligible for cytotoxic therapies
Any cytotoxic or biologic therapy less than 2 weeks prior to initiation of therapy.
Patients treated with prior chemotherapy, cytotoxic chemotherapy, radiation, biotherapy, or any investigational agent > 30 days prior to lymph node removal are eligible
4 weeks from prior cytotoxic therapy
Cytotoxic therapy: at least 14 days since the completion of cytotoxic therapy with the exception of hydroxyurea, low dose cytarabine, and intrathecal chemotherapy which is permitted up to 24 hours prior to the start of protocol therapy; for patients with aggressive disease that is in the peripheral blood and rising, this 14 day washout period may be omitted
At least 35 days following start of preceding leukemia induction cytotoxic chemotherapy
Prior cytotoxic chemotherapy or radiotherapy for this lymphoma
Chemotherapy: cytotoxic (At least 21 days since last dose of chemotherapy prior to first dose of tazemetostat)
Chemotherapy: non-cytotoxic (e.g., small molecule inhibitor) (At least 14 days since last dose of non-cytotoxic chemotherapy prior to first dose of tazemetostat)
Front-line treatment may include maintenance therapy following complete clinical or pathological response; however, maintenance cytotoxic chemotherapy must be discontinued for a minimum of 6 months prior to documentation of recurrent disease; patients receiving maintenance biological therapy or hormonal therapy are ELIGIBLE provided their recurrence is documented more than 6 months from primary cytotoxic chemotherapy completion (includes maintenance chemotherapy) AND a minimum 4 weeks has elapsed since their last infusion of biological therapy
Cytotoxic chemotherapy within 14 days before randomization
Cancer for which intraperitoneal cytotoxic chemotherapy is planned
Eligible for cytotoxic chemotherapy
Chemotherapy: cytotoxic At least 21 days
Chemotherapy: non-cytotoxic (e.g., small molecule inhibitor) At least 14 days
Prior cytotoxic chemotherapy;
No prior cytotoxic chemotherapy to treat their metastatic disease
Cytotoxic chemotherapy within 3 weeks of first trilaciclib (G1T28) dose
Cytotoxic chemotherapy; at least 21 days since last dose
Non-cytotoxic chemotherapy (e.g., small molecule inhibitor); at least 14 days since last dose
Any prior cytotoxic chemotherapy regimen, including antibody drug conjugates for RCC or cytotoxic chemotherapy within 3 weeks of study treatment for OCCC
Systemic cytotoxic chemotherapy, antineoplastic biologic therapy, or major surgery within 3 weeks of the first dose of study medication
Any cytotoxic chemotherapy,or other anticancer drugs for the treatment of advanced NSCLC from a previous treatment regimen within 14 days of the first dose of study treatment
Investigation or cytotoxic therapy within 28 days or nitrosoureas within 42 days of the first treatment with G-202
Systemic cytotoxic chemotherapy, antineoplastic biologic therapy, or major surgery within 21 days of the first dose of trial medication
Less than 7 days from the completion of any previous cytotoxic chemotherapy (with the exception of hydroxyurea)
Cytotoxic chemotherapy within the 28 days prior to randomization
Following prior treatments are not eligible:\r\n* Use of any investigational agent within 30 days preceding enrollment\r\n* Treatment with cytotoxic chemotherapy within previous 4 weeks\r\n* Failure to achieve =< grade 2 adverse events (AE) resolution from cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted)\r\n* Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Ra-223 dichloride) for the treatment of bony metastases
Patients who have received prior cytotoxic chemotherapy for castration-resistant prostate cancer unless enrolled in a previous chemotherapy cohort.
Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC.
No cytotoxic chemotherapy within 2 weeks of starting study treatment
Prior cytotoxic chemotherapy for the treatment of CRPC, including taxanes, mitoxantrone and estramustine
Treatment with cytotoxic chemotherapy for prostate cancer within the previous 4 weeks prior to randomization, or planned treatment with cytotoxic chemotherapy agents for prostate cancer during the treatment period or follow-up
Subject with rapidly progressing visceral disease who has not received and is thought to be able to tolerate cytotoxic chemotherapy. (However, subject who has previously received cytotoxic chemotherapy is permitted).
Prior cytotoxic chemotherapy or biologic therapy for the treatment of castration-resistant prostate cancer (CRPC)
Prior cytotoxic chemotherapy or biologic therapy for the treatment of castrate-resistant prostate cancer (CRPC)
At the time of registration; patients must have recovered from the toxic effects of prior therapy:\r\n* >= 28 days from any investigational agent\r\n* >= 28 days from prior cytotoxic therapy\r\n* >= 14 days from vincristine\r\n* >= 42 days from nitrosoureas\r\n* >= 21 days from procarbazine administration\r\n* > 21 days from bevacizumab administration and\r\n* >= 7 days 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 Academic principal investigator (PI)
Patients must be at least 21 days post cytotoxic chemotherapy prior to enrollment
At least 21 days from the completion of any previous cytotoxic chemotherapy or biological therapy at time of initiation of POL6326.
Having recovered from prior surgery, radiation, chemotherapy (cytotoxic and noncytotoxic) to toxicity grade =< 1 or returned to baseline; previous treatment with immunotherapies, cytotoxic drugs, or other targeted agents is permitted; if cytotoxic chemotherapy was previously received, the last dose must be >= 1 month before leukapheresis; for other agents, the last dose must be >= 14 days before leukapheresis
Prior use of cetuximab or another epidermal growth factor receptor (EGFR) inhibitor is allowable and if used as a single agent should not be considered as a cytotoxic chemotherapy (nor should other targeted therapies be considered as a prior line of cytotoxic chemotherapy)
Previous cytotoxic chemotherapy for advanced (metastatic) disease
Prior cytotoxic chemotherapy or biologic therapy for prostate cancer
Patient has received an investigational agent or cytotoxic chemotherapy (excluding hydroxyurea) within 2 weeks of study
Prior bevacizumab and any cytotoxic chemotherapy
More than 2 prior lines of cytotoxic chemotherapy
Cytotoxic chemotherapy: ? duration of the most recent cycle of the previous regimen (a minimum of 2 weeks for all)
Patients must have recovered from the toxic effects of prior therapy including but not limited to: \r\n* An interval of >= 4 weeks (28 days) from prior cytotoxic therapy except 6 weeks from nitrosoureas\r\n* An interval of >= 1 week (7 days) from any non-cytotoxic agents\r\n* An interval of >= 3 months from the completion of radiation therapy
No prior treatment with cytotoxic chemotherapy
No cytotoxic chemotherapy within 30 days prior to registration for protocol therapy.
Previous cytotoxic chemotherapy (e.g. alkylating chemotherapy, anthracyclines, and vinca alkaloids), radiation therapy, and any experimental therapy within the context of a clinical trial must have been discontinued at least 28 days prior to entry onto this study
Systemic cytotoxic therapy within 3 weeks of treatment
Prior cytotoxic or cyclosporin treatment for HLH.
Patients with prior cytotoxic chemotherapy are eligible to participate if they have been progression free for at least 12 months since the initiation of cytotoxic chemotherapy
Candidates for cytotoxic chemotherapy
14 days for non-cytotoxic cancer therapies and radiotherapy
Previous or concurrent cytotoxic chemotherapy for prostate cancer
A drug provided as maintenance therapy following cytotoxic chemotherapy will be considered to be part of that regimen.
Anyone with a second malignancy expected to require cytotoxic chemotherapy or immune modulating therapy within 3 months of enrollment
4 weeks from prior cytotoxic therapy
Any prior cytotoxic chemotherapy except Temozolomide
Patients must have had prior cytotoxic therapy for their disease; patients with diffuse large B-cell lymphoma must have been treated with at least 2 prior cytotoxic therapies
Patients must have received at least 1 line of cytotoxic chemotherapy
Patients may have had up to two prior cytotoxic chemotherapy regimens for their disease (immunological or targeted therapy e.g. vaccine, IL-2, B-RAF inhibitors, will not be considered prior cytotoxic chemotherapy). Patient should not have been treated with Docetaxel, Paclitaxel or other taxanes.
More than 1 prior cytotoxic chemotherapy regimen for advanced disease
Patient has had prior cytotoxic chemotherapy for the treatment of metastatic melanoma; however, patients who are randomized to the physician’s choice arm and treated with cytotoxic chemotherapy as part of this study will be allowed to cross over to receive their assigned molecularly guided therapy should disease progression occur and they meet the specific eligibility requirements of the molecularly guided agent
Positive cytotoxic crossmatch
Anyone with a second malignancy expected to require cytotoxic chemotherapy or immune modulating therapy within 3 months of enrollment
Patient has received more than one line of cytotoxic chemotherapy
Concurrent anti-cancer cytotoxic chemotherapy
Use of cytotoxic chemotherapy within 21 days of registration
Prior cytotoxic chemotherapy for metastatic prostate cancer
Prior cytotoxic chemotherapy or biologic therapy for CRPC
Prior treatment with more than one line of cytotoxic chemotherapy; prior treatment with one line of cytotoxic chemotherapy is permitted; prior treatment with targeted therapy (such as ipilimumab, anti-programmed cell death 1 [PD1] and BRAF inhibitor) is permitted
At least 21 days from last cytotoxic chemotherapy
Scheduled to start a new chemotherapy regimen (any line, combination cytotoxic chemotherapy with targeted agents are allowed)
Treatment with cytotoxic chemotherapy within 4 weeks prior to registration
Patient has received an investigational agent or cytotoxic chemotherapy (excluding hydroxyurea) within 7 days of study entry
Received cytotoxic chemotherapy within 21 days (or 42 days for nitrosureas or mitomycin C) prior to the first scheduled dose of MEDI7247.
Cytotoxic chemotherapy within 4 weeks.
28 days from administration of prior cytotoxic therapy with the following exceptions:
About to begin either oral or cytotoxic chemotherapy
1 month – 5 years following completion of cytotoxic chemotherapy treatment for any cancer, and are experiencing neuropathy
Planned cytotoxic chemotherapy during the WBRT only; patients may have had prior chemotherapy
Treatment with cytotoxic chemotherapy within the preceding four weeks
Patients who have not had any cytotoxic chemotherapy within 14 days of beginning the study
Currently on or expected to start cytotoxic chemotherapy within 1 week of study enrollment
Participants who have received cytotoxic chemotherapy within 1 year prior to screening breast MRI
Subjects must have received cytotoxic chemotherapy within 3 months of consent date (measured from the start date of chemotherapy).
Cytotoxic chemotherapy within 4 weeks prior to study enrollment
Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within defined values prior to start of study treatment
Previous treatment with brentuximab vedotin will be allowed if it was done 6 months prior to enrollment and was not refractory to or had progressive disease (PD) on brentuximab vedotin (BV)
Pregnancy or breast-feeding women; breastfeeding should be discontinued if the mother is treated with brentuximab vedotin
For patients with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin
Brentuximab vedotin naive OR had at least stable disease by Lugano Classification to prior brentuximab vedotin treatment
Refractory to prior brentuximab vedotin (i.e. progression while on treatment)
History of prior >= grade 3 hypersensitivity to either brentuximab vedotin or nivolumab
Brentuximab vedotin
Prior treatment with at least 2 lines of therapy for HL including brentuximab vedotin; in those patients who cannot receive brentuximab vedotin, treatment with 2 prior therapeutic regimens is sufficient
Prior treatment with brentuximab vedotin is allowed provided the patient did not progress on BV or within 30 days of last dose of BV; patients must be at least 3 months from the last dose of BV
Refractory to prior therapy with brentuximab vedotin (evidence of progression within 30 days of the last dose)
Previous exposure to brentuximab vedotin (BV)
Prior brentuximab vedotin is allowed in the dose-finding portion of the study (dose-finding cohort); in the expansion cohort, patients cannot be refractory to BV (defined as developing progressive disease while on treatment or progressed within 3 months of finished last dose of brentuximab vedotin)
Failed >= 2 prior systemic therapies\r\n* NOTE: For systemic anaplastic large cell lymphoma (ALCL) prior systemic therapy must also include progression on brentuximab vedotin
Known hypersensitivity to brentuximab vedotin components
Histologically confirmed CD30-positive (defined in this study as >= 1% expression) MF (including large cell transformation variant) or SS who have either:\r\n* Received prior systemic therapy (for whom commercial supply of brentuximab vedotin is available) OR\r\n* Not received prior systemic therapy (who will receive brentuximab vedotin free of charge)
Previous brentuximab treatment
Prior brentuximab vedotin is allowed provided that patients were not refractory (defined as developing progressive disease while on treatment or progressed within 3 months of finished last dose of brentuximab vedotin)
Patient has hypersensitivity to brentuximab vedotin
Refractory to prior brentuximab vedotin (defined as developing progressive disease while on treatment or progressed within 3 month of finished last dose of brentuximab vedotin)
Patients who have received prior histone deacetylase (HDAC) inhibitors, or brentuximab vedotin, may be permitted to enter the study unless they have received an HDAC inhibitor or brentuximab within the last 6 months
Eligible to receive standard brentuximab vedotin for relapsed Hodgkin lymphoma
Patients with prior receipt of brentuximab vedotin
Patients may have received prior brentuximab vedotin, but must not have received brentuximab vedotin within 6 months prior to registration, and must not have relapsed within 6 months of receiving previous brentuximab vedotin; patients may not have received prior nivolumab or PD1/PDL1 axis agents; patients in the nivolumab/brentuximab cohorts ONLY (D, E, F, Y) may have received prior ipilimumab
Patients must not have previously existing hypersensitivity to brentuximab vedotin or ipilimumab
RANDOMIZED PHASE II (ARMS K AND L): Patients may have received prior brentuximab vedotin, but must not have received brentuximab vedotin within 6 months prior to registration, and must not have relapsed within 6 months of receiving previous brentuximab vedotin; patients may not have received prior nivolumab or PD1/PDL1 axis agents; patients may not have received prior ipilimumab
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have previously existing hypersensitivity to brentuximab vedotin or ipilimumab
Relapsed or refractory CD30+ lymphoma that has either achieved < PR to brentuximab vedotin (minimum of 2 cycles), progressed while receiving brentuximab vedotin, or progressed within 6 months of the last dose of brentuximab vedotin
Resolution of all non-hematologic brentuximab vedotin-related adverse events (AEs) to < grade 2
Intolerance to brentuximab vedotin
Patients receiving chronic treatment with systemic steroids; however, patients can receive up to 10 days of steroid therapy prior to starting treatment with brentuximab vedotin (BV)+ doxorubicin, vinblastine, dacarbazine (AVD)
May have received either brentuximab vedotin or lenalidomide/immunomodulatory imide drugs (IMiD) without dose modification/delay due to toxicity\r\n* IMiDs defined as thalidomide analogues
If received prior brentuximab vedotin or lenalidomide, must be able to tolerate the dose level to which the participant will be enrolled to
Allergic reaction/hypersensitivity to lenalidomide or history of anaphylactic shock to brentuximab vedotin in the past
Previously untreated with either chemotherapy, radiation therapy or either brentuximab vedotin or nivolumab, or another check point inhibitor
Allergy to brentuximab vedotin and/or nivolumab
Prior treatment with brentuximab vedotin (BV)
Known allergy to bevacizumab or brentuximab vedotin or any of its excipients
Relapsed or refractory disease after standard therapy including brentuximab vedotin (Adcetris®).
Previously treated with brentuximab vedotin, immune-oncology agents, or received an allogeneic or autologous stem cell transplant
Classical Hodgkin lymphoma\r\n* Relapsed or refractory de novo classical Hodgkin lymphoma having failed standard first-line therapy; and\r\n* May have failed to achieve a response or progressed after treatment with brentuximab vedotin or may be brentuximab vedotin naïve but is ineligible or unable to receive brentuximab vedotin; and\r\n* May have failed to achieve a response to, progressed after, or is ineligible for autologous stem cell transplant (auto-SCT)
Subjects may be Brentuximab vedotin- naïve, or may have had prior Brentuximab vedotin treatment (cohort A, B & C - enrolment closed)
Prior treatment with brentuximab vedotin is allowed provided the patient did not progress on BV or within 30 days of last dose of BV; patients must be at least 3 months from the last dose of BV
Refractory to prior therapy with brentuximab vedotin (evidence of progression within 30 days of the last dose)
Male subject agrees to use an acceptable method for contraception during the entire study treatment period and through 6 months after the last dose of brentuximab vedotin
Previous primary progression or grade 3 toxicity on treatment with brentuximab vedotin
Participant may have failed to achieve a response or progressed after treatment with brentuximab vedotin or may be brentuximab vedotin naïve
If female of childbearing age, negative serum pregnancy test within 7 days prior to the first dose of brentuximab vedotin in this study
Prior treatment with brentuximab vedotin and bendamustine in combination; may have received prior therapy with brentuximab vedotin or bendamustine separately
Received either brentuximab vedotin or bendamustine within 3 months of receiving their first dose of protocol based therapy
If brentuximab vedotin or bendamustine was previously received, had disease progression during the first 3 cycles of either brentuximab vedotin or bendamustine
Known hypersensitivity to brentuximab vedotin, bendamustine, or mannitol
Prior to day 1 of brentuximab vedotin, please verify the patient does not meet the criteria below:\r\n* Symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
Previous receipt of brentuximab vedotin Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Previous treatment with brentuximab vedotin
Prior use of brentuximab vedotin
Must have had prior treatment with brentuximab vedotin or not a candidate for treatment with brentuximab vedotin
Prior administration of brentuximab vedotin
Previous treatment with brentuximab vedotin or bendamustine.
No prior brentuximab vedotin
Patient has hypersensitivity to brentuximab vedotin
Patient has received other investigational drugs within 14 days before treatment of treatment with brentuximab vedotin
In addition to the inclusion/exclusion criteria outlined, to be eligible for treatment with the higher 2.4 mg/kg dose of brentuximab vedotin in the new cohort of 20 additional patients, best response after 2 cycles of brentuximab vedotin administered at the 1.8 mg/kg dose, must be partial remission (PR) or stable disease (SD) as determined by radiographic imaging
Viral, bacterial, or fungal infection within two weeks prior to the first dose of brentuximab vedotin
Previous treatment with brentuximab vedotin.
Prior use of brentuximab vedotin for GVHD is not allowed; prior use of brentuximab vedotin for the treatment of malignancy is allowed
Patient must not have had prior exposure to brentuximab vedotin
Prior use of brentuximab vedotin for GVHD is not allowed; prior use of brentuximab vedotin for the treatment of malignancy, i.e. Hodgkin lymphoma, anaplastic large cell lymphoma, etc. is allowed
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.
Patients who have received prior anti-PD1 directed therapy (monoclonal antibody [mAb] or small molecule) are not eligible
Treatment with anti-myeloma monoclonal antibodies within 6 weeks prior first dose.
Treatment with a monoclonal antibody within 30 days prior to Cycle 1, Day 1
Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate within 4 weeks before first infusion
Prior treatment with a monoclonal antibody or chimeric antigen receptor T cell (CAR-T) infusion for the treatment of AML (CD33 or other target).
Immune therapy (including monoclonal antibody therapy) -6 weeks
At least 6 weeks must have elapsed since prior therapy that includes a monoclonal antibody prior to registration
Prior radiation therapy or chemotherapy within 2 weeks prior cycle 1, day 1, monoclonal antibody therapy within 4 weeks
Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before planned first dose of study drug
Monoclonal antibody or antibody-drug conjugate (ADC) therapy within 3 weeks prior to Day 1 of Cycle 1.
Prior treatment against NSCLC with an EGFR monoclonal antibody
?28 days for prior monoclonal antibody used for anticancer therapy with the exception of denosumab.
Prior treatment with a monoclonal antibody or chimeric antigen receptor T cell infusion for the treatment of AML
Any therapeutic antibody within 4 weeks of first dose of study drugs.
No monoclonal antibody within 3 months unless evidence of disease progression
Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents
Antibody therapy
Patients must not have had chemotherapy, major surgery, monoclonal antibody therapy or experimental therapy within the 21 days prior to the start of ibrutinib administration
Received a monoclonal antibody or immunoglobulin -based agent within 1 year of Screening, or has documented immunogenicity to a prior biologic.
Patients who have received any monoclonal antibody therapy within 4 weeks prior to entering the study
Patients who have received monoclonal anti-cancer antibody within 4 weeks of first dose of study drugs
Chemotherapy =< 21 days prior to first administration of study treatment and/or monoclonal antibody =< 4 weeks prior to first administration of study treatment
Received any prior monoclonal antibody (except an anti-CD20 antibody) within 90 days before the date of study start.
Prior chemotherapy, immunotherapy, radioactive, or biological cancer therapy (including monoclonal antibody [mAb]) within 28 days prior to registration
Prior use of any monoclonal antibody within 3 months of the start of Cycle 1
Subjects who have had treatments with anti-cancer agents including rituximab or obinutuzumab and/or other monoclonal antibody or radioimmunotherapy within 6 weeks before the starting IP treatment.
Participants who are receiving any other investigational agents or have received investigational therapy or any anti-cancer monoclonal antibody (mAB) within 4 weeks prior to the 1st dose of pembrolizumab
Use of other systemic anticancer treatments or agents within the past 2 weeks (4 weeks if the therapy was a monoclonal antibody)
Cytotoxic chemotherapy =< 21 days prior to first administration of study treatment and/or monoclonal antibody =< 4 weeks prior to first administration of study treatment and/or other renal cell carcinoma (RCC)-directed systemic therapy =< 2 weeks prior to first administration of study treatment
Patients who have had prior exposure to immune checkpoint inhibitors are not eligible; please contact principal investigator, William Gradishar at 312-695-4541 for specific questions on potential interactions\r\n* PD-1 monoclonal antibody: pembrolizumab, pidilizumab, MEDI-0680, anti-PD-1 fusion protein AMP-224 (AMP-224), anti-PD-1 checkpoint inhibitor PF-06801591 (PF-06801591), anti-PD-1 monoclonal antibody BGB-A317 (BGB-A317), anti-PD-1 monoclonal antibody PDR001 (PDR001), anti-PD-1 monoclonal antibody REGN2810 (REGN2810), anti-PD-1 monoclonal antibody SHR-1210 (SHR-1210)\r\n* PD-L1 monoclonal antibody: durvalumab, avelumab, anti-PD-L1 monoclonal antibody MDX-1105 (MDX-1105), atezolizumab, zirconium Zr 89-labeled anti-PD-L1 monoclonal antibody MPDL3280A (MPDL3280A)\r\n* CTLA4 monoclonal antibody: tremelimumab, abatacept\r\n* OX40: agonistic anti-OX40 monoclonal antibody MEDI6383 (MEDI6383), agonistic anti-OX40 monoclonal antibody MEDI6469 (MEDI6469), anti-OX40 monoclonal antibody MEDI0562 (MEDI0562), oxelumab, anti-OX40 antibody PF-04518600 (PF-04518600)
Any of the following within 3 weeks prior to initiating study treatment\r\n* Systemic biologic therapy\r\n* Monoclonal antibody\r\n* Chemotherapy\r\n* TSEB \r\n* Phototherapy\r\n* Other investigational therapy
Patients who have received a prior monoclonal antibody =< 28 days prior to study day -14 are not eligible
Major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 3 weeks prior to the first dose of the study drugs and/or monoclonal antibody =< 6 weeks prior to first administration of study treatment
Prior systemic use of any immunosuppressive chemotherapy (except low dose methotrexate) and/or monoclonal antibody treatment for CTCL
Known allergic reaction to a prior monoclonal antibody therapy or have any documented Anti-Drug Antibody (ADA) response
Prior therapy with monoclonal antibody (mAb) against CTLA-4
At least 7 days must have elapsed after the last of a biologic agent that is not a monoclonal antibody, to be enrolled on this study
Receipt of the following treatment prior to first dose of BGB-3111: corticosteroids given with anti-neoplastic intent within 7 days, chemotherapy or radiotherapy within 2 weeks, monoclonal antibody within 4 weeks.
Anticancer therapy, monoclonal antibody or major surgery within 4 weeks prior to the first dose of MEDI4736\r\n* Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
Patients must be at least 28 days post cytotoxic chemotherapy, and/or monoclonal antibody therapy (excluding bone-directed therapy), prior to enrollment
Use of other anticancer treatments or agents within the past 4 weeks (6 weeks if the therapy was a monoclonal antibody)
Prior monoclonal antibodies, antibody-drug conjugates, or radioimmunoconjugates within 4 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)
Received any antibody targeting T-cell check point or co-stimulation pathways within 4 weeks, received any other monoclonal antibody within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor) within 2 weeks prior to study treatment.
Prior treatment with a HER3 antibody
Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs.
Monoclonal antibody within 28 days prior to day 1 of protocol therapy
Any of the following:\r\n* Prior anti-cancer monoclonal antibody (mAb) =< 4 weeks prior to registration
Chemotherapy =< 21 days prior to first administration of study treatment and/or monoclonal antibody =< 6 weeks prior to first administration of study treatment
Previous monoclonal antibody (mAb) or other treatment specifically directed against CD19; history of serious allergy or reaction to any component of the MEDI-551 formulation that would prevent administration
Monoclonal antibody therapy administered within 30 days of the agent prior to apheresis
Other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies: 4 weeks (2 weeks with documented disease progression)
Use of any monoclonal based therapies within 2-4 weeks prior to the first dose of study treatment.
Monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks
At least 4 weeks from end of monoclonal antibody therapy
Prior monoclonal antibody treatment within 4 weeks before study Day 1
Any therapeutic antibody within 4 weeks of first dose of study drugs.
Monoclonal antibody (ies) At least 28 days
Prior use of any monoclonal antibody, radio-immuno-conjugate or antibody drug conjugate within 4 weeks before study start
Monoclonal antibody therapy within 4 weeks prior to the planned start of study treatment.
Chemotherapy =< 21 days prior to first administration of study treatment and/or monoclonal antibody =< 6 weeks prior to first administration of study treatment
Have received prior treatment with monoclonal antibodies within 6 weeks of first dose of Day 1;
Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks before Cycle 1, Day 1
Received prior monoclonal antibody (mAb) within 4 weeks prior to study.
Subjects who have previously received anti-GD2 monoclonal antibodies for biologic therapy or for tumor imaging are eligible unless they have had progressive disease while receiving prior anti-GD2 therapy; subjects who have received autologous marrow infusions or autologous stem cell infusions that were purged using monoclonal antibody linked to beads, but no other form of anti-GD2 monoclonal antibody, are eligible
Subject has received treatment with any monoclonal antibodies within 4 weeks prior to first dose of study therapy
Have received an antibody therapy within 3 weeks
Monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, chemotherapy, or other investigational anti-cancer agent within 4 weeks prior to study drug
History of severe infusion reactions to monoclonal antibody therapy
Use of investigational agents within 4 weeks prior to study enrollment (within 6 weeks if the treatment was with a long-acting agent such as a monoclonal antibody).
The participant has undergone major surgery or received anti-cancer monoclonal antibody therapy in the 30-days prior to study enrollment.
Has had a prior monoclonal antibody therapy within 2 weeks prior to study Day 1. (Prior anti-HER2 therapy is acceptable).
Patient has had a prior monoclonal antibody for treatment of MCC
Received an anti-CLL monoclonal antibody within 8 weeks prior to the first dose of study drug
A 3-week washout period is required from previous treatments (with the exception of a 12-week washout for antibody-directed or immunoglobulin-based immune therapy, or other monoclonal antibody therapies), unless it is not in the best interest of the patient in the opinion of the investigator. Individual cases should be discussed with the project clinician before enrollment.
Corticosteroid therapy within 3 weeks or immunosuppressive chemotherapy or any antibody-directed or immunoglobulin-based immune therapy (e.g., immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first dose of study drug
monoclonal antibody therapy must be completed at least 6 weeks prior to pre-infusion lymphodepletive chemotherapy
All previous cytotoxic chemotherapy, monoclonal antibody therapy, immune therapy should be washed out 3 weeks before apheresis and must be completed at least 3 weeks prior to pre-infusion lymphodepletive chemotherapy.
Subject has received a monoclonal antibody for anti-neoplastic intent within 8 weeks prior to the first dose of study drug.
Chemotherapy =< 21 days prior to first administration of study treatment and/or monoclonal antibody =< 3 weeks prior to first administration of study treatment
Previously received an EGFR-directed monoclonal antibody within the past 4 weeks.
In the absence of rapidly progressing disease and after discussion with the Principal Investigator (PI), the interval from prior treatment to time of IMGN901 administration will be at least 2 weeks or at least 5 half-lives for cytotoxic/noncytotoxic agents; for prior monoclonal antibody therapy the interval from prior monoclonal antibody treatment to time of IMGN901 administration will be at least 2 weeks; the use of chemotherapeutic or anti-leukemic agents other than hydroxyurea is not permitted during the study with the exception of intrathecal (IT) therapy for patients with controlled central nervous system (CNS) leukemia at the discretion of the PI; hydroxyurea is allowed prior to the initiation of IMGN901 and during the first 3 cycles, either prior to or concomitantly with IMGN901 administration initially to control leukocytosis
Subject has received a monoclonal antibody for anticancer intent within 8 weeks prior to the first dose of study drug.
Monoclonal antibody therapy < 30 days from study enrollment
Monoclonal antibody therapy less than 1 month
Monoclonal antibodies: at least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody
Treatment with chemotherapy or monoclonal antibody within 28 days prior to entering the study
Treatment with chemotherapy or monoclonal antibody during the time of participation in this trial
Prior treatment with any investigational drug, chemotherapy, or monoclonal antibody within the preceding 1 month
Less than four weeks since last monoclonal antibody-containing therapy
Known hypersensitivity to afatinib, monoclonal antibody
Patients who have not yet completed at least 28 days (30 days for prior monoclonal antibody therapy) since receiving other investigational drugs
Prior monoclonal antibody: participants having received prior in vivo monoclonal anti-GD2 antibodies for biologic therapy or for tumor imaging AND experienced a severe allergic reaction while receiving prior anti-GD2 therapy; (Note: participants who have received previous therapy with anti-GD2 monoclonal antibodies are eligible for this study, provided they did not experience a severe allergic reaction with the antibody)
Received the last administration of an anticancer monoclonal antibody, immunotherapy, hormonal therapy, or chemotherapy (except nitrosoureas and mitomycin-C) =< 28 days prior to study registration or who have not recovered from the side effects of such therapy
Systemic anticancer treatment (including investigational agents) less than 3 weeks before the first dose of study treatment (<=4 weeks for antibody-based therapy including unconjugated antibody, antibody-drug conjugate, and bi-specific T-cell engager agents; <=8 weeks for cell-based therapy or anti-tumor vaccine).
At least 14 days must have elapsed since the completion of therapy with a monoclonal antibody
Have received prior treatment with monoclonal antibodies within 6 weeks of first dose of Day 1;
EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Chemotherapy =< 21 days prior to first administration of study treatment and/or monoclonal antibody =< 6 weeks prior to first administration of study treatment
All previous cytotoxic chemotherapy, monoclonal antibody therapy, or immune therapy must be washed out 3 weeks before apheresis and must be completed at least 3 weeks prior to pre-infusion lymphodepletive chemotherapy.
Monoclonal antibody immunotherapies (eg, PD-1, CTLA-4): 6 weeks
History of infusion reactions to monoclonal antibody therapies
History of infusion reactions to panitumumab or other monoclonal antibody therapies
History of infusion reactions monoclonal antibody therapies
Prior chemotherapy, monoclonal antibody or immunotherapy (eg, tumor vaccine, cytokine, or growth factor given to control the cancer) must have been completed at least 4 weeks before study drug administration, and all AEs have either returned to baseline or resolved to Grade 0 or 1
Systemic anticancer treatment (including investigational agents) less than 3 weeks before the first dose of study treatment (<=4 weeks for antibody-based therapy including unconjugated antibody, antibody-drug conjugate, and bi-specific T-cell engager agent; <=8 weeks for cell-based therapy or anti-tumor vaccine).
Known intolerance to CD20 monoclonal antibody therapy
Systemic anticancer treatment including investigational agents or radiotherapy <2 weeks before the first dose of study treatment (<4 weeks for antibody-based therapy including unconjugated antibody, antibody-drug conjugate, and bi-specific T-cell engager agents; <=8 weeks for cell-based therapy or antitumor vaccine) or have not recovered from acute toxic effects from prior chemotherapy and radiotherapy.
Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior chemotherapy for a different cancer is allowable
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if completed more than two years prior to step 1 registration; prior androgen deprivation is allowed
Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable (except temozolomide)
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; however, at least 6-weeks recovery is necessary if the last regimen included nitrosourea or mitomycin
Prior systemic chemotherapy or radiation therapy for salivary gland malignancy; note that prior chemotherapy for a different cancer is allowable
Prior systemic chemotherapy for the current cervical cancer; note that prior chemotherapy for a different cancer is allowable
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; must be off treatment for at least 3 years; (applicable only to studies that incorporate systemic therapy)
Prior systemic chemotherapy is allowable
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable but cannot have any other primary cancer diagnosed or treated within the last 3 years other than cutaneous skin cancers; patient may have previous chemotherapy as treatment of this previous malignancy as long as the chemotherapy has completed more than 3 years ago
Prior systemic chemotherapy for the study cancer, if more than 4 cycles of induction chemotherapy or more than 6 months of targeted therapy; note that prior chemotherapy for a different cancer is allowable
Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable, except prior temozolomide. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted;
Prior systemic chemotherapy is allowable
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable
Prior systemic chemotherapy for the study cancer (including neoadjuvant chemotherapy); note that prior chemotherapy for a different cancer is allowable.
Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment is not permitted; prior chemotherapy for a different cancer is allowable if interval since last treatment cycle completion is > 3 years
Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior chemotherapy for a different cancer is allowable
Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a different cancer is permitted
Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment is not permitted. Prior chemotherapy for a different cancer is allowable if interval since last treatment cycle completion is > 3 years.
Prior systemic chemotherapy for the study cancer.
Prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Prior systemic anti-cancer therapy for pancreatic cancer; note that prior chemotherapy for a different cancer is allowable
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Prior treatment with chemotherapy or radiotherapy for lymphoma or chronic lymphocytic leukemia; note that prior chemotherapy for a different cancer is allowable
Prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a different cancer is allowable
Prior systemic chemotherapy or biological therapy (including erlotinib [erlotinib hydrochloride) or similar agents) for the study cancer; note that prior chemotherapy for a different cancer allowable
Allowable prior therapy:
Prior systemic chemotherapy for the current cancer (prior chemotherapy for a different cancer is allowed)
Patients entering on the study after pancreaticoduodenectomy, who have not already started chemotherapy must not have had prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a different cancer is allowable; for patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, patients must not have received adjuvant chemotherapy with agents other than gemcitabine, nab-paclitaxel, oxaliplatin, fluoropyrimidine, or irinotecan for the current pancreatic cancer; prior chemotherapy for a different cancer is allowable
Prior systemic chemotherapy or anti-EGF therapy for the study cancer; note: prior chemotherapy or anti-EGF therapy for a different cancer is allowable
Prior systemic chemotherapy for bladder cancer; prior chemotherapy for a different cancer is allowable
Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a different cancer is permitted
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.
Prior systemic chemotherapy for prostate cancer (note that prior chemotherapy for a different cancer is allowed)
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Prior systemic chemotherapy for the study cancer; NOTE: prior chemotherapy for a different cancer is allowable
Patient must not have had previous systemic chemotherapy for the study cancer; (Note: prior chemotherapy for a different cancer is allowable)
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Prior systemic chemotherapy for rectal cancer; prior chemotherapy for another malignancy is allowable as long as it has been > 2 years since completion of therapy for previous malignancy
Prior systemic chemotherapy for esophageal cancer; prior chemotherapy for another malignancy is allowable as long as it has been > 2 years since completion of therapy for previous malignancy
All previous treatments are acceptable as long as they did not contain bevacizumab, ramucirumab or PARP inhibitors
Has received treatment with any proscribed treatments within specified time frames prior to study drug administration
Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted
Prior history of receiving pazopanib treatments
Total carmustine (BCNU) dose of > 600 mg/m^2 with prior treatments including transplant conditioning regimen
More than two prior systemic treatments for MDS. Prior systemic therapies are those that have been received at standard doses for at least one full treatment cycle.
Any other cancer treatments within 2 weeks of planned study treatment
progressed during or within 3 months of completing adjuvant chemotherapy. Note: Generally, treatments that are separated by an event of progression are considered different regimens.
Pregnant or lactating as the treatments used in this study includes drugs that are FDA Pregnancy Category D.
At least 2 weeks post any treatments/therapies at the time of first dose.
All patients with verified diagnosis of LCH and MRI findings consistent with ND-CNSLCH irrespective of previous treatments (also those not registered to other Strata ofLCH-IV).
Previous liver-directed treatments including chemoembolization, radiosphere, hepatic arterial perfusion, or drug-eluting beads
Have discontinued previous treatments for cancer.
Condition requiring medication with potential photosensitizing effects (tetracyclines, quinolones, sulphonamides, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin, and amiodarone) if these treatments could not be stopped at least 10 days before and for 3 days after the VTP procedure or replaced by treatments without photosensitizing properties;
Any number of prior treatments allowed for patients under 65 years (y), over 65y must have at least one prior line of TKI treatment (excluding anaplastic patients).
Patients may have unlimited prior chemotherapy treatments
Additional prior systemic treatments not allowed
Discontinued all previous treatments for cancer ?4 weeks prior.
No restriction based on prior treatments but at least 4 weeks from prior immunotherapy, or prior investigational agents
Subject has history of severe infusion reactions related to prior biologics or antibody-based treatments
There is no limit to the number of prior treatments for this phase I trial
Has disease which is amenable to radical treatment with surgery or radiation or a combination of treatments
There is no upper limit on the number of prior treatments provided all inclusion/exclusion criteria are met
Patients with histologically confirmed peritoneal surface malignancies, including malignant peritoneal mesothelioma and peritoneal carcinomatosis (PC) from presumed appendiceal and colorectal primary tumors; most patients will have received extensive prior treatments, due to the recurrent nature of PC; prior therapies involve previous CRS, local and systemic chemotherapy, and their different numbers; none of these prior treatments disqualifies the patient from receiving the protocol-mandated experimental treatment
If sexually active, patients must agree to take contraceptive measures for the duration of the treatments
No restriction based on prior treatments
Has undergone ?3 previous regimens (depending on treatment arm) of cytoreductive therapies including, but not limited to, platinum-based compounds, taxanes, or 5-fluorouracil. for B7, no prior systemic treatments should have been received for RM SCCHN
Patients who have received prior EGFR treatments for lung cancer
Receiving other treatments for the condition (with exceptions and time limits)
Patients must have the following minimum wash-out from previous treatments:
Has received any treatments prohibited in this trial within specified time frames
Prior history of receiving pazopanib treatments
Recovered from acute toxicities of other treatments (? Grade 2). All other MDS treatments discontinued at least 4 weeks prior to treatment except epoetin alpha (Procrit) 2 weeks.
Subject is receiving prohibited medications or treatments that cannot be discontinued/replaced by an alternative therapy
After the T cell infusion, patients may not be on any other treatments for their cancer aside from those included in the treatment section of the protocol
Ongoing toxic manifestations of previous treatments.
Off all other treatments for MDS for at least 2 weeks prior to Screening.
Participants receiving the following medications or treatments within the 6 weeks (42 days) prior to consenting; these medication and treatments may not be re-started at any time throughout the study in order to be remain eligible:\r\n* Breast tumor resection surgery (reconstructive surgery permitted)\r\n* Chemotherapy\r\n* Radiation therapy\r\n* Allergy desensitization injections\r\n* Growth factors (Procrit, Aranesp, Neulasta)\r\n* Other agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents)\r\n* Any investigational medication
There is no limitation to prior treatments with local, regional, topical or systemic agents, except for prior systemic treatment with 5-fluorouracil or prodrugs thereof; prior topical treatment with 5-fluorouracil is permitted; patients who are on chronic daily doses of prednisone of greater than 10 mg are excluded; there is no restriction on timing of last treatments as long as patients have recovered from all expected toxicities and at least 21 days have passed since last administration
Patients are allowed to have up to 3 prior treatments
Prior anticancer treatments or therapies within the indicated time window prior to first dose of study treatment (ASTX660), as follows:
Patients with no more than 2 prior treatments with systemic anti-neoplastic therapy for CCA.
Have discontinued previous treatments for cancer;
Allowed prior treatments for localized prostate cancer (all treatments must have been completed >= 1 year prior to randomization) a) <= 3 years total of ADT; b) All other forms of prior therapies including radiation therapy, prostatectomy,lymph node dissection, and systemic therapies
Have ongoing clinically significant adverse event(s) due to prior treatments administered as determined by the investigator.
At least four weeks must have elapsed between the last dose of any MF- directed drug treatments for myelofibrosis (including investigational therapies) and study enrollment;
Patients previously treated with herbal supplements, or other potential or experimental therapies for prostate cancer (apart from LHRH agonists and antiandrogens), must have been discontinued these treatments and completed at least a one-month washout prior to first vaccination
No restriction based on prior treatments
No restriction based on prior treatments
Receipt of > 600 mg/m^2 total dose of carmustine (BCNU) with prior treatments including transplant conditioning regimen
Patients may not be on any other treatments for their cancer aside from those included in the protocol. Patients may not undergo another form of treatment concurrently with this study. Oncology supportive treatments such as growth factors, bone modifying agents, pain or nausea management are allowed.
Prior systemic cytotoxic chemotherapies and/or novel immunotherapy treatments for MCC are allowed. A wash-out period of 2 weeks prior to aNK treatment will be required.
The participant may have had any number of prior systemic cytotoxic therapies for advanced/metastatic disease and are considered appropriate candidates for anthracycline therapy. All previous anticancer treatments must be completed ? 3 weeks (21 days) prior to first dose of study drug.
Patients that have received systemic treatments within four weeks prior to the beginning of treatment
May have received one or more prior treatments with chemotherapy
No more than 3 previous treatments for cGVHD.
Ongoing toxic manifestations of previous treatments.
No more than 3 previous treatments for cGVHD, excluding topical agents.
For phase Ib, any line of prior treatments is permitted including prior neratinib and capecitabine
For phase II, up to 4 prior chemotherapy-based treatments are allowed; patients must have had prior trastuzumab-based therapy; prior neratinib treatment is not permitted; prior capecitabine is allowed, if not combined with neratinib
Prior therapy: there is no limit on the number of prior surgeries, radiation therapy treatments, radiosurgery treatments, or chemotherapy
Phase I patients: Histologic documentation of a solid malignancy and who have exhausted available standard medical treatments or for whom no standard treatments are currently available; this includes primary brain tumors
No prior treatment with bortezomib for cGVHD; participants may have received bortezomib for other reasons besides cGVHD (such as leukemia or solid tumor); any other previous treatments for cGVHD are allowed
Discontinued all prior cancer treatments for cancer & recovered from the acute effects of therapy
Phase Ib: Patients may have had any number of prior treatments, including 0, or prior pazopanib
Patients previously treated with herbal supplements, or other potential or experimental therapies for prostate cancer must have discontinued these treatments and completed at least a one-month washout prior to beginning treatment
Any of the following treatments, within the specified time frame, prior to the first dose of TAS4464:
Inadequate washout of prohibited hormonally active agents or other prior treatments for prostate cancer (PCa)
At least 3 weeks post any treatments/therapies at the time of first dose.
Direct bilirubin =< 1.5 mg/dl; Note: as many eligible patients will be pancytopenic secondary to their disease or prior treatments, hematologic abnormalities will not be used as a criteria for entry or exclusion
Patient has received any of the following treatments within the specified timeframe prior to dosing:
Patient has received any of the following treatments within the specified timeframe:
Prior Treatments:
Systemic treatments: Must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued:
Treatments in this category include chemotherapy and targeted therapies not targeting VEGF; 14 days must have elapsed since discontinuation of prior chemotherapeutic treatments for glioma and study treatment
No prior use of EGFR tyrosine kinase inhibitors or monoclonal antibodies; all other prior treatments are allowed if >= 4 weeks since treatment completed, including chemotherapy (systemic or intraperitoneal), radiation therapy, and/or surgery; there is no limit on the number of previous treatments allowed
Recovered or stabilized from prior treatments.
Active severe personality disorders (defined according to DSM-IV). Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug.
Underwent resection, radiofrequency ablation, radiation or chemoembolization within 4 weeks before enrollment or not recovered from such treatments.
The participant has received 0 - 2 systemic anticancer regimens in addition to depot octreotide, which may have included chemotherapy, interferon, antiangiogenic therapy, other targeted treatments, or a combination of such treatments
Patients with lymphomas that are felt to be incurable with any therapy and for whom there are no standard treatments that would be anticipated to be necessary or beneficial within the next 5 months; these patients can have received any amount of prior chemotherapy to enter this trial
Subjects who have had treatments with GnRH agonists/antagonists and/or anti-androgens within 1 year of randomization
Prior chemotherapies are permitted, except with prior treatments with taxanes, vinca alcaloids, gemcitabine, eribulin, ixabepilone, platinum drugs
Previous or ongoing physical therapy treatments are acceptable
PATIENTS: Completed more than half of prescribed chemotherapy treatments
Be receiving hospital-based treatment so that acupressure treatments and parents can be trained and monitored
BCS will not be excluded based on cancer treatments received or a history of diagnosis of mild depression, anxiety, and hypertension and diabetes
colon cancer: 2-4 prior treatments
Individuals with previous radiation treatments to the breast or axilla areas
Are willing to refrain from using other treatments for oral mucositis until they consult with the study investigator(s).
Prohibited treatments and/or therapies:\r\n* Prior history of breast cancer surgery and/or radiotherapy
COHORT I: Initially treated with definitive local therapy (surgery and radiation therapy are the most common treatments, but other treatments are also eligible)
Prior use of radiosensitizers, Gliadel wafers, or other interstitial intracranial treatments
Has received treatment with any prescribed treatments within specified time frames prior to study drug administration
Advanced low or intermediate grade gastroenteropancreatic or lung or thymus neuroendocrine tumor (NET), or NET of unknown primary, progressed after at least 1 line of anticancer therapy (unless no standard treatments available or such treatments are deemed not appropriate)
Advanced paraganglioma, pheochromocytoma, medullary thyroid carcinoma, Merkel cell carcinoma, or high grade extrapulmonary neuroendocrine carcinoma having progressed after 1 or more lines of anticancer chemotherapy (unless no standard treatments available or such treatments are deemed not appropriate)
Be receiving any active pharmaceutical treatments for cancer
Patients may receive no other concurrent anticancer treatments such as chemotherapy, hormone therapy (except for prostate cancer patients on luteinizing hormone-releasing hormone ((LHRH)) agonists), immunotherapy, biological agents, investigational agents, or radiation therapy during this trial, and should be off these treatments for at least 2 weeks, or until they have completely recovered from the side effects of these treatments, whichever is longest, except for persistent grade 1 neuropathy in patients who received prior platinum or taxanes.
Patients must not be participating or plan to participate in other clinical trials that involve investigational systemic cancer treatments or investigational uses of CSF during their first 6 months after registration
Use of topical or systemic agents/treatments for OM within 2 weeks of treatment day 1.
Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time
Previous therapy with at least radiotherapy and temozolomide
Prior gamma knife, stereotactic radiosurgery, or other focal high-dose radiotherapy is allowed but the subject must have either histopathologic confirmation of recurrent tumor, or new enhancement on MRI outside of the radiotherapy treatment field
Radiotherapy may be given before or after protocol treatment per standard of care guidelines; when radiotherapy is planned prior to protocol treatment administration, patients may be registered and screened while receiving radiation\r\n* Post-mastectomy radiotherapy is required for all patients with the following:\r\n** Primary tumor >= 5 cm (prior to neoadjuvant chemotherapy [clinically] or at the time of definitive surgery) or involvement of lymph nodes at the time of definitive surgery\r\n** For patients with primary tumors < 5 cm or without lymph node involvement prior to neoadjuvant chemotherapy and at the time of definitive surgery, provision of post-mastectomy radiotherapy is at the discretion of the treating physician\r\n** Radiation of regional nodal basins is at the discretion of the treating radiation oncologist\r\n* NOTE: Breast radiotherapy (whole breast or partial) is required for patients who underwent breast-conserving therapy, including lumpectomy or partial mastectomy
No prior mediastinal or thoracic radiotherapy
No prior radiotherapy or chemotherapy, with the exception of dexamethasone, which is allowed
Patients must have no previous radiotherapy or chemotherapy other than corticosteroids
Prior radiotherapy for patients with brain metastases prior to enrollment is acceptable.
Patients who received breast/axilla/post-mastectomy chest wall radiotherapy must be after last dose of radiotherapy and must have sufficient resolution of side effects.
Subject has failed or intolerant to radiotherapy.
Patients may have received prior radiotherapy
Patients who have had any prior radiotherapy to the treatment site(s)
Prior cranial or spinal radiotherapy
Has cSCC that is amenable to surgical resection, local control with radiotherapy, or local control with a combination of surgery and radiotherapy, or chemoradiotherapy.
Patients for whom surgery would be deemed appropriate rather than radiotherapy
Radiotherapy within 14 days before enrollment
Radiotherapy within one week prior to starting study treatment.
Radiotherapy within 28 days prior to baseline.
Prior radiotherapy to the target area.
Patients who have received prior radiotherapy to all areas of current active disease are ineligible
Radiotherapy administered less than 21 days prior to the first dose of the IMP, or localized palliative radiotherapy administered less than 7 days prior to the first dose of the IMP, or radiotherapy-induced toxicity of Grade 2 or greater based on NCI-CTCAE v 4.03.
Have not been treated with chemotherapy, biological therapy or breast radiotherapy
Prior radiation to the primary and/or regional radiotherapy for melanoma and/or NSCLC is acceptable
Prior thoracic radiotherapy
Radiotherapy within 14 days before enrollment; if the involved field covered =< 5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy
Prior radiotherapy to the upper abdomen
Patients must be registered on study no earlier than 7 days and no later than 56 days prior to Step 1 registration after completing chemotherapy, Note:\r\n* Post-chemotherapy restaging imaging must be completed no earlier than 56 days prior to Step 1 registration\r\n• For patients with limited-stage small cell lung cancer who receive thoracic radiotherapy concomitant with chemotherapy, patients must be registered on study no earlier than 7 days and no later than 56 days prior to Step 1 registration after completing thoracic radiotherapy\r\n• For patients with extensive-stage small cell lung cancer who are being considered for consolidative thoracic radiotherapy after chemotherapy, concomitant administration of consolidative thoracic radiotherapy and protocol-specified prophylactic cranial irradiation with or without hippocampal avoidance is permitted; if consolidative thoracic radiotherapy is performed prior to study registration, then patients must be registered on study no earlier than 7 days and no later than 56 days prior to Step 1 registration after completing thoracic radiotherapy
Radiotherapy or chemotherapy within the 14 days prior to the first dose of BGB324 being administered (other than hydroxyurea)
INCLUSION CRITERIA FOR STRATUM C: Patients must have received prior radiotherapy and/or chemotherapy with the following exceptions:\r\n* Patients with secondary CNS cancers after a previous medical problem/malignancy who cannot receive full dose of radiotherapy (> 50 Gy) as long as they meet all other eligibility criteria\r\n* Patients with progressive low-grade gliomas and CMMRD or Lynch syndrome\r\nPatients must have recovered from the acute treatment related toxicities (defined as =< grade 1 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study; there is no upper limit to the number of prior therapies that is allowed
Radiotherapy within 14 days before enrollment; radiotherapy is excluded during induction and consolidation 1 while receiving MLN 9708
Radiotherapy =< 14 days prior to enrollment; patients must have recovered from all radiotherapy-related toxicities
Prior radiotherapy to thoracic area.
Patients with a history metastatic melanoma involving the brain will be excluded if they have active disease or have had active disease within the prior six months that was not controlled with surgery or radiotherapy
Prior whole brain radiotherapy.
The metastases have been treated by surgery and/or radiotherapy.
Requires prohibited treatment (i.e., non-protocol specified anticancer pharmacotherapy, surgery or conventional radiotherapy for treatment of malignant tumor). Limited field single dose radiotherapy for pain palliation would be allowed.
Prior radiotherapy =< 14 days
Subject must refuse or not be eligible for radiotherapy.
Any prior radiotherapy to the lung
Any prior radiotherapy to the neck
Prior mediastinal radiotherapy
Has received prior approved radiotherapy within 14 days of study therapy.
Prior treatment: chemotherapy or radiotherapy or surgery
Interval of at least 8 weeks from the completion of radiotherapy; if patients are within 8 weeks of radiotherapy, they may still be eligible if they meet one or more of the following criteria\r\n* Progressive tumor is outside the original high-dose radiotherapy target volume as determined by the treating investigator, or\r\n* Histologic confirmation of tumor through biopsy or resection, or\r\n* Nuclear medicine imaging, magnetic resonance (MR) spectroscopy, or MR perfusion imaging consistent with true progressive disease, rather than pseudoprogression or radiation necrosis obtained within 28 days of registration
Patient must be selected for standard temozolomide chemotherapy to be administered with radiotherapy
Has received chemotherapy or radiotherapy within 14 days of first dose of study medication
More than one prior course of radiotherapy or prior prescription doses exceeding 60 Gy to target volumes
Patients who require immediate surgical or radiotherapy interventions
Patients must not have had chemotherapy =< 28 days or radiotherapy =< 7 days prior to study treatment
No prior breast or thoracic radiotherapy
Subjects must not have prior breast or thoracic radiotherapy
Previous chest radiotherapy
No prior chemotherapy or radiotherapy for NSCLC
Residual areas of limited disease should be considered for radiotherapy after and not prior to transplantation
Patients who have had previous radiotherapy in the thorax
Patients who have had chemotherapy or radiotherapy within 21 days of enrollment
Patient who has had any prior radiotherapy to the treatment site(s)
Prior radiation that precludes delivery of hypofractionated radiotherapy
Prior peptide-receptor radiotherapy (PRRT)
Prior radiotherapy to the mediastinal/pericardial region
Salvage therapy that includes involved field radiotherapy
History of receiving chemotherapy or radiotherapy
Completion of any prior radiotherapy (Cohort C)
Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time
Radiotherapy =< 14 days prior to registration
Must have previously untreated lymphoma; a short (< 2 week) course of steroids for symptom palliation is permitted; prior involved field radiotherapy for symptom palliation is permitted as long as there is measurable disease outside the radiation port; if radiotherapy has been given, there should be at least 7 days between last treatment and beginning of protocol therapy
Patients must not have had chemotherapy or radiotherapy =< 28 days prior to study registration
Previous extensive radiotherapy to the lung or liver during the last 4 months prior to lymphodepletion regimen.
At least 21 days have passed since completing radiotherapy (exception for radiotherapy: at least 7 days since completing a single fraction of =< 800 cGy to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of registration
Prior history of pseudoprogression or radionecrosis from cranial radiotherapy
Planning to undergo standard preoperative radiotherapy
Prior radiotherapy that precludes the proposed treatment with hypofractionated radiotherapy
Patients may not receive other concurrent chemotherapy, radiotherapy, or immunotherapy; localized radiotherapy to an area not compromising bone marrow function does not apply
No history of prior radiotherapy overlapping with high dose region of planned SABR course
Any prior chemotherapy, surgery, or radiotherapy for EAC
Prior radiotherapy to a dose of >= 50 Gy
Have received NO radiotherapy within 14 days prior to receiving study drug
Prior radiotherapy is allowed
Received prior hemibody external radiotherapy
Radiotherapy within 14 days before enrollment
Primary lung cancer or metastatic disease to the lungs to be treated with either conventionally-fractionated radiotherapy (CFRT) or hypo-fractionated stereotactic ablative radiotherapy (SABR)
A history of prior radiotherapy that precludes delivery of hypofractionated radiotherapy
Patients who have received prior radiotherapy at or adjacent to the primary tumor bed
Prior radiotherapy to doses >= 45 Gy to the area of recurrence, >= 6 months prior to enrollment
An interval of >= 2 months since completion of fractionated radiotherapy
No prior radiotherapy to the brain
Prior radiotherapy to the upper abdomen or radioembolization of the liver
Prior whole brain radiotherapy
Radiotherapy to any site for any reason within 28 days prior to study entry
Predominance of disease that is amenable to radiotherapy
Patients who received previous radiotherapy to the brain
Participants who have had any prior cranial radiotherapy
No prior radiotherapy to the upper abdomen
Prior radiotherapy to the paranasal sinus region or the upper neck (i.e., prior radiotherapy to another disease site is acceptable).
Prior radiotherapy that overlaps with planned radiotherapy portal
Planned IMRT (Intensity-Modulated Radiotherapy)
interval of ? 3 months following radiotherapy + TMZ;
Prior focal radiotherapy within 3 months of screening.
Prior radiotherapy
Patients are excluded if they have been treated with whole brain radiotherapy within the prior 3 months.
\Study entry\ is defined as the date of informed consent. Patients who received investigational therapy (agents that are not FDA approved), monoclonal antibody such as bevacizumab or cetuximab, or who received radiotherapy to the skull, spine, thorax or pelvis within 30 days of entry into the protocol. Patients are permitted to have received palliative radiotherapy to an extremity provided at least 14 days has elapsed since completion of therapy, provided the patient received no more than 10 radiotherapy fractions and a dose no higher than 30 Gy to that site, and provided skull, spine, thorax or pelvis were not in the radiotherapy field.
Within 120 days of completion of standard therapy (surgery, chemotherapy ± radiotherapy)
Previous radiotherapy to the brain.
Pelvic radiotherapy administered within less than 6 months prior to enrollment. Subjects who received radiotherapy ?6 months prior to enrollment must demonstrate no cystoscopic evidence or symptoms of radiation cystitis.
Concurrent radiotherapy, radiotherapy within 14 days of first G1T48 dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow
Treatment with prior radiotherapy within 28 days of initiating study drug; however, if the radiation portal covered =< 10% of the bone marrow reserve, the patient may be enrolled without respect to the end date of radiotherapy
Radiotherapy to any site for any reason within 28 days prior to treatment
Radiotherapy within 14 days prior to first IMP administration.
Prior breast or chest radiotherapy for any indication
Subjects with no previous radiotherapy treatment must have a consultation with a radiation oncologist or providers must have a discussion in the context of Neuro-Oncology Tumor Board within 60 days prior to start of IA/BBBD chemotherapy to determine the need for radiotherapy prior to or after IA/BBBD
Any prior radiotherapy to the neck
No prior cranial radiotherapy will be permitted
Prior cranial radiotherapy
No prior chemotherapy or radiotherapy for this malignancy
Previous radiotherapy to the lesion(s) of interest
The disease must be considered to be potentially curable by combined radiotherapy and cisplatin based chemotherapy
Previous radiotherapy (XRT) or chemotherapy
Previous stereotactic or highly conformal radiotherapy within 3 weeks before the start of dosing for this study. Note the stereotactic radiotherapy field must not have included the brain index lesion(s)
Prior radium-223 dichloride or hemibody external radiotherapy
Radiotherapy within 7 days of study treatment
Participants with prior mediastinal or thoracic radiotherapy. Prior tangential RT to prior breast cancer is acceptable.
Radiotherapy within 14 days of study treatment
CNS prophylaxis treatment must be stopped > 1 week prior to CTL019 infusion (e.g. intrathecal methotrexate) f. Radiotherapy:
Radiotherapy within the last 28 days prior to the first RO6958688 infusion with the exception of limited-field palliative radiotherapy.
Serious medical co-morbidities precluding radiotherapy
Patients requiring para-aortic radiotherapy
Prior radiotherapy within 21 days of screening. Localized radiation therapy to a single site within the last 7 days is acceptable. Concurrent radiotherapy is not permitted.
Completion of adjuvant radiotherapy according to standard guidelines (e.g. AGO Mamma, NCCN) is strongly recommended. If radiotherapy is not performed the reason for this needs to be documented in the eCRF.
Newly diagnosed participants who are considered appropriate candidates for comprehensive multimodality treatment (involving surgery and/or external beam radiotherapy or chemo radiotherapy).
Prior radiotherapy is allowed
Radiotherapy less than or equal to (<=) 7 days prior to Day 1
Concurrent radiotherapy, radiotherapy within 14 days of first trilaciclib (G1T28) dose
Radiotherapy, at least 14 days from last local site radiotherapy
Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
Prior stereotactic radiotherapy;
Prior treatment with radiotherapy is allowed.
Radiotherapy within 21 days prior to Cycle 1 Day 1. However, if the radiation portal covered ? 5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy
Prior therapies: BTK inhibitor, radiotherapy, radiotherapy in the adjuvant setting, or cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.
Radiotherapy
Prior systemic therapy or radiotherapy for MPM; local radiotherapy of noncurative intent (ie, for prevention of instrument-tract recurrence and/or symptom control) is permitted
Prior history of whole brain radiotherapy (only applicable for AZD3759 BM expansion)
Radiotherapy within 28 days prior to first dose.
Radiotherapy (except extremities) within 3 months prior to baseline imaging
History of radiotherapy for the treatment of melanoma
Radiotherapy within 14 days prior to day 1 of protocol therapy
Prior surgery or radiotherapy within 14 days of therapy.
Patients may not receive other concurrent chemotherapy, radiotherapy, or immunotherapy; localized radiotherapy to an area not compromising bone marrow function does not apply
Patient has received no prior treatment with any systemic therapy for the treatment of multiple myeloma\r\n* Prior treatment of hypercalcemia or spinal cord compression with corticosteroids does not disqualify the patient (the dose should not exceed the equivalent of 160 mg of dexamethasone in a 2 week period)\r\n* Patients may receive corticosteroids for the management of their multiple myeloma that should not exceed the equivalent of 160 mg of dexamethasone in a 2 week period and should be stable for at least 7 days prior to the initiation of therapy \r\n* Bisphosphonates are permitted\r\n* Patients treated with local radiotherapy with or without concomitant exposure to steroids, for pain control or management of cord/nerve root compression, are eligible; two weeks must have lapsed since last date of radiotherapy, which is recommended to be a limited field; patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed
Radiation therapy within 7 days of enrollment; enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 7 days have elapsed since the last date of therapy
Received prior hemibody external radiotherapy
Prior therapy with radium-223 or systemic radiotherapy (such as samarium, strontium)
Previous whole brain radiotherapy
Prior hemi-body external radiotherapy; subjects who received other types of prior external radiotherapy are allowed provided that bone marrow function is assessed and meets the protocol requirements for hemoglobin, ANC, and platelets
Prior radiotherapy to the thorax
Participants may or may not have received adjuvant radiotherapy, but must be at least 30 days after last dose radiotherapy, with no more than grade 1 residual toxicity at the time of screening
Prior systemic radiotherapy and hemibody external radiotherapy
Prior systemic radiotherapy and hemibody external radiotherapy
No radiotherapy within 21 days prior to cycle 1 day 1; however, if the radiation portal covered =< 5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy
COHORT B: Prior radiotherapy to the prostate (adjuvant or salvage radiotherapy) is allowed
Radiotherapy within 14 days of study treatment; patient must have recovered from acute effects of radiotherapy to baseline.
BREAST RADIOTHERAPY:
Prior radiotherapy less than 14 days prior to enrollment, except for WHO Grade 1 4 glioma (radiotherapy is not permitted within 3 months prior to enrollment) and ATC (radiotherapy is not permitted within 7 days prior to enrollment). Treatment-related AEs must have resolved prior to enrollment.
Has received or is in the process of completing a course of definitive radiotherapy of at least 45 Gray (Gy) with concurrent temozolomide (patient may be registered before completing radiotherapy as long as it is anticipated that s/he will complete at least 45 Gy)
Received prior salvage therapy, including radiotherapy
Previous chemotherapy, radiotherapy of other treatment for PC
Patient may have any prior therapy allowed aside from having had prior radiotherapy to the treatment site
Prior radiotherapy or biologic therapy
The patient is a candidate for definitive external beam radiotherapy; the patient has had no prior radiotherapy to the region of study; the patient has no inflammatory bowel disease, active collagen vascular or connective tissue disorders, and no other medical or social contraindications to radiotherapy, as determined by a participating radiation oncologist
No prior chemotherapy, radiotherapy, or antiangiogenic therapy
Concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal antibodies. Localized radiotherapy to an area not compromising bone marrow function does not apply. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received.
Patients treated with local radiotherapy with or without concomitant exposure to steroids, for pain control or management of cord/nerve root compression, are eligible; one week must have lapsed since last date of radiotherapy, which is recommended to be a limited field and from start of protocol therapy; patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed and one week have passed since the last date of therapy and from start of protocol therapy
Prior treatment with approximately 60 Gy of radiotherapy
Prior cranial radiotherapy
Radiotherapy within 21 days prior to cycle 1 day 1; however, if the radiation portal covered =< 5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy
Women with planned treatment of radiotherapy only (without chemotherapy)
Prior radiotherapy delivered to the target region
Chemotherapy given on the day of the planned radiotherapy treatment
Prior chemotherapy or radiotherapy
TREATED PRIMARY - PRIOR RADIOTHERAPY:
Glioblastoma disease-specific concerns: Patients must not have received previous or concurrent radiotherapy to the brain
Has had radiotherapy within 14 days of randomization. Participants who received radiotherapy >14 days prior to randomization must have completely recovered from any radiotherapy-related AEs/toxicities
Prior treatment with extended-field radiotherapy within 28 days prior to enrollment or prior treatment with extended-field radiotherapy for evaluating tumor lesions within 14 days prior to enrollment.
Patient may have any prior therapy allowed aside from having had prior radiotherapy to the treatment site
Patient who has had any prior radiotherapy to the treatment site(s)
Radiotherapy within the last 21 days;
Any radiotherapy within 1 week of starting treatment on protocol
Use of amifostine or pilocarpine before and during radiotherapy is not allowed
Patients may not receive other concurrent chemotherapy, radiotherapy, or immunotherapy; localized radiotherapy to an area not compromising bone marrow function does not apply
No prior radiotherapy to the brain
Subject has received radiotherapy within 1 week prior to the first dose of study drug. If the subject received radiotherapy > 1 week prior to study treatment, the irradiated lesion cannot be the only lesion used for evaluating response.
Radiotherapy within 14 days prior to first dose of study treatment
Prior radiotherapy =< 14 days, or if subjects have not recovered from radiotherapy
Pre- or post-operative radiotherapy
Has received radiotherapy within the 28 days prior to randomization, with the exception of palliative radiotherapy to focal lesions for pain or other symptom control
Chemotherapy or radiotherapy within 14 days prior to first dose of protocol therapy
Radiotherapy within 14 days prior to Baseline.
Subjects who received radiotherapy for DCIS may enroll
Treatment with radiotherapy-response or biological-response modifiers
Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time
Radiotherapy or chemotherapy ending within 14 days of study enrollment
Radiotherapy within the last 2 months in the area to be treated
interval of at least 3 months following initial radiotherapy and temozolomide
Prior focal radiotherapy
Unresected tumour prior to chemo-radiotherapy (CRT)
Patients may have had prior therapy, including radiotherapy (systemic and/or cranial and/or spinal) or chemotherapy; at least 28 days must have elapsed since completion of radiotherapy and 28 days since completion of prior chemotherapy (42 days for nitrosourea chemotherapy)
Previous whole brain radiotherapy (WBRT)
Treated with local radiotherapy
Radiotherapy within 28 days prior to first dose.
Participants who have had chemotherapy or radiotherapy for intrahepatic cholangiocarcinoma
Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days prior to Day 1 of Cycle 1, except palliative radiotherapy to bone lesions within 7 days prior to Day 1 of Cycle 1
Radiotherapy within 14 days before the first dose of study treatment.
Extensive prior radiotherapy.
Radiotherapy within 14 days preceding the first dose of study treatment
Previous radiotherapy for the treatment of unresectable, locally advanced/recurrent or metastatic breast cancer is not allowed if:\r\n* The last fraction of radiotherapy has been administered within 14 days of first on-study thormbokinetic study\r\n* The patient has not recovered from any resulting acute toxicity (to grade =< 1) prior to first on-study thormbokinetic study
Patients should not have received radiotherapy within 14 days prior to the first dose of orteronel
Treatment with prior radiotherapy within 21 days prior to first dose of study treatment; however, if the radiation portal covered ? 10% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy.
Prior chemotherapy or radiotherapy (other than limited, emergent radiotherapy for treatment of eg. spinal cord compromise or threatened airway)
Radiotherapy within 14 days of study treatment
Prior thoracic radiotherapy
At least 30 days since localized surgery, radiotherapy or chemotherapy
Radiotherapy to multiple sites or immunotherapy within 14 days of initiation of study drug treatment (localized radiotherapy to a single site at least 7 days before start is permissible)
Previous radiotherapy delivered to the upper abdomen.
No prior radiotherapy
Patients may not receive other concurrent chemotherapy, radiotherapy, or immunotherapy; localized radiotherapy to an area not compromising bone marrow function does not apply
Radiotherapy (external beam or CyberKnife) =< 28 days prior to starting study drug, or =< 14 days prior to study registration in the case of localized radiotherapy (e.g. for analgesic purpose or for lytic lesions at risk of fracture), or who have not recovered from radiotherapy toxicities
Prior cranial radiotherapy
Prior cranial radiotherapy or radiotherapy to the head and neck where potential field overlaps would exist
Prior chemotherapy or radiotherapy for any brain tumor
Having finished radiotherapy at least two months ago
Whole-brain radiotherapy (WBRT) < 14 days from the anticipated start of nintedanib/placebo administration
Must have received and completed radiotherapy with or without chemotherapy for head and neck cancer; time from completion of radiotherapy to registration must be at least 3 months and up to a maximum of 1 year
Pelvic radiotherapy administered within less than 6 months prior to enrollment. Subjects who received radiotherapy ? 6 months prior to enrollment must demonstrate no cystoscopic evidence or symptoms of radiation cystitis.
Patient has received prior radiotherapy to the involved breast
Participants who have had prior cHL-directed chemotherapy or radiotherapy
Utilization of amifostine during radiotherapy
Patient must not have history of prior cranial radiotherapy
Women who have undergone prior radiotherapy to the chest wall and/or breast
Receiving definitive or post-operative adjuvant radiotherapy
Receiving radiotherapy or chemoradiation
Prior chemotherapy for SCCHN and/or radiotherapy to the region of the study cancer or
Prior chemotherapy or radiotherapy
Prior cancer chemotherapy or radiotherapy
Previous brain radiotherapy
Prior radiotherapy to the upper abdomen/liver
Radiotherapy within 14 days of first study treatment with the exception of a single fraction of radiation administered for palliation of symptoms
Radiotherapy treatment prior to the first veledimex dose:
Participants may or may not have received adjuvant radiotherapy, but must be at least 30 days after last dose radiotherapy, with no more than grade 1 residual toxicity at the time of screening
Concurrent radiotherapy prior to the performance of both CMR studies, however consolidative radiotherapy after the completion of DOX and after the acquisition of the second CMR study is acceptable
No prior malignancy treated with chemotherapy or mediastinal radiotherapy
Participants may have had prior therapy for the primary brain tumor, including surgery, radiotherapy or chemotherapy
No prior history of breast radiotherapy that will prevent the use of radiotherapy for the present DCIS
Interval of at least 6 months from the completion of any prior radiotherapy and registration; if patients have not passed an interval of at least 6 months, they may still be eligible if they meet one or more of the following criteria:\r\n* New areas of tumor outside the original radiotherapy fields as determined by the investigator, or\r\n* Histologic confirmation of tumor through biopsy or resection, or\r\n* Nuclear medicine imaging, magnetic resonance (MR) spectroscopy, or MR perfusion imaging consistent with true progressive disease, rather than pseudo progression or radiation necrosis obtained within 28 days of registration AND an interval of at least 90 days between completion of radiotherapy and registration
Prior chemotherapy or radiotherapy within the last three years
Radiotherapy of brain tumor within 3 months before enrollment
A plan to treat with radiotherapy