Received prior chemotherapy for any abdominal or pelvic tumor that include neoadjuvant chemotherapy (NACT) for ovarian, primary peritoneal or fallopian tube cancer
Myelosuppressive chemotherapy: must not have received within 2 weeks of entry onto this study
Subjects may have had up to 8 cycles of standard first-line platinum-based chemotherapy for mUC (e.g., as per National Comprehensive Cancer Network [NCCN] guidelines); able to commence study treatment within 2 to 6 weeks of receiving last dose of first-line chemotherapy
Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\r\n* >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
More than one prior chemotherapy regimen administered in the metastatic setting.
Receipt of any other cytotoxic chemotherapy before Induction therapy, with exception of hydroxyurea or steroid pretreatment
The patient must have experienced disease progression during or within 4 months after the last dose of chemotherapy for metastatic disease, during or within 6 months after the last dose of adjuvant chemotherapy, or have been intolerant of previous chemotherapy
Documented progression on or following most recent systemic chemotherapy regimen (not required for chemotherapy-naïve patients), within 4 months prior to screening
All adjuvant or neoadjuvant chemotherapy, radiation, and surgery completed at least 21 days prior to registration\r\n* All triple negative patients must receive chemotherapy of the treating physician’s choice\r\n* ER/PR+ patients must receive chemotherapy (of the treating physician’s choice) unless Oncotype Dx or another genomic predictor score indicates that they are at low or intermediate risk of disease recurrence with endocrine therapy alone\r\n* Patients may have breast reconstruction during protocol participation, but definitive breast cancer surgery must be completed at least 21 days prior to registration\r\n** Concomitant biologic therapy, hormonal therapy, and bisphosphonates are acceptable
Patients must have completed standard neoadjuvant or adjuvant taxane and/or anthracycline based chemotherapy prior to randomization; completion of chemotherapy will be determined by the treating oncologist, but should include a minimum of 4 cycles (a cycle of weekly paclitaxel is considered 3 doses); patients must be registered within 42 weeks after the last dose of chemotherapy; patients may have started endocrine therapy at any time after the diagnosis of the current breast cancer
Patients must have completed all chemotherapy prior to surgery; sandwich chemotherapy is not allowed (i.e. chemotherapy planned to be given after surgery); patients must have completed at least 4 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen without evidence of disease progression in the breast or the lymph nodes\r\n* Note: Delays/dose modifications due to toxicities/adverse events are allowed as long as a minimum of 4 cycles of neoadjuvant chemotherapy is administered; more than 4 cycles of neoadjuvant chemotherapy (NAC) may be administered at the discretion of the treating medical oncologist
All patients must have a clinically negative axilla (no bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy\r\n* Note: an ultrasound of the axilla is not required at completion of neoadjuvant chemotherapy; if performed, its findings do NOT impact eligibility
Chemotherapy within 5 years prior to registration; (hormonal therapy is allowable if the disease free interval is >= 5 years)
Patients must not have received any chemotherapy within 14 days prior to registration
Patients may have received one and only one cycle of chemotherapy prior to enrolling on Cancer and Leukemia Group B (CALGB) 30610, which must have included carboplatin or cisplatin and etoposide; if a patient has had one cycle of cisplatin (or carboplatin)/etoposide prior to registration, the patient must have had all of the prior to registration tests prior to starting their first cycle of chemotherapy; additionally, these patients also must have met all of the eligibility criteria prior to receiving the first cycle of chemotherapy; registration to CALGB 30610 must take place within 7-21 days after the start of the non-protocol therapy; failing to do all of the above will make the patient NOT eligible for CALGB 30610
No prior radiotherapy or chemotherapy (except for the chemotherapy described in the bullet above) for small cell lung cancer (SCLC)
No neoadjuvant chemotherapy =< 4 weeks before pre-registration
Patients may have received only one prior chemotherapy regimen for metastatic disease provided treatment was completed >= 3 weeks prior to randomization
Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen
For patients who receive adjuvant chemotherapy after surgery, a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization; (if treatment delays occur, chemotherapy must be completed within 14 weeks); the dose and schedule of the adjuvant chemotherapy are at the investigator's discretion; Note: it is preferred that all intended chemotherapy be administered in the neoadjuvant setting
The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 70 days; also, if adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 70 days
If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved
Patients may not have had any prior systemic treatment for this malignancy (for example chemotherapy or somatostatin analogues); prior palliative radiation is permitted but radiated lesions may not be used for measurement
Any prior chemotherapy (based on administration schedule) must have been completed in greater than or equal to the following times prior to registration:\r\n* Chemotherapy/ targeted oral therapy administered in a daily or weekly schedule must be completed >= 1 week prior to registration; \r\n* Any chemotherapy administered in an every 2 week or greater schedule must be completed >= 2 weeks prior to registration\r\n* Additionally, patients should be recovered to equal to or less than grade 1 Common Terminology Criteria for Adverse Events (CTCAE) v5.0 from toxicities related to any prior treatment, unless adverse event (AE)(s) are clinically nonsignificant and/or stable on supportive therapy
Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor
Patients receiving systemic chemotherapy within 3 weeks prior to randomization
Patients must have had neoadjuvant chemotherapy followed by surgery; the recommended neoadjuvant treatment should include 16-24 weeks of a third generation chemotherapy regimen as recommended by National Comprehensive Cancer Network (NCCN) guidelines for triple negative breast cancer (examples include dose dense adriamycin-cytoxan [AC] followed by dose-dense paclitaxel; weekly paclitaxel x 12 followed or preceded by cyclophosphamide-adriamycin-fluorouracil [FAC], fluorouracil-epirubicin-cytoxan [FEC], AC or dose dense AC; docetaxel either followed or preceded by FEC/FAC or AC; carboplatin-containing neoadjuvant chemotherapy is also allowed); patients who cannot complete all planned treatment cycles for any reason are considered high risk and therefore are eligible for the study if they have residual disease; patients must have resolution of adverse event(s) of the most recent prior chemotherapy to grade 1 or less, except alopecia and =< grade 2 neuropathy which are allowed
Patients must have completed their final breast surgery (rendering them free from disease) with clear resection margins for invasive cancer and DCIS within the following timelines:\r\n* 90 days prior to screening registration for patients not receiving post-operative (adjuvant) chemotherapy OR\r\n* 270 days prior to screening registration for patients who have received post-operative (adjuvant) chemotherapy\r\nPatients who receive postoperative chemotherapy may receive radiation therapy before or after the chemotherapy; a short course of reduced dose chemotherapy concomitant with radiation for radiation sensitization is not considered to be adjuvant chemotherapy; positive margins are allowed only if the surgical team of the patient deems further resection impossible
Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior chemotherapy for a different cancer is allowable
Patients with cervix cancer who have received any previous radiation or chemotherapy
Newly diagnosed and histopathologically confirmed, potentially resectable NRSTS of the extremity and trunk will be eligible for the chemotherapy or non-chemotherapy cohort based on:\r\n* Evidence of chemotherapy sensitivity of the histologic sarcoma subtype based on existing evidence from prior clinical trials\r\n* Sufficient risk of metastatic disease to warrant chemotherapy based on size and grade and\r\n* Medically deemed able or unable to undergo chemotherapy\r\n* Notes: an incisional biopsy or core biopsy is preferred; fine needle aspiration biopsy is not acceptable to establish the diagnosis
Patients meeting the above criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the chemotherapy cohort or the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort
Patients meeting the criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort; note that tumors arising in bone are NOT eligible for this study
Patients who have received any chemotherapy (excluding steroids) and/or RT prior to this enrollment
Patients who received chemotherapy directed at the present recurrence
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
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
Prior treatment with oxaliplatin chemotherapy within 6 months prior to randomization
No prior radiotherapy or chemotherapy, with the exception of dexamethasone, which is allowed
Patients must have completed induction therapy within 120 days prior to registration to step 1, AND no more than 300 days may have elapsed from the first dose of induction chemotherapy (cycle 1 [C1] day 1 [D1]) given, until the last day of induction chemotherapy administered; for those assigned to Arms A, C, or D, the date of transplant (“day 0”) must not be greater than 365 days after the first dose of induction chemotherapy (C1D1) given\r\n* Patient must have received at least four (4) cycles of induction therapy \r\n* Up to two regimens of chemotherapy are allowed as long as a continuous response was ongoing throughout therapy\r\n** NOTE: For example, a patient who started treatment with rituximab/bendamustine and was then switched to R-CHOP (due to insufficient response or excessive toxicity) would be counted as having received 2 regimens; however, R-CHOP alternating with R-DHAP as a planned induction regimen would count as one regimen
Patients who have received treatment with any other cytotoxic chemotherapy prior to beginning protocol therapy (other than allowed in above criteria) are excluded
With the exception of steroid pretreatment or the administration of intrathecal methotrexate or intrathecal cytarabine, receipt of any other prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL15P1
Patient must have progressed or be refractory to prior anthracycline-containing chemotherapy (e.g. R-CHOP, DA-EPOCH-R, etc)
Patients must have no previous radiotherapy or chemotherapy other than corticosteroids
Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of ALCL or any cancer diagnosed previously are not eligible
Intrathecal chemotherapy prior to enrollment is allowed for the current diagnosis of ALCL as long as adequate cerebrospinal fluid (CSF) is obtained prior to administration of the intrathecal chemotherapy and subsequently demonstrated to be negative for ALCL
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
Patient must have previously started induction therapy, which includes vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or other standard cytotoxic chemotherapy
ALL developing after a previous cancer treated with cytotoxic chemotherapy
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)
Patient must not have had prior immunotherapy or chemotherapy for malignant pleural mesothelioma
Patients who have received any prior cytotoxic chemotherapy or biologics for sex cord-stromal tumors (SCSTs)
Must have received 3-6 cycles of cisplatin-based chemotherapy as part of first-line (initial) chemotherapy; prior cisplatin, vincristine, methotrexate, bleomycin, actinomycin D, cyclophosphamide, etoposide (POMBACE), carboplatin, bleomycin, vincristine, and cisplatin-bleomycin, etoposide, and cisplatin (CBOP-BEP), or methotrexate, actinomycin-D, etoposide, cisplatin, peg filgrastim (GAMEC) are allowed; Note: for patients requiring immediate treatment, 1 cycle of conventional-dose salvage chemotherapy is allowed (including TI or TIP); therefore, these patients may have received 7 prior cycles of chemotherapy; 6 cycles as part of first-line chemotherapy and 1 cycle of salvage conventional chemotherapy
No more than one prior line of chemotherapy for GCT (other than the 1 cycle of salvage chemotherapy)\r\n* Definition of one line of chemotherapy: One line of therapy can in some cases consist of 2 different cisplatin-based treatment combinations, provided there is no disease progression between these two regimens; for example, a patient could have received 2 cycles of bleomycin, etoposide, and cisplatin (BEP) followed by 2 cycles of cisplatin, ifosfamide, and etoposide (VIP) if the switch from BEP to VIP was made due to pulmonary toxicity rather than disease progression; this would be considered 1 line of prior therapy; in addition, if a patient received 4 cycles of BEP and then underwent post-chemotherapy resection of residual tumor with findings of residual viable non-teratomatous GCT, and subsequently received 2 additional cycles of adjuvant chemotherapy (etoposide, cisplatin [EP] or an alternate regimen such as VIP) in the absence of disease progression, this would also be considered 1 regimen; however, if any change in therapy is prompted by tumor progression including rising tumor markers, this is considered to represent 2 lines of prior treatment\r\n* Prior treatment with carboplatin as adjuvant therapy is allowed, provided patients meet other eligibility criteria (e.g., the patient has also received 3-4 cycles of cisplatin-based chemotherapy)\r\n* Prior treatment with 1-2 cycles of BEP or EP as adjuvant chemotherapy for early stage GCT is allowed, provided the patient also received 3-4 cycles of BEP or EP again at relapse; patients treated with 3-4 cycles of VIP at relapse following 1-2 cycles of BEP/EP are not eligible as this would be considered more than 1 line of prior therapy
Prior chemotherapy is allowed, including platinum therapy; patients must not have received chemotherapy for 4 weeks prior to the initiation of study treatment and must have recovery =< grade 1 from any adverse events from any prior chemotherapy (other than alopecia); patients must not have had nitrosoureas or mitomycin C for 6 weeks prior to the initiation of study treatment
Planned neoadjuvant treatment with anthracycline and taxane containing chemotherapy
At least 1 prior chemotherapy regimen
More than one prior chemotherapy-containing line(re-challenge with the same initial regimen is not allowed)
Participants who have had systemic chemotherapy or radiotherapy within 14 days prior to entering the study, except for hydroxyurea or 6-mercaptopurine (MP) as noted; empiric intrathecal chemotherapy during a diagnostic lumbar pucture is allowed, as long as central nervous system (CNS) disease is not suspected
Prior chemotherapy for castration resistant disease; chemotherapy given in the castration-sensitive setting is permissible if stopped at least 4 weeks prior to treatment start
If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of external beam radiation therapy (EBRT) should have resolved
SCLC, endometrial carcinoma: one prior chemotherapy-containing line.
H&N, NETs, biliary tract, CUP: one or two prior chemotherapy-containing lines
EFTs: no more than two prior chemotherapy-containing lines in the metastatic/recurrent setting.
BRCA 1/2-associated metastatic breast carcinoma: at least one but no more than three prior chemotherapy-containing lines.
At least three weeks since the last chemotherapy
Soft tissue sarcoma Rhabdomyosarcoma (At relapse after standard of care therapy [surgery, and/or radiation, chemotherapy] and/or non-responsive/progressive to accepted curative chemotherapy) Non-rhabdomyosarcoma (At relapse after standard of care therapy [surgery, and/or radiation, chemotherapy] and/or non-responsive/progressive to accepted curative chemotherapy)
Bone Ewings sarcoma (At relapse after standard of care therapy [surgery, and/or radiation, chemotherapy] and/or non- responsive/progressive to accepted curative chemotherapy) Osteosarcoma (At relapse after standard of care therapy [surgery, chemotherapy] and/or non- responsive/progressive to accepted curative chemotherapy)
Subjects who have received any cytotoxic chemotherapy within the last 7 days prior to biopsy
Participants who received any lymphoma directed chemotherapy or radiotherapy with the exception of a single dose of intrathecal chemotherapy given at the time of the diagnostic lumbar puncture (spinal tap); patients who received chemotherapy or radiotherapy for Kaposi’s sarcoma > 2 years prior to study enrollment are allowed as long as the prior treatment did not include doxorubicin in its non-liposomal form; prior exposure to liposomal doxorubicin is allowed; prior exposure to intrathecal therapy given as prophylaxis within 30 days is allowed
Must not have received cytotoxic chemotherapy within 14 days of entry on to this study
Patient must have not received gemcitabine, oxaliplatin and/or paclitaxel chemotherapy agents
Multiple myeloma: must have received prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative HCT is permitted
Patients with refractory anemia with excess blasts (RAEB)-2 who have not received myelosuppressive chemotherapy i.e. induction chemotherapy
Chemotherapy
For dose-expansion cohort only: no more than two prior systemic chemotherapy-containing regimens in the advanced/metastatic setting (excluding trastuzumab emtansine, which is considered a targeted cytotoxic agent)
No prior chemotherapy for metastatic colorectal cancer
Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted
Patients may not have progressed on more than two chemotherapy regimens in the metastatic setting; the following will NOT be counted as a prior line of cytotoxic chemotherapy:\r\n* If a patient discontinued a cytotoxic regimen due to toxicity (e.g., hypersensitivity or neuropathy) but had not progressed on that regimen, or if a prior chemotherapy regimen was discontinued after response achieved, it will not be counted in the number of prior chemotherapy regimens allowed\r\n* Prior hormonal therapy and non-hormonal targeted therapy; including the combination of an aromatase inhibitor and everolimus\r\n* Targeted and biologic therapies\r\n* The patient can receive a stable dose of bisphosphonates or denosumab for bone metastases, before and during the study as long as this was started at least 5 days prior to study treatment
Patient must be a candidate to receive at least 2 doses of mFOLFOX6 chemotherapy
Treatment-naive participants unfit for induction chemotherapy for AML due to comorbidities who are >/=65 years old
Cohort B Safety Run-In (Ribociclib + PDR001 + Fulvestrant): Prior chemotherapy:\r\n* Participants may have received chemotherapy for advanced breast cancer as long as the last dose is >= 21 days prior to registration
Expansion Cohort B (Ribociclib + PDR001 + Fulvestrant): Prior chemotherapy:\r\n* Participants may have received up to one prior line of chemotherapy for advanced breast cancer as long as the last dose is >= 21 days prior to first dose of study treatment
Prior systemic chemotherapy requirements are as follows:\r\n* Nivolumab plus carboplatin and pemetrexed cohorts (Cohorts A and B): NO prior systemic chemotherapy is allowed; NOTE: Prior adjuvant or neoadjuvant chemotherapy is allowed if received more than 12 months prior to the study; in addition, one prior cycle (dose) of chemotherapy is allowed if there was no evidence of disease progression following the dose\r\n* Nivolumab plus ipilimumab cohorts (Cohorts C and D): Participants must have received a platinum-based combination chemotherapy for their advanced lung cancer and either progressed on/after this chemotherapy or are intolerant; up to two prior lines of chemotherapy are allowed; NOTE: Prior adjuvant or neoadjuvant chemotherapy does not count as an additional line of chemotherapy if received more than 12 months prior to the study
At least 4 weeks (112 days) from last induction cycle of combination/multi-agent cyto-reductive chemotherapy and no single agent chemotherapy/maintenance within 7 days (e.g. lenalidomide, pomalidomide, bortezomib, dexamethasone, etc).
Previous anti-cancer chemotherapy, immunotherapy or investigational agents =< 28 days prior to registration
Received =< four (4) prior chemotherapy regimens in the metastatic setting
Cytotoxic chemotherapy -2 weeks
Positive serology for HTLV 1 or 2. Re-screening for infection disease markers is not required at baseline (prior to lymphodepleting chemotherapy)
Cytotoxic chemotherapy or immunotherapy within 3 weeks of study entry
Prior cytotoxic chemotherapy is allowed.
Presence of any remaining toxicities due to previous chemotherapy
Receiving prior hepatic intra-arterial chemotherapy
Unless either drug is medically contraindicated, patients must have received oxaliplatin and irinotecan as part of standard metastatic chemotherapy regimens.
Prior chemotherapy for pleural mesothelioma
Received ? 2 prior chemotherapy regimens and have relapsed or progressive disease as confirmed by radiologic assessment
Prior chemotherapy for castration resistant disease; chemotherapy given in the castration-sensitive setting is permissible; at least 6 months from registration must have elapsed since chemotherapy was last received
SAFETY RUN-IN: Patients are candidates for chemotherapy with carboplatin and gemcitabine
Any prior chemotherapy for castration-resistant disease is not allowed. Previous and/or concurrent treatment with other anti-cancer treatments is permitted. Patients are allowed to be treated with chemotherapy during the duration of the trial. Patients who have received chemotherapy as part of initial androgen deprivation therapy for metastatic castration sensitive disease are eligible.
Patient has had prior treatment with bevacizumab, a chemotherapy wafer implant (Gliadel), or any other FDA- approved chemotherapy except temozolomide.
Patients must have progressed after prior high dose chemotherapy (HDCT) treatment, been deemed not to be a candidate for high dose chemotherapy or refused high-dose chemotherapy, and be considered incurable by other standard therapies including further chemotherapy or surgery; there is no maximum allowable number of previous therapies\r\n* “Failure” of prior therapy is defined as:\r\n** A > 25% increase in the products of perpendicular diameters of measurable tumor masses during prior therapy which are not amenable to surgical resection\r\n** The presence of new tumors which are not amenable to surgical resection\r\n** An increase in AFP or beta-human chorionic gonadotropin (hCG) (two separate determinations at least one week apart are required if rising tumor markers are the only evidence of failure)\r\n* NOTE: patients with clinically growing “teratoma” (normal declining tumor markers and radiographic or clinical progression) should be considered for surgery
History of previous chemotherapy
Patient must be >= 3 months since high dose chemotherapy and peripheral blood stem cell rescue prior to registration
UCC and SCCHN and salivary gland cancer - No more than three different prior treatment regimens in the advanced/metastatic setting with a maximum of two chemotherapy-containing regimens
Myelosuppressive chemotherapy: at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
Prior chemotherapy for mCRPC prostate cancer; chemotherapy given neoadjuvantly, adjuvantly, or for hormone sensitive metastatic disease is permitted as long as the cancer did not progress on chemotherapy AND > 6 months have elapsed
Previous high-dose chemotherapy requiring stem cell rescue.
Evidence of progressive disease during or following no more than 2 prior chemotherapy regimens
Prior chemotherapy for metastatic castration-resistant prostate cancer; chemotherapy administered in the castration-sensitive setting is allowed provided last dose of chemotherapy was greater than 12 months prior to study entry
Receipt of more than 3 prior regimens of cytotoxic chemotherapy for metastatic disease unless prior approval is granted by the Sponsor.
In Stage 1, patients may or may not have received prior chemotherapy for mCRPC. In Stage 2, patients will be enrolled into two cohorts based on whether or not they have received prior chemotherapy for mCRPC. Any prior chemotherapy must have been completed ? 4 weeks prior to administration of ES414. Additionally, in countries where abiraterone or enzalutamide are commercially available, patients in Stage 1 and 2 must have progressed on abiraterone and/or enzalutamide prior to study entry.
Chemotherapy less than or equal to 4 weeks prior to registration
Prior systemic chemotherapy (docetaxel, cabazitaxel, estramustine, other cytotoxic agents)
Previous use of investigational agents, chemotherapy or immunotherapy for lymphoma any time prior to enrollment (i.e. must have untreated disease); prior allogeneic or autologous transplants are also not allowed
a) Active Disease (1) Clinically suspected or documented relapse/progression, in first or second relapse following at least one cycle of an asparaginase-based chemotherapy regimen OR (2) Initial disease or first or second relapse and unable to tolerate one full cycle of asparaginase-based chemotherapy regimen OR b) High-risk disease (stage III/IV, KPI groups 3-4 or IPI intermediate-high) prior to second CR regardless of previous chemotherapy.
Progression at any time during initial asparaginase based chemotherapy and up to 3 months after end of initial asparaginase based chemotherapy, OR
Failure to achieve at least PR with initial asparaginase based chemotherapy.
Subjects may not be receiving any chemotherapy or other agents intended for oncologic treatment
Previous treatment for MDS or AML with intensive chemotherapy regimen (induction chemotherapy) or hypomethylating agent
Patients who were previously treated with standard anthracycline- and/or taxane-based chemotherapy will be recruited for this study
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
Patients must not have received more than 3 prior lines of cytotoxic chemotherapy for advanced disease; treatment with targeted agents or biologic agents such as antibodies as single agents will not count as a line of cytotoxic chemotherapy
Patients must have received some immunosuppressive chemotherapy in the preceding 3 months.
Chemotherapy: 3 weeks
For lymphoma patients only: At least one prior systemic chemotherapy including an alkylating agent and anthracycline (unless contraindicated), and an anti-CD20 monoclonal antibody if the tumor is CD20+; prior treatment with anthracycline and alkylating agent is not required for patients with natural killer (NK)/T cell lymphoma but prior treatment with platinum based chemotherapy and/or l-asparaginase is required
Candidate for neoadjuvant chemotherapy
Prior high dose chemotherapy requiring stem cell rescue.
one prior hormonal therapy and one prior chemotherapy regimen; or
Scheduled to receive cisplatin chemotherapy of 80-100 mg/m²
Chemotherapy treatment within the previous 12 months
More than one prior line of chemotherapy administered at any time; a subject treated with chemotherapy in the hormone sensitive setting would count as one line of chemotherapy; a subject treated with chemotherapy in the hormone sensitive setting and subsequently treated with chemotherapy in the castration resistant setting would count as two lines of chemotherapy and would be excluded
Subject has AML secondary to prior chemotherapy.
Previous high-dose chemotherapy requiring allogenic stem cell rescue.
Patients must have received at least one cycle of the cytotoxic chemotherapy regimens (or regimen of similar intensity) listed in Appendix D within 3 months of enrollment (measured from the start date of chemotherapy) OR have had an autologous transplant within 24 months of enrollment OR receive 300 cGy as part of the preparative regimen
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
Patients who have received prior chemotherapy for any abdominal or pelvic tumor within the last three years are excluded; patients may have received prior adjuvant chemotherapy and radiotherapy for localized breast cancer, provided that it was completed more than 2 years prior to registration, the patient remains free of recurrent or metastatic disease and hormonal therapy has been discontinued
Cohort B: Patients with recurrent endometrial cancer may have received up to 2 lines of cytotoxic chemotherapy (adjuvant and one line for recurrent disease, or 2 lines of chemotherapy for recurrent uterine cancer in patients who did not receive adjuvant chemotherapy); patients must have received and failed, or have been intolerant to platinum agents, taxanes, liposomal doxorubicin or other agents known to confer clinical benefit; patients are not required to fail all these agents if, in the investigator’s opinion, patients would benefit from treatment on current protocol
Prior radiation therapy (RT) after initial diagnosis will be allowed but there must be at least 6 months from the completion of RT (or radiosurgery); prior chemotherapy and any systemic molecularly targeted anti-tumor therapy will be allowed, and there must be at least 28 days from the last temodar chemotherapy, 42 days for nitrosourea? at least 14 days from the last dose for chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity
Prior chemotherapy within the last 2 years
Received chemotherapy/immunotherapy in the last 4 weeks
Received a minimum of 2 cycles of standard of care platinum-based chemotherapy in the S1 setting and had a response of progressive metabolic disease (PMD), no metabolic response (NMR), partial metabolic response (PMR) as centrally assessed by PET-/ CT scan or received at least 1 cycle of S1 chemotherapy and had evidence of PMD as centrally assessed. A pre-salvage scan is required to be submitted to the central reader if a subject had only 1 cycle of pre-salvage chemotherapy.
Prior systemic chemotherapy
HER2 IHC 1+ or IHC2+/FISH- breast cancer patients who have received at least 1 and no more than 3 prior systemic chemotherapy regimens
HER2 IHC 2+ or 3+ FISH+ or FISH- gastric/GEJ cancer patients who have received at least 1 and no more than 3 prior systemic chemotherapy regimens.
>= 2 weeks off cytotoxic chemotherapy
Patients must not have received previous systemic cytotoxic chemotherapy for urothelial carcinoma
Have not been treated with chemotherapy, biological therapy or breast radiotherapy
Recurrent malignant gliomas previously treated with radiotherapy and/or chemotherapy
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
other lymphotoxic chemotherapy (including steroids except as below) within 2 weeks of enrollment
Must have previously received and progressed on at least 1 prior chemotherapy regimen.
Prior radiation therapy (RT) after the initial diagnosis will be allowed; patients with prior RT must be at least 6 months from the completion of RT (or radiosurgery); prior chemotherapy or molecularly targeted therapy will be allowed; patients with prior chemotherapy must be at least 6 months from the last dose of chemotherapy or molecularly targeted therapy
Progressive disease after >= 1 prior chemotherapy regimens
Chemotherapy: at least 2 weeks since prior cytotoxic chemotherapy
AML unsuitable for intensive chemotherapy
Previous treatment with chemotherapy for metastatic CRPC (mCRPC) (adjuvant chemotherapy is permitted), or chemotherapy for any reason within 2 years prior to registration
Intention to receive chemotherapy within 6 months after enrollment in protocol therapy
Progressive disease after 1-3 prior chemotherapy regimens (perioperative chemotherapy within 12 months will be considered one regimen)
Subjects with MIBC not meeting the above criteria are still eligible provided the patient declines neoadjuvant cisplatin-based chemotherapy, after specific informed consent describing the known benefits of cisplatin-based chemotherapy
Prior systemic chemotherapy or radiation therapy for transitional cell carcinoma of the bladder\r\n* Subjects who have received prior intravesical chemotherapy are allowed
Prior chemotherapy if this precludes administration of concurrent chemotherapy for protocol treatment; note that induction chemotherapy is allowed as long as concurrent chemotherapy is possible
Conventional cytotoxic chemotherapy: ?4 weeks
Prior chemotherapy or tumor vaccine therapy or biological therapy for the treatment of melanoma. Subjects who received chemotherapy for the management of other malignancies are potentially eligible if the subject has not received chemotherapy in prior 5 years, remained disease free, and following discussion with and agreement by the principal investigator
No indication for chemotherapy; candidate for observation
There is no limit to the number of prior chemotherapy regimens received; patients must have received at least one line of prior systemic chemotherapy for advanced unresectable and/or metastatic disease
Patients who have received any of the following:\r\n* > 2 chemotherapy regimens\r\n* Myeloablative chemotherapy with stem cell rescue\r\n* Craniospinal irradiation
Any number of prior chemotherapy or targeted agents including rapamycin analogues are allowed
No prior chemotherapy or thoracic radiotherapy for lung cancer
Any number of prior chemotherapy regimens are allowed
Patients must be able to receive protocol chemotherapy in the judgment of the treating medical oncologist
Must be at least 7 days since last chemotherapy was administered (this does not include intrathecal chemotherapy which can be administered at any given time pre study or upon enrollment nor does it include maintenance chemotherapy for the subset of patients who relapse during maintenance); for patients who were previously enrolled on the trial but were removed prior to receiving T cell therapy and are re-enrolling on the trial and already have a useable T cell product generated during previous enrollment, the duration and chemotherapy agents used is not restricted
Triple negative (ER-/PR-/HER2-) (Note: This group of patients must have received at least 1 and up to 3 prior chemotherapy regimens in the advanced setting.)
Patients must have relapsed or refractory disease following at least two prior platinumcontaining chemotherapy regimens
Participant has received no prior radiotherapy or chemotherapy for RMS (excluding steroids); at least 6 weeks must have passed since last dose of myelosuppressive chemotherapy or radiation therapy for conditions other than RMS; patients must have recovered from acute toxicity of any prior myelosuppressive chemotherapy or radiation therapy; prior biopsy, surgical resection and lymph node sampling is allowed
Prior chemotherapy for metastatic CRPC; prior neoadjuvant chemotherapy or chemotherapy for metastatic hormone sensitive prostate cancer are allowed so long as this treatment was completed at least 6 months prior to initiation of sipuleucel-T
Ineligible for or have declined initial conventional combination chemotherapy
Part B4 only: Participants must have malignant pleural or peritoneal mesothelioma and appropriate candidate for treatment with cisplatin/pemetrexed; no prior systemic chemotherapy
Part B5 only: Participants must have histologically confirmed diagnosis of B-cell iNHL, with histological subtype; prior treatment with ?2 prior chemotherapy- or immunotherapy-based regimens for iNHL
COHORT B, GROUP 3: COLORECTAL CANCER: Patients must have failed a minimum of one previous line of chemotherapy
Patients that have undergone immunotherapy in combination with non-myeloablative chemotherapy
Patients receiving concomitant chemotherapy administration in the 5 days preceding brachytherapy (except for gynecological cancer patients who may have received concurrent chemotherapy as a component of their treatment regimen)
Refusal to practice contraception during chemotherapy
Has received no more than 5 previous lines of chemotherapy and has received at least two lines of chemotherapy in the metastatic setting.
Subjects who progressed on at least one prior chemotherapy
Patients who have had chemotherapy (for other malignancies) within 3 years prior to registration.
Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study
Failure to one induction course of chemotherapy (these patients will be analyzed separately)
Planned treatment with radiation therapy alone without concurrent chemotherapy or chemotherapy alone
Chemotherapy naive (prior docetaxel chemotherapy [as per chemohormonal therapy versus androgen ablation randomized trial for extensive disease (CHAARTED) data] for castration sensitive disease is allowed)
Patients who have been treated with chemotherapy or radiation for the purpose of induction, re-induction or consolidation, within two weeks of planned study enrollment
INCLUSION - TREATMENT: Undergo neoadjuvant chemotherapy with a trastuzumab based regimen prior to surgery and plan for completion of one year of trastuzumab
Immunotherapy, chemotherapy, radiotherapy, or investigational therapy within 6 months prior to drug dosing
Prior chemotherapy (e.g. docetaxel, cabazitaxel) for CRPC; prior docetaxel administered in the castrate-sensitive space is allowed
Plans for administration of neoadjuvant chemotherapy or hormonal therapy
3 weeks from prior chemotherapy.
More than two prior cytotoxic chemotherapy regimens for the treatment of mCRPC
Patients must have had at least one prior chemotherapy regimen that includes pemetrexed and cisplatin or carboplatin; there is no limit to the number of prior chemotherapy regimens received
Any diagnosis without prior immunosuppressive chemotherapy within 3 months of intended admission for transplant.
Treatment with cytotoxic chemotherapy within 3 months prior to enrollment
The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 4 weeks, or intravesical Bacillus Calmette-Guerin (BCG) within 6 weeks of the first dose of study treatment
Part A patients who have received more than 3 prior cytoreductive chemotherapy regimens.
Treatment with any systemic chemotherapy within 3 weeks
Subjects must refuse or be deemed ineligible for cisplatin-based chemotherapy.
One prior line of chemotherapy and/or targeted agents for metastatic disease are permitted. This chemotherapy can include maintenance therapy, as long as it was given in the front line setting. In addition, prior antiangiogenic therapy (e.g. bevacizumab) is permitted if used as frontline treatment.
Only one line of prior systemic treatment for metastatic urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)
Must have received at least two one prior line of therapy for mCRPC; a taxane chemotherapy administered for metastatic castration sensitive disease will not count, unless patient develops disease progression within 12 months from the last dose chemotherapy
Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the trial.
No limit to the number of prior chemotherapy or endocrine therapy regimens received; use of a previous fluoropyrimidine-containing regimen in advanced/metastatic setting is permitted as long as the subject discontinued the regimen for reasons other than progression
For Dose Escalation, NSCLC and Ovarian Expansion Cohorts: Subject must have failed at least one prior chemotherapy regimen for metastatic disease (urothelial and bladder cancer subjects are not required to have failed prior chemotherapy regimen if considered unfit for cisplatin-based chemotherapy)
Eligible for neoadjuvant chemotherapy
No prior systemic cancer therapy for recurrent or metastatic disease (except if chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).
Salvage chemotherapy including TKIs for Ph+ ALL within 1 week prior to enrollment
Previous high-dose chemotherapy requiring stem cell rescue
Myelosuppressive chemotherapy
Absence of baseline imaging studies (CT abdomen/pelvis and Chest x-ray minimum) both prior to beginning chemotherapy and following chemotherapy
Received cytotoxic chemotherapy, radiation therapy, or targeted therapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 28 days of study enrollment.
Prior or concomitant chemotherapy for metastatic or recurrent disease with the following exceptions:\r\n* Prior chemotherapy for local primary disease is permitted\r\n* Bisphosphonates or receptor activator of nuclear factor kappa-? (RANK) ligand inhibitors are allowed at doses and schedule consistent with the treatment or prevention of osteoporosis
Patients previously treated with chemotherapy must have no more than two prior chemotherapy regimens for the treatment of metastatic prostate cancer
Patients scheduled to receive intraoperative chemotherapy.
Prior use of chemotherapy, radiotherapy, and / or investigational agents for pancreatic cancer
Patients must be considered candidates for intensive chemotherapy treatment with standard doses of cytarabine and anthracycline regimen (“7+3 regimen”)
Patients who have had prior chemotherapy for AML
Must be at least 7 days since last chemotherapy was administered (this does not include intrathecal chemotherapy which can be administered at any given time pre study or upon enrollment nor does it include maintenance chemotherapy for the subset of subjects who relapse during maintenance)\r\n* If subject has an apheresis product or T cells available for manufacturing of T cell product, the duration and chemotherapy agents used is not restricted
Completion of preoperative systemic chemotherapy.
Treatment with chemotherapy within 28 days of registration including subjects who received more than 2 chemotherapy regimens in the metastatic setting at any time prior to registration
Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study
History of prior chemotherapy (chemotherapy allowed for lead-in cohort in castration resistant disease)
Prior treatment: chemotherapy or radiotherapy or surgery
Patients must have received at least one prior chemotherapy regimen and up to any number of prior systemic regimens including chemotherapy and molecular targeted therapy other than PD1/ PDL1/ PDL2 inhibitors
Prior systemic chemotherapy (docetaxel, cabazitaxel, estramustine, other cytotoxic agents)
Prior chemotherapy or targeted small molecule therapy of the current sarcoma. In patients with locally recurrent disease, previous systemic chemotherapy of the primary tumor is allowed, as long as treatment was completed prior to study enrollment and patient has recovered (i.e., < grade 1 or at baseline) from any adverse events due to previously administered agents.
Chemotherapy or immunotherapy =< 28 days prior to registration
Patient must be selected for standard temozolomide chemotherapy to be administered with radiotherapy
Patients must have NOT received more than two total prior lines of cytotoxic chemotherapy for management of recurrent or persistent disease, including re-treatment with initial chemotherapy regimens
Has received cytotoxic chemotherapy for post-transplant relapse prior to study entry
Patients must have no had adjuvant therapy for the management of endometrial carcinoma; this includes chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen; this also pertains to hormonal, vascular, and targeted therapy for the management of endometrial cancer
Patients may have had prior chemotherapy or be chemotherapy naive
Has received chemotherapy or radiotherapy within 14 days of first dose of study medication
If HCC patients, they should have progressive disease (PD) on intolerant of or refusing sorafenib. If mCRC, they should have received at least one regimen of 5-fluouracil based systemic chemotherapy such as FOLFOX, FOLFIRI, CAPOX, or XELOX, with or without a VEGF or EGFR receptor inhibitor. For patients with metastatic gastric cancer, they should have failed at least one line of systemic chemotherapy. For patients with NSCLC, they should have been treated with a PD-1 inhibitor (either with or without chemotherapy) for at least 4 months but are not able to achieve a response.
Patients must discontinue therapies for mCRPC, with the exception of GnRH agent, for 14 days, with the exception of anti-androgens with which there may be a withdrawal PSA response\r\n* Prior chemotherapy is allowed if no progression of disease on chemotherapy\r\n* Prior treatment with sipuleucel-T, radium-223, or PARP inhibitor (e.g. olaparib) is allowed\r\n* Tissue biopsy may be performed during washout period
Prior taxane-based chemotherapy with progressive disease on chemotherapy\r\n* Prior docetaxel for metastatic hormone sensitive prostate cancer is allowed, if no progression of disease on docetaxel as defined by RECIST v1.1 and PCWG3\r\n* Prior taxane-based chemotherapy (i.e. docetaxel or cabazitaxel with or without platinum agent) for mCRPC is allowed if no progression of disease on chemotherapy as defined by RECIST v1.1 and PCWG3
Multiple myeloma – must have received prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative HCT is permitted
Patients with refractory anemia with excess blasts (RAEB) who have not received myelosuppressive chemotherapy i.e. induction chemotherapy and will receive conditioning Regimen C (fludarabine and total body irradiation [TBI]) will be excluded; patients with RAEB who have not received myelosuppressive chemotherapy but who will receive conditioning Regimen A or B are eligible for this study as long as other inclusion and exclusion criteria are met
Must be at least 7 days since last chemotherapy was administered (this does not include intrathecal chemotherapy which can be administered at any given time pre study or upon enrollment nor does it include maintenance chemotherapy for the subset of subjects who relapse during maintenance)\r\n* If subject has an apheresis product or T cells available for manufacturing of T cell product, the duration and chemotherapy agents used is not restricted
Received systemic treatment for cancer, including immunotherapy, within 28 days prior to initiation of conditioning chemotherapy administration within this protocol
Patient has received any previous intravesical therapy for bladder cancer- chemotherapy, immunotherapy, or previous exposure to Qapzola in the last 3 years
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Compete history and physical examination will be required within 2 weeks prior to initiation of chemotherapy
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Chemotherapy must not have been received within 2 weeks of entry onto this study
have impending visceral crisis that requires chemotherapy;
Prior chemotherapy for any other cancer within the last 2 years
other lymphotoxic chemotherapy (including steroids except as below) within 2 weeks of enrollment
Previous cytotoxic chemotherapy including cisplatin, carboplatin, oxaliplatin, etoposide, docetaxel, cabazitaxel, and gemcitabine is allowed, up to 3 prior regimens
Not considered eligible for any of the chemotherapy agents included in the induction regimen
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
Patients may have unlimited prior chemotherapy treatments
No chemotherapy or radiotherapy within the past 28 days
Received at least 3 prior chemotherapy-containing regimens.
Received fewer than 3 prior chemotherapy-containing regimens.
Prior systemic therapy (chemotherapy, biologic, or immunotherapy) for the same OPSCC. Prior chemotherapy, biologic therapy, and radiotherapy is allowed in patients with loco-regional recurrent disease, if administered at least 6 months prior to study enrolment
Must not have received nor be planned for neoadjuvant chemotherapy prior to SABR or surgery
Subjects must not have received or plan to receive neoadjuvant chemotherapy either before radiotherapy or before surgery
At least 21 days elapsed from prior systemic chemotherapy (at least 14 days elapsed from prior systemic chemotherapy in the setting of rapidly progressive disease without significant residual extramedullary toxicity). Hydroxyurea and dexamethasone permitted up to approximately 24 hours prior to the start of therapy. Interruption of tyrosine kinase inhibitor (TKI) not required in Ph positive ALL subset
No prior chemotherapy for locally advanced or metastatic urothelial cancer\r\n* Perioperative chemotherapy previously administered in the neoadjuvant and/or adjuvant setting is permitted\r\n* Prior chemotherapy administered in the context of chemoradiation as definitive treatment for bladder preservation is also permitted, provided that disease progression outside the prior radiotherapy field is demonstrated histologically or cytologically
Ability to undergo potentially curative chemotherapy plus radiotherapy
Received chemotherapy for lung cancer within 6 months of registration
Chemotherapy is planned for the patient in the neoadjuvant setting
No prior chemotherapy or radiotherapy for NSCLC
Patients must have received platinum based chemotherapy; the submission of a tissue sample for the mesothelin assay to determine eligibility for the study may occur prior to, during or after receipt of the frontline chemotherapy; patients will not be required to submit another tissue sample after receipt of the chemotherapy
Patients should receive chemotherapy to attempt to achieve CR or minimal disease state pre-transplantation; the use of up to three cycles of non-cross resistant combination chemotherapy is advised
Chemotherapy resistant disease
Subjects have received at least two standard chemotherapy regimens for which they would be considered eligible (at least one containing a 5-fluoropyrimidine), or systemic chemotherapy is not indicated in the setting of low volume metastatic disease
Received neoadjuvant chemotherapy
Patients who have received induction chemotherapy for their cancer diagnosis.
Prior chemotherapy with nitrosoureas, prior mitomycin C cumulative dose ? 25 mg/m2, prior bone marrow transplant, or prior intensive chemotherapy with stem cell support;
Pancreas patients must have progressed on at least 1 prior line of chemotherapy
CRITERIA FOR LYMPHODEPLETING CHEMOTHERAPY AND huJCAR014 TREATMENT
CRITERIA FOR LYMPHODEPLETING CHEMOTHERAPY AND huJCAR014 TREATMENT: Uncontrolled and serious infection
CRITERIA FOR LYMPHODEPLETING CHEMOTHERAPY AND huJCAR014 TREATMENT: DLI within 6 weeks prior to lymphodepletion chemotherapy
Last dose of any systemic non-taxane cytotoxic chemotherapy completed at least one day prior to Day 1. Last dose of any systemic taxane cytotoxic chemotherapy completed at least 4 weeks prior to Day 1
Prior to initiating chemotherapy in this study, twenty-one or more days must have elapsed since the patient's last radiation or chemotherapy administration (Hydrea, Gleevec and other tyrosine kinase inhibitors [TKI] as well as intrathecal therapy are accepted exceptions).
Radiotherapy and cancer chemotherapy (except for intrathecal chemotherapy, hydroxyurea, and cytarabine. Cytarabine and hydroxyurea are allowed to be used emergently in case of leukocytosis) or any investigational drug within 2 weeks before study entry
Prior chemotherapy allowed, but last dose must have been at least 2 months prior to enrollment
Must have received systemic chemotherapy, minimum 3 months or maximum 6 months, prior to enrollment\r\n* Systemic therapy should consist of at least fluoropyrimidine-based and/or platinum-based chemotherapy\r\n* Trastuzumab may be added for HER2-neu over-expressing cancers as clinically indicated\r\n* Last dose of chemotherapy within 8 weeks of enrollment with recovery to grade 1 from chemotherapy-related toxicities\r\n* Documentation of chemotherapy administration must be obtained
Patients who have had chemotherapy or radiotherapy within 21 days of enrollment
No more than 3 prior regimens of cytotoxic chemotherapy unless approved by the sponsor (Note: all platinum-containing regimens are not to be counted separately but are considered to be a single regimen for the purposes of this criterion)
Treatment with cytotoxic chemotherapy for malignancies other than ovarian cancer within the past 5 years
Any prior radiotherapy or chemotherapy for pancreatic cancer
Patients who received recent chemotherapy for pancreatic cancer are eligible; patients who received chemotherapy > 5 years ago for malignancies other than pancreatic cancer are also eligible, provided that chemotherapy was completed > 5 years ago and that there is no evidence of the second malignancy at the time of study entry
Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable
Patients at least 3 weeks from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least two weeks prior to administration of lymphodepleting chemotherapy.
Prior immunotherapy or chemotherapy is allowed as long as > 14 days prior to enrollment
Prior treatment with intravenous chemotherapy
Subjects receiving cytotoxic chemotherapy
Taxane-based chemotherapy that was aborted due to allergic reactions or intolerance to chemotherapy and therefore received 1 cycle of prior therapy is allowable
PRE-SCREENING: Must have had at least one and not more than two prior chemotherapy regimens for advanced disease (neoadjuvant chemotherapy would not be counted as a line of therapy)
An anthracycline containing chemotherapy regimen
Prior cytotoxic chemotherapy or radiotherapy for this lymphoma
Low dose chemotherapy (e.g., vincristine, rituximab, cyclophosphamide ?300 mg/m2) given after leukapheresis to maintain disease control must be stopped ?7 days prior to lymphodepleting chemotherapy.
History of receiving chemotherapy or radiotherapy
Myelosuppressive chemotherapy: must not have received within 4 weeks of entry onto this study
Patients who have had chemotherapy (including investigational cytotoxic chemotherapy), biologic agents (e.g. targeted therapy or antibodies) or radiotherapy within 4 weeks prior to the first dose of study treatment
Prior chemotherapy for castration resistant disease; chemotherapy given in the hormone-sensitive setting is permissible if stopped at least 4 weeks prior to registration\r\n* Note: Patients can receive a stable dose of bisphosphonates for bone metastases, including zoledronic acid, or denosumab before and during the study as deemed appropriate by the treating physician
At least 1 prior platinum-based chemotherapeutic regimen, but not more than 2 prior chemotherapeutic regimens, for management of endometrial carcinoma. Prior treatment may include chemotherapy, chemotherapy/radiation therapy, and/or consolidation/maintenance therapy. Chemotherapy administered in conjunction with primary radiation as a radio-sensitized therapy will be considered a systemic chemotherapy regimen.
LYMPHODEPLETION: Subjects currently receiving “maintenance” doses of chemotherapy are eligible and the need for intrathecal prophylaxis prior to lymphodepletion is left to the discretion of the investigator; maintenance chemotherapy is defined as methotrexate =< 30 mg/m^2/week, mercaptopurine =< 100 mg/m^2/day and vincristine =< 2 mg/28 days; for subjects who receive chemotherapy, including intrathecal chemotherapy, that does not fit this definition of maintenance chemotherapy, a two week washout between the last dose of standard of care chemotherapy and the beginning of lymphodepletion will be required
Not a candidate for or refuse chemotherapy
Prior systemic chemotherapy for the study cancer (including neoadjuvant chemotherapy); note that prior chemotherapy for a different cancer is allowable.
Requires urgent treatment with cytotoxic chemotherapy or other therapy is indicated (e.g., symptomatic visceral metastases)
Another primary malignant disease, which requires systemic treatment (chemotherapy or radiation)
A minimum of 4 weeks from prior chemotherapy, including but not limited to, docetaxel, cabazitaxel, mitoxantrone, carboplatin, cisplatin, or estramustine; if applicable, prior to registration
Patients will have received at least 2 cycles of induction chemotherapy with pemetrexed/cisplatin or pemetrexed/carboplatin
A female patient who is a woman of child-bearing potential (WCBP) and a male patient with a partner who is a WCBP must agree to use a medically accepted method for preventing pregnancy for the duration of immunotherapy and neoadjuvant chemotherapy and until after completion of breast surgery or, for patients who do not receive neoadjuvant chemotherapy, for a minimum of 4 months following the last dose of pembrolizumab
At least 4 weeks post-completion of chemotherapy
Patient who received any prior systemic hormonal therapy for advanced breast cancer; no more than one prior regimen of chemotherapy for the treatment of metastatic disease is permitted Note:
No major surgeries within 3 weeks of starting chemotherapy
Participants in cohort B must have completed 1 cycle of systemic chemotherapy; therapy with the combination must start no sooner than 3 weeks from the last dose of chemotherapy and no later than 5 weeks from the last dose of chemotherapy; participants in cohort B must not have had progression of disease prior to the start of therapy
Previous systemic chemotherapy or radiation for pancreatic cancer is not allowed
At least 1 line of prior taxane-based chemotherapy
Prior androgen deprivation or chemotherapy is allowed if discontinued at least 30 days prior to enrollment
Patients must not have had chemotherapy or radiotherapy =< 28 days prior to study registration
Patients who already received chemotherapy for recurrent metastatic IBC are not eligible
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
Incurable cervical or anal cancer, as defined by:\r\n* Relapsed or progressive disease at the primary site and/or regional lymph nodes after initial treatment (e.g. systemic chemotherapy) with no potentially curative option (i.e. surgery or chemoradiotherapy); chemotherapy administered in conjunction with primary radiation as a radiosensitizer will not be counted as a systemic chemotherapy regimen; OR\r\n* Distant metastasis refractory to initial treatment (at least one prior chemotherapeutic regimen which can include a single chemotherapeutic, a combination of chemotherapeutics, or biologic drugs); cervical cancer subjects with distant metastases will have received and failed bevacizumab prior to enrollment onto the trial
Prior treatment with at least one standard chemotherapy regimen or targeted agent prior to enrollment
Systemic chemotherapy within 3 weeks of registration
Subjects must have received at least one prior line of chemotherapy including an irinotecan or oxaliplatin-fluoropyrimidine-based systemic treatment for colorectal cancer
Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months
Planned neoadjuvant therapy with six cycles of combined pertuzumab, trastuzumab and chemotherapy
Participants who are not considered candidates for pertuzumab + trastuzumab + chemotherapy
Treatment with other chemotherapy regimen within the past 2 weeks
Participants must have received at least one prior chemotherapy regimen for their disease
Patients must have had at least one prior chemotherapy regimen that includes pemetrexed and cisplatin or carboplatin; there is no limit to the number of prior chemotherapy regimens received
Patients currently receiving chemotherapy/biologic/immunotherapy as these need to be held during FFSRT
Patients must have had no more than 3 prior lines of chemotherapy; this includes the initial treatment and two relapses; concurrent and adjuvant TMZ-based chemotherapy, including the combination of TMZ with another agent, is considered one line of chemotherapy; for clarification, please contact the principal investigator (PI), Dr. Orin Bloch, at (312) 695-6200
Have previously received prior treatment with at least 1 but no more than 3 chemotherapy regimens in the metastatic setting.
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
The patient has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) within 3 weeks or biologic agents (e.g., cytokines or antibodies) within 4 weeks prior to study enrollment
Undergone lumpectomy and/or mastectomy, are at 2 weeks from end of treatment with adjuvant chemotherapy or radiation and/or chemotherapy or are at a maximum of 5 years out from completion of such treatment;
BC patients with a previous history of another cancer who have NOT received any chemotherapy or chemotherapy and radiation, but have only received surgical treatments are eligible;
Previous chemotherapy
Patients who have had previous chemotherapy or radiotherapy for pancreatic adenocarcinoma prior to entering the study
Patients who have not previously undergone radiation therapy can have a history of treatment with either chemotherapy (for unresectable/borderline resectable disease) or any combination of surgery and chemotherapy (for resectable disease); patients with no history of prior radiation treatment will constitute Cohort B and will receive SBRT as 6.6 Gy x 5; please note that patients must have received at least two cycles of chemotherapy (with selection of drugs at the discretion of the treating oncologist) before SBRT treatment on protocol
At least 21 days must have elapsed after the last dose of myelosuppressive chemotherapy; patients who have been treated with chemotherapy at time of recurrence are NOT eligible for either Stratum
Patients with solid organ malignancy who have received chemotherapy within the past six months
No prior systemic chemotherapy for transitional cell carcinoma of the bladder (prior intravesical therapy is allowed); any other prior chemotherapy must have been completed > 5 years prior to initiation of therapy
More than two prior courses of induction chemotherapy
Patients who have received prior chemotherapy
Patients previously treated with systemic chemotherapy and/or biologic agents for colorectal cancer are eligible
Planned chemotherapy with combination carboplatin and paclitaxel given intravenously
Patients must be at least 4 weeks from last dose of chemotherapy.
Prior chemotherapy within 28 days of starting treatment
Prior systemic chemotherapy or radiation therapy for urothelial carcinoma or cytotoxic chemotherapy for another malignancy within 1 year of study entry are ineligible
Have received the last dose of induction or consolidation chemotherapy within 3 months of enrollment
Planned pre-operative chemotherapy (patients with planned post-operative chemotherapy are eligible)
Has had no prior systemic cytotoxic chemotherapy for urothelial carcinoma (prior intravesicular chemotherapies are permitted)
PRIOR TO LYMPHODEPLETION: Received chemotherapy within the previous 3 weeks prior to lymphodepletion
Subjects requiring daily corticosteroids, other than those given as premedication for the anthracycline-based chemotherapy
Any prior treatment with radiation therapy or chemotherapy for the currently diagnosed breast cancer prior to registration; endocrine therapy may be given but not within 28 days prior to study entry and must be stopped if the patient will be receiving chemotherapy until completion of chemotherapy; patients must discontinue any hormonal agents such as raloxifene, tamoxifen, or other selective estrogen receptor modulators prior to registration
Failed at least 1 prior chemotherapy regimen for advanced NSCLC
Willing to reside < 50 kilometers from Kamuzu Central Hospital (KCH) until chemotherapy completion
Patients who received chemotherapy directed at the present disease
Subjects must be considered suitable for chemotherapy with either single-agent pemetrexed or docetaxel.
Patients who have had more than one line of chemotherapy for LAPC (other than the 4-8 cycles of FOLFIRINOX or gemcitabine/abraxane based chemotherapy); patients will be allowed to switch between FOLFIRINOX and gemcitabine/abraxane due to intolerance, but cannot have switched chemotherapy regimens due to radiographic or clinical disease progression
Patients must not have received any systemic chemotherapy for advanced biliary cancer
Patients who failed to respond first line standard of care chemotherapy or chemotherapy suspended due to toxicity or other reasons
Patients who do not undergo chemotherapy
Patients with prior chemotherapy for this cancer
Patients must have an intact evaluable primary tumor or biopsy proven axillary node involvement with at least 1.0 centimeter (cm) smallest dimension based on imaging after neoadjuvant anthracycline-based chemotherapy and prior to initiation of neoadjuvant chemotherapy under this protocol; baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; all areas of disease should be recorded in order to assess response and uniformity of response to therapy
Subjects must not be receiving any chemotherapy agents (except hydroxyurea)\r\n* Intrathecal methotrexate and cytarabine are permissible
At least 1 prior chemotherapy regimen containing cisplatin or carboplatin
Subject has received chemotherapy within the last 4 weeks prior to first treatment.
Patients with any prior chemotherapy regimens are eligible
No other active cancer that requires systemic chemotherapy or radiation
Patients must have been treated with at least one prior chemotherapy regimen in the metastatic setting or within 12 months of their last adjuvant systemic treatment and must be felt to be chemotherapy refractory; patients with ER positive disease must have demonstrated to be clinically endocrine-insensitive by progressing through at least one line of endocrine therapy, including approved combinations and considered candidate for more aggressive therapies (e.g. chemotherapy) per principal investigator (PI) or treating physician
Have received induction chemotherapy and at least one cycle of consolidation chemotherapy; patients should have achieved a CR within 12 months of enrollment onto protocol
Any prior chemotherapy, surgery, or radiotherapy for EAC
Cytotoxic chemotherapy within 21 days prior to enrollment
Must have received at least one regimen containing gemcitabine chemotherapy
Cytotoxic chemotherapy or non-hormonal targeted therapy within 28 days of Cycle 1 Day 1 is not permitted.
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)
Subject would not benefit from additional cytotoxic chemotherapy as determined by the treating physician
Individuals who would benefit from additional cytotoxic chemotherapy as determined by the treating physician
Patients receiving maintenance biologic therapy are eligible, provided their recurrence is documented more than 6 months from completion of primary cytotoxic chemotherapy (includes maintenance chemotherapy) and a minimum of 3 weeks has elapsed since their last infusion of biologic therapy at the start of protocol intervention, day 1
Patients who have received prior chemotherapy for endometrial cancer.
Prior cytotoxic chemotherapy (for example, but not limited to, docetaxel, mitoxantrone, cabazitaxel) within 6 months of registration is prohibited
Patients are allowed to receive, but are not required to receive, up to 5 additional prior chemotherapy treatment regimens (including platinum-based chemotherapy); prior hormonal therapy is allowed, does not count towards this prior regimen requirement, and must be discontinued at least one week prior to T cell infusion; continuation of hormone replacement therapy is permitted
ARM C COHORT 4: Patients must not have received prior systemic chemotherapy for advanced or metastatic disease; prior adjuvant chemotherapy or concurrent chemotherapy and radiation are allowed if they were completed >= 6 months prior to the diagnosis of recurrent disease
A \washout\ period of at least 14 days from last previous cytotoxic chemotherapy will be required prior to starting treatment on this protocol; no “washout” period will be required for previous bcr-abl TKI therapy given with the aforementioned previous chemotherapy cycles; hydroxyurea and corticosteroids may be given as bridge therapy up until 24 hours prior to initiating protocol treatment
At least one prior chemotherapy
Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months
Has not received chemotherapy in the last 28 days
Neoadjuvant chemotherapy
Subjects screened between 1 to 12 weeks after last cycle of chemotherapy
Have had prior chemotherapy for metastatic disease in castration-resistant prostate cancer (prior chemotherapy for hormone-sensitive disease, more than six months prior to registration, is acceptable)
Patients who were exposed to neoadjuvant chemotherapy or chemotherapy after prostatectomy
May have been previously chemotherapy-treated; patients may have received up to two prior lines of chemotherapy (excludes neoadjuvant or adjuvant therapy) for recurrent/advanced disease (it is anticipated that patients would have been previously treated with MVAC or GC, or variations of these standard frontline regimens); chemotherapy-naive patients who decline to receive frontline chemotherapy are eligible
Received chemotherapy, radiotherapy, or biologic therapy within the last 30 days (neoadjuvant chemotherapy excluded)
Phase II: patients are eligible if their previous chemotherapy regimen did not contain bortezomib, carfilzomib, or other known proteasome inhibitor or a combination of gemcitabine >= 800 mg/m^2 plus adriamycin >= 30 mg/m^2; patients who receive sequential or alternating therapy as part of front-line treatment will be counted as having one prior regimen; patients who have failed prior neoadjuvant chemotherapy will be eligible for this trial
Concurrent chemotherapy (except intrathecal chemotherapy)
Patients who have received systemic chemotherapy or radiotherapy within two months prior to first scheduled cycle of postoperative chemotherapy
Patients must have received prior induction chemotherapy for at least 2 months and up to 6 months; at least three weeks should have elapsed after the last chemotherapy
Any prior adjuvant cytotoxic chemotherapy within 12 months of registration; subjects who received chemotherapy for earlier stage disease more than 12 months prior to study registration are eligible for this trial
At the time of registration, patient must be at least 4 weeks from other prior cytotoxic chemotherapy
be considered unfit to receive chemotherapy on reason of age, concomitant morbidities, and/or residual toxicity from previous treatments, or unwillingness to receive chemotherapy. These patients must also have had a progression-free and treatment-free interval of at least 6 months after completion of the last rituximab-containing treatment. Patients in whom chemotherapy is contraindicated are defined by one of the following features:
At least 1 prior line of chemotherapy
Patients who are not eligible for resection and are chemotherapy naïve
Patients with prior oral or intravenous chemotherapy for metastatic disease\r\n* Patients may have had adjuvant or neoadjuvant chemotherapy, if therapy was completed more than 6 months prior to enrollment\r\n* Patients whose comorbidities prevent them from being able to receive the designated chemotherapy regimen\r\n* Patients who are assigned to receive epirubicin must have cardiac ejection fraction (EF) of 45% or greater
Received chemotherapy, radiotherapy, or biologic therapy within the last 30 days (neoadjuvant chemotherapy excluded)
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)
Systemic chemotherapy or radiation cannot have been given within 4 weeks prior to the Y-90 dose of radioimmunotherapy (RIT), with the exception of single agent cyclophosphamide priming chemotherapy administered for mobilization
Chemotherapy (including hormonal therapy) within the past 5 years from date of registration
ELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: If a patient has received anthracycline chemotherapy after enrollment, they must have demonstrated adequate cardiac function at any time following latest administration of an anthracycline chemotherapy (does NOT need to be within 48 hours of T cell infusion) defined as shortening fraction > 28% by echocardiogram or an ejection fraction > 50% by MUGA
Patient is suitable to receive standard chemotherapy with radiation during weeks 2-7 (e.g. cisplatin+ etoposide or carboplatin+paclitaxel)
Prior cytotoxic chemotherapy or molecularly-targeted agents (e.g. erlotinib, crizotinib), unless > 2 years prior
Administration of chemotherapy or any other cancer therapy in the pre-operative period
Patients must be anticipated to complete 2 cycles of chemotherapy
Prior chemotherapy within the past 5 years
Exposure to any systemic chemotherapy within 21 days of date of randomization.
Prior chemotherapy within the past 5 years
Progressive disease or intolerable toxicities during or after treatment with first-line chemotherapy and have not received further second-line chemotherapy; patients treated with prior chemo-radiation to the primary pancreatic tumor, for which the chemotherapeutic agent was used as a radio-sensitizing agent, are eligible
Patients previously treated with chemotherapy are eligible unless they have evidence of local or distant disease progression; patients must have completed their last cycle of chemotherapy at least two weeks prior to study enrollment
Patients may be enrolled in the study regardless of prior chemotherapy regimens
Disease Status: For the purposes of this study, aggressive multidrug chemotherapy is defined as chemotherapy including 2 or more agents that must include an alkylating agent and a platinum-containing compound. Patients must have ONE of the following:
Patients with higher risk MDS (International Prognostic Scoring System [IPSS] int-2 or high; or >= 10% blasts as defined by World Health Organization [WHO])\r\n* No prior intensive chemotherapy or high-dose cytarabine (>= 1 g/m^2)\r\n* Prior biologic therapies (=< 1 cycle of prior decitabine or azacitidine), targeted therapies, or single agent chemotherapy is allowed\r\n* Off chemotherapy for 2 weeks prior to entering this study with no toxic effects of that therapy, unless there is evidence of rapidly progressive disease\r\n* Hydroxyurea is permitted for control of counts prior to treatment\r\n* Hematopoietic growth factors are allowed
Patients should have received induction chemotherapy for AML and at least 1 consolidation
Prior first-line treatment with surgery or biopsy followed by fractionated radiotherapy with concurrent temozolomide-containing chemotherapy is required for glioblastoma patients; additional prior chemotherapy is allowed, without limitation on number of recurrences
Patients who have received prior chemotherapy
Prior induction therapy had to include no more than two cycles of cytotoxic chemotherapy and at least one induction cycle must have consisted of an anthracycline or anthracenedione and cytarabine combination with a reasonable schedule/dose according to the discretion of the investigator
Prior myelosuppressive chemotherapy or other investigational drug therapy within the last 6 months prior to initiation of sunitinib or valproic acid
Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior chemotherapy for a different cancer is allowable
No prior treatment (chemotherapy, biological therapy, or radiotherapy) for resectable pancreatic cancer
Patients who received chemotherapy > 5 years ago for malignancies other than pancreatic cancer are eligible
The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy), biologic agents (e.g. cytokines or antibodies) within 3 weeks, or any other anti-cancer systemic therapy (including multi-kinase inhibitors)
If a cancer survivor, the patient received prior systemic chemotherapy or radiotherapy
Chemotherapy (including hormonal therapy) within the past 5 years from date of registration
Receiving intensive chemotherapy within 21 days of registration; maintenance type of chemotherapy will be allowed
Subjects who have received chemotherapy within 12 months prior to randomization
Prior high-dose chemotherapy (HDC)-ASCT
Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months
Patients who have had prior chemotherapy or radiotherapy for the treatment of pancreas cancer
Subjects must have received adjuvant post-operative chemotherapy meeting the following requirements:\r\n* Completed chemotherapy as per the discretion of their physician\r\n* Chemotherapy must have been completed within 1-6 months of starting study treatment
Subjects with rectal cancer must have received chemotherapy meeting the following requirements:\r\n* Completed chemotherapy as per the discretion of their physician\r\n* Chemotherapy must have been completed within 1-6 months of starting study treatment
Cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) within 3 weeks before the first dose of study treatment
Prior chemotherapy or radiotherapy for colorectal cancer
Patients who will receive neoadjuvant chemotherapy are not eligible
At least 2 weeks should have elapsed since any chemotherapy causing myelosuppression
Patients treated with neoadjuvant chemotherapy are not eligible
If chemotherapy is planned, new chemotherapy regimen should have started no more than 21 days prior to enrollment
Subject has received chemotherapy within the past 28 days
Patients >= 60 are eligible if not a candidate for standard cytarabine plus anthracycline chemotherapy as determined by Kantarjian’s score; patients younger than 60 may also be included if felt not to be a candidate for intensive anthracycline plus cytarabine based chemotherapy
If systemic chemotherapy was given, patient must have had clips or markers placed at the time of surgery (if they are needed) and patient must have simulation scans within 6 weeks of the completion of the chemotherapy.
Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months
Patients must be anticipated to complete at least 2 cycles of chemotherapy on study
> 2 lines of prior chemotherapy in the metastatic setting
Prior receipt of induction chemotherapy followed by referral for concurrent chemoradiation is allowed
Participants may have undergone prior chemotherapy for their uterine malignancy or may undergo chemotherapy in conjunction with adjuvant proton therapy per discretion of treating physicians; the agents, doses, routes and schedule of administration will be determined by their attending gynecologic oncologist or medical oncologist; for participants who have undergone prior chemotherapy, protocol radiation may commence no sooner than 21 days after the last chemotherapy treatment
Fit to receive chemotherapy and radiotherapy with curative intent.
Patients with cervix cancer who have received any previous radiation or chemotherapy
Previous chemotherapy for this tumor
Prior systemic chemotherapy within the last three years
Any number of prior lines of chemotherapy in the metastatic setting is allowed
Radiation treatment alone without concurrent chemotherapy or chemotherapy use alone
Systemic chemotherapy or radiation within 4 weeks prior to the Y-90 dose of radioimmunotherapy (RIT), with the exception of single agent Cytoxan priming chemotherapy administered for mobilization
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).
Documented FGF/FGFR alteration and have either 1a) failed at least 1 previous treatment for their metastatic or surgically unresectable urothelial carcinoma (ie, chemotherapy, immunotherapy) or 1b) have not received chemotherapy due to poor ECOG status or 2) have insufficient renal function.
Has been treated with more than two lines of cytotoxic chemotherapy or molecular targeted therapy or interferon for Lung NET
Prior systemic chemotherapy
Note: patients enrolled after chemotherapy do not have to meet the above criteria
Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a different cancer is permitted
Patients with more than one prior chemotherapy regimen for management of primary disease
Must not have received cytotoxic chemotherapy within 14 days of entry on to this study
Patient must have not received gemcitabine, oxaliplatin and/or paclitaxel chemotherapy agents
Patients may have received prior chemotherapy
Chemotherapy-sensitive (at least stable disease) large cell, mantle cell or Hodgkin's lymphomas that have failed at least 1 prior regimen of multi-agent chemotherapy and are ineligible for an autologous transplant
Stage I: subjects may have already received no more than 2 cycle of their platinum-based chemotherapy but should not have received other prior chemotherapy regimens with the exception of patients with metastatic disease who received neoadjuvant or adjuvant chemotherapy and that chemotherapy was completed > 6 months prior to enrollment
Stage II: subjects must have received no more than 1 prior chemotherapy regimen for metastatic disease; and no more than 2 cycles of their current platinum chemotherapy regimen for metastatic disease; they must have recovered to < grade 1 from all toxicities related to the prior chemotherapy; patients who have received perioperative (i.e. adjuvant or neoadjuvant therapy) > 1 year prior to being treated with chemotherapy for metastatic disease will be eligible provided any chemotherapy-related toxicity has recovered to specified levels
>= 3 weeks between completion of chemotherapy or immunotherapy and first (1st) vaccination
Have received at least one prior chemotherapy regimen for SCLC
Patients must be enrolled within 6 months of completing chemotherapy or after surgery of the primary site; any acute/subacute > or = grade 3 toxicities from the chemotherapy must be resolved to < or = grade 2 at the time of study entry; it is suggested that patients undergo prophylactic cranial irradiation as a soon as they have recovered from chemotherapy or surgery, at a minimum of 2 weeks, and up to 6 months following chemotherapy or surgery
At least one cycle of induction or re-induction chemotherapy or lymphoma chemotherapy or azacitidine or decitabine or tyrosine kinase inhibitor
Multiple myeloma: Must have received prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative hematopoietic cell transplant (HCT) is permitted
Prior chemotherapy (i.e., as administered strictly for cancer treatment) within the previous 3 years. Use of chemotherapy agents for non-cancer treatment purposes (i.e., arthritis treatment, etc.) are excluded from this criterion.
Prior chemotherapy (last 4 weeks)
Clinical performance status of ECOG 0 - 2 at the time of chemotherapy infusion (Turnstile II - Chemotherapy/Cell Infusion - Inclusion Criteria)
Has had prior systemic cancer cytotoxic chemotherapy within the past four weeks at the time of the start of the lymphodepletion regimen
Any form of primary or secondary immunodeficiency; must have recovered immune competence after chemotherapy or radiation therapy as evidenced by lymphocyte counts (> 500/mm^3), white blood cell (WBC) (> 3,000/mm^3) or absence of opportunistic infections (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)
Prior chemotherapy within 5 years.
Cytotoxic chemotherapy or other chemotherapy known to be myelosuppressive: ?21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea).
Clinically stable and eligible to receive conditioning chemotherapy
Has had prior therapy with more than one cytotoxic chemotherapy regimen NOTE: Treatment with maintenance therapy after initial chemotherapy will not be considered a separate regimen and will be allowed.
Previous chemotherapy for this lung or mediastinum tumor; chemotherapy for another invasive malignancy is permitted if it has been treated definitively and the patient has remained disease free for > 3 years
No contraindications to protocol chemotherapy.
Prior treatment with cytotoxic chemotherapy for advanced NSCLC
Prior chemotherapy for recurrent GBM with nitrosourea compounds including Gliadel® wafers or bevacizumab.
Have received more than 2 previous lines of cytotoxic chemotherapy (if receiving cisplatin, 5-FU or pemetrexed)
At least one prior regimen of chemotherapy, with no maximum number of chemotherapy cycles
Stage IV NSCLC, or recurrent NSCLC that is not potentially curable by radiotherapy or surgery whether or not they have received prior chemotherapy. There is no limit to the number of prior chemotherapy regimens received.
Chemotherapy-naïve
At least 2 weeks since chemotherapy
Subjects must refuse cisplatin-based combination chemotherapy (and understand the risk and benefits of doing so) or be deemed ineligible for cisplatin-based chemotherapy by meeting at least one of the following criteria:
Patients who have received more than 2 systemic cytotoxic chemotherapy regimens for metastatic urothelial carcinoma\r\n* Note: prior perioperative chemotherapy is allowed and is not counted as a line of therapy
Patients must be 7 days to 6 weeks out from prior therapy:\r\n* Chemotherapy cytotoxic: At least 21 days since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Chemotherapy nitrosoureas: At least 6 weeks since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Chemotherapy non-cytotoxic (e.g. small molecule inhibitor): At least 7 days or five half-lives, whichever is shorter, since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Monoclonal antibody(ies): At least 28 days since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Immunotherapy: At least 21 days since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Radiotherapy (RT): At least 28 days from last local site RT prior to first dose of tazemetostat\r\n* At least 21 days from stereotactic radiosurgery prior to first dose of tazemetostat\r\n* At least 28 days from craniospinal, > 50% radiation of pelvis or total body irradiation prior to first dose of tazemetostat
Patients receiving any systemic chemotherapy, hormonal therapy or radiotherapy.
Must have received at least 2 prior regimens of standard chemotherapy for mCRC and must have been refractory to or failed (includes intolerance to) those regimens. Prior standard chemotherapy may not have included TAS-102 or regorafenib, but must have included agents as specified in the protocol.
Has received prior systemic chemotherapy treatment for metastatic/recurrent NSCLC
Prior treatment with non-chemotherapy investigational agents is permitted
Expansion cohort (gastric or GE junction): histologically or cytologically confirmed diagnosis of advanced gastric cancer or GE junction with positive PD-L1 (threshold of positivity combined positive score [CPS] >= 1) whose disease progressed on or after two or more prior systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu targeted therapy, refused chemotherapy, or were not candidates for chemotherapy
Chemotherapy regimen given on every 3-week schedule within the last 3 weeks. Chemotherapy given on the weekly basis with limited potential for delayed toxicity within the last 2 weeks
Recurrence or refractory to 1 line of systemic chemotherapy.
For Part 1, prior treatment with less than 4 prior lines of chemotherapy
For Part 2, prior treatment with less than 2 prior line of chemotherapy
Patients must have received previous systemic therapy to include: a regimen of chemotherapy, immunotherapy including anti-PDL or anti-PD-L1 therapies, combined chemotherapy and immunotherapy, provided treatment was discontinued >= 2 weeks prior to initiation of treatment on the present protocol
Patients who have been treated with more than one chemotherapy regimen, immunotherapy regimen or chemotherapy/immunotherapy regimen for metastatic non-small cell lung cancer
Adequate renal functions within 48 hours prior to induction chemotherapy
Eligible for intensive cytarabine/daunorubicin (7+3) chemotherapy specified
Must be within 3 months from the last induction regimen at the time of starting cytarabine chemotherapy in this protocol
Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months
Systemic chemotherapy or immunotherapy within 14 days of enrollment;
Previous chemotherapy or radiotherapy, except:\r\n* Pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin\r\n* Non-seminoma and poor prognosis by IGCCC criteria in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (e.g. organ failure, vena cava obstruction, overwhelming burden of disease); acceptable regimens include cisplatin 20 mg/m^2 days 1-2 and etoposide 100 mg/m^2 days 1-2; carboplatin area under curve (AUC) 3 days 1-2 and etoposide 100 mg/m^2 days 1-2; or baby-BOP; patients must meet all other inclusion and exclusion criteria at the time of registration\r\n* Participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomization; such patients must be discussed with the coordinating center prior to registration, and must be registered within 10 days of commencing study chemotherapy
Patients at least 3 weeks from last cytotoxic chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least two weeks prior to administration of lymphodepleting chemotherapy.
Previous chemotherapy or hormonal therapy for treatment of ovarian cancer.
Other than the 3 cycles of neoadjuvant chemotherapy and surgery (mentioned above), must not have received other treatment for their gastric cancer.
Received more than 2 prior systemic chemotherapy regimens, including adjuvant systemic chemotherapy following definitive chemoradiation (OUTBACK chemotherapy); concurrent chemotherapy with prior radiation treatment is not to be counted
Previously treated with two prior regimens of systemic chemotherapy for metastatic or locally advanced, unresectable disease, including fluoropyrimidines (5-fluorouracil and/or capecitabine), oxaliplatin, and irinotecan\r\n* A maintenance regimen of 5-fluorouracil or capecitabine, with or without bevacizumab, should not be counted as a separate line of treatment\r\n* For patients who experienced disease recurrence during or within 6 months of completion of adjuvant chemotherapy with fluoropyrimidine and oxaliplatin, only one regimen of systemic chemotherapy for metastatic disease is required
Patients must not be suitable for fluorouracil (5FU)/mitomycin chemotherapy
Subjects with not meeting the above criteria are still eligible provided the patient declines concurrent chemotherapy with radiation, after specific informed consent describing the known benefits of adding chemotherapy to the definitive bladder radiation regimen; the reason for declining must be documented
Prior systemic chemotherapy for bladder cancer; prior intravesical chemotherapy for the treatment of non-muscle invasive urothelial bladder cancer (UBC) is allowed
Received chemotherapy drugs within previous 2 weeks
Patients must be anticipated to complete at least 2 cycles of chemotherapy
Another primary malignant disease, which requires systemic treatment (chemotherapy or radiation)
No more than one prior chemotherapy regimen for advanced or metastatic breast cancer is allowed; prior chemotherapy for metastatic disease must have been completed >= 14 days prior to randomization\r\n* Any single agent therapy, and any combination of cytotoxic, endocrine, biological targeted agents, and/or humanized antibodies, scheduled to be administered as a preplanned treatment, given concomitantly, sequentially or both, is considered one regimen\r\n* Planned neoadjuvant chemotherapy and postoperative adjuvant chemotherapy is considered one regimen\r\n* If the dosing of one or more of the chemotherapy components of a regimen must be reduced for toxicity, the modified version of the original regimen is not considered a new regimen\r\n* If one or more of the chemotherapy components of a regimen must be omitted for toxicity, the modified version of the original regimen is not considered a new regimen\r\n* If one of the chemotherapy components of a regimen must be replaced with another similar drug of the same therapeutic class, the modified version of the original regimen is not considered a new regimen; however, if a new component, dissimilar to any of the original components, is added to the regimen, the modified version is considered a new regimen\r\n* If chemotherapy is interrupted for surgery or radiotherapy and then continues with an unchanged schedule and components, treatment is considered as one regimen despite the interruption
No prior cytotoxic chemotherapy for metastatic disease; prior immunotherapy is permitted
No prior therapy with enzalutamide (previous chemotherapy and/or other AR-targeted approaches is allowed)
Systemic chemotherapy for the study cancer < 2 weeks prior to registration
One to two line(s) of prior taxane-based chemotherapy allowed. If docetaxel chemotherapy is used more than once, this will be considered as one regimen.
Received no more than one prior regimen of chemotherapy in the metastatic setting
No prior systemic chemotherapy treatment in the metastatic setting
Participants who have received any chemotherapy or radiotherapy for previous malignancy are not eligible
Prior systemic chemotherapy for the study cancer.
Have received treatment with at least one or more lines of cytotoxic chemotherapy in the metastatic setting.
Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy
Patients who have had chemotherapy or radiotherapy =< 14 days prior to registration are not eligible\r\n* NOTE: Patients may not have had systemic chemotherapy within 28 days
Patients are not eligible who have received systemic chemotherapy or investigational agents =< 28 days prior to registration
The subject has an active cancer being treated with chemotherapy at the time of screening
Refractory to at least 1 cycle of induction chemotherapy
Subjects must have had prior high dose chemotherapy (HDCT) treatment when indicated
Subjects must be at least 3 weeks from last chemotherapy
Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of T-ALL, T-L-Ly or for any cancer diagnosis prior to the initiation of protocol therapy on AALL1231, with the exception of:\r\n* Steroid pretreatment: prednisone or methylprednisolone for =< 120 hours (5 days) in the 7 days prior to initiating induction chemotherapy or for =< 336 hours (14 days) in the 28 days prior to initiating induction chemotherapy; prior exposure to ANY steroids that occurred > 28 days before the initiation of protocol therapy does not affect eligibility; the dose of prednisone or methylprednisolone does not affect eligibility\r\n* Intrathecal cytarabine (the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment) system chemotherapy must begin with 72 hours of this IT therapy; or\r\n* 600 cGy of chest irradiation, if medically necessary\r\n** Pre-treatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone use during sedation to prevent or treat airway edema; inhalation steroids and topical steroids are not considered pretreatment
Prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
More than 2 prior chemotherapy regimens for the current malignancy; full dose chemotherapy used in conjunction with concurrent radiation therapy will be included as prior therapy\r\n* Note: Prior hormonal therapy (e.g. leuprolide, aromatase inhibitors, tamoxifen) and immunotherapy will be allowed and not included as a prior chemotherapy; if the chemotherapy regimen is altered during the course due to issues with tolerability or safety, the regimen will be counted as one; using the same regimen at recurrence is counted as one regimen; the addition of bevacizumab to a prior regimen is considered one regimen
No prior cancer chemotherapy allowed
All patients must have completed any prior chemotherapy, targeted therapy and major surgery, >= 28 days before study entry; for daily or weekly chemotherapy without the potential for delayed toxicity, a washout period of 14 days may be acceptable, and questions related to this can be discussed with study principal investigator
Subjects must not be receiving any chemotherapy agents (except hydroxyurea); intrathecal methotrexate and cytarabine are permissible
Patients must have received prior treatment with chemotherapy. Chemotherapy may have previously been given with a PD-1 or PDL-1 inhibitor.
Relapsed after or refractory to one or two prior lines of chemotherapy for advanced or metastatic/recurrent disease (at least one cycle each) which have not included a PD-L1 or FGFR inhibitor; at least one regimen should have included a platinum agent unless contraindicated for the subject; prior neoadjuvant or adjuvant chemotherapy (without a PD-L1 or FGFR inhibitor) is permitted and will not be counted as first-line chemotherapy, as long as the subject has not progressed within 12 months of the last dose; however, a regimen of neoadjuvant or adjuvant chemotherapy will be counted as first-line chemotherapy if the patient progressed within 12 months of the last dose
Patients must have had at least one prior chemotherapeutic regimen for management of endometrial carcinoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen\r\n* Patients are allowed to receive, but not required to receive, up to a total of 3 lines of chemotherapy
Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
Myelosuppressive chemotherapy: must not have received myelosuppressive chemotherapy within 3 weeks of entry onto this study (excluding hydroxyurea)\r\n* Cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of CPX-351
Patients treated with prior chemotherapy, cytotoxic chemotherapy, radiation, biotherapy, or any investigational agent > 30 days prior to lymph node removal are eligible
No more than a total cumulative dose of 450 mg/m^2 of prior doxorubicin chemotherapy
Medical oncologist or consenting physician verifies that chemotherapy options exist after treatment with intracranial therapy, and that chemotherapy is planned to initiate after completion of radiation; or, survival as estimated by the medical oncologist or enrolling physician is > 3 months
Concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation
At a maximum of twelve weeks after the last dose of chemotherapy, patients must fulfill the following criteria:\r\n* Complete clinical response after first-line chemotherapy for newly-diagnosed patients, or after second-line chemotherapy for relapsed patients who require secondary cytoreduction\r\n** Complete clinical response is defined as normal exam, normal computed tomography (CT) scan, and normal CA-125 level; tumor tissue for relapsed patients would be obtained under informed consent at the time of a secondary surgical debulking, which would be performed as part of standard relapse management in appropriate patients\r\n* Asymptomatic, low volume disease not requiring further chemotherapy prior to initiating vaccination
The patient should have no immediate need for chemotherapy
Corticosteroids should not be used during chemotherapy administration as an antiemetic
Up to 4 prior chemotherapy regimens for recurrent disease are allowed; adjuvant chemotherapy and maintenance Taxol after completion of six cycles of adjuvant carboplatin - Taxol will not be counted as a \prior chemotherapy regimen\ for the purpose of this study; treatment with targeted agents or hormones would not be considered as a systemic chemotherapy regimen; eligible Patients are those with documented disease recurrence/progression within 0-6 months of completing platinum-based chemotherapy; patients should not have received any non-oncology, viral vaccines within 30 days prior to starting protocol treatment
Patients who have had cytotoxic chemotherapy, radiotherapy, interferon (IFN), or ipilimumab before entering the study
No prior chemotherapy or radiotherapy for this malignancy
>= 28 days from completion of frontline chemotherapy for NHL
No prior chemotherapy or radiotherapy for the extra-ocular retinoblastoma may have been administered prior to entering this study; prior treatment (chemotherapy and/or radiation therapy) for intra-ocular retinoblastoma is permissible
No prior chemotherapy
Patients must have progression after prior treatment with Enza at any point in the disease course (pre- or post-chemotherapy)
Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study
Predicted inability to tolerate standard induction chemotherapy with daunorubicin and cytarabine
The disease must be considered to be potentially curable by combined radiotherapy and cisplatin based chemotherapy
Previous radiotherapy (XRT) or chemotherapy
Prior chemotherapy within the last 4 weeks
Patients must have had one prior systemic chemotherapeutic regimen for management of persistent, recurrent or metastatic carcinoma of the cervix (e.g.; paclitaxel/cisplatin, paclitaxel/cisplatin/bevacizumab); chemotherapy administered concurrent with primary radiation (e.g.; weekly cisplatin) is not counted as a systemic chemotherapy regimen; adjuvant chemotherapy given following the completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted as a systemic chemotherapy regimen (e.g.; paclitaxel and carboplatin for up to 4 cycles); NOTE: patients who have received more than one prior regimen are NOT eligible
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
Myelosuppressive chemotherapy: at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen
Prior chemotherapy with 0-2 regimens is allowed
Treatment with chemotherapy within 3 months of registration
Patients with chemotherapy prior to TEMLA are eligible
Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months
Patients receiving any systemic chemotherapy or targeted agents for treatment of the current HNSCC outside of induction chemotherapy per standard institutional practice
Participants who have received oxaliplatin during prior systemic chemotherapy regimens are eligible for enrollment in this protocol
Participants who have received oxaliplatin during prior systemic chemotherapy regimens are eligible for enrollment in this protocol
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
At least one adverse prognostic factor: \r\n* Initial relapse =< 12 months after primary chemotherapy\r\n* Staged as Ann Arbor classification initial stage III or IV disease\r\n* Chemotherapy resistant disease\r\n* Failure to achieve a complete response (CR) with cytoreductive chemotherapy or persistent positive fludeoxyglucose F 18 (18FDG)-positron emission tomography (PET) imaging
No chemotherapy within 4 weeks of first vaccine administration
Prior treatment with chemotherapy or radiotherapy for lymphoma or chronic lymphocytic leukemia; note that prior chemotherapy for a different cancer is allowable
No previous chemotherapy
All previous cytotoxic chemotherapy must be completed at least 2 weeks prior to study entry; any prior non-hematologic vital organ toxicity (cardiac, pulmonary, hepatic, renal) of any previous therapy must have resolved to grade 1 or less, unless specified elsewhere\r\n* Exceptions:\r\n** There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects; or\r\n** Subjects receiving standard ALL maintenance chemotherapy will not require washout
No prior cytotoxic chemotherapy, radiotherapy, immunotherapy, or radioimmunotherapy
FOR COHORT A ONLY: high-dose chemotherapy and AHCT must be planned; post-transplant maintenance therapy will not be permitted
Patients who have had prior chemotherapy for this tumor
Concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation)
Prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a different cancer is allowable
Participants who are untreated or who received a maximum of one (1) cycle of combination chemotherapy, including rituximab-containing regimens, prior are eligible; the start of previous chemotherapy cycle must occur at least 21 days prior to beginning treatment under this protocol, and such cycle will count towards the total maximum of 6 cycles under this study
Prior cytotoxic chemotherapy or radiotherapy for this lymphoma
Must have failed at least 1 regimen for metastatic disease, and have been treated with up to 2 prior chemotherapy regimens\r\n* There is no limit on the number of total prior regimens
Prior chemotherapy:\r\n* Ovarian cancer: patients with no prior PLD exposure are eligible after failure of platinum-containing chemotherapy; no more than 2 prior platinum containing regimens is permitted; dose escalating cohorts only: patients already on PLD are also eligible if they are receiving PLD beyond 3 cycles without prohibitive (i.e. no grade 3 or 4) skin or mucosal toxicities, and showing no progressive disease compared to a computed tomography (CT) scan obtained 2 or more months earlier; these patients are eligible in spite of any progression from baseline determined prematurely (i.e., applicable to those patients who are deemed in their best interest to continue to receive PLD after a CT obtained at 2 or 3 months has shown progression from baseline)\r\n** Breast cancer: patients may have received 0-2 prior chemotherapy regimens for metastatic disease; breast cancer patients may not have received prior PLD, and will not be eligible for the expanded cohort A \r\n** Interval between prior chemotherapy and registration for breast and ovarian cancer; there should be at least a 3 week interval between the last chemotherapy regimen and registration, and the patient should have recovered from acute toxicity related to prior therapy (6 weeks if the last regiment included BCNU or mitomycin C)\r\n** Dose escalating cohorts only: patients will be categorized in the following strata based upon prior PLD exposure: Stratum A –patients with ovarian cancer who have had prior PLD exposure and received at least 3 cycles of PLD without prohibitive (i.e. no grade 3 or 4 skin toxicity) and have not had progressive disease; Stratum B: patients with ovarian or breast cancer who have had no prior PLD exposure
Prior cytotoxic chemotherapy for another condition treated with curative intent is allowed provided at least 18 months has elapsed between last treatment and enrollment on protocol
Patients who have received prior chemotherapy for any abdominal or pelvic tumor within the last five years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
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
Cytotoxic chemotherapy, steroids or monoclonal antibody (Mab) within 3 weeks of enrollment, except anti-Tac Mab (i.e. daclizumab) which cannot be used within 12 weeks of enrollment; hydroxyurea is considered different from cytotoxic chemotherapy and may be used up to the day before enrollment providing it is not increased during the week prior to enrollment and that the patient’s disease burden is not decreasing during that time
Patients with chemotherapy resistant disease
Patients must be able to receive taxane and/or anthracycline based chemotherapy
Subject is eligible for pre-selected salvage chemotherapy.
Subject has AML secondary to prior chemotherapy for other neoplasms (except for MDS).
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)
Received only frontline CD20-directed immunotherapy with anthracycline- or anthracenedione-based multi-agent chemotherapy. Monotherapy rituximab or other CD20-directed immunotherapy as maintenance therapy prior to frontline chemotherapy, and radiotherapy in a limited field or as part of the frontline treatment plan are permitted.
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
Patients who have received more than one previous regimen of chemotherapy (maintenance is not considered a second regimen)
Patients should not be felt to have an immediate need for chemotherapy
Patients must not have received previous systemic cytotoxic chemotherapy for urothelial carcinoma
Patients must consent to have voided urine (40-50 mL) submitted prior to initiating chemotherapy (pre-treatment) and after chemotherapy prior to surgery (post-treatment)
Patients must consent to whole blood (2 x 10 mL) submitted prior to initiating chemotherapy
Each block of chemotherapy is a separate reinduction attempt.
No more than 5 total previous regimens of systemic therapy, including cytokines and cytotoxic chemotherapy.
Subjects who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (docetaxel and prednisone)
No prior chemotherapy for the treatment of metastatic disease at study entry. Adjuvant chemotherapy is permitted providing cytotoxic chemotherapy was completed 12 months prior to starting the study and without disease recurrence.
Patients must have had prior first-line therapy with oxaliplatin-based fluoropyrimidine-containing chemotherapy and bevacizumab for metastatic colorectal cancer
No prior therapy with drugs other than oxaliplatin and a fluoropyrimidine plus bevacizumab for this disease; chemotherapy drugs and bevacizumab may be stopped and started as long as no prior disease progression requiring change in chemotherapy agents occurred
More than two prior lines of cytotoxic chemotherapy (e.g., gemcitabine, doxorubicin, capecitabine) for metastatic disease.
First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy unless the Investigator determines that one of the 4 cytotoxic chemotherapy agents in the control arm would otherwise be offered to the subject
Cytotoxic chemotherapy within 14 days before randomization
Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
Previous chemotherapy for this tumor
Cancer for which intraperitoneal cytotoxic chemotherapy is planned
Patients Must have completed 3 or 4 previous chemotherapy regimens.
Patients must have completed their last chemotherapy regimen > 4 weeks prior to treatment initiation.
Chemotherapy:
The following drugs must be stopped >2 weeks prior to CTL019 infusion: salvage chemotherapy (e.g. clofarabine, cytosine arabinoside > 100 mg/m2, anthracyclines, cyclophosphamide, methotrexate ? 25 mg/m2), excluding the required lymphodepleting chemotherapy drugs
PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have documented progressive cancer following at least one but no more than two prior regimens of systemic therapy for lung cancer, one of which must have been platinum based combination chemotherapy; treatment with an immune therapy or targeted therapy for advanced disease will be considered a separate regimen and will count toward the prior regimens; maintenance therapy will not be counted as a separate regimen; adjuvant chemotherapy or chemotherapy administered as part of concurrent chemotherapy and radiation therapy for the treatment of lung cancer will not count as a prior regimen of systemic therapy as long as recurrence of patient’s lung cancer occurred more than 12 months after the last day of chemotherapy
Chemotherapy other than lymphodepleting chemotherapy within 2 weeks of infusion
Have received no more than one prior systemic chemotherapy regimen in the relapsed or metastatic setting. Prior treatment with no more than one prior immune checkpoint inhibitor is permitted and will not be considered as a line of systemic chemotherapy.
At least 2 weeks from end of chemotherapy with resolution of neutropenia to above level
Prior systemic chemotherapy for the current cancer (prior chemotherapy for a different cancer is allowed)
Previous chemotherapy or chemoradiotherapy outside of the InPACT trial
Not a candidate for chemotherapy as determined by the treating physician
Eligible for cytotoxic chemotherapy
Subjects who have previously undergone intraperitoneal chemotherapy
Must be eligible to receive second-line standard-of-care chemotherapy with either 1) an oxaliplatin-based chemotherapy regimen, or 2) an irinotecan-based chemotherapy regimen
Will have completed the first line chemotherapy regimen completed at least 14 days prior to initiation of 2nd line chemotherapy under the protocol
Chemotherapy given within one week of study registration/enrollment except concurrent chemotherapy may to be given at the investigator’s discretion to patients randomized to the standard arm (arm B, 30-33 fractions)
Prior systemic chemotherapy (prior intravesical therapy is allowed)
Patients who have received any radiotherapy or chemotherapy for their current gynecological cancer
Patients must NOT have received prior chemotherapy or targeted therapy, including chemotherapy used for radiation sensitization for treatment of endometrial carcinoma
No clinical evidence for locoregional or distant relapse during or after preoperative chemotherapy. Local progression during chemotherapy is not an exclusion criterion.
REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY:
REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Total bilirubin =< IULN
REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: SGOT (AST) or SGPT (ALT) =< 2.5 x IULN
Previously received > 1 course of chemotherapy (not including immunotherapies or targeted therapies) for the treatment of metastatic a. Note: Subjects may have received 1 course of chemotherapy prior to surgery for the treatment of locally advanced disease and 1 course of chemotherapy for the treatment of metastatic BC; however, if surgery could not be performed, this will count as the 1 chemotherapy course allowed prior to study
Chemotherapy: The following drugs must be stopped > 1 week prior to CTL019 infusion and should not be administered concomitantly or following lymphodepleting chemotherapy: hydroxyurea, vincristine, 6-mercaptopurine, 6-thioguanine, methotrexate < 25 mg/m2, cytosine arabinoside < 100 mg/m2/day, asparaginase (non-pegylated) The following drugs must be stopped >2 weeks prior to CTL019 infusion: salvage chemotherapy (e.g. clofarabine, cytosine arabinoside > 100 mg/m2, anthracyclines, cyclophosphamide), excluding the required lymphodepleting chemotherapy drugs Pegylated-asparaginase must be stopped > 4 weeks prior to CTL019 infusion
Previous exposure to chemotherapy for rectal cancer
Part A: Subject must have failed at least one prior chemotherapy regimen for metastatic disease and/or is unfit for cisplatin-based chemotherapy.
Part B: Subject must not have received any prior lines of chemotherapy in the metastatic setting (prior treatment with immunotherapy is allowed).
Patients are allowed to receive any number of prior chemotherapy regimens for recurrent disease
At least one, but no more than three, prior chemotherapy regimens for MBC.
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
Chemotherapy: cytotoxic At least 21 days
Patient has received systemic chemotherapy =< 3 weeks prior to registration
At least 3 weeks must have elapsed from the use of any chemotherapy
Previous single agent exposure to the selected chemotherapy regimen for randomisation.
Subjects must have received at least 1 line of chemotherapy for metastatic MCC and must have progressed after the most recent line of chemotherapy
Prior cytotoxic chemotherapy;
Patients must not have MDS secondary to treatment with radiotherapy, chemotherapy, and/or immunotherapy for malignant or autoimmune diseases
Prior chemotherapy is allowed; patients must not have received chemotherapy for 4 weeks prior to the initiation of study treatment and must have full recovery from any acute effects of any prior chemotherapy; patients must not have had nitrosoureas or mitomycin C for 6 weeks prior to the initiation of study treatment
MDS: No previous myelosuppressive therapy; for the purpose of this protocol myelosuppressive chemotherapy will be defined as chemotherapy given with the intent of inducing a complete remission (e.g., standard 7+3, high dose intermittent ARA-C [HIDAC], or Mylotarg)
MPD: No previous myelosuppressive therapy; for the purpose of this protocol myelosuppressive chemotherapy will be defined as chemotherapy given with the intent of inducing a complete remission (e.g., standard 7+3, HIDAC, or Mylotarg)
Atypical CML: No previous myelosuppressive therapy; for the purpose of this protocol myelosuppressive chemotherapy will be defined as chemotherapy given with the intent of inducing a complete remission (e.g., standard 7+3, HIDAC, or Mylotarg)
Subject meets the criteria per investigator's institution to receive SOC R-chemotherapy (ie, R-CHOP [14 or 21] or R-DA-EPOCH or R-CHOEP) of 6 cycles. Subjects may be enrolled on study prior to cycle 1 or cycle 2 of SOC R-chemotherapy
Subject must have completed 6 cycles of SOC R-chemotherapy and achieved CR, PR or stable disease by PET/CT performed 3 weeks (± 3 days) after cycle 6 of SOC R-chemotherapy. Subjects with PD are not eligible for treatment with blinatumomab and will end the study.
Cytotoxic chemotherapy within 3 weeks of first trilaciclib (G1T28) dose
Cytotoxic chemotherapy; at least 21 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
Subject who has had cytotoxic chemotherapy within 3 weeks prior to lymphodepleting chemotherapy; immune therapy (including monoclonal antibody therapy, checkpoint inhibitors or biological therapy within 4 weeks prior to lymphodepleting chemotherapy; corticosteroids or any other immunosuppressive therapy within 2 weeks prior to lymphodepleting chemotherapy; tyrosine kinase inhibitor (TKI) (e.g. erlotinib, gefitinib) within 1 week prior to lymphodepleting chemotherapy.
Prior chemotherapy for extensive-stage SCLC
Participants for whom endocrine therapy (example [e.g.], fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study
Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen for metastatic breast cancer
Patients who previously received BBI608 for treatment of PDAC on the BBI608-118 (BBI608-201PANC) study may continue with BBI608 in monotherapy between discontinuation of the first chemotherapy backbone and start of the second chemotherapy backbone. Patients may begin chemotherapy backbone on a date determined by the investigator and medical monitor for the sponsor after a minimum of 14 days and a maximum of 30 days since last receiving anti-cancer treatment which included BBI608, provided that all treatment-related adverse events have resolved or have been deemed irreversible (except for alopecia).
Prior systemic chemotherapy unless it was part of definitive-intent (curative intent) treatment more than 6 months before study entry
Subject must have received at least 6 months of chemotherapy
Patients who received prior systemic chemotherapy for the study cancer.
No prior palliative chemotherapy
Patients with histologically confirmed metastatic colorectal cancer, who have received and/or progressed on a prior oxaliplatin-based chemotherapy regimen
Neoadjuvant chemotherapy before or after prostatectomy
Phase 1b Dose Escalation - Individuals may have had unlimited prior hormonal therapy and a total of 2 prior chemotherapy regimens (adjuvant chemotherapy is considered 1 regimen). Individuals may have progressed on fulvestrant or exemestane.
Subject who was previously treated with at least one prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy.
Prior cytotoxic chemotherapy for metastatic prostate cancer. Prior cytotoxic chemotherapy with curative intent in the neoadjuvant or adjuvant setting is allowed but must have been completed at least 6 months prior to registration. No cytotoxic chemotherapy is allowed during protocol specified therapy.
Newly diagnosed locally advanced tumour which requires upfront systemic chemotherapy but is still amenable to curative treatment (i.e. chemotherapy followed by definitive chemoradiotherapy)
Previous administration of > 2 cycles of systemic chemotherapy as induction treatment before definitive chemoradiotherapy for early stage disease
Achievement of SD or PR after a minimum of 12 weeks of pre-study first- or second-line standard chemotherapy
Patients may have a history of resectable urothelial cancer (including neoadjuvant chemotherapy) as long as patients meet one of the following:\r\n* pT0, Tis, or T1N0 and have no evidence of disease (NED) for more than 2 years from surgery or chemotherapy;\r\n* pT2-3aN0 and NED for more than 3 years from surgery or chemotherapy; or\r\n* > pT3b, or N+ and NED for more than 5 years from surgery or chemotherapy
Have received previous chemotherapy for advanced NSCLC. Participants who have received adjuvant or neoadjuvant chemotherapy are eligible if the last administration of the prior regimens occurred at least 1 year prior to study entry.
Previous systemic chemotherapy or radiation for bladder cancer. Note: Prior immunotherapy or intravesical (administered within the bladder) chemotherapy for superficial disease is acceptable
Anticipated use of chemotherapy or radiotherapy not specified in the study protocol while on study
Prior therapy with ? 1 systemic chemotherapy regimens for urothelial carcinoma
Any chemotherapy less than 28 days before first dose of study
Subjects who have had any prior chemotherapy within 5 years of enrollment
At least 2 weeks from last chemotherapy or before chemotherapy
Prior chemoradiotherapy for a pelvic recurrence is permitted. Prior chemotherapy in the adjuvant setting for Stage I, II or III disease is permitted. Note: No prior chemotherapy in the setting of Stage IV disease is permitted unless the patient was without evidence of disease at the completion of chemotherapy and had at least six months of progression-free survival since the completion of chemotherapy. Regardless of circumstances, no more than one prior chemotherapy regimen (including chemo-radiotherapy) is permitted.
Anticipated need for systemic chemotherapy within 2 weeks before apheresis and infusion of CART-meso cells
Not be receiving neoadjuvant hormonal or chemotherapy (other clinical trials)
Documentation of recurrent or progressive GBM following at least one (1) prior therapeutic regimen including upfront radiation and chemotherapy with temozolomide; up to three additional therapeutic regimens for disease progression prior to enrollment to the study is permitted
Chemotherapy in the 6 months prior to registration
Previous therapy for metastatic gastroesophageal cancer; previous perioperative chemotherapy is allowed as long as the duration without treatment has been greater than 6 months
Previous systemic chemotherapy for MPM
The following eligibility criteria pertain to patients enrolling into PART 2 of the study:\n\n        Inclusion:\n\n          -  Have a histologically confirmed diagnosis of high grade serous or Grade 2 or Grade 3\n             endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer\n\n          -  Received at least 3 prior chemotherapy regimens. Non-chemotherapy regimens and\n             maintenance therapies administered as single agent treatment will not count as a\n             chemotherapy regimen\n\n          -  Relapsed/progressive disease as confirmed by CT scan\n\n          -  Have biopsiable and measurable disease. Note: biopsy is optional for patients known to\n             harbor a deleterious gBRCA mutation\n\n          -  Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue\n             available for planned analyses\n\n        Exclusion:\n\n          -  History of prior cancers except for those that have been curatively treated, with no\n             evidence of cancer currently (provided all chemotherapy was completed >6 months prior\n             and/or bone marrow transplant >2 years prior to first dose of rucaparib).\n\n          -  Prior treatment with any PARP inhibitor\n\n          -  Symptomatic and/or untreated central nervous system metastases\n\n          -  Pre-existing duodenal stent and/or any other gastrointestinal disorder or defect that\n             would, in the opinion of the Investigator, interfere with absorption of rucaparib\n\n          -  Hospitalization for bowel obstruction within 3 months prior to enrollment
Patients must have received frontline therapy (including surgery, chemotherapy, autologous stem cell transplant [SCT] +/- MIBG, immunotherapy, radiotherapy, and retinoids) but may NOT have received second line chemotherapy for resistant/refractory, relapsed disease or progressive disease
A minimum of 4 weeks must have elapsed since the completion of prior chemotherapy; hydroxyurea for control of blasts is not counted as chemotherapy, and may be given until initiation of therapy
Patient must have not received systemic chemotherapy for metastatic disease; prior chemotherapy, radiation therapy, concurrent chemoradiation are allowed if used for treatment of non-metastatic disease; prior palliative radiation for symptom management is allowed; any chemotherapy must have been completed 4 weeks prior to enrollment; any radiotherapy must have been completed 2 weeks prior to enrollment
The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first
Patients may not have received more than one prior chemotherapy
Prior systemic chemotherapy for bladder cancer; prior chemotherapy for a different cancer is allowable
Patients who have received any prior chemotherapy are not eligible
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 (prior intravesical therapy is allowed)
Use of chemotherapy
Patients must be treated with a standardly accepted chemotherapy regimen if chemotherapy is indicated; (certain tumors of low-grade or small size may not require chemotherapy)
Prior taxane or anthracycline chemotherapy for malignancy
No previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy)
Prior chemotherapy for extensive-stage SCLC
Patients must have had no more than two prior chemotherapeutic regimens for recurrent endometrial carcinoma. Chemotherapy administered in conjunction with primary radiation as a radio-sensitizer is not counted as a prior treatment for recurrent or advanced disease.
Prior nab-paclitaxel chemotherapy excluded.
Has received a prior anthracycline chemotherapy either for ovarian cancer treatment or another previous malignancy
Patients must have received less than 3 prior chemotherapy regimens for progressive meningioma
Have received prior treatment with at least 2 chemotherapy regimens, of which at least 1 but no more than 2 have been administered in the metastatic setting.
History of prior chemotherapy
Any prior exposure to neurotoxic chemotherapy
MEDI4736 + nab-paclitaxel + gemcitabine chemotherapy cohort: treatment-naïve patients with metastatic PDAC who have received no previous systemic chemotherapy 5 MEDI4736 + Cohort: Patient should receive no more than 1 prior systemic chemotherapy regimen.
Participants for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study
Patient has had any prior intravesical chemotherapy, immunotherapy, or previous exposure to apaziquone.
Progression of disease after the most recent anticancer treatment. At least 1 prior chemotherapy regimen must have included a taxane.
More than 3 prior lines of cytotoxic chemotherapy for ovarian cancer.
Progression during or after prior first- or second-line chemotherapy and eligible to receive topotecan therapy
Prior systemic chemotherapy for prostate cancer (note that prior chemotherapy for a different cancer is allowed)
Prior treatment with any of the chemotherapy medications (cisplatin or docetaxel) for HNSCC or with AZD1775
Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.
Patients who have received induction chemotherapy for their cancer diagnosis
Undergone neoadjuvant chemotherapy
Neoadjuvant chemotherapy
Failed first-line chemotherapy
Prior cytotoxic chemotherapy for prostate cancer, but up to 2 cycles of docetaxel chemotherapy for metastatic disease is permitted.
Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
No more than three prior systemic chemotherapy regimens
Patients who have relapsed or are refractory to at least one prior chemotherapy regimen, and for whom no standard therapy exists; there is no limit to the number of prior chemotherapy regimens received
Previous treatment with CLAG or other chemotherapy regimen containing both cladribine and cytarabine
Less than 7 days from the completion of any previous cytotoxic chemotherapy (with the exception of hydroxyurea)
Any neoadjuvant chemotherapy
Cytotoxic chemotherapy within the 28 days prior to randomization
No induction chemotherapy
Subject that have received more than 2 prior lines of chemotherapy must not have liver metastases
Patients must have received at least one prior systemic chemotherapy regimen for metastatic pancreatic cancer; they should have experienced disease progression or intolerable toxicity from that regimen
Patients who have received prior non-gemcitabine-based systemic chemotherapy for metastatic disease or those who are beyond 12 months of exposure to gemcitabine-based chemotherapy regimen are allowed
Subject has received > 1 prior line of chemotherapy in the metastatic setting
Subject has received any chemotherapy within 21 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
Prior therapy with ? 1 systemic chemotherapy regimen for unresectable or metastatic pancreatic cancer or unwilling/unable to receive systemic chemotherapy
Patients who have received prior cytotoxic chemotherapy for castration-resistant prostate cancer unless enrolled in a previous chemotherapy cohort.
May have received one or more prior treatments with chemotherapy
Have undergone treatment with systemic chemotherapy within the last 1-5 years
Patients must have previously received at least one line of prior systemic chemotherapy or targeted treatment for metastatic disease OR have received prior adjuvant systemic chemotherapy within prior 6 months; patients with MBC, must have received at least a taxane based regimens; patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma receptor tyrosine kinase (ALK) mutations should have failed prior standard tyrosine kinase inhibitor (TKI) therapy; patients must have completed previous treatment (including other investigational therapy) in greater than or equal to the following times prior to initiation of study treatment:\r\n* Chemotherapy/targeted therapy administered in a daily or weekly schedule must be completed >= 2 weeks prior to study treatment \r\n* Chemotherapy/targeted therapy administered in a 2-weekly schedule must be completed >= 3 weeks prior to study treatment\r\n* Chemotherapy/targeted therapy administered in a 3-weekly or greater schedule must be completed >= 4 weeks prior to study treatment
Has had chemotherapy for castration-resistant disease; chemotherapy for castration-sensitive disease is permitted
Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC.
No more than 2 prior lines of systemic chemotherapy for metastatic urothelial cancer
Patient currently receiving lithium, steroid, chemotherapy or radiotherapy treatment
At least one prior line of platin-based chemotherapy (unless refused or not tolerated)
> 2 prior chemotherapy regimens
Note: Trastuzumab emtansine (T-DM1) is considered acceptable as prior Trastuzumab/chemotherapy regimen
After completion of all chemotherapy, lung metastases must be =< 2 cm
Eligible to receive treatment with the selected doublet-chemotherapy
Patients may have up to three prior lines of systemic cytotoxic chemotherapy for metastatic or unresectable disease; prior use of hormonal agents (agents targeting the androgen receptor or biosynthesis pathway [goserelin, leuprolide, bicalutamide, enzalutamide, abiraterone], tamoxifen, aromatase inhibitors, fulvestrant, etc) are allowed; other hormonal agents not listed need to be reviewed by the principal investigator prior to enrollment; combination chemotherapy is considered to be a single line of chemotherapy; docetaxel is a reasonable treatment option for their malignancy
Current or previous chemotherapy or bisphosphonate therapy is permissible
Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded; patients who have received neoadjuvant chemotherapy prior to their initial debulking are excluded; patients may have received prior adjuvant chemotherapy for breast cancer
Suitable for conventional single agent chemotherapy
Completion of cytoreductive surgery and has completed one (and only one) course of platinum-based chemotherapy (5-9 cycles) >= 4 but =< 20 weeks prior to registration; NOTE: cytoreductive surgery may have been prior to or after the first cycle of chemotherapy but must include hysterectomy and bilateral salpingo-oophorectomy, if the uterus and/or ovaries had not previously been removed; NOTE: patients may have had more than one chemotherapy regimen (ex: paclitaxel/carboplatin switched to docetaxel/carboplatin due to allergy; weekly treatment switched to every 3 week treatment due to intolerance), but may not have received a separate course of treatment for recurrent ovarian cancer (OC); NOTE: patients may receive both neoadjuvant and adjuvant chemotherapy provided both regimens are platinum-based and total 9 or fewer chemotherapy cycles
No cytotoxic chemotherapy within 2 weeks of starting study treatment
Myelosuppressive chemotherapy: must not have received within 4 weeks of entry onto this study
Received cytotoxic chemotherapy, investigational agents, or radiation within 14 days, except SRS or stereotactic body radiosurgery.
Completion of preoperative systemic chemotherapy
Patients must have one of the following a) low volume disease (defined as no visceral metastases and < 4 bone metastases) or b) are not candidates for docetaxel based chemotherapy or c) refused docetaxel chemotherapy
Patients must have received first line chemotherapy, from 4-6 cycles, and achieved stable disease or a partial response
Prior cytotoxic chemotherapy for the treatment of CRPC, including taxanes, mitoxantrone and estramustine
Patients who have had conventional intensive cytotoxic induction chemotherapy for treatment of specifically MDS or AML are excluded
Participants who have had chemotherapy or radiotherapy any time prior to entering the study or at any prior time for mesothelioma. Patients receiving chemotherapy type drugs for benign conditions can participate in this trial
Prior chemotherapy\r\n* Up to 3 prior chemotherapy regimens for treatment of metastatic disease are allowed as long as study subject is in the investigator’s opinion acceptable for study treatment with the chemotherapy agents required on this study in cohort 2 study treatment at progression on T+P; all chemotherapy has to be discontinued >= 21 days before starting the study treatments with T+P\r\n* The chemotherapy regimen in cohort 2 will be based on the patients’ prior treatment; patient must not have previously progressed on the chemotherapy agent chosen by the principal investigator (PI) for the addition to the trastuzumab + pertuzumab backbone in this study\r\n* One of the following chemotherapy agents: eribulin mesylate (eribulin) or paclitaxel or nab-paclitaxel (abraxane) or docetaxel or vinorelbine tartrate (vinorelbine) or capecitabine at schedules and doses prespecified in the body of this protocol has to be acceptable for the study treatment and can be chosen by the PI at progression on trastuzumab and pertuzumab therapy\r\n* If needed chemotherapy dose adjustments are allowed per standard of care
For chemotherapy part of this study the study chemotherapy drug label guidelines have to be used to assure safety
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).
For the randomised phase only, patients must have received chemotherapy in the form of docetaxel treatment for metastatic castration-resistant prostate cancer. Note: patients who discontinued docetaxel for toxicity reasons and without completing the full course will still be eligible to enter this study provided they received at least 2 cycles of chemotherapy.
Patients who received chemotherapy > 5 years ago for malignancies other than pancreatic cancer are eligible, provided that chemotherapy was completed > 5 years ago and that there is no evidence of the second malignancy at the time of study entry
No prior therapy with the exception of 1 cycle of chemotherapy based on current diagnosis and clinical condition
Patients must have had one prior chemotherapeutic regimen for management of cervical carcinoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or chemotherapy as consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radiosensitizer will not be counted as a systemic chemotherapy regimen
Other chemotherapy regimens may have been administered between the time of progression on prior trastuzumab containing regimen and protocol therapy; no restriction on prior chemotherapy regimens for advanced stage disease
Complete pathologic response to neoadjuvant chemotherapy (NAC).
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Cytotoxic chemotherapy or other chemotherapy known to be myelosuppressive: ?21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
No treatment with prior taxane-based chemotherapy for metastatic disease\r\n* Patients who received prior taxane-based chemotherapy as neoadjuvant or adjuvant therapy for local disease, or who received taxane-based therapy in the PSA clinical (non-metastatic) state is allowable provided that the total duration of exposure was six cycles or less and chemotherapy was completed more than 6 months prior to registration\r\n* Taxane-based chemotherapy that was aborted due to allergic reactions or intolerance to chemotherapy and therefore received 1 cycle of prior therapy is allowable
Prior chemotherapy is allowed
Prior treatment with HAI chemotherapy
Prior systemic chemotherapy for the study cancer; NOTE: prior chemotherapy for a different cancer is allowable
Prior chemotherapy or biologic therapy for the same HNSCC; prior chemotherapy or biologic therapy for a different previous HNSCC is allowed
Any number of prior chemotherapy regimens is allowed
Patients must be at least 21 days post cytotoxic chemotherapy prior to enrollment
Participants may have received prior docetaxel-based chemotherapy for prostate cancer; such chemotherapy must have been stopped at least three weeks prior to the first dosing in this study
Participants who have received more than two prior chemotherapy regimens for metastatic CRPC
Subjects must have a clinically indicated need for systemic chemotherapy for adenocarcinoma of the lung based on the investigator's assessment
History of prior chemotherapy
Patients must be, in the opinion of the investigator, in response (partial or complete radiological response), or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125, following completion of this chemotherapy course
Patients must be randomized within 8 weeks of their last dose of chemotherapy
Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study.
History of prior chemotherapy in the past 5 years
Must have received at least 1 prior platinum-based chemotherapy regimen but have received no more than 3 lines of prior chemotherapy regimens, with no limit to the number of lines of prior hormonal therapy. Front-line therapy may include neoadjuvant and adjuvant therapy and will be counted as 1 prior systemic regimen. Biological therapy (e.g. bevacizumab) administered as a single agent is considered a prior systemic regimen and not a prior chemotherapy regimen. Maintenance therapy is not considered its own regimen but should be included with the regimen that it follows.
Patients must be randomized within 8 weeks of their last dose of chemotherapy
Patients who have previously received chemotherapy for any abdominal or pelvic tumour, including treatment for prior diagnosis at an earlier stage for their ovarian, fallopian tube or primary peritoneal cancer. (Patients who have received prior adjuvant chemotherapy for localised breast cancer may be eligible, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease).
Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months
At least 21 days from the completion of any previous cytotoxic chemotherapy or biological therapy at time of initiation of POL6326.
Up to one prior line of chemotherapy for advanced disease is allowed; if received, prior chemotherapy must be discontinued at least 14 days prior to initiation of protocol therapy
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 chemotherapy for prostate cancer, with the exception of neo-adjuvant chemotherapy, because of the potential effect of chemotherapy on the immune system.
No more than two lines of prior cytotoxic chemotherapy in the recurrent/metastatic (palliative intent) treatment setting
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)
Patients must have had no more than two prior chemotherapeutic regimens for recurrent management of endometrial carcinoma; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer is not counted as a prior treatment for recurrent or advanced disease
PRE-REGISTRATION EXCLUSION CRITERIA: Prior chemotherapy for this cancer (excluding initiation of best practice chemotherapy to be given as standard of care, which may be initiated after the pre-registration bone marrow collection but before final confirmation of eligibility and randomization)
REGISTRATION EXCLUSION CRITERIA: Prior chemotherapy for this cancer (excluding initiation of best practice chemotherapy to be given as standard of care, which may be initiated after the pre-registration bone marrow collection but before final confirmation of eligibility and randomization)
Patients receiving preoperative (Neoadjuvant) and postoperative adjuvant chemotherapy (within 12 weeks of surgery) with the same agent(s) will be considered to have received a single chemotherapy regimen.
Previous chemotherapy, radiotherapy of other treatment for PC
Patients must complete the standard chemotherapy appropriate for the histologic subtype of lymphoma and be able to start radiation therapy within 3 months of completing chemotherapy
At least 2 prior chemotherapy regimens; at least one fludarabine or other nucleoside analog containing regimen; chemotherapy in combination with monoclonal antibody (Rituxan) will be considered one prior regimen, but single agent Rituxan will not be considered one prior regimen; single agent ofatumumab will be counted as a regimen
Prior chemotherapy treatment unless =< 5 years ago
More than 3 prior lines of chemotherapy for recurrent cancer.
Prior chemotherapy (unless allowed for some study arms)
Prior cytotoxic chemotherapy (e.g. docetaxel, mitoxantrone, cabazitaxel) within 6 months of registration is prohibited
Less than 3 weeks elapsed since prior exposure to chemotherapy
Patients must have recovered from the acute toxicity of all prior chemotherapy; patients may not have received cytotoxic chemotherapy within 2 weeks of first dose of G-CSF (filgrastim) therapy, with exception of hydroxyurea, which is allowed for up to 24 hours prior to first dose of G-CSF, and intrathecal chemotherapy, which is allowed prior to, or in the 1st 72 hours after start of G-CSF therapy
Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol with the exception of intrathecal chemotherapy; this includes the tyrosine kinase inhibitor sorafenib which must not be initiated until patient demonstrates count recovery
Patients with second malignancies in remission may be eligible if there is clinical evidence of disease stability for a period of greater than 6 months off cytotoxic chemotherapy, documented by imaging, tumor marker studies, etc., at screening. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are eligible.
Patient must not have had previous systemic chemotherapy for the study cancer; (Note: prior chemotherapy for a different cancer is allowable)
Prior systemic chemotherapy
Experienced progression after one or more prior regimens of cytotoxic chemotherapy
Patients who have had previous chemotherapy or radiotherapy for pancreatic adenocarcinoma prior to entering the study.
Relapsed after ? 2 prior chemotherapy- or immunotherapy-based regimens for indolent NHL, or refractory to 2 prior chemotherapy and/ or immunotherapy-based regimens.
Relapsed after ? 2 prior chemotherapy regimens, including the following: First-line treatment with standard anthracycline-containing regimen (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone or equivalent). At least 1 additional combination chemotherapy regimen. Patients relapsed after or refractory to first prior chemotherapy- and/or immunotherapy-based regimen for aggressive NHL and not eligible for high-dose regimen followed by transplant. High-dose chemotherapy, or chemoradiotherapy with autologous stem cell transplantation is considered 1 regimen. Patients with CD20 expressing neoplastic cells must have received prior rituximab, if available.
Patients with transformed indolent lymphoma must have received at least 2 prior chemotherapy- and/or immunotherapy-based regimens
For patients with HL or ALCL, subjects are eligible after failure of at least one prior multi-agent chemotherapy regimen
Patients that have been treated with > 3 prior chemotherapy regimens
Not considered eligible for one or more of the chemotherapy agents included in the induction regimen
Patients must have received at least one chemotherapy regimen which contained doxorubicin.
Prior systemic chemotherapy (prior intravesical therapy is allowed)
Patients who have had chemotherapy or radiotherapy within 2 weeks except for intrathecal chemotherapy (i.e., methotrexate, cytarabine, or thiotepa)
Patients with up to 2 prior chemotherapy regimens are eligible
Chemotherapy administered for the diagnosis of seminoma:\r\n* Prior chemotherapy for a different cancer is allowed, provided therapy was completed more than twelve months from first fraction of proton therapy administered in this study and the participant has recovered to grade =< 1 toxicity related to agents previously administered
Current or prior chemotherapy
Prior bevacizumab and any cytotoxic chemotherapy
Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
Patients must not have received neoadjuvant chemotherapy for the present disease
Patients who received chemotherapy directed at the present disease
More than 2 prior lines of cytotoxic chemotherapy
Two weeks must have elapsed since administration of previous chemotherapy
Have received at least three prior chemotherapy regimens and have relapsed disease confirmed by radiologic assessment
Subject who the investigator considers that chemotherapy is not indicated.
No prior chemotherapy, radiotherapy, or antiangiogenic therapy
Cytotoxic chemotherapy: ? duration of the most recent cycle of the previous regimen (a minimum of 2 weeks for all)
Currently receiving any chemotherapy, investigational agents or registration on another therapy based trial or received chemotherapy with radiation therapy (e.g., temozolomide)
Part C: Glioblastoma multiforme that has progressed or recurred after radiotherapy and/or chemotherapy
For patients > 60 years of age the 1 cycle of standard chemotherapy is not required if either of the following criteria is met:\r\n* Relapse within 6 months of last chemotherapy\r\n* Blast count < 30% within 10 days of starting protocol therapy
Planned cytotoxic chemotherapy during the SRS or WBRT
Women with planned treatment of radiotherapy only (without chemotherapy)
Failure to one induction course of chemotherapy (these patients will be analyzed separately)
Prior anti-cancer therapy that fulfills the following criteria: a total of more than three (Arms A and B) or two (Arms C and D) prior cytotoxic chemotherapy regimens, high-dose chemotherapy requiring stem-cell support, and irradiation to >=25 percent (%) of bone marrow-bearing areas
Patients who have had 2 or more regimens containing cytotoxic chemotherapy for metastatic melanoma.
Patients may receive any number of cycles of chemotherapy prior to treatment with SBRT, but not within 2 weeks of the first fraction of radiotherapy (RT); patients are not required to receive any chemotherapy to be eligible for study enrollment
Completed cancer specific therapy (including surgery, radiotherapy and/or chemotherapy) a minimum of 4 weeks prior to entry; (subjects with hormone receptor positive breast carcinoma maintained on hormonal therapy following chemotherapy and radiation are eligible)
Fludarabine-based chemotherapy within 6 months
Any number of previous chemotherapy regimens (except those containing TMZ or dacarbazine [DTIC]) in the metastatic setting are allowed as long as >= 4 weeks have elapsed from last treatment
More than 1 prior chemotherapy regimen for mCRC; previous adjuvant FOLFOX based chemotherapy is allowed; prior FOLFIRI or single agent irinotecan is prohibited
Prior treatment with not more than 1 systemic agent (including chemotherapy or biologic agent e.g. vandetanib for patients with medullary thyroid cancer)
Patients must have had one prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent carcinoma of the cervix\r\n* Chemotherapy administered concurrent with primary radiation (e.g.; weekly cisplatin) is not counted as a systemic chemotherapy regimen for management of advanced, metastatic, or recurrent disease; adjuvant chemotherapy given following the completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted as a systemic chemotherapy regimen for management of advanced, metastatic, or recurrent disease (e.g.; paclitaxel and carboplatin for up to 4 cycles)
Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of cervical cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
Documentation regarding the details of administration of all systemic chemotherapy must be available
Patients with refractory anemia with excess blasts (RAEB) who have not received myelosuppressive chemotherapy i.e. induction chemotherapy
Prior neoadjuvant chemotherapy for this cancer is permitted however patients must have completed treatment within 70 days prior to cystectomy and recovered from all associated toxicities at the time of registration
Chemotherapy given on the day of the planned radiotherapy treatment
No prior treatment with cytotoxic chemotherapy
Prior chemotherapy or radiotherapy
Exclusion criteria below (*) apply only to patients who are enrolled AFTER completing 3 to 6 cycles of first-line chemotherapy; exclusion criteria (*) DO NOT APPLY to patients who are enrolled prior to completing 3 to 6 cycles of first-line chemotherapy; these patients can be enrolled but ultimately MAY not be treated with radiation therapy/SBRT; this is dependent on their restaging imaging after the completion of chemotherapy
* Patients with complete response to first-line chemotherapy with no measurable target for SBRT/RT
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
Subject may have received chemotherapy or other therapy after harvest of tumor and prior to enrollment; subjects who have achieved complete response following chemotherapy are still eligible for participation
May have received up to two prior lines of chemotherapy for advanced disease
Expansion Cohort 3: Subjects with UC with transitional cell histology (including bladder, renal pelvis, ureter, urethra) who are ineligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy for inoperable, locally advanced, or metastatic disease
Expansion Cohort 4: Subjects with UC with transitional cell histology (including bladder, renal pelvis, ureter, urethra) eligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy for inoperable, locally advanced, or metastatic disease
Able to receive intensive induction chemotherapy
Previous chemotherapy for AML except for the following, which are allowed:
Participants may have 0-1 prior lines of cytotoxic chemotherapy in the metastatic setting
Patients who have received induction chemotherapy before radiation treatment
Any number of prior chemotherapy regimens is permitted
Patients who are chemotherapy naive
Patients must have had one prior platinum-based chemotherapeutic regimen for management of endometrial carcinoma or carcinosarcoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as radio-sensitizer WILL be counted as a systemic chemotherapy regimen
Any chemotherapy within 30 days of enrollment.
Completed all planned therapy for T >= 1.0 cm, Nx, M0 or Tx, N >= N1, M0  triple negative breast cancer (TNBC) (American Joint Committee on Cancer, 7th edition) meeting the following guidelines:\r\n* Received neoadjuvant chemotherapy and/or completed adjuvant chemotherapy with or without radiation; (the patient may have had adjuvant and/or neoadjuvant chemotherapy for their disease); patients who received neoadjuvant chemotherapy may have either residual disease or a complete response; adjuvant/neoadjuvant chemotherapy regimens must include at least 4 cycles of a standard chemotherapy regimen, and generally this should include one of the generally accepted standard regimens (including but not limited to: doxorubicin hydrochloride, cyclophosphamide and paclitaxel [AC-T], Taxotere and cyclophosphamide [TC], doxorubicin hydrochloride and cyclophosphamide [AC], or cyclophosphamide, methotrexate and fluorouracil [CMF]); for patients who received their standard chemotherapy as part of a clinical trial, the regimen should include at least 4 cycles of therapy; patients who initiate planned chemotherapy but discontinue before receiving 4 cycles due to toxicity will be eligible\r\n* All planned radiation therapy and surgery for the treatment of the current cancer should be complete (not including plastic or reconstructive surgery)\r\n* Patients with local-regional recurrence without evidence of distant metastases (no definite stage IV disease) who are treated with curative intent may be eligible following completion of all surgery and/or chemotherapy and/or radiotherapy; such patients must have no evidence of residual disease by standard clinical and radiological examination (per investigator discretion) following completion of curative intent treatment
Prior non-cisplatin based neoadjuvant systemic chemotherapy for urothelial carcinoma (prior intravesical chemotherapy or immunotherapy is permissible)
Prior cisplatin based neoadjuvant systemic chemotherapy for more than 4 cycles
Induction chemotherapy is allowed
Patients with complete response, partial response, or stable disease following 4, 5 or 6 cycles of first-line chemotherapy with pemetrexed AND either cisplatin or carboplatin; a maximum of 6 cycles of chemotherapy may have been given
Patients with more than one previous chemotherapy regimen
Patients with recurrent or progressive disease after one or more regimens of pre-radiation chemotherapy
Previously treated with a maximum of four unique chemotherapy containing treatment regimens
Women undergoing neoadjuvant chemotherapy are not eligible
Multiple myeloma or plasma cell leukemia must have received more than one line of prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative HCT is permitted
Previous chemotherapy for any malignancy including temozolomide, dacarbazine (DTIC) or prior nitrosourea
No prior chemotherapy, including carmustine-containing wafers (Gliadel®)
No previous radiotherapy or chemotherapy other than corticosteroid therapy
Failed at least one prior chemotherapy
TIER I SUBJECTS: Patients with relapsed follicular lymphoma achieving at least a PR following their most recent systemic chemotherapy and/or immunotherapy regimen; Tier I subjects must have had at least two prior chemotherapy and/or immunotherapy regimens; partial response from pre-study regimen may be either a clinically determined response by the principal investigator or physician co-investigator member of the study team, or a measured response as per the response criteria of this protocol
All patients may have received up to two prior lines of chemotherapy for recurrent/advanced disease
More than 4 prior cytotoxic chemotherapy regimens
No previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy).
Chemotherapy within 28 days prior to C1D1
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
Women with TNBC who have received at least one but no more than two prior chemotherapy regimens for TNBC
Inclusion Criteria:\n\n        Part 1 and Part 2 cohort 3: Patients diagnosed with AML ( bone marrow (BM) or peripheral\n        blood (PB) blast counts >/= 20%) and have received prior chemotherapy and/or standard of\n        care and have relapsed, refractory or Minimal Residual Disease (defined as patients showing\n        residual blast 10-14 days post-induction chemotherapy).\n\n        • Patients that are not candidates to receive standard of care and/or refusing the standard\n        care of therapies will also be considered.\n\n        Part 2 - Cohort 1 and 2: Newly diagnosed, previously untreated de novo or secondary AML\n        population (AML with bone marrow or peripheral blast counts 20%):\n\n          -  Cohort 1: Fit to receive intensive remission induction chemotherapy.\n\n          -  Cohort 2: Unfit to receive or not considered a candidate for intensive remission\n             induction chemotherapy.\n\n        Part 1 and 2:\n\n          -  Life expectancy at least 12 weeks.\n\n          -  Hydroxyurea is allowed on study to control total peripheral white blood cell count but\n             must be ceased 24 hours prior to first dose.\n\n          -  Off of prior therapy for 2-4 weeks prior to first dose.\n\n          -  ECOG performance status: 0 to 2.\n\n          -  Resolved acute effects of any prior therapy.\n\n          -  Adequate renal and hepatic function.\n\n        Exclusion Criteria:\n\n          -  Patients with acute promyelocytic leukemia, AML with known central nervous system\n             (CNS) involvement unless the patient has completed treatment for the CNS disease, has\n             recovered from the acute effects of therapy prior to study entry, and is\n             neurologically stable.\n\n          -  Patient is known refractory to platelet or packed red cell transfusions per\n             institutional guidelines.\n\n          -  Prior treatment with a compound targeting CXCR4.\n\n          -  Chronic systemic corticosteroid treatment.\n\n          -  Known or suspected hypersensitivity to recombinant human proteins.\n\n          -  Chronic graft versus host disease (GVHD), active GVHD with other than Grade 1 skin\n             involvement, or GVHD requiring systemic immunosuppressive treatment (Part 1 and cohort\n             3).\n\n          -  Not recovered from stem cell transplant associated toxicities (Part 1 and cohort 3).\n\n          -  Prior treatment with hypomethylating agents or chemotherapy for antecedent\n             myelodysplastic syndrome (MDS) (Part 2, cohort 2)\n\n          -  AML associated with favorable risk karyotypes, including inv(16), t(8;21), t(16;16),\n             or t(15;17) (cohort 2)\n\n          -  Candidates for allogeneic stem cell transplant (Part 2, cohort 2)\n\n          -  Known hypersensitivity to cytarabine or daunorubicin (Part 2, cohort 1) and decitabine\n             or azacitidine or mannitol (Part 2, cohort 2).
Recent chemotherapy within 3 weeks of screening
Candidates for cytotoxic chemotherapy
Received more than one line of chemotherapy
Patients who have had more than 4 prior chemotherapy regimens
Patients who have received prior chemotherapy for any abdominal or pelvic tumor other than for treatment of ovarian carcinoma within the last 3 years are excluded; patients may have received prior chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration and the patient remains free of recurrent of metastatic disease
Chemotherapies: Salvage chemotherapy must be stopped at least 1 week prior to leukapheresis
Patients who have had chemotherapy or radiotherapy to the oropharynx prior to entering the study
Prior treatment with cytotoxic chemotherapy for advanced NSCLC; neoadjuvant/adjuvant chemotherapy is permitted if at least 6 months has elapsed between the end of chemotherapy and randomization
Prior treatment with docetaxel-based chemotherapy
Patients must have had 16 to 20 weeks of first-line therapy with oxaliplatin, and/or irinotecan-based fluoropyrimidine-containing chemotherapy plus bevacizumab
Patients must have stable disease (or better) during the initial induction chemotherapy with first-line chemotherapy
Chemotherapy or radiotherapy within 14 days prior to first dose of protocol therapy
Prior chemotherapy regimens =< 1
Pre-registration chemotherapy given within 42 days of treatment (treatment meaning surgery if Arm A, chemotherapy if Arm B)
Progressive disease after ? 1 prior chemotherapy regimen.
Chemotherapy: no limit to prior therapies; however, patients with multiple chemotherapy regimens will be screened for lymphocyte proliferation at investigator’s discretion
Prior systemic chemotherapy treatment for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib single agent only)
Received one prior line of chemotherapy for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib + mFOLFOX6 only)
Participants who have received > 1 prior line of chemotherapy in the advanced or metastatic setting. (Immunotherapy will not be considered a line of chemotherapy.)
Prior treatment with chemotherapy for CRPC
Intrathecal therapy with cytarabine is allowed prior to registration for patient convenience; systemic chemotherapy must begin within 72 hours of the first intrathecal treatment
Patient who received neoadjuvant chemotherapy for ovarian cancer
Has experienced failure of at least 1 prior chemotherapy regimen:
A drug provided as maintenance therapy following cytotoxic chemotherapy will be considered to be part of that regimen.
Must have received at least 3 cycles of first-line chemotherapy.
Two or more relapses after initial response to induction chemotherapy
Patients should have received at least 2 cycles of induction therapy or 1 induction and 1 consolidation cycle, OR patient should be considered to have completed all planned chemotherapy, OR patient is considered to be unable, unfit or unwilling to receive additional chemotherapy
Subjects should have received and failed at least one prior cytotoxic chemotherapy regimen for advanced disease that included trastuzumab
Prior treatment with taxanes if given as full-dose chemotherapy for advanced disease; as neoadjuvant therapy, taxanes cannot be used in 6 months prior to enrollment
Front-line chemotherapy that did not contain trastuzumab
Patient not eligible for (immediate) standard induction chemotherapy based on the opinion of the treating physician and the frailty score
More than one prior line of chemotherapy (i.e., 2nd or 3rd line chemotherapy) for advanced and/or metastatic (stage III B or IV NSCLC) or recurrent disease.
Another active primary malignant disease, which requires systemic treatment (chemotherapy or radiation)
Patients in first relapse must be chemoresistant or intolerant to chemotherapy
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
No prior systemic chemotherapy or WEE1 kinase inhibitor therapy for metastatic or recurrent disease will be allowed; patients are permitted to have received prior systemic chemotherapy as a part of the initial multimodality treatment for locally advanced disease if this treatment was completed more than 6 months prior to enrollment
Patients with muscle invasive bladder cancer (MIBC) must have never received and currently be ineligible for cisplatin-based neoadjuvant chemotherapy due to any of the following:\r\n* Calculated creatinine clearance of < 60 ml/min\r\n* Karnofsky performance status (KPS) < 80\r\n* Solitary kidney or\r\n* Patient refusal to undergo neoadjuvant chemotherapy
Previous treatment with hypomethylating agent or induction chemotherapy for MDS
Prior immunotherapy (e.g. sipuleucel-T), and chemotherapy are permitted (4 week washout period from chemotherapy)
No more than 2 prior chemotherapy regimens.
Pts with NSCLC who have received, are receiving or are planning to receive two to four cycles of standard frontline chemotherapy are eligible; choice of chemotherapy is at the discretion of the medical oncologist; concurrent chemoradiotherapy will not be permitted during the active study period; post-operative radiotherapy can be administered as clinically indicated
Prior treatment for NSCLC except for pleurodesis and/or standard frontline chemotherapy
Previously undergone chemotherapy, brachytherapy, or radiotherapy prior to entering the study
Patients on chemotherapy &/or targeted agents for palliation
Prior anti-cancer treatments are permitted (i.e., chemotherapy, radiotherapy, hormonal, or immunotherapy)
Prior chemotherapy, radiation for any malignancy in which they received any thoracic radiotherapy
For subjects who developed liver metastases >/=6 months after completing treatment for primary CRC and having undergone surgery with curative intent for liver metastases, a second course of chemotherapy is not permitted unless initial adjuvant therapy consisted of fluoropyrimidine monotherapy. Subjects who received fluoropyrimidine alone must have received a second course of chemotherapy with fluoropyrimidine and either oxaliplatin or irinotecan or both, which should not exceed 9 months.For subjects with initial Stage I or II disease, no chemotherapy is required for a primary CRC lesion treated with surgery with curative intent. These subjects must receive chemotherapy for the treatment of liver metastases (which were also treated with surgery with curative intent), which must last at least 3 months, including a fluoropyrimidine and either oxaliplatin or irinotecan or both. The total course of chemotherapy should not exceed 9 months.
Prior systemic chemotherapy (prior intravesical therapy is allowed)
Myelosuppressive chemotherapy: patients must not have received myelosuppressive chemotherapy within 3 weeks of enrollment (6 weeks if prior nitrosourea)
4. Received only one prior chemotherapy regimen consisting of ? 4 cycles of pemetrexed/cisplatin or pemetrexed/carboplatin; subjects must have documentation of an ongoing response (confirmed PR or SD) following completion of this regimen. Subjects changing from cisplatin to carboplatin or vice versa within the same course of treatment because of platinum toxicity will be considered to have had first-line chemotherapy. Note: Subjects may have undergone previous surgical resection of their disease providing it was completed prior to initiation of chemotherapy.
5. Received last dose of prior chemotherapy within ? 6 weeks of first dose of VS-6063.
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Patient must not have received prior chemotherapy or radiation for pancreatic cancer
Treatment with more than one prior chemotherapy regimen
Patients who have received chemotherapy within 7 days prior to the cryoablation procedure
Any prior cytotoxic chemotherapy except Temozolomide
INDUCTION CHEMOTHERAPY:
Patient must not have received prior chemotherapy or radiation for pancreatic cancer and no exposure to systemic chemotherapy
Prior chemotherapy for recurrent glioblastoma with nitrosourea compounds or bevacizumab
Cytotoxic chemotherapy, such as dacarbazine, temozolomide, carboplatin +/-paclitaxel.
MESOTHELIOMA COHORTS (COHORTS 1 AND 2 ONLY): Patients must have had at least one prior chemotherapy regimen, with the Food and Drug Administration (FDA)-approved regimen of a platinum-based therapy in combination with pemetrexed being preferred unless there was a specific contraindication for an individual patient; there is no limit to the number of prior chemotherapy regimens received
PANCREATIC CANCER COHORT (COHORT 4 ONLY): Patients must have had at least one prior chemotherapy for advanced disease; there is no limit to the number of prior chemotherapy regimens received
Prior chemotherapy.
ERLOTINIB HYDROCHLORIDE ARM: Patients with SCLC or thymic malignancies must have been treated with at least 1 previous standard of care chemotherapy regimen or refuse to be treated with conventional chemotherapy agents
SELUMETINIB ARM: Patients must have been treated with at least 1 previous standard of care chemotherapy regimen or refuse to be treated with conventional chemotherapy agents
AKT INHIBITOR MK2206 ARM: Patients must have been treated with at least 1 previous standard of care chemotherapy regimen or refuse to be treated with conventional chemotherapy agents
LAPATINIB DITOSYLATE ARM: Patients must have been treated with at least 1 previous standard of care chemotherapy regimen or refuse to be treated with conventional chemotherapy agents
SUNITINIB MALATE ARM: Patients must have been treated with at least 1 previous standard of care chemotherapy regimen or refuse to be treated with conventional chemotherapy agents
Candidate for chemotherapy
Any medical contraindications for chemotherapy
Patient has received more than one line of chemotherapy for advanced disease.
PRIOR THERAPY: Patients should have had NO prior chemotherapy agents for advanced or recurrent endometrial cancer; prior chemotherapy administration in conjunction with primary radiation therapy as a radiosensitizer would NOT exclude a patient from participation in this trial
Patients must have received at least 1 line of cytotoxic chemotherapy
Localised palliative radiotherapy Prior chemotherapy must be > 6 months before screening
Patients must have had at least one but no more than four prior chemotherapeutic regimens for management of endometrial carcinoma (including neo-adjuvant and/or adjuvant chemotherapy); initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen
an anthracycline containing chemotherapy regimen
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.
Subjects must have received treatment for CLL with chemotherapy agents or antibodies OR if subjects are previously untreated they must state in the consent form that they are refusing to be treated with chemotherapy or antibodies
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)
Patient must be eligible for chemotherapy with docetaxel
Received Plasma cell directed chemotherapy within 6 months
There are no limits on prior therapy; patients are allowed to have prior chemotherapy and surgery; patients are allowed to have concurrent chemotherapy with radiation treatment; patients are allowed to have chemotherapy or surgery after radiation treatment
Any of the following prior therapies:\r\n* Systemic chemotherapy for bladder cancer at any time; NOTE: intravesical chemotherapy is allowed\r\n* Systemic chemotherapy for other malignancies =< 3 years prior to pre-registration
More than 1 prior chemotherapy regimen (a subject who received first- line carboplatin and taxane and then receives the same taxane second- line will be considered to have had 1 prior chemotherapy regimen)
Currently receiving vismodegib, biologics or chemotherapy
Prior chemotherapy regimen given for first (1st) relapse, not including the use of hydroxyurea or plasmapheresis that is used prior to the initiation of chemotherapy
Patients must have completed at least 1 prior line of chemotherapy for germ cell tumor (except patients who present with primary pure teratoma who need not have received any previous chemotherapy)
More than three prior lines of chemotherapy
Less than three weeks since the last chemotherapy-containing regimen
Patients younger than 50 years old, after first induction of chemotherapy, who are able to safely tolerate re-induction therapy with high dose chemotherapy are not eligible for this study (patients who are 50 years old or older or patients younger than 50 who are not able to tolerate an aggressive reinduction chemotherapy, based on the physician assessment, are still be eligible for this study if they fail their first induction)
The cycles of chemotherapy must be consecutive (i.e. one followed by the other) but do not have to be the first and second cycle of a line of treatment.
For patients who received prior adjuvant chemotherapy or chemoradiotherapy: a treatment-free interval of at least 12 months since last chemotherapy or chemoradiotherapy cycle
Prior treatment with ? 2 prior chemotherapy-based or immunotherapy-based regimens for iNHL
Completed 12 to 24 weeks of first- or second-line treatment with trastuzumab in combination with chemotherapy
Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least 6 months prior to study entry)
Subjects considered eligible for intensive chemotherapy
Prior chemotherapy for curative intent is permitted providing the cytotoxic chemotherapy was completed >= 12 months prior to enrollment; patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 30 days prior to registration; patient must not have brain metastases unless: (1) metastases have been treated and have remained controlled for at least two weeks following treatment, AND (2) patient has no residual neurological dysfunction off corticosteroids for at least 1 day; any radiation therapy completed prior to chemotherapy, except gamma-knife radiosurgery, 1 week prior to chemotherapy
Prior treatment with a trastuzumab containing chemotherapy regimen is required.
Active serious infection that at the discretion of treating physician makes patient ineligible for chemotherapy
Received systemic treatment for lymphoma such as chemotherapy, immunotherapy, radiotherapy, investigational agents, or radioimmunotherapy.
Prior systemic anticancer therapy: patients will have received no more than 2 prior chemotherapy regimens; the regimen(s) may have included biological, molecularly targeted or immune therapies; patients with primary refractory disease (i.e., those patients with progressive disease on first line chemotherapy) and patients with disease relapse within 90 days of completion of initial chemotherapy (chemotherapy resistant) are excluded; patients with limited stage small cell lung cancer (SCLC) and systemic relapse who are not felt to be candidates for repeat platinum-based chemotherapy at relapse are eligible for enrollment
Chemotherapy for glioma other than temozolomide or Gliadel wafers (steroids are allowed)
More than 1 prior cytotoxic chemotherapy regimen for advanced disease
Up to 2 prior chemotherapy regimens for recurrent disease are allowed; adjuvant chemotherapy and maintenance Taxol after completion of six cycles of adjuvant carboplatin-Taxol will not be counted as a “prior chemotherapy regimen” for the purpose of this study; treatment with targeted agents or hormones would not be considered as a systemic chemotherapy regimen; previous treatment with gemcitabine is not allowable
Prior primary chemotherapy.
Participants who have had chemotherapy or radiotherapy for intrahepatic cholangiocarcinoma
Prior chemotherapy
Patients with second malignancies in remission may be eligible if there is clinical evidence of disease stability for a period of greater than 6 months off cytotoxic chemotherapy, documented by imaging, tumor marker studies, etc., at screening. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are eligible.
More than one prior chemotherapy regimen administered in the metastatic setting.
Radiographic progression during treatment with erlotinib; prior chemotherapy regimens are permitted
Patients must be pemetrexed-naïve; patients may have received any number of prior chemotherapy or molecularly targeted agents; if crizotinib was used in the first (1st) line setting then chemotherapy naive patients are also eligible; if patient received crizotinib in combination with chemotherapy, prior chemotherapy must have been discontinued at least 14 days prior to registration and all adverse events must have resolved to =< grade 1
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
Exposure to any systemic chemotherapy within 30 days of date of randomization.
Concomitant chemotherapy or radiotherapy is not permitted.
Refractory to at least 1 cycle of induction chemotherapy
Patients should have received a minimum of one, and up to five prior chemotherapy regimens
Planned to receive standard cisplatin chemotherapy administered either weekly or every third week.
Chemotherapy treatment within the previous 12 months.
Prior chemotherapy is allowed if >= one month from the end of treatment; patients must not have received chemotherapy within 4 weeks of the start of study drug
Histologically or cytologically confirmed high-grade metastatic sarcoma that has been stable on 6-12 cycles of one chemotherapeutic regimen (cytotoxic or biologic) although a change in chemotherapy is allowed if it is a result of toxicity/tolerability rather than progression; a patient must not have evidence of progression at any time while on chemotherapy in order to be eligible for this trial
Patients whose treatment plans include continuing chemotherapy after ablation as per the treating physician
More than two regimens of systemic cytotoxic chemotherapy for recurrent or advanced NSCLC
Received radiotherapy and temozolomide chemotherapy
For the Phase 1b portion of the study, more than 3 prior chemotherapy regimens and for the Phase 2 portion of the study more than 2 prior chemotherapy regimens. Maintenance therapy following induction chemotherapy does not count as a separate regimen. In addition, hormonal therapy (e.g., tamoxifen or an aromatase inhibitor) does not count as a separate regimen.
Patient has received more than one line of cytotoxic chemotherapy
Has advanced gastrointestinal tumors refractory to at least 1 chemotherapy
Evidence of progressive disease during or following 1 or 2 prior chemotherapy regimens
Chemotherapy regimens within the last 21 days (or within 6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens, biologic, and targeted therapy given continuously or on a weekly basis with limited potential for delayed toxicity within the last 14 days.
Untreated relapse of cHL (with the exception of steroids) as follows:\r\n* HL that relapsed >= 3 months after completion of first-line chemotherapy or combined modality therapy, and has not yet been treated with salvage chemotherapy\r\n* Stage I-II HL that relapsed >= 3 months after first-line chemotherapy, then relapsed after radiation therapy delivered with curative intent, and has not yet been treated with salvage chemotherapy
Any prior chemotherapy must have been completed >= 2 weeks prior to day 1 of study treatment and the participant must have recovered to eligibility levels from prior toxicity\r\n* Only one prior regimen is allowed for relapsed AML patients; note one prior regimen is defined as follows:\r\n** Induction chemotherapy followed by consolidation is considered one regimen\r\n** Induction chemotherapy followed by re-induction in case of persistent disease followed by consolidation is considered one regimen\r\n* Hydroxyurea is allowed prior to day 1 of study treatment to keep white blood cell (WBC) below 20 K
Patients who are not appropriate to receive more intensive chemotherapy in the judgment of the investigator
Prior treatment and relapse following chemotherapy and autologous bone marrow or stem cell transplant. Patients who are not transplant eligible or who did not respond to chemotherapy may be considered for the study following a single regimen of chemotherapy such as R-CHOP or R-EPOCH. There is no limit to number of prior therapies allowed.
For Part 3, subject has received 4 or more prior lines of cytotoxic chemotherapy for systemic disease.
Received prior docetaxel chemotherapy
Administration of conventional chemotherapy within 2 weeks of enrollment date. In the event that subjects have received chemotherapy > 2 weeks from the date of enrollment, they may be included provided they have recovered from the associated non-hematological toxicities to ? grade 1.
Chemotherapeutic agents for chemotherapy
Chemotherapy =< 21 days before first study treatment
Patients may not have received any cytotoxic chemotherapy for treatment in the metastatic setting
Patients must have progressed on or been intolerant to a fluoropyrimidine-based chemotherapy regimen; there is no limit on the number of prior treatment regimens permitted
Subjects must not have had more than 1 previous treatment regimen with chemotherapy, interferon, or IL-2 for metastatic melanoma
Subject must have had at least one prior cytotoxic chemotherapy regimen for unresectable or metastatic disease. Prior taxane therapy is allowed.
If a transplant is used as consolidation following chemotherapy, without intervening disease progression, it will be considered 1 line of treatment with the preceding chemotherapy
Subject previously treated with chemotherapy must have no more than two prior chemotherapy regimens for the treatment of metastatic prostate cancer
Prior radiation or chemotherapy exposure inclusive of low dose chemotherapy such as methotrexate for autoimmune conditions.
Use of cytotoxic chemotherapy within 21 days of registration
Cohort A: Eligible for chemotherapy
Patients previously treated with systemic chemotherapy will be eligible
Prior chemotherapy is acceptable if last dose given >= 3 weeks prior to registration to this study; (Note: no chemotherapy to be given after resection of liver lesions prior to treatment on this study)
RT must be administered within 12 weeks of definitive surgery if the patient is not treated with chemotherapy; if adjuvant chemotherapy is given, RT must begin within 2-8 weeks after the last dose
No plans for additional post-remission chemotherapy.
All patients must have received at least one standard chemotherapy or chemoradiotherapy
Prior cell transfer therapy which included a myeloablative chemotherapy regimen (i.e. 1200 total body irradiation [TBI] or 200 TBI plus chemotherapy)
Prior treatment with docetaxel-based chemotherapy
Have received or refused at least one chemotherapy regimen
Subjects who have received more than one course of chemotherapy for recurrent disease
Concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation)
Radiation use as part of induction regimen or consolidation (within 90 days after completion of induction chemotherapy) is allowed
Treated in any order with at least: an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen
Prior anthracycline exposure: patients must have had less than 350 mg/m^2 lifetime exposure of anthracycline chemotherapy
For patients in the dose-expansion cohort of the study, not more than two prior lines of cytotoxic chemotherapy in the metastatic setting
Dose expansion cohort (B): no prior chemotherapy is allowed
Patients with locally advanced or metastatic disease, any solid tumor except hepatocellular carcinoma, who have been previously treated with systemic chemotherapy (chemotherapy administered through the blood) and who have had relapsed or had progressive disease following standard of care treatment with chemotherapy prior to enrollment, or intolerant to prior standard of care treatment with chemotherapy
Participants who received prior chemotherapy that included cisplatin, carboplatin, or oxaliplatin
Patients with recurrent or progressive advanced stage NSCLC (no small cell lung cancer [SCLC] component) who have been treated with at least one and a maximum of two prior chemotherapy regimens for advanced NSCLC; chemotherapy as part of initial potentially curative therapy (given as part of adjuvant or concomitant chemoradiotherapy) that was completed < 1 year counts as 1 prior regimen; prior erlotinib, other EGFR tyrosine-kinase inhibitors (TKIs) or monoclonal antibodies targeting EGFR are not allowed; NOTE: Chemotherapy as part of initial potentially curative therapy (given as part of adjuvant or concomitant chemoradiotherapy) that was completed one or more years prior to screening for this study does not count as a prior regimen; if the tumor is refractory (progressed) after a prior chemotherapy regimen, then that regimen would count; if a prior chemotherapy regimen has been changed due to other reasons than disease progression (e.g. poor tolerance, allergic reaction), then it would not count as a separate prior regimen; a chemotherapy drug added for “maintenance” following disease stabilization or response to a chemotherapy regimen (in the absence of prior disease progression) does not count as a separate prior regimen; NOTE: Pathology reports documenting the diagnosis of NSCLC are required to be reviewed by the screening physician investigator
More than one prior chemotherapy regimens
Chemotherapy regimens with delayed toxicity within the last 4 weeks. Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks.
For patients < 60 years old: at least two induction chemotherapy treatments.
Chemotherapy within 2 weeks of first planned fraction of SBRT
Concomitant chemotherapy or radiotherapy is not permitted.
Prior chemotherapy within the last 4 weeks
Prior cytotoxic chemotherapy or biologic therapy for CRPC
Patients must have had at least one prior chemotherapy regimen that included temozolomide and no more than one prior salvage chemotherapy
Prior chemotherapy for metastatic colorectal cancer is not allowed.
May not receive chemotherapy until valacyclovir completed
No prior chemotherapy
Prior systemic chemotherapy for transitional cell carcinoma of the bladder; subjects who have received prior intravesical chemotherapy are allowed if completed 28 days prior to cycle 1 day
Patients with prior docetaxel chemotherapy
Previous chemotherapy, and/or biological therapy for cancer are permitted provided that the acoustic properties of the tumor were not affected, but the subject should have recovered from the effects of these or of any prior surgery; chemotherapy can be within 70 days of operation
Prior systemic chemotherapy must be completed > 2 weeks of radioembolization
Chemotherapy, radiotherapy, immunotherapy or other medications intended for antitumor activity
Prior systemic chemotherapy for cholangiocarcinoma or gallbladder carcinoma; NOTE: adjuvant chemotherapy is allowed if completed > 6 months prior to the start of registration
Prior chemotherapy with combination of capecitabine (or 5-flourouracil [5-FU]) “and” temozolomide (or dacarbazine [DTIC]) will be excluded; patients can have had prior therapies up to 3 prior chemotherapy regimens such as streptozocin, anthracyclines, irinotecan, etoposide, or a platinum agent including single agent capecitabine (or 5FU) or temozolomide (or DTIC).
A treatment with any other agent with antitumor activity including chemotherapy, radiotherapy, or immunotherapy
Prior systemic anticancer therapy: Patients will have received at least 1 platinum-based chemotherapy regimen, but no more than 2 cytotoxic chemotherapy regimens in the setting of recurrent or metastatic disease; the regimen(s) may have included biological, molecularly targeted or immune therapies; adjuvant chemotherapy is considered 1 cytotoxic chemotherapy regimen if the last administration occurred < 1 year prior to entry
Patients may have received one prior chemotherapy regimen for recurrence or progression; cisplatinum with concurrent radiation does not count as a prior chemotherapy; prior treatment with bevacizumab is allowable
At least 21 days from last cytotoxic chemotherapy
Be scheduled to receive a single-day chemotherapy regimen that contains doxorubicin and/or cyclophosphamide and/or carboplatin; Herceptin (trastuzumab) and other chemotherapy agents will be allowed with any of these regimens
CYCLE II PORTION ONLY: Participants must be scheduled to receive the same chemotherapy regimen as received at cycle 1
At the time of enrollment, patient must have completed at least 24 weeks of maintenance chemotherapy, and is scheduled to receive at least 24 more weeks of maintenance chemotherapy
Plan to start a new cancer treatment regimen within 4 weeks from time of baseline registration; the treatment regimen is up to the discretion of the treating oncology physician; the regimen must include a chemotherapy drug or other agents that have similar prevalence of toxicity; patients who will receive monoclonal antibody therapy or other cancer therapies (e.g., tyrosine kinase inhibitors) are eligible if the other agents present a prevalence of toxicity similar to chemotherapy; these therapies can be used in combination with chemotherapy, as a single agent, or in combination with each other\r\n* Chemotherapy will be defined as cytotoxic drugs; in addition, agents (e.g., monoclonal antibodies and targeted agents) that have a prevalence of grade 3-5 toxicity in older patients similar to chemotherapy (> 50%) will be allowed; a list of allowable agents (single and in combination) meeting this toxicity criteria will be available on the University of Rochester Cancer Center (URCC) NCORP Research Base website as part of the study materials; given the rapidly changing landscape of new drugs for cancer, the study team led by the principal investigator (PI) will update the list accordingly after reviewing the toxicity profile of new therapies; if the potentially eligible participant is to receive an approved drug or regimen not on the list, contacting the URCC NCORP Research Base study team is required for approval prior to participant enrollment\r\n* Patients who are receiving approved cancer treatment in combination with radiation are eligible\r\n* A patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and exclusion criteria are met
Prior chemotherapy or radiotherapy for any brain tumor
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
Concurrent chemotherapy; patients may be on other non-chemotherapy anti-cancer treatments, per Food and Drug Association (FDA) labeling of radium-223, provided that these are not changed during the primary pain assessment period
with same chemotherapy regime (as documented from patient medical dossier), And
do NOT plan to initiate a new chemotherapy for pain palliation should be eligible for the study. Note: Planned multiple courses of chemotherapy are not considered New Chemotherapy.
Patients initiating a new chemotherapy regime for pain purposes only, or radiation (for the targeted most painful lesion) within the last 2 weeks Note: Planned multiple courses of chemotherapy are not considered New Chemotherapy.
Neutropenia (absolute neutrophil count < 1.0 x 10^9/L) at the time of study enrollment (bloodwork is not required if patient did not have chemotherapy within past 2 weeks).
Planned chemotherapy during radiosurgery
Have completed neurotoxic chemotherapy at least 3 months prior to enrollment
Have received cancer treatment that includes chemotherapy for at least 2 months
Receiving chemotherapy (CTX) for breast, colon, rectal, small intestine, or ovarian cancer on a 7, 14, or 21 day schedule with the chemotherapy dose given on day 1
Clinical indication for additional doses of the chemotherapy as determined by the patient’s oncologist
Chemotherapy treatment schedule < 12 weeks
COHORT C SPECIFIC INCLUSION: Histologically confirmed PCNSL that has recurred after prior methotrexate-based chemotherapy or for whom methotrexate-based chemotherapy is deemed medically not in the patient's best interest
Patients who are candidates for treatment with standard chemotherapy agents (there is no limit to the number of lines of chemotherapy);
Participants are allowed to have received up to 2 prior lines of chemotherapy in the metastatic setting; if a prior chemotherapy was given for less than 1 cycle, it will not be counted as a prior line; the last dose of chemotherapy must be =< 14 days prior to initiation of study therapy; participants should be adequately recovered from acute toxicities of prior treatment; no prior treatment with eribulin mesylate is allowed
Cytotoxic chemotherapy within 4 weeks.
No prior chemotherapy
Patients receiving intensive chemotherapy requiring a prolonged 4-6 week hospitalization
Received previous chemotherapy
Treated with chemotherapy within the past 12 months
Subject has received chemotherapy within the past 2 weeks
Active treatment with chemotherapy
Anticipated 2 or more subsequent chemotherapy infusions of either carboplatin or oxaliplatin at the time of study registration; NOTE: the dose of carboplatin or oxaliplatin, choice of other chemotherapy, and other ancillary treatment, such as antiemetics, will be left to the discretion of the treating healthcare provider
Patients undergoing AML induction chemotherapy with an anthracycline + cytarabine-based chemotherapy regimen
The expected hospitalization is at least 3 days to receive moderate to high intensity chemotherapy
Received neoadjuvant chemotherapy, any autoimmune or immunological disease or taking any immune suppression drugs
Has not yet begun chemotherapy
Chemotherapy has already commenced or been completed
Eligible patients must not be currently undergoing standard cytotoxic chemotherapy
Individuals who are actively undergoing standard cytotoxic chemotherapy
Prior chemotherapy is allowed
EXCLUSION - STUDY 1: Pre-existing neuropathy including CIPN from prior neurotoxic chemotherapy
Subject with neoadjuvant chemotherapy or chemoradiation
Scheduled to start a new treatment regimen for MBC, but no more than 3 previous chemotherapy regimens
No more than 3 prior chemotherapy regimens
Unresectable pancreatic adenocarcinoma, receiving either 1) no chemotherapy 2) 1st cycle of chemotherapy or 3) greater than 1 cycle of chemotherapy if the patient’s prognosis is greater than 6 months as determined by oncology collaborators
Planned non-myelosuppressive chemotherapy regimen
Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician)
Off active chemotherapy treatment for minimum of 6 months
Scheduled to receive first-line intravenous chemotherapy treatment for colorectal cancer (stages II-IV)
Patients receiving 3rd-line palliative chemotherapy
Planned to initiate a new systemic chemotherapy regimen (including patients starting on first chemotherapy or patients previously treated but starting on a new regimen)
Patients with previously diagnosed peripheral neuropathy pre-dating their neurotoxic chemotherapy administration or from causes other than chemotherapy
Be scheduled for planned cancer treatment (e.g. chemotherapy or biologics such as Herceptin)
Have at least 6 weeks of cancer treatment (e.g. chemotherapy or biologics such as Herceptin) remaining
Radiation therapy, cytotoxic chemotherapy, and combined modality (both radiation and chemotherapy) used to treat other cancers or medical conditions and administered within 6 months prior to study enrollment; use of hydroxyurea or emergent leukapheresis (for cytoreduction of highly elevated white blood cell counts) is permissible; those AML patients who initially receive treatment with all-trans retinoic acid (ATRA) for presumptive diagnosis of APL but if APL is ruled out in final pathology will be eligible for the study
Planned treatment with R-CHOP chemotherapy
Unable to receive R-CHOP chemotherapy
Experimental anti-CMV chemotherapy in the last 6 months
Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician).
Off active chemotherapy treatment for minimum of 6 months.
PATIENTS: Treatment plans to include weekly outpatient chemotherapy
PATIENTS: Completed more than half of prescribed chemotherapy treatments
Diagnosed with incurable cancer (defined as receiving treatment with palliative intent as per chemotherapy order entry designation, trial consent forms, or not receiving chemotherapy but followed for incurable disease as per oncology clinic notes)
Experimental anti-CMV chemotherapy in the last 6 months
Patients who have or have not undergone chemotherapy are both eligible; if the patient has undergone chemotherapy she must have completed adjuvant chemotherapy for >= 3 months and =< 5 years prior to study enrollment
Patients with at least one more chemotherapy appointment at the time of enrollment
Experimental anti-CMV chemotherapy in the last 6 months
Subjects who have had previous chemotherapy exposure
Patients must have completed all of their prescribed chemotherapy at least one week prior to study entry; the plan for PCI should be such that PCI begins no more than 240 days from the start of induction chemotherapy
Recent administration (less than 1 week) of highly emetogenic chemotherapy (Hesketh scale class 4-5); subjects may otherwise be undergoing chemotherapy
Be scheduled to receive chemotherapy on one of the five schedules
Have not received chemotherapy in the past 2 months
Prior induction chemotherapy
Planned cytotoxic chemotherapy during the WBRT only; patients may have had prior chemotherapy
Willing to participate in blood draws and cognitive testing at three time points: baseline prior to starting chemotherapy, prior to the final cycle of neo-adjuvant chemotherapy, several weeks prior to scheduled surgery or several weeks after final cycle of adjuvant chemotherapy; and ~ 6 months after completion of chemotherapy
Individuals who have already started chemotherapy for breast cancer or who have previously had systemic chemotherapy for a malignancy
Women who have completed more than two rounds of chemotherapy
Undergoing cancer treatment (chemotherapy, radiotherapy, and/or immunotherapy)
Receiving weekly chemotherapy
Prior exposure to neurotoxic chemotherapy
Scheduled for neoadjuvant chemotherapy and/or chemoradiation for pancreatic cancer
Randomized cohort only:\r\n* No prior chemotherapy within 12 months of start date of study\r\n* No planned chemotherapy at least 12 months from study entry
Non-randomized pilot cohort:\r\n* Concurrent chemotherapy (initiated within 3 months of study entry) or planned chemotherapy within 3 months of study entry
Subjects must be deemed ineligible for cisplatin-based combination chemotherapy by the attending medical oncologist.
Currently receiving other intravesical chemotherapy.
Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least 6 months prior to study entry)
Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms;
Prophylactic intrathecal chemotherapy;
Are unwilling to receive intensive (e.g. 7+3) chemotherapy, or
Patients ?60 years unfit to receive intensive (e.g., 7+3) chemotherapy who have:
Have had prior chemotherapy for metastatic disease in castration-resistant prostate cancer (prior chemotherapy for hormone-sensitive disease, more than twelve months prior to registration, is acceptable)
Participants who have had prior cHL-directed chemotherapy or radiotherapy
Have received prior chemotherapy regimens within 4 weeks of Day 1;
Current systemic chemotherapy or radiation therapy that potentially causes bone marrow suppression that would preclude safe treatment of HSIL; Note: Kaposi’s sarcoma limited to the skin is not exclusionary unless requiring systemic chemotherapy
Chemotherapy induced menopause with last menses >1 year ago
Treatment with cytotoxic chemotherapy within the preceding four weeks
Allergic to selinexor or any of the chemotherapy intended to receive
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: No history of prior chemotherapy
Receipt of induction chemotherapy
Patients with active non-hematologic cancer:\r\n* The patients have previously received a chemotherapy regimen including one or more of the following agents:\r\n** Nucleoside analogue, including gemcitabine and fluorouracil\r\n** Carboplatin or cisplatin\r\n** Anthracycline\r\n** Alkylating agent\r\n** Other chemotherapy agents with thrombocytopenia as known common toxicity
Patients who have not had any cytotoxic chemotherapy within 14 days of beginning the study
Receiving outpatient chemotherapy
Expected to receive at least 1 additional cycle of chemotherapy after the recruitment visit (i.e., day of randomization); participants will be retained on study if treatment regimens change during the study period (e.g., change in chemotherapy drugs or doses prescribed)
There are no restrictions on the amount or types of prior therapy; eligible patients must be receiving ongoing chemotherapy that is planned to continue for at least one month following enrollment in this trial; any dose or schedule of chemotherapy administration is allowed as long as patients have self-reported taste disturbance that has either: 1) developed since the initiation of chemotherapy, or 2) a pre-existing, treatment-induced taste disturbance has subjectively worsened since initiating chemotherapy
Patients receiving chemotherapy at the University of Wisconsin-Madison
Platelet count =< 50 x 10^9/L untransfused of at least 2 weeks duration, secondary to prior chemotherapy; if there is a platelet count of > or = 50 x 10^9/L after a transfusion, that value will be discounted; this may include a combination regimen including lenalidomide; these regimens will include dexamethasone, cyclophosphamide, etoposide, cisplatin (DCEP), Velcade with Doxil, Cytoxan and/or lenalidomide; patients who have thrombocytopenia (CIT) from lenalidomide or from radiation therapy alone will not be allowed; patients may be retreated with Nplate within 6 months of their initial response, with a different chemotherapy regimen
Neutropenia (absolute neutrophil count < 1.0) (bloodwork is not required if patient did not have recent chemotherapy within last 2 weeks)
Patient must not have received chemotherapy within 3 weeks of initiation of PCI
Patients may have previously received other chemotherapy
No prior trastuzumab or anthracyclines prior to this chemotherapy regimen
Expected to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy after randomization. Subjects should not be expected to receive only maintenance chemotherapy.
scheduled to begin chemotherapy or radiotherapy
chemotherapy or radiotherapynaïve
At least one prior line of chemotherapy in the metastatic setting
Be receiving chemotherapy in either weekly, 2-week or 3-week cycles and have at least 6 weeks of chemotherapy treatment remaining; patients are eligible any time before chemotherapy cycle 3 if on a 2- or 3-week cycle, or cycle 4 if on a 1-week cycle; (Note: use of biologics [e.g., Herceptin (trastuzumab)] is permitted)\r\n* For patients on a weekly regimen, there should be at least 3 dosages of chemotherapy remaining\r\n* For patients on either a 2 week or 3 week cycle, there should be at least 2 dosages of chemotherapy remaining\r\n* Patients will not be dropped from the study if their chemotherapy is discontinued after they are enrolled
Treated with any established chemotherapy regimen based on either:
Previous chemotherapy for AML
Have a plan to receive a standard cisplatin chemotherapy regimen administered weekly (30-40 mg/m2) or approximately every 21 days (80-100 mg/m2)
Planned use of cisplatin as induction chemotherapy.
Scheduled to receive 14-day cycles of intravenous chemotherapy (e.g. doxorubicin and cyclophosphamide)
Subjects may have had chemotherapy prior to radiation; a minimum of two weeks is required between end of chemotherapy and start of RT
Anticipate receiving chemotherapy for at least 12 weeks total from the time of recruitment (ongoing chemotherapy not required for focus group participants)
Anticipated initiation of cetuximab treatment with or without additional chemotherapy
Undergoing induction or neoadjuvant chemotherapy prior to radiotherapy
Prior chemotherapy for SCCHN and/or radiotherapy to the region of the study cancer or
Must have received at least one taxane or platinum based chemotherapy drug within two years prior to enrollment; must exhibit a typical symptom of CIPN that was not present prior to chemotherapy; symptoms include numbness, tingling, thermal hyperalgesia, cold allodynia in the hands and/or feet, muscle weakness or unsteady gait in at least two of the last seven days prior to registration
Be chemotherapy naïve and about to begin her first course of chemotherapy.
Be scheduled to receive one of the following four common chemotherapy regimens with the specified antiemetic regimen. They are:
Chemotherapy regimen: Docetaxel/carboplatin. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, & 3.
Myelodysplastic syndromes requiring induction (myelosuppressive) chemotherapy
Subjects who are undergoing re-induction chemotherapy and have participated in this study during their first induction chemotherapy
Currently receiving chemotherapy
No prior chemotherapy
Participants who have received cytotoxic chemotherapy within 1 year prior to screening breast MRI
Prior chemotherapy or radiotherapy
Patients must have completed all primary chemotherapy and consolidation therapy (if administered) at least 6 weeks, and no more than 6 months and 2 weeks, prior to enrollment and must be in complete remission; consolidation therapy is defined as any chemotherapy or biological therapy used for a patient who has completed at least four courses of primary chemotherapy and had documented complete remission prior to initiation of such chemotherapy (chemo) or biological therapy
Scheduled to receive chemotherapy
Receiving or scheduled to receive first or second line chemotherapy (within 4 weeks)
Scheduled to receive anthracycline-based chemotherapy therapy
Scheduled to receive chemotherapy with an Anthracycline (doxorubicin or epirubicin)
Cancer diagnosis or received treatment (chemotherapy or radiotherapy) for malignancy within the previous 6 months
Prior cancer chemotherapy or radiotherapy
Use of chemotherapy, trastuzumab, or pertuzumab within the past 3 weeks
Multiple myeloma – must have received prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative HCT is permitted
Receiving chemotherapy known to cause alopecia within 60 days of study or during the study.
Patients with history of cancer must be in remission, with surgery completed at least 6 months prior to enrollment and chemotherapy completed at least 1 year prior to enrollment (except for basal cell carcinoma of the skin)
Chemotherapy =< 6 months prior to randomization (Note: topical chemotherapy will be assessed on a case-by-case basis)
Patients that are receiving or have received chemotherapy regimens are allowed
Currently receiving vismodegib, biologics or chemotherapy
Treatment with intravesical BCG or chemotherapy for a patient’s current < T2 tumor during the 12 months prior to the current diagnosis
Patients not eligible for chemotherapy with taxane and/or anthracycline based chemotherapy regimens
Patients who have received chemotherapy for pancreatic cancer, other than up to 4 cycles of mFOLFIRINOX as noted above
Subjects must have received cytotoxic chemotherapy within 3 months of consent date (measured from the start date of chemotherapy).
Prior chemotherapy is allowed; patients must not have received chemotherapy for 3 weeks prior to the initiation of study treatment and must have full recovery from any acute effects of any prior chemotherapy; patients must not have had nitrosoureas or mitomycin C for 6 weeks prior to the initiation of study treatment
Receiving chemotherapy during study period
Two or more prior chemotherapy regimens for advanced disease
Low dose chemotherapy given after leukapheresis to maintain disease control must be stopped ? 7 days prior to lymphodepleting chemotherapy.
Pregnant women will be excluded; for women of childbearing potential; negative pregnancy testing within 72 hours prior to or on study visit #1 (day 0) and willingness to use adequate contraception during the study intervention OR post-menopausal defined as any one of the following 1) prior hysterectomy, 2) absence of menstrual period for 1 year in the absence of prior chemotherapy or 3) absence of menstrual period for 2 years in women with a prior history of chemotherapy exposure who were pre-menopausal prior to chemotherapy
Not currently undergoing or planning to initiate chemotherapy
Subject is scheduled to receive a chemotherapy regimen that includes a cumulative cisplatin dose of ? 200 mg/m2.
Subject is receiving sodium-thiosulfate or amifostine therapy with chemotherapy.
Has vomited in the 24 hours prior to chemotherapy initiation on Treatment Day 1
Between 1-5 years post completion of chemotherapy
Patients who elect to shave the scalp hair prior to the initiation of chemotherapy or who plan to do so during the chemotherapy treatment.
Induction chemotherapy regimen
Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen
Patients receiving neoadjuvant chemotherapy or recently completed neoadjuvant chemotherapy and will undergo surgery within 6 weeks are eligible
Patient must NOT have a history of > 1 line of administered chemotherapy for metastatic disease and must be off chemotherapy for a minimum of 2 weeks; prior chemotherapy in the adjuvant setting is allowed
Any prior chemotherapy is allowed including prior treatment with platinum-containing chemotherapy
Prior chemotherapy completed < 7 days prior to planned study entry
No prior malignancy treated with chemotherapy or mediastinal radiotherapy
Received chemotherapy for treatment of childhood cancer
Participants who enroll in a preoperative therapy trial or who have been treated with neoadjuvant chemotherapy
Scheduled to have high-dose chemotherapy and ASCT
Need to be treated with taxane containing chemotherapy as determined by their treating physician
Prior exposure to neurotoxic chemotherapy
Subjects who had prior chemotherapy or radiotherapy for pancreatic adenocarcinoma cannot participate in the study
Use of bleomycin (chemotherapy agent)
Patients currently on chemotherapy or with other primary cancers requiring systemic or hepatic loco-regional treatment
Women undergoing neoadjuvant chemotherapy
Previously or currently receiving taxane-based chemotherapy
Patient has received prior chemotherapy or radiotherapy for this cancer
Cytotoxic chemotherapy within 4 weeks prior to study enrollment
Prior or chemotherapy or endocrine therapy is permitted
Patient to be treated with neoadjuvant chemotherapy or patient to be treated with definitive radiation therapy (RT), sequential chemotherapy (chemo)-RT, or concurrent chemo-RT (minimum dose of 50 Gy in 25 fractions)
Participants must be eligible for preoperative chemotherapy for IBC as determined by the treating physician
Participants must be willing to have research biopsies at baseline and after 2 cycles of preoperative chemotherapy, and possibly at the completion of preoperative chemotherapy
Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU;
Androgen deprivation therapy or chemotherapy prior to PET imaging
Be scheduled for neoadjuvant chemotherapy
Group I: Treatment plan to include or have included chemotherapy
Group II: Treatment plan does not and has not included chemotherapy
Prior docetaxel-based chemotherapy is permitted but not required
No obvious contraindications for primary chemotherapy
Women scheduled to receive neoadjuvant chemotherapy as part of their treatment plan
Chemotherapy (taxanes) or Radium-223 alpha-particle treatment within the last 6 weeks prior to imaging
Patients must not have history of chemotherapy for cancer within 6 months prior to registration
Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded; patients who have received neoadjuvant chemotherapy prior to their initial debulking are excluded; patients may have received prior adjuvant chemotherapy for breast cancer
Patients must have received less than three prior chemotherapy regimens for progressive meningioma
Known sensitivity to any of the study medication components or the chemotherapy regimen
Had or plan to receive any chemotherapy
Patients currently on chemotherapy or with other primary cancers requiring systemic treatment
Prior chemotherapy or radiotherapy within the last three years
Cancer survivors who have previous exposure to medications or chemotherapy that cause neuropathy are excluded from this study
Receiving neoadjuvant chemotherapy
Patients who have received previous treatment (chemotherapy or radiotherapy) for any brain tumor (primary or metastatic)
Patients that receive chemotherapy (induction or sequential)
Neoadjuvant chemotherapy
Candidate for neoadjuvant chemotherapy
Received prior chemotherapy for colorectal cancer
Subjects who have had chemotherapy or radiotherapy within 1 week of entering the study
Patient has received prior chemotherapy or radiotherapy for this cancer
Participants must have no immediate requirements for chemotherapy, radiotherapy or hormonal therapy
For study arm 2, patients that are currently undergoing chemotherapy for recurrence; maintenance chemotherapy is not considered an exclusion criteria; additionally, as noted above if a patient has not yet begun chemotherapy for recurrence or adjuvant chemotherapy for initial diagnosis they are still a candidate to be enrolled on this study arm; patients undergoing neoadjuvant chemotherapy are not eligible for the study under the current protocol at this time
Chemotherapy in the last four weeks
Chemotherapy: ?14 days from any myelosuppressive chemotherapy and abs neutrophil ct ?1000/mm3 , 42 days if prior nitrosurea
Treated with at least one other chemotherapy that did not work or where cancer relapsed
hospitalized for consolidation chemotherapy within 1 day (+/- 2 days)
an anthracycline containing chemotherapy regimen
Prior chemotherapy for AML
Part C: must have previously received prior treatment with at least 1 but no more than 2 chemotherapy regimens in the metastatic setting
Participants must not have had chemotherapy within the past 10 days
The patient must have recovered from surgery with the incision completely healed and no signs of infection; if adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved; the patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky performance status [KPS] > 70%)
The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 180 days if chemotherapy is not delivered adjuvantly; if adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 180 days
Has received prior therapy with any taxane chemotherapy
Histologically proven trophoblastic neoplasia, or clinically demonstrated trophoblastic neoplasia that has progressed following treatment with at least one chemotherapy regimen that included 2 or more chemotherapy agents.