Documented progression on or following most recent systemic chemotherapy regimen (not required for chemotherapy-naïve patients), within 4 months prior to screening
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
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
If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved
Patients may receive post-operative (adjuvant) chemotherapy for up to 24 weeks of duration (e.g. 8 cycles of capecitabine as in the CREATE-X trial) after completion of surgery at the discretion of the treating physician; 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 that have received adjuvant chemotherapy must be registered to screening within 35 days after completing treatment
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
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
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
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
At least three weeks since the last chemotherapy
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
Chemotherapy
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).
Receiving prior hepatic intra-arterial chemotherapy
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
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
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
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
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.
Chemotherapy: 3 weeks
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
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.
CMR following S1 chemotherapy
Prior systemic chemotherapy
Previous treatment with chemotherapy for metastatic CRPC (mCRPC) (adjuvant chemotherapy is permitted), or chemotherapy for any reason within 2 years prior to registration
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
Refusal to practice contraception during chemotherapy
TREATMENT WITH SJCAR19: Receiving intrathecal chemotherapy in the 7 days prior to CAR T-cell infusion
Subjects who progressed on at least one prior chemotherapy
Receiving any investigational agents or concurrent biological, intensive chemotherapy or radiation therapy for the previous 2 weeks from conditioning\r\n* NOTE: low dose chemotherapy or maintenance chemotherapy given within 7 days of planned study enrollment is permitted; these include: hydroxyurea, 6-meraptopurine, oral methotrexate, vincristine, oral etoposide, and tyrosine kinase inhibitors (TKIs); FLT-3 inhibitors can also be given up to 3 days before conditioning regimen
3 weeks from prior chemotherapy.
Treatment with any systemic chemotherapy within 3 weeks
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.
History of prior chemotherapy (chemotherapy allowed for lead-in cohort in castration resistant disease)
Patients may have had prior chemotherapy or be chemotherapy naive
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
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
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Compete history and physical examination will be required within 2 weeks prior to initiation of chemotherapy
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
Prior chemotherapy with nitrosoureas, prior mitomycin C cumulative dose ? 25 mg/m2, prior bone marrow transplant, or prior intensive chemotherapy with stem cell support;
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
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
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 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 treatment with intravenous chemotherapy
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.
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
At least 4 weeks post-completion of chemotherapy
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
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
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;
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 must be at least 4 weeks from last dose of chemotherapy.
Prior chemotherapy within 28 days of starting treatment
Planned pre-operative chemotherapy (patients with planned post-operative chemotherapy are eligible)
Willing to reside < 50 kilometers from Kamuzu Central Hospital (KCH) until chemotherapy completion
Patients who failed to respond first line standard of care chemotherapy or chemotherapy suspended due to toxicity or other reasons
Patients with prior chemotherapy for this cancer
No other active cancer that requires systemic chemotherapy or radiation
At least one prior chemotherapy
Patients should be off all previous intensive therapy, chemotherapy or radiotherapy for 3 weeks prior to commencing therapy on this study\r\n* (NOTE: Low dose chemotherapy or maintenance chemotherapy given within 7 days of planned study enrollment is permitted; these include: hydroxyurea, 6-meraptopurine, oral methotrexate, vincristine, oral etoposide, and tyrosine kinase inhibitors [TKIs]; FLT-3 inhibitors such as sorafenib, crenolanib, midostaurin can also be given up to 3 days before conditioning regimen)
Patients may not be receiving any other investigational agents, or concurrent biological, intensive chemotherapy, or radiation therapy for the previous three weeks from conditioning\r\n* (NOTE: Low dose chemotherapy or maintenance chemotherapy given within 7 days of planned study enrollment is permitted; these include: hydroxyurea, 6-meraptopurine, oral methotrexate, vincristine, oral etoposide, and tyrosine kinase inhibitors [TKIs]; FLT-3 inhibitors such as sorafenib, crenolanib, midostaurin can also be given up to 3 days before conditioning regimen)
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
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
Must be at least 7 days since last chemotherapy or biologic therapy administered; for patients previously enrolled on this trial who had a usable T cell product generated but removed prior to receiving T cell therapy and are re-enrolling on the trial, the time from chemotherapy agent or biologic agent is not restricted
Administration of chemotherapy or any other cancer therapy in the pre-operative period
Patients must be anticipated to complete 2 cycles of chemotherapy
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
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
Receiving intensive chemotherapy within 21 days of registration; maintenance type of chemotherapy will be allowed
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
If chemotherapy is planned, new chemotherapy regimen should have started no more than 21 days prior to enrollment
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 must be anticipated to complete at least 2 cycles of chemotherapy on study
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
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 systemic 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
Chemotherapy is allowed; if chemotherapy is indicated and brachytherapy boost is planned, it must be administered after the accelerated whole breast irradiation (AWBI) but should begin no earlier than 21 days following completion of radiation therapy; alternatively if chemotherapy is indicated and external beam boost is planned, the chemotherapy can be delivered first, followed by radiation therapy beginning 21-63 days after the last cycle of chemotherapy or the radiation therapy can be delivered first and the chemotherapy can be delivered no earlier than 21 days post radiation therapy
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
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)
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
At least one prior regimen of chemotherapy, with no maximum number of chemotherapy cycles
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 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
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
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
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
Patients must be anticipated to complete at least 2 cycles of chemotherapy
Chemotherapy-naive patients (for this malignancy)
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
Subjects must have had prior high dose chemotherapy (HDCT) treatment when indicated
Subjects must be at least 3 weeks from last chemotherapy
No prior cancer chemotherapy allowed
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
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
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
>= 28 days from completion of frontline chemotherapy for NHL
No prior chemotherapy
Prior chemotherapy within the last 4 weeks
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
Patients with chemotherapy prior to TEMLA are eligible
Patients receiving any systemic chemotherapy or targeted agents for treatment of the current HNSCC outside of induction chemotherapy per standard institutional practice
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
Patients who have had prior chemotherapy for this tumor
Patients with chemotherapy resistant disease
Any prior chemotherapy; the only exception will be patients with a history of stage I seminoma treated with adjuvant carboplatin for 1 of 2 cycles
Patients should not be felt to have an immediate need for chemotherapy
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)
Subjects who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (docetaxel and prednisone)
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
Chemotherapy other than lymphodepleting chemotherapy within 2 weeks of infusion
Antiproliferative therapies other than lymphodepleting chemotherapy within two weeks of infusion
Subjects who are not eligible for standard chemotherapy
At least 2 weeks from end of chemotherapy with resolution of neutropenia to above level
No clinical evidence for locoregional or distant relapse during or after preoperative chemotherapy. Local progression during chemotherapy is not an exclusion criterion.
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
For patients who have not started their chemotherapy prior to registration, the interval between definitive tumor-related surgery and 1st step registration must be between 21-70 days; for patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, the interval between definitive tumor-related surgery and day one of adjuvant chemotherapy must be between 21-77 days
Patients receiving any systemic chemotherapy within 3 weeks prior to first dose of study treatment
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.
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.
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.
Within 3 weeks prior to the first dose of CDX-0158 of any biologic treatment or IV 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
Any chemotherapy less than 28 days before first dose of study
At least 2 weeks from last chemotherapy or before chemotherapy
Anticipated need for systemic chemotherapy within 2 weeks before apheresis and infusion of CART-meso cells
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
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)
No previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy)
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.
Chemotherapy < 2 weeks prior to the first planned dose of study treatment
Has had chemotherapy for castration-resistant disease; chemotherapy for castration-sensitive disease is permitted
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
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
Completion of preoperative systemic chemotherapy
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
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
Prior chemotherapy is allowed
Prior treatment with HAI chemotherapy
Prior chemotherapy or biologic therapy for the same HNSCC; prior chemotherapy or biologic therapy for a different previous HNSCC is allowed
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 must be randomized within 8 weeks of their last dose of chemotherapy
Prior chemotherapy for prostate cancer, with the exception of neo-adjuvant chemotherapy, because of the potential effect of chemotherapy on the immune system.
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
Prior chemotherapy (unless allowed for some study arms)
Prior systemic chemotherapy
Patients who have had chemotherapy or radiotherapy within 2 weeks except for intrathecal chemotherapy (i.e., methotrexate, cytarabine, or thiotepa)
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
The first dose of study treatment must be at least three weeks since prior chemotherapy, including sunitinib or everolimus
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
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
More than 1 prior chemotherapy regimen for mCRC; previous adjuvant FOLFOX based chemotherapy is allowed; prior FOLFIRI or single agent irinotecan is prohibited
Documentation regarding the details of administration of all systemic chemotherapy must be available
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.
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
Failed at least one prior chemotherapy
No previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy).
Prior treatment with chemotherapy for CRPC
Chemotherapy < 2 weeks prior to starting study drug with the following exception: There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such
Patients in first relapse must be chemoresistant or intolerant to chemotherapy
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
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 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
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
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
Key inclusion criteria:\n\n          1. Histological or cytological confirmation of epithelial ovarian, primary peritoneal, or\n             fallopian cancer from any previous time point.\n\n          2. Recurrent or relapsed after completion of initial therapy of epithelial ovarian,\n             primary peritoneal, or fallopian cancer from any previous time point (includes\n             completion of surgery with or without postoperative chemotherapy, including\n             maintenance chemotherapy)\n\n          3. Elevation of CA-125 according to the following definitions:\n\n               -  Patients with an elevated CA-125 before chemotherapy and normalization of CA-125\n                  with/after chemotherapy must show evidence of CA-125 greater than or equal to 2\n                  times the upper limit of normal (ULN) on 2 occasions at least 1 week apart\n\n               -  Patients with an elevated CA-125 before cancer chemotherapy, which never\n                  normalizes, must show evidence of CA-125 greater than or equal to 2 times the\n                  nadir value on 2 occasions at least 1 week apart\n\n               -  Patients with CA-125 in the normal range before cancer chemotherapy must show\n                  evidence of CA-125 greater than or equal to 2 times the ULN on 2 occasions at\n                  least 1 week apart\n\n                    -  For patients who have received subsequent treatment for recurrent cancer,\n                       \chemotherapy\ in the above criteria refers to the most recent round of\n                       chemotherapy.\n\n          4. Patients with a history of ovarian cancer who are asymptomatic and who do not have\n             documented previous CA-125 levels may enroll if the CA-125 is greater than three times\n             the ULN on two occasions, at least one week apart\n\n          5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0\n\n        Key exclusion criteria:\n\n          1. Symptoms (other than ? grade 1 fatigue, anxiety, depression, or other psychological\n             symptoms) that, in the opinion of the treating oncologist, are a direct result of\n             cancer recurrence. (Examples of symptoms that would preclude enrollment include\n             unintentional weight loss, ? grade 2 fatigue, and new abdominal pain unrelated to\n             operative procedures for the ovarian malignancy.)\n\n          2. Receiving any other investigational agent that would be considered a treatment for the\n             primary neoplasm. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or\n             investigational agents ?14 days of first dose of study drug\n\n          3. Major surgery ?28 days before start of treatment\n\n          4. History of another primary malignancy with an associated disease-free interval of less\n             than 5 years, except for curatively treated basal cell or squamous cell carcinoma of\n             the skin or in situ cancer of the cervix.
Subject has had chemotherapy within 4 weeks prior to the first study dose.
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
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.
Prior chemotherapy
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
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.
Chemotherapeutic agents for chemotherapy
Chemotherapy =< 21 days before first study treatment
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
Prior radiation or chemotherapy exposure inclusive of low dose chemotherapy such as methotrexate for autoimmune conditions.
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
Prior cell transfer therapy which included a myeloablative chemotherapy regimen (i.e. 1200 total body irradiation [TBI] or 200 TBI plus chemotherapy)
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
Chemotherapy within 2 weeks of first planned fraction of SBRT
Prior chemotherapy within the last 4 weeks
Patients must have had at least one prior chemotherapy regimen that included temozolomide and no more than one prior salvage chemotherapy
No prior 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 for cholangiocarcinoma or gallbladder carcinoma; NOTE: adjuvant chemotherapy is allowed if completed > 6 months prior to the start of registration
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
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
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.
Planned chemotherapy during radiosurgery
Clinical indication for additional doses of the chemotherapy as determined by the patient’s oncologist
Patients stable enough to undergo chemotherapy as determined by the patient’s oncologist
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);
No prior chemotherapy
Patients receiving intensive chemotherapy requiring a prolonged 4-6 week hospitalization
Active treatment with chemotherapy
Has not yet begun chemotherapy
Prior chemotherapy is allowed
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
Off active chemotherapy treatment for minimum of 6 months
Patients with previously diagnosed peripheral neuropathy pre-dating their neurotoxic chemotherapy administration or from causes other than chemotherapy
Have at least 6 weeks of cancer treatment (e.g. chemotherapy or biologics such as Herceptin) remaining
Planned treatment with R-CHOP chemotherapy
Off active chemotherapy treatment for minimum of 6 months.
PATIENTS: Treatment plans to include weekly outpatient chemotherapy
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)
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 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
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
Pain or symptoms of CIPN of >= 3 months duration, for which the patient wants intervention\r\n* Note: neurotoxic chemotherapy must have been completed >= 3 months prior to registration and there must be no further planned neurotoxic chemotherapy for > 5 months after registration
Receiving weekly chemotherapy
Prior exposure to neurotoxic chemotherapy
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
Prophylactic intrathecal chemotherapy;
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
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
chemotherapy or radiotherapynaïve
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
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)
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.
No prior chemotherapy
Receiving chemotherapy known to cause alopecia within 60 days of study or during the study.
Chemotherapy =< 6 months prior to randomization (Note: topical chemotherapy will be assessed on a case-by-case basis)
Pathologic complete response following preoperative chemotherapy
Receiving chemotherapy during study period
Low dose chemotherapy given after leukapheresis to maintain disease control must be stopped ? 7 days prior to lymphodepleting 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.
Prior exposure to neurotoxic chemotherapy
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
Group I: Treatment plan to include or have included chemotherapy
Group II: Treatment plan does not and has not included chemotherapy
Chemotherapy (taxanes) or Radium-223 alpha-particle treatment within the last 6 weeks prior to imaging
No preoperative treatment for endometrial cancer including radiation or chemotherapy
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
Treated with at least one other chemotherapy that did not work or where cancer relapsed
hospitalized for consolidation chemotherapy within 1 day (+/- 2 days)
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.