Patients with the following will be ineligible for registration onto this study:
INTRA-OPERATIVE REGISTRATION/RANDOMIZATION CRITERIA
Patients must not have received any chemotherapy within days prior to registration
Patients must not have received any immunotherapy, biologic or any investigational drug within days prior to registration; patients must not have received bevacizumab within days prior to registration
SUB-STUDY REGISTRATION:
Patients must not have received any anti-cancer drug within days prior to registration, and must not have received any nitrosoureas or mitomycin C within days prior to registration
None of the following conditions:\r\n* Grade or greater infection, or infection requiring intravenous systemic treatment within days prior to registration; patients should be off antibiotics at the time of registration.\r\n* Serious non-healing wound/ulcer/bone fracture within days prior to registration\r\n* History of organ transplant\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within days prior to registration\r\n* History of surgery as follows:\r\n** Major surgery (as an example, surgery requiring anesthesia and a > hour hospital stay) within months prior to registration, with wound healing at least days prior to registration\r\n** Minor surgery within days prior to registration with complete wound healing at least days prior to registration\r\n** Minor procedures within days prior to registration such as thoracentesis, paracentesis, or g or smaller needle biopsy of tumor\r\n** Patients with clinically relevant ongoing complications from prior surgery are not eligible
Use of finasteride within days prior to registration
Use of dutasteride or dutasteride/tamsulosin (Jalyn) within days prior to registration
For all forms of systemic therapy, patients must have completed therapy at least days prior to registration; patients must have completed any radioimmunotherapy at least days prior to registration; patients must have recovered from all treatment related toxicities from these therapies prior to registration
All patients must have a Medical Oncology evaluation within weeks prior to registration
Patients must have a baseline electrocardiograph (ECG) performed within days prior to registration
Charlson modified co-morbidity score =< for patients under and =< for patients and over days prior to registration
Completion of all items of the EPIC- which will be data entered at registration days prior to registration
Patients must NOT have received a prior autologous or allogeneic hematopoietic stem cell transplant at any time. Patients must NOT have received any chemotherapy, investigational agents, or undergone major surgery within days prior to registration, with the following exceptions:\r\n* Monoclonal antibodies must not have been received for week prior to registration\r\n* Chimeric antigen receptor (CAR) T-cells must not have been received for days prior to registration\r\n* Steroids, hydroxyurea, vincristine, -mercaptopurine, methotrexate, thioguanine and intrathecal chemotherapy are permitted within any timeframe prior to registration; Food and Drug Administration (FDA)-approved TKIs may also be administered until day prior to start of study therapy (C, D); IV cyclophosphamide may be administered at doses of g/m^ or less until up to days prior to registration
Comorbid conditions\r\n* No evidence of active bleeding, bleeding diathesis, or hemoptysis (>= / teaspoon of red blood) =< weeks prior to registration\r\n* No evidence of intracranial hemorrhage =< weeks prior to registration\r\n* Patients who have experienced thromboembolic event within months prior to registration must be on stable therapeutic anticoagulation for at least weeks prior to registration\r\n* No symptomatic congestive heart failure (New York Heart Association class II, III, or IV) within months prior to registration\r\n* No current unstable angina or uncontrolled arrhythmia\r\n* No uncontrolled hypertension at time of registration (blood pressure [BP] > / despite antihypertensive therapy)\r\n* No known history of prolonged QT syndrome\r\n* No known history of ventricular arrhythmia within months of registration\r\n* No known history of uveitis or iritis =< weeks prior to registration\r\n* No known history of or evidence of retinal pathology that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular macular degeneration within months of registration
Patients must not have received any chemotherapy, investigational agents, or undergone major surgery within days prior to registration with the following exceptions:\r\n* Monoclonal antibodies must not have been received for week prior to registration\r\n* Chimeric antigen receptor (CAR) T-cells must not have been received for days prior to registration\r\n* Steroids, hydroxyurea, vincristine, -mercaptopurine, methotrexate, thioguanine and intrathecal chemotherapy are permitted within any time frame prior to registration; Food and Drug Administration (FDA)-approved tyrosine kinase inhibitors may also be administered until day prior to start of study therapy (cycle [C], day [D])\r\n* All drug-related toxicities must have resolved to =< grade
Serum HCGbeta and AFP levels must be assessed within days prior to registration
No craniotomy within days of registration
Prior treatment specifics:\r\n* Participants must have radiological or objective evidence of progression to a CDK/ inhibitor regimen in the metastatic setting AND relapse/progression on an nonsteroidal anti-inflammatory drug (NSAI) (defined as either relapsed =< months after completing adjuvant NSAI or progressed through an NSAI for metastatic or locally advanced breast cancer)\r\n* Participants may have received any number of previous endocrine/hormonal lines of therapy in the metastatic setting, as long none of them were exemestane-based and the last dose is >= days prior to registration\r\n* Participants may have received any CDK/ inhibitor (i.e. palbociclib, ribociclib, abemacicliclib, etc) as long as the last dose is >= days prior to registration\r\n* Participants may have received up to one prior chemotherapy line for advanced breast cancer as long as the last dose is >= days prior to registration\r\n* Participants may have received prior biologic treatments or investigational drugs as long as the last dose is >= days prior to registration\r\n* Participants may have received radiotherapy for palliative purposes but must not be experiencing > grade treatment related toxicities and have completed treatment >= days prior to registration
Within weeks prior to study registration: \r\nTotal bilirubin =< . x the upper limits of normal (ULN) within weeks prior to study registration
Within weeks prior to study registration: \r\nSerum creatinine =< . x the ULN within weeks prior to study registration
Within weeks prior to study registration: \r\nPlatelet count > /mm^ within weeks prior to study registration
Patient must have recovered from any toxicity potentially related to the agent and received their last dose of the biologic agent >= days prior to study registration; for biologic agents that have a prolonged half-life, the appropriate interval since last treatment should be discussed with the study chair prior to registration
At least three half-lives must have elapsed prior to registration; such patients should be discussed with the study chair prior to registration
Prior ablative, radiation, resection, or transplant therapies less than weeks before study registration
Protocol treatment plan must include beginning therapy within consecutive days after registration
Chemotherapy less than or equal to weeks prior to registration
Biologic therapy less than or equal to weeks prior to registration
Treatment must be scheduled to commence within working days after registration and may not begin prior to registration.
Prior treatment:\r\n* Patients may have received prior radiation therapy to index lesions >= days prior to registration on this protocol if there has been documented progression by RECIST criteria; prior radiation therapy to the non-index lesions is allowed if >= days prior to registration on this protocol\r\n* Prior RAI therapy is allowed if >= days prior to registration on this protocol and evidence of progression (as defined above) has been documented in the interim (a diagnostic study using < mCi of RAI is not considered RAI therapy)\r\n* Prior chemotherapy is allowed if >= days prior to registration on this protocol\r\n* Patient may have received any number of prior lines of therapy\r\n* No prior use of sorafenib or an mammalian target of rapamycin (mTOR) (including phosphoinositide -kinase [PIk] or protein kinase B [AKT]) inhibitor for the treatment of thyroid cancer
Monoclonal antibody treatment: at least three half-lives must have elapsed prior to registration; such patients should be discussed with the study chair prior to registration; for bevacizumab, patients must have received last dose >= days prior to study registration
REGISTRATION
In addition to the pathologic diagnosis, at least ONE of the following cytopenias must be present:\r\n* Hemoglobin < g/dL within days of registration; this includes patients with transfusion dependency\r\n** NOTE: transfusion dependency at screening is defined for this protocol as - disease-related units red blood cells (RBC) transfused in the previous weeks; patients receiving more than disease-related units of RBCs within weeks of registration are excluded\r\n* Platelet count must be ? ,/mm^ and < ,/mm^ within days of registration\r\n* Absolute neutrophil count (ANC) < /mm^ within days of registration
At time of registration and within weeks prior to initiating on-protocol treatment: Platelets >= x ^ /L
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, biologic therapy or radiotherapy prior to study entry\r\n* Myelosuppressive chemotherapy: Patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to registration on the Re-treatment Study or at least six weeks if a nitrosourea\r\n* Biologic agent: Patient must have received their last dose of the biologic agent >= days prior to study registration; for biologic agents and monoclonal antibody treatment, at least three half-lives must have elapsed prior to registration\r\n* Other investigational agents (not fitting into one of the above specified categories): patients must have received their last dose of any other investigational agent greater than days prior to enrollment\r\n* Radiation: Patients must have:\r\n** Had their last fraction of local irradiation to the primary tumor >= months prior to registration; investigators are reminded to review potentially eligible cases to avoid confusion with pseudo-progression;\r\n** Had their last fraction of craniospinal irradiation (> Gy) > months prior to registration\r\n* Corticosteroids: Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least week prior to registration\r\n* Growth factors: Patients must be off all colony-forming growth factor(s) for at least week prior to registration (filgrastim, sargramostim, erythropoietin) and at least weeks for long-acting formulations
Prior Treatment\r\n* Patient must have failed at least one prior systemic therapy that included everolimus; disease progression or treatment intolerance leading to discontinuation is considered treatment failure\r\n* Prior treatment (except somatostatin analogs) with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, and/or radiation must be completed at least days prior to registration\r\n* Prior treatment with somatostatin analogs is allowed, and continuation of treatment with somatostatin analogs while on cabozantinib/placebo is allowed provided that the patient has been on a stable dose for at least two months\r\n* Prior systemic treatment with radionuclide therapy must be completed at least weeks prior to registration\r\n* Prior treatment with hepatic artery embolization (including bland embolization, chemoembolization, and selective internal radiation therapy) or ablative therapies is allowed if measurable disease remains outside of the treated area or if there is documented disease progression in a treated site; prior liver-directed or other ablative treatment must be completed at least days prior to registration\r\n* Prior treatment with cabozantinib is not allowed\r\n* Patients should have resolution of any toxic effects of prior therapy (except alopecia and fatigue) to National Cancer Institute (NCI) CTCAE, version ., grade or less\r\n* Patients must have completed any major surgery at least weeks prior to registration and any minor surgery (including uncomplicated tooth extractions) at least days prior to registration; complete wound healing from major surgery must have occurred at least days prior to registration, and complete wound healing from minor surgery must have occurred at least days prior to registration
Patient History\r\n* No class III or IV congestive heart failure (CHF) within months of registration\r\n* No clinically significant cardiac arrhythmia within months of registration\r\n* No unstable angina or MI within months of registration\r\n* No thromboembolic events within months of registration (including [incl.] stroke, transient ischemic attack [TIA], deep vein thrombosis [DVT], & pulmonary embolism [PE])\r\n* No known history of congenital long QT syndrome\r\n* No uncontrolled hypertension within days of registration (defined as systolic blood pressure [SBP] >= mmHg and/or diastolic blood pressure [DBP] >= mmHg despite optimal medical management)\r\n* No clinically significant GI bleeding within months of registration\r\n* No clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within months of registration including, but not limited to: active peptic ulcer, known endoluminal metastatic lesion(s) with history of bleeding, inflammatory bowel disease, or other gastrointestinal conditions with increased risk of perforation\r\n* No GI perforation within months of registration\r\n* No known tumor invading the GI tract within days of registration\r\n* No radiologic or clinical evidence of pancreatitis\r\n* No known cavitary lung lesions\r\n* No known endobronchial lesions involving the main or lobar bronchi and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage; (CT with contrast is recommended to evaluate such lesions)\r\n* No hemoptysis greater than / teaspoon (. mL) or any other signs of pulmonary hemorrhage within the months prior to registration\r\n* No known tumor invading or encasing any major blood vessels\r\n* No history of non-healing wounds or ulcers within days of registration\r\n* No history of fracture within days of registration\r\n* No brain metastases or cranial epidural disease unless adequately treated, stable, and off steroid support for at least weeks prior to registration\r\n* No known medical condition causing an inability to swallow oral formulations of agents\r\n* No history of allergic reaction attributed to compounds of similar chemical or biological composition to cabozantinib/placebo\r\n* No currently active second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ; patients are not considered to have a currently active malignancy if they have completed therapy and are free of disease for >= years
REGISTRATION
Prior therapy:\r\n* Any number of prior chemotherapy regimens and/or targeted therapies and/or prior external beam radiation therapy and/or prior hormonal therapy for endometrial cancer are allowed provided the last treatment was > weeks prior to registration\r\n* Vaginal brachytherapy may have been administered at any time prior to registration
Any of the following prior therapies:\r\n* Chemotherapy =< weeks prior to registration\r\n* Targeted biologic therapy =< weeks prior to registration\r\n* Immunotherapy =< weeks prior to registration\r\n* Any viral or gene therapy prior to registration\r\n* External beam radiotherapy =< weeks prior to registration\r\n** NOTE: Vaginal brachytherapy may be performed at any time prior to registration
Performed within days (+ working days) prior to registration: Creatinine < . mg/dL
Any of the following prior therapies:\r\n* Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =< weeks prior to registration\r\n* Immunotherapy (monoclonal antibodies) =< weeks prior to registration\r\n* Experimental agent in case of AML or TCL within half-lives of the last dose of the agent
Any of the following prior therapies:\r\n* Cytotoxic chemotherapy =< days prior to registration\r\n* Immunotherapy =< days prior to registration\r\n* Biologic therapy (i.e. antibody therapies) =< days prior to registration\r\n* Radiation therapy =< days prior to registration\r\n* Targeted therapies (i.e. PARP inhibitors, =< days or half-lives whichever is shorter)\r\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< days prior to registration
Concurrent use of ovarian hormone replacement therapy. Prior treatment should be stopped at least days prior to registration.
Recent prior chemotherapy:\r\n* Newly diagnosed patients (regardless of group); any prior chemotherapy for POEMS with the following exceptions:\r\n** Prior immunomodulators like azathioprine, cyclosporin, and/or corticosteroids are not exclusionary therapies if used for prior diagnosis of chronic inflammatory demyelinating polyneuropathy\r\n** Prior chemotherapy directed at a myeloproliferative neoplasm like hydroxyurea is not exclusionary\r\n* Previously treated patients (group )\r\n** Alkylators (e.g. melphalan, cyclophosphamide) =< days prior to registration\r\n** Anthracyclines =< days prior to registration\r\n** High dose corticosteroids, immune modulatory drugs (thalidomide or lenalidomide), or proteosome inhibitors (e.g. ixazomib or bortezomib) =< days prior to registration
Receipt of corticosteroids =< days prior to registration, unless patient has been taking a continuous dose of no more than mg/day of prednisone for at least days prior to registration
Not pregnant or breastfeeding; a negative pregnancy test is required within days of registration for pre- or perimenopausal (i.e., last menstrual period within one year of registration) women
Systemic chemotherapy within weeks of registration
Pulmonary conditions - any of the following:\r\n* Respiratory condition that required any oxygen supplementation =< months prior to registration\r\n* Prior or current pneumonitis\r\n* Clinically significant pulmonary hypertension =< months prior to registration\r\n* Lung infection requiring treatment =< months prior to registration\r\n* Pulmonary embolism requiring treatment =< months prior to registration\r\n* Pleural effusion requiring drainage =< months prior to registration
Treatment with biologic therapy within days of registration.
Any of the following prior therapies:\r\n* Chemotherapy =< weeks prior to registration\r\n* Immunotherapy =< weeks prior to registration\r\n* Biologic therapy =< weeks prior to registration\r\n* Radiation therapy =< weeks prior to registration
Any of the following prior therapies:\r\n* Cytotoxic chemotherapy =< days prior to registration\r\n* Immunotherapy =< days prior to registration\r\n* Biologic therapy (i.e. antibody therapies) =< days prior to registration\r\n* Radiation therapy =< days prior to registration\r\n* Targeted therapies (i.e. kinase inhibitors, =< days or half-lifes whichever is shorter)\r\n* For steroids or other non-cytotoxics given for blast count control, patient must be off for > hours (hrs) before starting therapy; NOTE: hydroxyurea (HU) is allowed for blast count control throughout study\r\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< days prior to registration
Pharmacologic therapy (e.g. statins or ezetimibe) to lower cholesterol within days prior to registration.
-alpha reductase inhibitors (e.g. finasteride or dutasteride) within days prior to registration.
Prior GEM therapy is acceptable as long as the last dose was >= months from registration on this study
Use of VEGF inhibitors within days prior to registration
Staging work-up prior to registration
Use of finasteride within days prior to registration; PSA should not be obtained prior to days after stopping finasteride
Use of dutasteride within days prior to registration; PSA should not be obtained prior to days after stopping dutasteride
Any of the following prior therapies:\r\n* Chemotherapy =< weeks prior to registration\r\n* Immunotherapy =< weeks prior to registration\r\n* Biologic therapy =< weeks prior to registration\r\n* Extensive abdominal surgery if it includes enterotomy(ies) =< weeks prior to registration; this criterion does not apply to placement of the peritoneal Port-A-Cath or lysis of adhesions at the time of registration\r\n* Any viral or gene therapy prior to registration\r\n* Radiation therapy to the abdomen or pelvis
Use of finasteride within days prior to registration
Use of dutasteride or dutasteride/tamsulosin (Jalyn) within days prior to registration
ECOG performance =< at the time of second registration
Subjects must not have received medical therapy for any cancer within ONE year prior to registration
ELIGIBILITY CRITERIA FOR REGISTRATION: Leukocytes >= ,/mcL (within one week of registration if patient postop, otherwise within two weeks of registration)
ELIGIBILITY CRITERIA FOR REGISTRATION: absolute neutrophil count >= ,/mcL (within one week of registration if patient postop, otherwise within two weeks of registration)
ELIGIBILITY CRITERIA FOR REGISTRATION: platelets >= ,/mcL (within one week of registration if patient postop, otherwise within two weeks of registration)
ELIGIBILITY CRITERIA FOR REGISTRATION: total bilirubin =< upper normal institutional limits (except for patients with Gilberts disease who are eligible despite elevated serum bilirubin level) (within one week of registration if patient postop, otherwise within two weeks of registration)
ELIGIBILITY CRITERIA FOR REGISTRATION: AST(SGOT)/ALT(SGPT) =< . x institutional upper limit of normal (within one week of registration if patient postop, otherwise within two weeks of registration)
Patients must not have received: cytochrome P A (CYPA) inhibitors within seven () days prior to registration on protocol and for the duration of the study; however, amiodarone, another CYPA inhibitor, should have been discontinued months prior to registration and for the duration of the study
Patient must begin therapy within calendar days of registration
Serum HCGB and AFP levels must be assessed within days prior to registration
Prohibited treatments and or therapies\r\n* Autologous stem cell transplant (ASCT) =< weeks prior to registration\r\n* Prior chemotherapy =< weeks prior to registration\r\n* Prior treatment with nitrosureas =< weeks prior to registration\r\n* Therapeutic anticancer antibodies =< weeks prior to registration\r\n* Radio- or toxin immunoconjugates =< weeks prior to registration\r\n* Radiation therapy to the injected area =< weeks prior to registration\r\n* Major surgery =< weeks prior to registration
Prior chemotherapy within weeks of study registration
Patients with other ongoing serious medical issues must be approved by the study chair prior to registration
Prior treatment\r\n* Current or prior treatment for this cancer with immunotherapy and/or any other investigational agents\r\n* Surgery =< weeks prior to registration\r\n* Radiotherapy =< weeks prior to registration\r\n* Treatment with bevacizumab or any cytotoxic chemotherapy =< weeks prior to registration
Any number of the following prior therapies is allowed:\r\n* Chemotherapy >= days prior to registration\r\n* Mitomycin C/nitrosoureas >= days prior to registration\r\n* Immunotherapy >= days prior to registration\r\n* Biologic therapy >= days prior to registration\r\n* Targeted therapy >= days prior to registration\r\n* Radiation therapy >= days prior to registration\r\n* Radiation to < % of bone marrow
Systemic chemotherapy for the study cancer < weeks prior to registration
The patient must have failed at least one prior therapy - surgery followed by high dose chemotherapy with stem cell rescue or multi-modality therapy of surgery, radiation and chemotherapy - prior to study registration; patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n* Myelosuppressive chemotherapy: Patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to study registration or at least six weeks prior if nitrosourea\r\n* Biologic agent: Patient must have recovered from any toxicity potentially related to the agent and received their last dose of the biologic agent >= days prior to study registration\r\n** For agents that have known adverse events occurring beyond days after administration, this period must be extended to beyond the time during which adverse events are known to occur; the duration of this interval should be discussed with the study chair\r\n** For biologic agents that have a prolonged half-life, the appropriate interval since last treatment should be discussed with the study chair prior to registration\r\n* Monoclonal antibody treatment: At least three half-lives must have elapsed prior to registration; such patients should be discussed with the study chair prior to registration\r\n* For bevacizumab, patients must have received last dose >= days prior to study registration\r\n* Bone marrow transplant: Patient must be:\r\n** >= months since allogeneic bone marrow transplant prior to registration\r\n** >= months since autologous bone marrow/stem cell prior to registration
Fiberoptic exam with laryngopharyngoscopy within days prior to registration
Patients must have adequate organ and bone marrow function =< days prior to registration, as defined below (Note: blood transfusion or growth factors is not permitted within days of registration):
Any of the following prior therapies:\r\n* Chemotherapy =< weeks prior to registration\r\n* Immunotherapy =< weeks prior to registration\r\n* Biologic therapy =< weeks prior to registration\r\n* Radiation therapy =< weeks prior to registration
REGISTRATION:
Any of the following prior therapies:\r\n* Chemotherapy =< weeks prior to registration\r\n* Mitomycin C/nitrosoureas =< weeks prior to registration\r\n* Immunotherapy =< weeks prior to registration\r\n* Biologic therapy =< weeks prior to registration\r\n* Radiation therapy =< weeks prior to registration\r\n* Radiation to > % of bone marrow \r\n* Investigational therapy or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation) =< weeks prior to registration; subjects with prostate cancer will be permitted to continue hormone therapy
Subjects must have received trastuzumab in the metastatic setting and experienced disease progression on this drug; any number of prior therapies is permitted; prior therapy with other HER targeted agents (trastuzumab emtansine [TDM-], pertuzumab, lapatinib) is allowed; the last dose of cytotoxic chemotherapy must have occurred >= weeks prior to study registration; the last radiation therapy must have occurred >= weeks prior to study registration
STUDY ELIGIBILITY CRITERIA FOR OVERALL STUDY PARTICIPATION (INITIAL REGISTRATION FOR COHORT ; ONLY REGISTRATION FOR COHORTS A & B):
Any of the following prior therapies:\r\n* Chemotherapy =< weeks prior to registration\r\n* Mitomycin C/nitrosoureas =< weeks prior to registration\r\n* Immunotherapy =< weeks prior to registration\r\n* Biologic therapy =< weeks prior to registration\r\n* Radiation therapy =< weeks prior to registration\r\n* Radiation to > % of bone marrow
Any of the following therapies:\r\n* Chemotherapy =< weeks prior to registration ( wks for nitrosourea-based chemotherapy)\r\n* Immunotherapy =< weeks prior to registration\r\n* Biologic therapy =< weeks prior to registration\r\n* Bevacizumab =< weeks prior to registration\r\n* Non-cytotoxic antitumor drugs, i.e., small molecule cell cycle inhibitors =< weeks prior to registration\r\n* Radiation therapy =< weeks prior to registration\r\n* Any viral or gene therapy prior to registration
Patients with other ongoing serious medical issues must be approved by the study chair prior to registration
Patients must have an eye exam performed within days prior to sub-study registration; patients with uncontrolled glaucoma or intra-ocular pressure >= mm Hg at screening should be referred for ophthalmological management and the condition controlled prior to registration
Patients must have MUGA/echocardiogram performed within days prior to sub-study registration
Patients must have a Na, K, Cl, Ca, Mg, and HbAc performed within days prior to sub-study registration
Appropriate for study entry based on the following diagnostic workup:\r\n* History/physical examination within days prior to registration\r\n* Imaging of target lesion(s) within days prior to registration\r\n* Further protocol-specific assessments:\r\n** Recovery from adverse effects of recent surgery, radiotherapy or chemotherapy\r\n** Any other prior therapy directed at the malignant tumor including chemotherapy, biologic/targeted agents and immunologic agents must be discontinued at least three weeks prior to registration\r\n** Investigation agents must be discontinued for at least days prior to registration\r\n** Any prior radiation therapy must be completed at least weeks prior to registration\r\n** At least weeks must have elapsed since any major surgery prior to registration
Patients must have undergone an electrocardiogram (EKG) within days prior to registration
> % lymphoplasmacytic cells (measured within days prior to registration OR
Treatment with chemotherapy within months of registration
All of the above inclusion criteria must occur within weeks prior to patient registration, with the exception of pathologic assessment of the mediastinum and biopsy to confirm NSCLC, which can be done within weeks of patient registration
Any of the following prior therapies:\r\n* Chemotherapy =< days prior to registration\r\n* Mitomycin C/nitrosoureas =< days prior to registration\r\n* Immunotherapy =< days prior to registration\r\n* Biologic therapy =< days prior to registration\r\n* Radiation therapy =< days prior to registration\r\n* Radiation to > % of bone marrow
Prior chemotherapy (except PLD in Dose Escalation Cohorts only) or any investigational agent within weeks prior to registration
Electrocardiogram (EKG) within weeks of registration
Patients with other ongoing serious medical issues must be approved by the study chair prior to registration.
REGISTRATION # - PRIOR TO CONSOLIDATION CHEMOTHERAPY:
CA- must be performed within days prior to registration
Creatinine levels =< twice the institutional upper limit of normal within days of registration on study (or within days prior to day of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
Serum glutamic oxaloacetic transaminase (SGOT) must be =< . x institutional ULN within days of registration on study (or within days prior to day of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
Patients must have completed systemic therapy at least days prior to registration, any surgical procedure must have been performed at least days prior to registration, and radiation therapy must be completed at least days prior to registration; patients must have recovered from major side effects of prior therapies or procedures in the opinion of the local site investigator prior to registration
Patients must have CA- obtained within days prior to registration; if CA- is normal a carcinoembryonic antigen (CEA) must be tested within days prior to registration
Patient has received systemic chemotherapy =< weeks prior to registration
Digital rectal exam within days of registration on study
Patients must have measurable disease within days prior to registration (or prior to initiation of first induction course for patients with prior therapy)
Patients with ECHO EF >= % within days prior to registration
Prior surgical treatment for prostate cancer is allowed but must have been completed at least days prior to registration and any toxicity from such therapy must have recovered to ? grade per CTCAE version criteria by the time of registration.
Chemotherapy in the months prior to registration
No radioimmunotherapy within months prior to registration
Use of finasteride within days prior to registration
Use of dutasteride within days prior to registration
Any of the following prior therapies: \r\n* Chemotherapy =< weeks prior to registration\r\n* Mitomycin C/nitrosoureas =< weeks prior to registration\r\n* Immunotherapy =< weeks prior to registration\r\n* Biologic therapy =< weeks prior to registration
Current use of or use =< weeks prior to registration of exogenous corticosteroids; patients clinically proven to require maintenance steroids will be allowed on the study provided that there has been no change in the corticosteroid dose =< weeks prior to registration
Other concurrent chemotherapy, immunotherapy, radiotherapy, any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation) or receiving any other investigational agent which would be considered as a treatment for the primary neoplasm:\r\n* Chemotherapy =< weeks of registration\r\n* Nitrosoureas or mitomycin C =< weeks of registration\r\n* Small molecule cell cycle inhibitors =< weeks prior to registration\r\n* Immunotherapy =< weeks prior to registration\r\n* Monoclonal antibodies =< half-lives prior to registration\r\n* Radiation therapy\r\n** Last fraction of craniospinal irradiation or total body irradiation =< months prior to registration or last fraction of focal irradiation to symptomatic metastatic sites =< weeks prior to registration\r\n* Growth factors\r\n** Colony forming growth factors < weeks prior to registration (i.e., filgrastim, sargramostim, erythropoietin)\r\n** Neulasta < weeks prior to registration
Any of the following:\r\n* Chemotherapy =< weeks prior to registration \r\n* Radiotherapy =< weeks prior to registration\r\n* Nitrosoureas =< weeks prior to registration or\r\n* Mitomycin C =< weeks prior to registration\r\n* Those who have not recovered from adverse events (to grade =< in severity) due to agents administered more than weeks earlier; prior palliative radiotherapy to bone metastases =< weeks prior to registration (i.e. prior palliative radiotherapy to bone metastases is allowed if it is performed > weeks prior to registration)
Any of the following prior therapies with interval since most recent treatment:\r\n* Chemotherapy =< weeks prior to registration\r\n* Biologic or immunologic therapy =< weeks prior to registration\r\n* Radiation therapy =< weeks prior to registration
Any of the following prior therapies:\r\n* Chemotherapy =< days prior to registration\r\n* Mitomycin C/nitrosoureas =< days prior to registration\r\n* Immunotherapy =< days prior to registration\r\n* Biologic therapy =< days prior to registration\r\n* Radiation therapy =< days prior to registration\r\n* Radiation to > % of bone marrow prior to registration\r\n* Hormonal therapy =< days prior to registration
Anti-cancer therapy (including immunotherapy) =< weeks prior to registration/randomization; exception: adjuvant Leukine =< days prior to registration/randomization
Any of the following prior therapies:\r\n* Cytotoxic chemotherapy =< days prior to registration\r\n* Immunotherapy =< days prior to registration\r\n* Biologic therapy (i.e. antibody therapies) =< days prior to registration\r\n* Radiation therapy =< days prior to registration\r\n* Targeted therapies (i.e. kinase inhibitors, =< days or half-lifes whichever is shorter)\r\n* Patients must be off other biologic therapies including hematopoietic growth factors >= days prior to registration\r\n* For steroids or other non-cytotoxics given for blast count control, patient must be off for > hours (hrs) before starting therapy; NOTE: hydroxyurea (HU) is allowed for blast count control throughout study\r\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< days prior to registration
Patients who have active local-regional disease prior to registration
REGISTRATION
Any number of the following prior therapies is allowed:\r\n* Chemotherapy >= days prior to registration\r\n* Mitomycin C/nitrosoureas >= days prior to registration\r\n* Immunotherapy >= days prior to registration\r\n* Biologic therapy >= days prior to registration\r\n* Radiation therapy >= days prior to registration\r\n* Radiation to < % of bone marrow
Any of the following prior therapies:\r\n* Chemotherapy =< days prior to registration\r\n* Mitomycin C/nitrosoureas =< days prior to registration\r\n* Immunotherapy =< days prior to registration\r\n* Biologic therapy =< days prior to registration\r\n* Radiation therapy =< days prior to registration\r\n* Investigational therapy or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA] approved indication and in the context of a research investigation) =< days prior to registration\r\n* Prior poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor therapy
Recent prior chemotherapy:\r\n* Alkylators (e.g. melphalan, cyclophosphamide) =< days prior to registration\r\n* Anthracyclines =< days prior to registration\r\n* High dose corticosteroids, immune modulatory drugs (thalidomide or lenalidomide) =< days prior to registration
Protocol treatment must begin within consecutive days after registration
Patient must have undergone ASCT between and days prior to study registration
REGISTRATION
Any of the following prior therapy: Chemotherapy ? weeks prior to registration. Biologic therapy ? weeks prior to registration. Radiation therapy ? weeks prior to registration
Patients may have received palliative radiotherapy to non-target lesions within days prior to registration provided all radiotherapy related toxicities have resolved to =< grade prior to registration; patients must not have received any major surgery within days prior to registration
Any of the following prior therapies:\r\n* Chemotherapy =< weeks prior to registration\r\n* Mitomycin C/nitrosoureas =< weeks prior to registration\r\n* Immunotherapy =< weeks prior to registration\r\n* Biologic therapy =< weeks prior to registration\r\n* Radiation therapy =< weeks prior to registration\r\n* Radiation to > % of bone marrow prior to registration
Any of the following recent therapies:\r\n* Alkylators (e.g. melphalan, cyclophosphamide) =< days prior to registration\r\n* Anthracyclines =< days prior to registration\r\n* High dose corticosteroids, immune modulatory drugs (thalidomide or lenalidomide), or proteosome inhibitors (bortezomib) =< days prior to registration
For purposes of determining prior drug regimens the following should be used as a standard; radiation therapy counts as treatment, BMT including induction counts as one treatment, radioimmunotherapy is not considered a chemotherapy regimen, and rituximab alone is not considered a treatment; all prior therapy must have been completed at least days prior to registration; patients should not have taken valproic acid, or any other histone deacetylase inhibitor (e.g., vorinostat, romidepsin), for at least days prior to registration; patients must have recovered from any toxicities related to therapies prior to registration
Patients with other ongoing serious medical issues must be approved by the study chair prior to registration.
Donation of blood within the preceding days prior to study registration.
Patient must begin therapy within calendar days of registration
No methadone within weeks prior to registration
Patients must not have initiated chemotherapy or radiation prior to registration to this study
Current oral steroid use > weeks prior to registration
Received a new anti-cancer agent within weeks prior to registration
Patients must not have had surgery, biologic therapy, or hormonal therapy within days prior to registration; patients must not have had chemotherapy, targeted small molecule therapy, or radiation therapy within days ( days for nitrosoureas or mitomycin C) prior to registration; patients must not have had an investigational agent or monoclonal antibodies, except anti-PD/L antibodies, within days prior to registration\r\n* Patients must have recovered from all adverse events due to prior anti-cancer therapy (residual toxicity =< grade ) prior to registration, with the exception of patients with =< grade neuropath or =< grade alopecia\r\n* If patients received major surgery, they must have recovered adequately from toxicity and/or complications from the intervention prior to registration
Presence of CRF >= days prior to registration
New use of Ambien and/or other benzodiazepines =< days prior to registration
New use of sleep aids including melatonin =< days prior to registration
Patients must not take MAO-Inhibitors for days before registration or any time during study treatment; concomitant therapy with heparin and warfarin is also not permitted at registration
Pain or symptoms of CIPN of >= months duration, for which the patient wants intervention\r\n* Note: neurotoxic chemotherapy must have been completed >= months prior to registration and there must be no further planned neurotoxic chemotherapy for > months after registration
Use of probiotics =< weeks prior to registration
Use of antibiotics =< days prior to registration
No untreated urinary retention within weeks prior to registration
No cryotherapy for prophylactic mucosal protection within weeks prior to registration
Patients who have had chemotherapy or other systemic therapy or radiotherapy, or those who have not recovered from adverse events due to prior administered agents as follows:\r\n* Chemotherapy < weeks prior to registration\r\n* Hormone therapy < weeks prior to registration\r\n* Targeted therapy (other than below) < weeks prior to registration (e.g., tyrosine kinase inhibitors)\r\n* Trastuzumab < weeks prior to registration\r\n* Bevacizumab < weeks prior to registration\r\n* Nitrosoureas/mitomycin C < weeks prior to registration\r\n* Radiotherapy < weeks prior to registration (NOTE: a previously irradiated lesion may not be used as a target lesion unless there is evidence of post-radiation progression)\r\n* Surgery < weeks prior to registration\r\n* Other approved or investigational agents < weeks prior to registration unless otherwise noted by the protocol chair\r\n* Patients who have received prior epigenetic (e.g., histone deacetylase [HDAC] inhibitors such as entinostat, panobinostat, vorinostat, romidepsin or demethylating agents such as -azacitidine or decitabine) immunomodulatory or other checkpoint inhibitors should only be considered after discussion with the protocol chair\r\n* Those who have not recovered from acute adverse events to grade < or baseline due to agents administered, with exception of alopecia, unless approved by the protocol chair
Patients must have begun postoperative oral intake of food prior to registration
Patients must not be on narcotics within days of registration
Psychostimulant use in the past days prior to registration
Patients must be receiving stable or increasing doses of morphine for - weeks prior to registration for protocol therapy; NOTE: switching patient from current pain regimen to morphine equivalent for at least - weeks prior to registration for protocol therapy is required
Use of probiotics =< weeks prior to registration
Use of antibiotics =< days prior to registration
Digital mammogram within days prior to pre-registration
Patients with a prior thoracotomy within week of study registration
Pregnancy or lactation at the time of study registration; (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within weeks prior to study registration)
No prior MRI of study breast within the months prior to registration
Patients must not have history of chemotherapy for cancer within months prior to registration
No prior MRI of the breasts within the months prior to registration
Have taken antibiotics =< days prior to registration
Complete initial work up earlier than weeks prior to subject registration