Participants must have histologically confirmed solid tumor malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; participants with uncontrolled Kaposi sarcoma are permitted (KS must be increasing despite HAART and HIV suppression for greater than or equal to 2 months, or stable KS despite HAART for greater than or equal to 3 months)\r\n* For participants in the 24 participant solid tumor cohort, only those histologies not known to respond to single agent nivolumab (such as pancreas, prostate, and microsatellite stable [MSS] colorectal cancer) will be excluded\r\n* For participants in the relapsed refractory HIV-cHL expansion cohort, participants must have histologically confirmed, relapsed/refractory (defined as relapsed/refractory to one or greater lines of therapy) HIV-associated classical Hodgkin lymphoma
Participants are required to be on antiretroviral regimens that are in accordance with the current International Acquired Immune Deficiency Syndrome (AIDS) Society guidelines concurrently with chemotherapy; the specific agents are at the discretion of the investigator and the use of investigational agents currently available on an expanded access basis is allowed; use of experimental antiretroviral agents or those containing zidovudine (including Combivir and Trizivir) or ritonavir (includes Norvir or Kaletra), cobicistat, didanosine (Videx or Videx EC), or similar potent cytochrome P450 (CYP)3 inhibitors are prohibited; in order to be eligible, participants taking zidovudine or ritonavir, or cobicistat, didanosine, or other CYP3 inhibitors must change to a different regimen 7 days prior to therapy initiation; changes to HAART therapy during the study may be made if medically necessary (toxicity, failure of regimen, etc.); participants must be on HAART at least 7 days prior to therapy
Radical or partial nephrectomy with lymphadenectomy in select participants
Eligible participants will be asked to sign a separate consent form for this optional study at the time they are enrolling on SJMB12; participants will then be randomly assigned to either the standard-of-care control group or the exercise intervention group
Eligible participants will be asked to sign a separate consent form for this optional study; participants will then be randomly assigned to either the standard-of-care control group or the Cogmed computerized intervention group
All participants must have screening prior to enrollment; participants whose results indicate that they are carrier of hepatitis B can still be treated per group B and C but will NOT receive rituximab
Participants known to be HIV positive (for therapeutic part of protocol, HIV participants are eligible for biology studies)
For participants in Part 2:
Participants cannot have received more than two prior regimens Specifically for participants in Arm B:
Female participants must not be pregnant, breastfeeding or considering becoming pregnant during the study or for at least 5 or 6 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.
Male participants must not be considering fathering a child or donating sperm during the study or for at least 3 or 6 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.
Male participants who are considering fathering a child or donating sperm during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.
Serum bilirubin =< 2.5 times ULN except for participants who are on atazanavir or indinavir, provided that the participant’s direct bilirubin is within normal institutional limits
Participants may not have been treated intratumorally with polyICLC.
For Parts A, B, and C, eligibility of participants who require blood transfusion before and after the start of the study treatment should be discussed by the Sponsor and investigator
Participants with prior Hepatitis B or C are eligible on the condition that participants have adequate liver function as defined by Inclusion Criterion number 16 and Exclusion Criterion number 5
Participants must be willing to undergo a research biopsy at baseline and at cycle 2 day 1 if extracranial metastases are safely accessible. Participants for whom biopsies cannot be safely performed must be willing to submit an archival primary and/or metastatic specimen. The biopsies may be waived with prior principal investigator (PI) approval for the first 6 participants enrolled to the safety run in phase
Participants =< 12-15 years Lansky 100-70%
Participants with symptomatic hyperviscosity or serum IgM > 5,000 mg/dL to undergo plasmapheresis prior to treatment initiation
Participants who have undergone a pneumonectomy due to known potential for pulmonary toxicities and heightened risk for complications
For participants treated with prior neoadjuvant chemotherapy: tumor stage of ypT2-4a or ypN+ (ypT2-4 or ypN+ for participants with upper urinary tract UC) and M0
For participants who have not received prior neoadjuvant chemotherapy: tumor stage of pT3-4a or pN+ (pT3-4 or pN+ for participants with upper urinary tract UC) and M0
Participating participants MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications, when clinically indicated and should be under the care of a physician experienced in HIV management; participants will be eligible regardless of antiretroviral medication (including no antiretroviral medication) provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 8 weeks following study entry; as study-specific (antiretroviral-based) strata fill, however, only participants who are receiving the therapies eligible for the remaining open strata will be accrued
Participants with relapsed primary malignancy, or who have been treated for relapse after the alloSCT was performed
Participants with neuroblastoma with only metaiodobenzylguanidine (MIBG)-positive evaluable disease may be enrolled
Participants must have operable breast cancer, with tumors greater than or equal to 2 cm in size; participants must not have any evidence of metastatic disease
Study participants will be women who have gone through a bi-lateral oophorectomy procedure
Participants who are azoospermic males are exempt from contraceptive requirements
Participants must not have a known additional malignancy that could confuse analysis of on-study treatment; inclusion of all study participants with more than one malignancy must be discussed and approved by the principal investigator (PI)
COHORT II ONLY: Participants are ineligible for ruxolitinib – do not have splenomegaly or symptoms of myelofibrosis as defined by the MPN-SAF. Or participants failed ruxolitinib as defined by loss of response to therapy and no allergy to ruxolitinib in the past
Research participants being treated for severe infection or who are recovering from major surgery are ineligible until recovery is deemed complete by the investigator
Research participants with any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
Participants with chronic autoimmune diseases
Participants must have had prior therapy
Participants must agree to undergo a research biopsy, if tumor is safely accessible, at baseline and within 14 days prior to course 3 day 1 (C3D1); participants for whom newly-obtained samples cannot be provided (e.g. inaccessible or participant safety concern) may submit an archived specimen\r\n* Note: After the first 6 participants undergo biopsy on cabozantinib, we will review their adverse event profiles to ensure no more than a 20% rate of grade 3 or higher bleeding or wound healing complications occur; if more than 2 patients (> 20%) have safety concerns, we will reassess the safety of collecting the research biopsies; full review of all grade (including grade 1 and 2) may also prompt changes and will be reviewed by the study team; Exelixis may be consulted if necessary
Participants may have received 0-3 prior chemotherapeutic regimens for metastatic breast cancer and must have been off treatment with chemotherapy for at least 14 days prior to registration; participants should also be adequately recovered from acute toxicities of prior treatment
Participants that cannot take alternate medications will be excluded from this study
Participants may have had any extent of prior surgery and/or chemotherapy
Western Safety Cohort Only: Participants with Japanese heredity.
Male or female study participants with sickle cell disease
All participants will undergo standard written informed consent procedures as dictated by the City of Hope Human Research Protections Office prior to performing any screening procedures that are not part of standard-of-care; informed consent will be obtained by the principal investigator, collaborating investigators, or other Institutional Review Board (IRB) designated personnel who will meet the training requirements established by the IRB; with the support of research personnel, he/she will explain the nature, duration, purpose of the study, potential risks, alternatives and potential benefits, and all other information contained in the informed consent document; in addition, they will review the experimental subject's bill of rights and the Health Insurance Portability and Accountability Act (HIPAA) research authorization form; prospective research participants will be informed that they may withdraw from the study at any time and for any reason without prejudice; prospective research participants will be afforded sufficient time to consider whether or not to participate in the research
Participants with treated brain metastases are allowed; radiation must be completed at least 2 weeks prior to pembrolizumab dosing and participants must not require ongoing steroids; participants with untreated brain metastases that are all < 5 mm with no clinical symptoms or vasogenic edema may be allowed on study on a case-by-case basis on discussion with sponsor; these participants will require MRI monitoring every 6 weeks to ensure stability
Previously treated with ixazomib (excluding comparator or placebo participants not on current treatment with ixazomib) in a Millennium-sponsored study. Participants will be eligible to enter the rollover study when:
Participants must not have an invasive infection at time of protocol entry
For Part 2 and Part 3 of the study, participants with R/R FL, MZL/MALT, MCL, or any other NHL subtypes according to the WHO classification.
Relapsed or refractory solid tumor malignancy that has progressed on standard anticancer therapy with no available curative options. (Note: Osteosarcoma participants must be in first or subsequent relapse [greater than or equal to first relapse]). Only the osteosarcoma participants enrolled to Cohorts 3A and 3B must be deemed candidates for ifosfamide and etoposide chemotherapy).
Research participants with presence of other active malignancy; however, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible; any history of myelodysplasia is excluded
Research participants being treated for severe infection or who are recovering from major surgery are ineligible until recovery is deemed complete by the investigator
Research participants with any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
All research participants must have the ability to understand and willingness to sign a written informed consent or age appropriate assent for pediatric patients\r\n* Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed
Research participants with presence of other active malignancy; However, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible
Research participants who received memory-enriched CD19R(EQ):CD28:zeta/EGFRt+ on IRB#13277
Research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of screening; research participants with any signs of symptoms of active infection, positive blood cultures or radiological evidence of infections
Research participants with presence of other active malignancy; however, research participants with history of prior malignancy treated within 2 years with curative intent and in a complete remission are eligible
Research participants with confirmed 1st or higher relapse of disease by morphology, cytogenetics or molecular, or research participants with refractory or residual disease
All research participants must have the ability to understand and the willingness to sign a written informed consent\r\n* Note: For research participants who do not speak English, a short form consent may be used with a COH certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent in processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed
Research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) positive based on testing performed within 4 weeks of enrollment; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
Research participants with presence of other active malignancy; however, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible
Participants must not have an invasive infection at time of protocol entry
Participants in Part E must have melanoma of any subtype.
For HER2+ breast cancer participants in parts A, C, and F: participants may receive concurrent treatment (ongoing or initiated simultaneously with abemaciclib) with IV trastuzumab.
Inclusion Criteria:\n\n          -  Study Participants must be 18 years or older.\n\n          -  Study Participants must have 2 sites of cutaneous metastatic melanoma that can not be\n             removed with surgery.\n\n          -  Study Participants may have been previously treated with chemotherapy or immunotherapy\n             but not with in 4 weeks of first dose of study treatment.
Participants must be currently participating in a PCI-32765 clinical study considered completed and have received at least 6 months of treatment with PCI-32765.
At study entry, participants must be actively receiving treatment with single-agent PCI-32765 or participants must have participated in a PCI-32765 randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior PCI-32765 treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments
Participants with a history of cranial nerve palsy
Specifically, for participants in Cohorts A1 and A2: Age greater than or equal to (>=) 18 years, disease progression or failure to achieve complete or partial response after intensive cytotoxic therapy, participants cannot have received more than two prior intensive regimens (e.g., induction + consolidation and one salvage therapy + consolidation)
Participants who have received prior chest radiation are excluded
Participants who have received any chemotherapy or radiotherapy for previous malignancy are not eligible; participants who have ever previously received any anti-neoplastic agent, including methotrexate, 6-mercaptopurine, 6-thioguanine, vincristine cyclophosphamide, cytarabine (except for IT cytarabine), or any anthracycline, for any reason (e.g., rheumatologic or autoimmune condition) are not eligible
Participants must have adequate organ function including:\n\n               1. Bone Marrow Reserve:\n\n                    1. Absolute neutrophil count (ANC) ? 1.5x10^9/L prior to treatment.\n                       Participants on maintenance doses of granulocyte colony stimulating factor\n                       (G-CSF) are eligible.\n\n                    2. Platelets ? 100x10^9/L\n\n                    3. Hemoglobin ? 9 g/dL\n\n                    4. Use of supportive care measures (eg, use of white blood cell [WBC] growth\n                       factors, antiemetics, epoetin) should follow the ASCO guidelines as listed\n                       at www.asco.org.  Participants should receive full supportive care,\n                       including transfusion of blood as mandated by clinical need; however,\n                       transfusions administered for the sole purpose of meeting the study\n                       inclusion criteria between the time informed consent is signed and first\n                       dose of EC145/placebo/PLD is administered are not allowed.\n\n               2. Hepatic: Total bilirubin level < 1.5 x ULN and ALT, AST, GGT, and alkaline\n                  phosphatase levels < 2.5 x ULN.\n\n               3. Renal: Serum creatinine level ? 1.5 x ULN or for participants with serum\n                  creatinine levels above 1.5 x ULN, creatinine clearance ? 50 mL/min/1.73m^2\n\n               4. Cardiac: Left ventricular ejection fraction (LVEF) equal to or greater than the\n                  institutional lower limit of normal.
All Participants:
Participants who are newly diagnosed and not considered for high-dose chemotherapy due to: being age >=65 years; or participants less than (<) 65 years with presence of important comorbid condition(s) likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation. Sponsor review and approval of participants below 65 years of age is required before randomization
For Part E: Participants must have adenoid cystic carcinoma (ACC).
For Part F dose confirmation: Participants must have leiomyosarcoma and prescreened alterations in a defined pathway.
Measurable disease per RECIST v1.1 for participants with solid malignancies. Disease-specific criteria for participants with prostate cancer, glioblastoma multiforme (GBM), malignant lymphoma, or multiple myeloma
Have a histologically confirmed diagnosis of STS for which olaratumab and doxorubicin would be appropriate therapy. Participants with a diagnosis of Grade 1 liposarcoma are eligible if there is histological or radiographic evidence of evolution to more aggressive disease. Participants with Kaposi's sarcoma and gastrointestinal stromal tumors (GIST) will be excluded. Participants must have potentially resectable disease (as assessed by the study investigator) and have a primary tumor lesion deemed amenable to serial biopsy.
Has had encephalopathy in the last 6 months. Participants on rifaximin or lactulose to control their encephalopathy are not allowed
For CMML participants: WBC count <20,000/mcL before administration of the first dose of study drug on Cycle 1 Day 1; participants must have been off hydroxyurea for at least 1 week prior to WBC count assessment.
Participants with intracardiac defibrillators.
Recipient of any drug with potential QT interval prolonging effects within 14 days prior to the first dose for all participants and while on treatment through the end of the study for crizotinib-treated participants only
Participants must have stopped any hormonal therapy at least 1 week prior to treatment with nivolumab and bevacizumab; participants may continue on hormone replacement therapy administered for post-menopausal symptoms
Willing to use acceptable contraceptive measures as defined by the protocol during and at least for 6 months (male participants) or 12 months (female participants) after the last dose of study drug
Male participants, even if surgically sterilized (ie, status postvasectomy), who:
Research participants with any uncontrolled illness including ongoing or active infections; research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) positive based on testing performed within 4 weeks of enrollment; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
Research participants with presence of other active malignancy; however, research participants with history of prior malignancy treated with curative intent in complete remission are eligible
Warfarin use is excluded; other anticoagulants are permitted, but for participants enrolled in the RP2D cohort, the investigator must deem it safe to temporarily hold to facilitate pre and on-treatment tumor biopsies; participants where this is not feasible are excluded from participation
Participants who are >= 18 years of age or Legally Authorized Representative (LAR) of participants who are younger than 18 years must sign an informed consent for the Pediatric Oncology Branch (POB) Screening Protocol (01-C-0157: Eligibility Screening and Tissue Procurement for the National Cancer Institute [NCI], Pediatric Oncology Branch [POB] Clinical Research Protocols) prior to participating in studies required to determine eligibility for this trial; after confirmation of eligibility, participants who are >= 18 years of age or LAR of minor participants must sign an informed consent document for this trial, indicating that they are aware of the investigational nature of the proposed treatment, the risks and benefits of participating and the alternatives to participating, prior to the conduct of any study procedures
Participants must use effective birth control throughout study until at least 30 days after study treatment or 1 year after rituximab treatment, whichever is later; female participants must not be pregnant or breast-feeding
Phase 1b: Participants with AML who are refractory to or have relapsed after initial treatment for their disease, with no more than three prior lines of therapy. Participants who have received prior treatment with cytarabine or decitabine are not excluded.
Participants who have had or are planning to have the following invasive procedures
Participants may have had any number of previous hormonal therapies (antiandrogens, steroids, estrogens, finasteride, dutasteride, ketoconazole, abiraterone) provided these were discontinued >= 4 weeks before enrollment; participants on prednisone 10 mg daily or another equivalent steroid dose are eligible; participants on inhaled steroid are eligible
Participants must have had a diagnosis of symptomatic multiple myeloma (MM), MM + amyloidosis, or POEMS (osteosclerotic myeloma: polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) requiring treatment; participants with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy; note that study participants do not need to have active disease at the time of study entry, as participants may have received up to 12 months of prior chemotherapy, which might have induced a response
Participants must have received =< 12 months of prior chemotherapy for this disease without evidence of progressive disease with treatment; participants may have received prior radiotherapy provided approval has been obtained from the principal investigator (PI); participants with a history of radiation who have a platelet count < 150,000 due to radiation (disease, chemo, and other factors have been ruled out) will be excluded from this study
Participants who have undergone allogenic stem cell transplant are ineligible unless they meet the following criteria, a) participants who are off all immunosuppressive therapy, b) participants who have no signs and/or symptoms of acute or chronic graft versus host disease, or c) participants must have appropriate hematology counts
For Cohort 3, participants must have WHO grade II astrocytoma, oligoastrocytoma or oligodendroglioma that is histologically confirmed either by the previous biopsy or resection, or at the time of re-operation (re-operation before entry to the current study is allowed; however participants must be off post-surgery dexamethasone for at least 4 weeks before administration of the first vaccine)
Participants with relapsed and/or refractory multiple myeloma (RRMM) who had received 1 to 3 prior therapies. NOTE: population included the following 3 categories of participants:
Must have also adhered to the guidelines of the RevAssist program (US participants), RevAid program (Canadian participants), iAccess program (Australian participants), RevMate program (Japanese participants) or The Lenalidomide Pregnancy Risk Minimisation Plan as outlined in the study Manual (all other participants who were not using commercial supplies)
Participants may have received prior hydroxyurea but may not be currently being treated with hydroxyurea at the time of study initiation
Participants who have an indwelling draining IP catheter (to be drained only under medical supervision)
Inclusion Criteria -\n\n          1. Between the ages of greater or equal to (?) 6 months and less than (<) 18 years of age\n\n          2. Must have histologically proven B-cell acute lymphoblastic leukemia (ALL) or B-cell\n             lymphoblastic lymphoma with marrow involvement\n\n          3. All participants (both ALL and participants with lymphoblastic lymphoma) must have M2\n             or M3 bone marrow classification\n\n          4. Disease status: a) Participants must have relapsed or refractory disease b) In the\n             event of relapse after prior allogeneic hematopoietic stem cell transplant (HSCT),\n             participants must be at least 3 months post-transplant and have no evidence of active\n             graft-vs-host disease, and must have been off immunosuppression for at least 4 weeks,\n             c) Must have resolution of the acute toxic effects to less than or equal to (?) Grade\n             2 from prior chemotherapy before entry, in the opinion of the investigator\n\n          5. Participants with the following central nervous system (CNS) 1 or 2 status are\n             eligible only in the absence of neurologic symptoms\n\n          6. Female participants of childbearing potential and post-pubertal male participants must\n             use an approved method of contraception for the study.\n\n        Exclusion Criteria\n\n          1. Concurrent enrollment in another clinical study for cancer treatment, unless the\n             subject is in the follow-up period from a previous study.\n\n          2. Isolated testicular or CNS ALL\n\n          3. Participants with mixed-lineage leukemia (MLL) gene rearrangement\n\n          4. Inadequate Hepatic function\n\n          5. Inadequate Renal function\n\n          6. Radiologically-detected CNS lymphoma\n\n          7. Participants with clear laboratory or clinical evidence of disseminated intravascular\n             coagulation (DIC)\n\n          8. Hyperleukocytosis or rapidly progressive disease that would compromise ability to\n             complete study therapy\n\n          9. QT interval corrected using Fridericia's formula (QTcF) greater than or equal to a\n             Grade 2, confirmed by 2 additional seperate electrocardiographs (ECG's) within 28 days\n             prior to starting study drug. The initial screening ECG need not be repeated for\n             confirmation if the QTcF interval is <481 milliseconds.\n\n         10. Pregnant or breast-feeding females\n\n         11. Prior treatment with CAT-3888 (BL22), moxetumomab pasudotox, or any\n             pseudomonas-exotoxin-containing compound\n\n         12. Prior treatment with any anticancer biologic therapy within 2 weeks prior to starting\n             study drug, including but not limited to therapeutic monoclonal antibodies or\n             antibody-drug conjugates\n\n         13. Systemic chemotherapy ? 2 weeks (6 weeks for nitrosoureas) and radiation therapy ? 3\n             weeks prior to starting study drug\n\n         14. Clinically significant ophthalmologic findings (evidence of retinal damage or injury)\n             during the screening\n\n         15. Presence of a second invasive malignancy\n\n         16. Uncontrolled pulmonary infection, presence of pulmonary edema\n\n         17. Serum albumin < 2 gram per deciliter (g/dL). Albumin infusions for correction of\n             hypoalbuminemia are allowed, but cannot have administered within 7 days prior to start\n             of study drug\n\n         18. Radioimmunotherapy within 2 years prior to study start of study drug\n\n         19. Participants with prior history of thrombotic microangiopathy or hemolytic uremic\n             syndrome (HUS)\n\n         20. T-cell ALL or T-cell lymphoblastic lymphoma\n\n         21. Participants currently receiving high-dose estrogen therapy defined as >0.625\n             milligram per day (mg/day) of an estrogen compound or within 2 weeks prior to starting\n             study drug.
Participants for whom front-line cytotoxic therapy is indicated (i.e., symptomatic visceral or pulmonary KS or symptomatic KS impairing functional status); all participants must have a chest X-ray to rule out pulmonary KS within 28 days of study enrollment
Participants MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications, when clinically indicated and should be under the care of a physician experienced in HIV management; participants will be eligible regardless of antiretroviral medication (including no antiretroviral medication) provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 8 weeks following study entry; as study-specific (antiretroviral-based) strata fill, however, only participants who are receiving the therapies eligible for the remaining open strata will be accrued
Participants must have recurrent or refractory disease after receiving at least one prior platinum-containing chemotherapy regimen, or standard therapy is refused or not suitable. For participants in Canada: participants should also not be suitable for treatment with topotecan hydrochloride
Participants with untreated central nervous system metastases, or history of previously treated disease. Participants must have stable hematological parameters, satisfying eligibility, platelet count must be stable for >=2 weeks prior to study drug administration
Participants with evidence of electrolyte imbalance
Participants who have failed at least one line of systemic therapy for advanced stage HCC or participants who are ineligible or unable to tolerate the standard of care treatment.
Participants who received prior treatment with a hypomethylating agent
Male participants, even if surgically sterilized (ie, status postvasectomy), who:
Participants with stable enhancement/edema are eligible if they require corticosteroids to control symptoms
Male participants, even if surgically sterilized (that is, status postvasectomy), who:
Participants who are willing to refrain from donating blood for at least 90 days after their final dose of MLN4924 and (for male participants) willing to refrain from donating semen for at least 4 months after their final dose of MLN4924.
Participants with a cardiac pacer whose heart rate is set at a fixed rate and participants on concomitant medication that may limit increase in heart rate in response to hypotension (example, high-dose beta blocker).
Donor-specific antibodies (DSA) will be assessed by the local laboratory 30 days or less prior to transplant using solid phase micro particle technology (by Luminex phenotype panel or Luminex single antigen bead test); the following criteria apply:\r\n* Participants without detectable DSA will be deemed eligible if they meet other entry criteria\r\n* Participants with detectable DSA and a positive flow cytometric crossmatch may undergo de-sensitization per standard of care if they are cytotoxic crossmatch negative; such participants must demonstrate a negative flow cytometric crossmatch by day -9 in order to receive the first dose of study therapy (ATG); participants who do not demonstrate an acceptable response to de-sensitization by day -9 will be considered screen failures and will be terminated from the study\r\n* Participants with a positive cytotoxicity crossmatch will be excluded
All participants must demonstrate a negative QuantiFERON (QFT) assay result within 52 weeks of transplant regardless of purified protein derivative (PPD) status; participants with a positive QFT assay must complete treatment for latent tuberculosis (TB) and have a negative chest x-ray; QFT testing done within 52 weeks before transplant is acceptable as long as there is documentation of the results; prior recipients of a bacillus calmette-guerin (BCG) vaccination are not exempt
Participants must have relapsed or progressed after at least 1 prior course of anti-lymphoma therapy
PART II: Oncology participants must have histologically or cytologically diagnosed malignancy; ideally the subject has completed treatment within 6 months to a year and cancer is stable
Participants must be ?18 years since no dosing or adverse event data are currently available on the use of OGX-427 in participants <18 years of age.
Participants with evidence of electrolyte imbalance greater than or equal to (>/=) Grade 2 which cannot be corrected prior to study initiation
Inclusion criteria:\n\n        Phase 1 Part (dose escalation): Participants with a histologically confirmed solid tumor\n        including tumors of the central nervous system that was recurrent or refractory and for\n        which no further effective standard treatment was available. All participants must had\n        measurable disease. Participants with diffuse pontine glioma were eligible without a biopsy\n        after evidence of progressive disease post radiation therapy.\n\n        Phase 2 Part (safety and activity): Participants with recurrent or refractory high grade\n        glioma or diffuse intrinsic pontine glioma for whom no further effective therapy was\n        available. All participants must had measurable disease. Participants with diffuse pontine\n        glioma were eligible without a biopsy after evidence of progressive disease post radiation\n        therapy. Participants with a grade III or grade IV glioma must had pathologic confirmation\n        either at the time of initial diagnosis or at the time of recurrence.\n\n        Participants aged ?2 years and ?18 years\n\n        Participants met the body surface area (BSA) requirements to be eligible:\n\n          1. Minimal BSA requirements for a particular dose level;\n\n          2. During the Phase 1 part participants must had a BSA <2.1 m² at the time of enrollment\n\n          3. During the Phase 2 part participants with a BSA ?2.1 m² were eligible, however the\n             actual dose of cabazitaxel for these participants were adjusted to a maximum dose\n             calculated with (capped at) the BSA of 2.1 m²\n\n        Performance status by:\n\n          1. Lansky score ?60 (participants ?10 years of age)\n\n          2. Karnofsky score ?60% (participants >10 years of age) Participants who were unable to\n             walk because of paralysis, but who were mobile in a wheelchair, were considered\n             ambulatory for the purpose of assessing the performance score.\n\n        Participants must had adequate liver, renal and marrow function as defined below:\n\n          1. Total bilirubin ?1.0 x the upper limit of normal (ULN) for age\n\n          2. AST (SGOT) and ALT (SGPT) ?2.5 x ULN\n\n          3. Serum creatinine ?1.5 x ULN for age or creatinine clearance ?60 mL/min/1.73 m²\n\n          4. Absolute neutrophil count ?1.0x10^9 /L\n\n          5. Platelets ?75x10^9/L (transfusion independent)\n\n          6. Hemoglobin ?8.0 g/dL (could be transfused)\n\n        Female participants of child-bearing potential must had a negative pregnancy test ?7 days\n        before starting cabazitaxel treatment.\n\n        Male and female participants of reproductive potential must agreed to use adequate\n        contraception prior to study entry, for the duration of study participation and for 6\n        months following the last dose of cabazitaxel.\n\n        Written informed consent/assent prior to any study-specific procedures. Consent must be\n        obtained from the participant and/or parent(s) or legal guardian(s) and the signature of at\n        least one parent or guardian was required. Investigators also obtained assent of\n        participants according to local, regional or national guidelines.\n\n        Participants must have recovered from the acute toxic effects of all prior therapy to ?\n        grade 1 before entering the study.\n\n        Exclusion criteria:\n\n        Prior treatment within the following timeframes:\n\n          1. Systemic anti-cancer treatment within 3 weeks (6 weeks for nitrosourea, mitomycin and\n             monoclonal antibodies including bevacizumab)\n\n          2. Surgery or smaller field radiation therapy within 4 weeks\n\n          3. Treatment with an investigational agent within 4 weeks or within 5 half-lives of the\n             agent, whichever was longer Craniospinal or other large field radiation therapy\n             (defined as >25% of bone marrow irradiated) within 6 months prior to the first dose.\n\n        Prior systemic radioisotope therapy (this did not include diagnostic imaging or\n        radioimmunoconjugates lacking myelosuppressive properties) or total body irradiation.\n\n        Prior bone marrow or stem cell transplant\n\n        Participants with any clinically significant illness that, in the investigator's opinion,\n        could not be adequately controlled with appropriate therapy, would compromise a\n        participant's ability to tolerate cabazitaxel or result in inability to assess toxicity.\n        This included, but was not limited to uncontrolled intercurrent illness including ongoing\n        or active infection, cardiac disease, renal impairment, planned surgery or psychiatric\n        illness/social situations that would limit compliance with study requirements.\n\n        Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency-syndrome\n        (AIDS)-related disease Known history of hepatitis C or known active hepatitis B infection.\n        Pregnant or breast feeding women Treatment with strong inhibitors or strong inducers of\n        CYP3A4 or enzyme inducing anti-epileptic drugs (EIAED) within 14 days prior to first dose\n        of cabazitaxel and for the duration of study. Non-EIAEDs were permitted.\n\n        Known history of hypersensitivity to taxanes or polysorbate 80 or G-CSF. Participation in\n        another interventional clinical trial and/or concurrent treatment with any investigational\n        drug.\n\n        Participants not able to comply with scheduled visits, treatment plans, laboratory tests,\n        and other study procedures.\n\n        The above information was not intended to contain all considerations relevant to a\n        participant's potential participation in a clinical trial.
Participants who have stopped study drug dosing for greater than 56 days
Participants continuing to require dose modifications
Participants who are less than 6 weeks post-131 I-metaiodobenzylguanidine (mIBG) therapy.
Participants with carcinoma of the cervical stump
Participants requiring anti-hyperglycemic therapy
Female participants must not be pregnant or breast-feeding. Female participants of childbearing potential and fertile male participants must agree to use a highly effective contraceptive during the trial and for a period of at least 6 months following the last administration of trial drug(s)
Part E - Diagnosed with cholangiocarcinoma, either intrahepatic or extrahepatic, that is unresectable, recurrent, or metastatic. Participants must not have received prior systemic front line therapy for metastatic or resectable disease (i.e. participants may have received adjuvant gemcitabine but have not yet received gemcitabine/cisplatin for recurrent metastatic disease). Participants must be, in the opinion of the investigator, an appropriate candidate for experimental therapy. Participants should be evaluated for the need to undergo biliary drainage by stent placement prior to study participation. Participants should have adequate biliary drainage with no unresolved biliary obstruction.
Participants in whom the required program of oral (PO) and IV fluid hydration is contraindicated
Participants who have received prior Pemetrexed treatment.
Inclusion Criteria:\n\n        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please\n        visit www.BMSStudyConnect.com\n\n          -  Kidney tumor has been completely resected 4 to 12 weeks prior to randomization\n\n          -  Pathologic TNM staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G\n             any, N0 M0; pT3, G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0\n\n          -  Post-nephrectomy tumor shows RCC with a predominantly clear cell histology, including\n             participants with sarcomatoid features\n\n        Exclusion Criteria:\n\n          -  Participants with an active known or suspected autoimmune disease\n\n          -  Known history of positive test for human immunodeficiency virus (HIV) or known\n             acquired immunodeficiency syndrome (AIDS)\n\n          -  Any severe or serious, acute or chronic medical or psychiatric condition, or\n             laboratory abnormality that may increase the risk associated with study participation\n\n          -  Participants with a condition requiring systemic treatment with corticosteroids\n\n        Other protocol defined inclusion/exclusion criteria could apply
Glycosylated hemoglobin is <=6.5% hyperglycemic participants permitted if glucose is well controlled by hypoglycemic medication).
Pregnant participants will not be entered on this study
ALL PARTICIPANTS
Participants must self-identify as Hispanic/Latina
Participants must be willing and able to attend four 4-hour in-person sessions
Participants with untreated depression or anxiety as assessed by self-report and review of medical history
Participants must have documentation of a plexiform neurofibroma (PN), based on either clinical exam or imaging
PATIENT PARTICIPANTS:
Insurance information will be reviewed to ensure geriatric referral is covered for all potential participants
Participants must be oriented to person, place, and time
Research participants having any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of enrollment; research participants with any signs or symptoms of active infection, positive blood cultures, or radiological evidence of infections
Participants receiving any medications or antibiotics to treat Clostridium difficile infection prior to the initiation of the study will be ineligible for this study
Illiterate participants
Deaf participants
PATIENT PARTICIPANTS:
Participants may be on anti-depressants and/or anxiolytics as long as the dosing has remained stable over the preceding 4 weeks
Participants with acute, active gastrointestinal infection (e.g., typhlitis, diverticulitis, appendicitis)
Participants with non-evaluable or non-measurable cancer are eligible if they have a confirmed increase in tumor antigens >=2 x upper limit of normal (ULN).
The participant’s SISCCA must not have been ablated
Concurrent malignancy. Participants with carcinoma in situ of any origin and participants with prior malignancies in remission may be eligible with sponsor approval.
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Women with no history of cancer
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: No history of prior chemotherapy
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Willing to come to MDACC and HIAE for the assessment session
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Right handed
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Mini-Mental State Examination score of 23 or below
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Primary caretaker of a cancer patient
Participants may have had prior breast surgery and/or chemotherapy
Participants using other contraindicated medications (thioridazine, yohimbine)
PATIENT PARTICIPANTS
Participants will be diagnosed with breast cancer; the participants will be scheduled for a lumpectomy or a mastectomy at UH GMC Seidman Cancer Center
CHILD PARTICIPANTS:
ADULT PARTICIPANTS:
PATIENT PARTICIPANTS:
Participants must be diagnosed with cancer
All at-risk relatives of the participants found to have LS
Participants with a core biopsy diagnosis of atypia with associated malignancy (in the same quadrant) will be excluded.
Participants who have had a metal injury to the eye
Participants from Franklin County or from Appalachia Ohio (depending on program location)
Participants in other ongoing clinical trials are eligible for this study
Participants who only have a single HSIL lesion that is likely to be removed entirely with the initial screening biopsy
WHITE, NON-HISPANIC: Participants reporting sun-sensitive phenotypes.
If the study staff or principal investigator (PI) have serious concerns about the participant’s ability to engage in and/or complete the study protocol.
Participants will be excluded from participation in future stages
Participants must have the ability to safely undergo bronchoscopy in the judgment of the investigators
Participants must not have been treated with iloprost at any time; Note: participants on the placebo arm of previous iloprost trials are eligible, but participants on the placebo arm of cohort A of this study may not be enrolled in cohort B
Participants must not have used any other investigation agent within the last six months
Participants with known genotype for Thr1482Ile polymorphism in TRPM7
The number of participants from the same street address will be limited to 1
Participants must be willing to forego foods, beverages and supplements containing pomegranate for the duration of the study
Participants in the control group must be disease free, never-smokers and otherwise healthy
Participants with hyperplasia, in absence of dysplasia or carcinoma in situ, will be excluded
All participants must be nonsmokers at the time of the study (i.e., have not used any tobacco product); have not smoked an entire cigarette, cigar, or hookah session before
All participants must score 3 out of 5 or above on the place attachment scale (i.e., measuring adolescents’ feeling of attachment to their after-school program)
Participants who in the opinion of the principal investigator (PI) will be at higher risk of acetylsalicylic acid (ASA)-related complications
Participants with known genotype for rs174535 in fatty acid desaturase 1 (FADS1)
Participants must have an echocardiogram within normal limits within the last year
PARTICIPANTS: Self-identified as Filipino, Hmong, or Korean Americans
PARTICIPANTS: live in relevant area and intend to stay there for at least 12 months
Participants with a known Li-Fraumeni or Cowden’s disease
Participants with prior mantle radiation
Participants must have a pre-operative standard mammogram with or without ultrasound; these may be performed at outside institutions
Participants with known Li-Fraumeni or Cowden’s disease
Participants with prior mantle radiation
Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation
Participants at higher risk due to age, frailty, or the emergent nature of their condition
GROUPS 1, 2, AND 3: \All participants” described above
Participants who do not have residual calcifications present on mammogram following biopsy
BREAST CANCER PARTICIPANTS: Patients participating in other research imaging protocols will be excluded from this study
Women matched to age with our 16 post-cancer treatment participants
Participants with any extent of resection are eligible
Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
Participants with AML must either refuse or not be considered candidates for intensive induction chemotherapy. Previously treated participants should have evidence of persistent or recurrent AML in the peripheral blood and/or bone marrow. Participants must have white blood cell (WBC) < 15 x 10^9cells/L.
For CMML, participants must have been treated with at least one prior therapy (hydroxyurea or an hypomethylating agent [HMA]).
Participants with genetic diseases of the liver that may complicate review of safety data
Previous treatment with a selective FGF19-FGFR4 targeted therapy and/or selective pan-FGFR inhibitor 14. Use of any vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of study therapy 15. Presence of gastric or esophageal varices requiring active treatment 16. A clinically significant ECG abnormality, including a marked baseline prolonged QTc interval (eg, a repeated demonstration of a QTc interval >500 ms) 17. Significant cardiovascular impairment or any other major illness, medical condition 19. Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria 20. Hypersensitivity to the study drug or to any of the excipients 21. Intolerance or hypersensitivity to both CT and MRI contrast material that would preclude the ability to acquire the triphasic liver imaging required by the protocol 22. Participants with inorganic phosphorus > upper limit of normal for the institution 23. Participants with total or ionized serum calcium > upper limit of normal for the institution 24. Participants with endocrine changes that may result in increases in calcium or phosphate, including but not limited to hyperparathyroidism and tumoral calcinosis 25. Participants with past medical history and/or current evidence of tumoral calcinosis or tissue calcification 26. Participants who take calcium, vitamin D or systemic corticosteroids
Participants not capable of keeping moderately still for the imaging portion of the study session (~1 hour for imaging)
Participants whose girth exceeds the bore of the MRI scanner
If is neither a citizen of the United State nor a Permanent Resident Alien (Green Card holder) (to facilitate compensation of participants)
Male participants are required to use a condom during the entire study period with RO6958688 and up to 90 days after last administration of RO6958688. Male participants should not donate sperm for 90 days after the last dose of RO6958688.
Adequate cognitive status as determined by a research coordinator at recruitment; to assess the participant‘s capacity to take part in the interview, the interviewer will note and comment on the participant's spontaneous speech and capacity to write date at the time of consent; participants should be oriented to person, place, date, time, and events (RCT)
For Part B only, participants must have advanced or metastatic CRC expressing either low or high levels of GCC, for whom standard treatment is no longer effective or does not offer curative or life-prolonging benefit. A portion of participants should have tumors amenable for serial biopsy and a willingness to provide consent for pharmacodynamic assessment.
Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx is allowed, but these participants will not be included as response-evaluable participants for efficacy analysis of HNSCC.