ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
ELIGIBILITY CRITERIA - PHASE II (ARM D): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
RANDOMIZED PHASE II CLINICAL TRIAL: Patients participating in another trial of an investigational agent within 4 weeks of the first dose of the study
RANDOMIZED PHASE II CLINICAL TRIAL: Subjects who do not consent to providing pre and post treatment tissue sample for future research would not be eligible to participate in the trial
No concurrent treatment on another clinical trial; supportive care trials or nontreatment trials, e.g. quality of life, are allowed
Clinical Laboratories:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Enrolled in another clinical trial testing a novel therapy or drug within the past 4 weeks.
Is currently receiving tazemetostat as either monotherapy or in combination with other approved drug(s) or investigational agent(s) on an Epizyme-sponsored clinical trial or any other clinical trial being conducted with tazemetostat that is not sponsored by Epizyme (including but not limited to, Investigator initiated trials). For subjects on combination therapy, the other therapeutic(s) must have been completed or will be provided by a source other than Epizyme
Patients may not be enrolled on any other therapeutic trial for which they are receiving an anti-tumor therapy; (Note: patients on the standard therapy arm of another GBM trial that otherwise meet eligibility requirements for this trial remains eligible for cohort 1)
Previous clinical trial enrollment is allowed
Patients participating in a clinical trial where prevention of GVHD is the primary endpoint.
Concurrent use of other investigational drugs or treatment in another clinical trial with a non-FDA-approved medication within the past 4 weeks before start of therapy
Actively participating in another clinical treatment trial
Is currently participating and receiving trial therapy or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 4 weeks of the first dose of trial treatment.
Male breast cancer patients. 19. Patients may not be on a concurrent clinical trial, unless approved by Investigator.
Patients must have life-expectancies > 6 months to be included in the trial
Patients voluntarily participate in the clinical trial, understanding they may withdraw participation at any time
Patients who were enrolled into any other treatment clinical trial and received treatment on that trial within 4 weeks of study treatment
Have participated in a prior oregovomab clinical trial. Prior treatment with Hiltonol® does not exclude a subject from participation.
Symptoms of a clinically significant illness that may place the subject at risk by trial participation or influence the outcome of the trial in the four weeks before first treatment and during the trial;
Participation in the treatment phase of another clinical trial within the four weeks prior to treatment in this clinical trial;
Participated within the last 30 days in a clinical trial.
Patients may not be on a concurrent clinical trial, unless approved by PI.
No clinical symptoms of hypothyroidism
IMMUNE RECONSTITUTION STUDY ONLY: Decline to participate in the main trial, or main trial closed to accrual due to safety review
Patients may not be receiving the treatment targeting the activated gene as part of a clinical treatment trial other than the Precision Oncology Trial
Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial
Enrolled on another clinical trial testing a novel therapy or drug
Current treatment on another clinical trial
Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial
Clinical T-classification T1-3
Clinical T4 disease
Patients must have at least one lesion which can be biopsied with acceptable clinical risk as judged by the clinical services who perform the biopsy
Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
Participation in another clinical trial with drugs received within 3 months prior to dosing (calculated from the previous study's last dosing date).
Patients are excluded from this trial if they have melanoma, small cell carcinoma, lymphoma/leukemia, or germ cell histology (note, melanoma patients will be eligible for the sister trial to this trial which will be open simultaneously)
Clinical stages T3-4 disease
Currently participating in another clinical trial using an investigational study medication, or recent participation in such a trial
Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out.
Use of GSK2315698 (CPHPC), or participation in a separate clinical trial involving CPHPC within 3 months of screening
Are participating or have participated in another clinical trial for the palliation of their targeted bone metastasis tumors in the last 30 days
Previous treatment with crenolanib or prior participation in clinical trial involving crenolanib.
Currently participating in another clinical trial
History of previous malignancy that in the principal investigator (PI)’s opinion has a reasonable chance of recurrence during the study period or otherwise confounding this clinical trial
Any other experimental treatment on another clinical trial
Participation in any other ongoing ceftolozane/tazobactam trial
THE PATIENT IS INELIGIBLE TO PARTICIPATE IN PART 2 IF ANY OF THE FOLLOWING OCCUR: Any other exclusion criteria set forth by individual treatment protocol of the active clinical trial(s) through which patients are going to be treated.
The trial is open to both genders
Participation in a clinical trial using immunological experimental therapy (e.g. monoclonal antibodies, cytokines or active cellular immunotherapies) within the last 6 months prior to randomization
Concurrent treatment on another clinical trial; supportive care trials or non-treatment trials, e.g. quality of life (QOL), are allowed
Patients whose entry to the trial will cause unacceptable clinical delays in their planned management
Current treatment with any systemic anti-cancer therapies for advanced disease or any systemic experimental treatment on another clinical trial
Have a clinical indication for treatment as determined by the investigator
The trial is open to both genders
Currently enrolled in another clinical trial (exclude non-cancer treatment trial) or received an investigational agent within 4 weeks of study initiation
A clinical indication for treatment as determined by the investigator
Use of any investigational drug within 4 weeks before start of trial treatment or concomitantly with this trial.
Patients (at institutions listed) must be offered the opportunity to participate in the optional S1406 Co-Clinical PDX Model trial; participating patients must have a fresh tissue biopsy for the Co-Clinical PDX Model Trial completed within 7 days of Step 2 Randomization
Patients must not be participating in any other therapeutic clinical trial or taking any other experimental medications within 14 days prior to registration
Concurrent treatment on another clinical trial; supportive care trials or non-treatment trials, e.g. quality of life (QOL), are allowed
Prior treatment in clinical trial UTX-TGR-304
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial
Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial
Eligibility to a higher priority trial for first line or recurrent endometrial cancer (unless patient is unwilling to participate in such a trial)
Concurrent treatment on another clinical trial; supportive care trials or non-treatment trials, e.g. quality of life (QOL), and imaging trials, are allowed
The patient was informed about the positive survival results of the RTOG 96-01 clinical trial, and has elected to forgo treatment with high-dose bicalutamide
PART A: Able (physically and financially) to travel to University of Colorado for clinical trial treatment
Enrolled on another clinical trial testing a novel therapy or drug
Concurrent treatment on another clinical trial; supportive care trials or non-treatment (i.e. quality of life) are allowed
Breast-feeding should be discontinued if a nursing mother is to be treated on clinical trial
Participation in another clinical trial unless approved by the lead principal investigator
Patients with nervous system tumors associated with NF2 (e.g., schwannomas, meningiomas, ependymomas, or gliomas) will not be excluded from this clinical trial unless (in the opinion of the investigator) these tumors are growing and are likely to require treatment during the clinical trial
Any treatment in a BMS-936558 (Nivolumab) trial
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial
Concurrent treatment on another clinical trial; supportive care trials or non-treatment trials, e.g. quality of life (QOL), are allowed
Current treatment on another clinical trial
Patient participating in another clinical trial or receiving an investigational drug
Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial
Concurrent treatment on another clinical trial; supportive care trials, surgical clinical trials, or non-treatment trials, e.g. quality of life (QOL), are allowed
Any previous treatment with study drug (RO5185426) or participation in a clinical trial that includes RO5185426
Has been withdrawn from the CS35 trial.
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial
Receipt of investigational therapy in a clinical trial setting within 30 days of enrollment;
Was enrolled on the Phase 1 clinical trial ONT-10-001 and:
Clinical Laboratories:
Patient has not previously participated in any clinical trial of iniparib.
Prior history of malignancy other than chronic lymphocytic leukaemia (exceptions to this rule are defined in the clinical trial protocol).
current treatment in another clinical trial
Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial.
Patients who previously participated in or are currently participating in another intervention clinical trial designed to improve adherence
Are participating or have participated in another clinical trial in the last 30 days
Concurrent treatment on another clinical trial; supportive care trials or non-therapeutic trials (i.e. quality of life) are allowed
Active treatment on another clinical trial.
Patients whose participation in this trial would require exclusion from participation in another clinical research trial related to the patient's malignant diagnosis
Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial
Currently receiving hospice care (patients who enroll in hospice during the trial will have the option of continuing trial participation)
Enrolled on a therapeutic or supportive care clinical trial
For the part 2 randomized controlled trial (RCT), participated in part 1, step 1 or 2
Lactating patients must agree not to nurse a child while on this trial
TRIAL SUBJECTS:
Participants will have no previous history of clinical trial research participation
Ability to give informed consent before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
Subject has previously participated in any clinical trial with the investigational device.
Discontinued from study treatment from another clinical trial within 28 days prior to randomization.
Patients who are enrolled in another symptom management trial or receiving active treatment under another clinical trial
Note: Patients who enroll in hospice during the trial will have the option of continuing trial participation
All patients who are receiving chemotherapy and/or radiation therapy are eligible for study if they have completed > 1 week of radiation therapy, and if they have been approved to go on study by their primary oncologist; the principal investigator (PI)/designated research staff of this study will obtain and document approval from the primary oncologist and principal investigator of the clinical trial in case the patient is on another clinical trial as referenced in the patient's study documents
All patients who are receiving chemotherapy and/or radiation therapy are eligible for study if they have completed at least one cycle of chemotherapy or targeted therapy, or > 1 week of radiation therapy, and if they have been approved to go on study by their primary oncologist; the principal investigator (PI)/designated research staff of this study will obtain and document approval from the primary oncologist and principal investigator of the clinical trial in case the patient is on another clinical trial as referenced in the patient's study documents
Patients are not required to be registered on a COG therapeutic trial
Patients are permitted to participate in other clinical trials while participating in this trial
Current daily application of a prescribed topical product to the skin within the RT area for an unrelated skin condition that cannot be discontinued during the participation in this clinical trial
Participants must have been informed of their eligibility for a specific phase II or III therapeutic clinical trial open for enrollment at the participating National Cancer Institute (NCI) Community Oncology Research Program (NCORP) site
Participants must not have been asked previously to participate in another therapeutic cancer clinical trial
Participation of patients on other clinical trial protocols permitted, if not prohibited by trial guidelines
CLINICAL PROCOTOL USED AS REFERENCE FOR THIS STUDY:
RANDOMIZED CONTROL TRIAL:
Individuals must not currently be participating in any other clinical trial for the treatment or prevention of cancer unless they are no longer receiving the intervention and are in the follow-up phase only; patients must also agree not to join such a trial while participating in this study
Previous participation in any clinical trial involving rolapitant
Patient’s deemed otherwise clinically unfit for clinical trial per investigator’s discretion
Must not participate in any other clinical trial for the treatment or prevention of cancer unless they are no longer receiving the intervention and are in the follow-up phase only. Participants must also agree not to join such a trial while participating in this study.
Have participated in any clinical trial in the previous 30 days.
Patients receiving active therapy on an investigational trial at the time of enrollment should consult with the study chair regarding potential interactions with other study agents; patients who are enrolled in a clinical trial but are off-therapy and in follow up are eligible
The participant will be excluded from participation in another clinical research trial (i.e., a trial in which an agent is actively administered to the study subject), while being imaged (on active treatment) on this protocol
Enrollment into this study may occur in tandem with other clinical therapeutics trials occurring at Vanderbilt University Medical Center (VUMC) as long as this trial does not violate protocol or inclusion criteria of that study
Intention to enroll in a blinded therapeutic clinical trial
Subject must have a life expectancy that exceeds the duration of the clinical trial
Participating in a concurrent clinical trial or has participated in another clinical trial with an investigational compound within the past 30 days
Have not participated in a clinical trial before
Inclusion:\n\n          -  21 years of age or older\n\n          -  Have a cancer diagnosis\n\n          -  Self identify as African American\n\n          -  Therapeutic Phase I, II or III clinical trial at Massey Cancer Center (regardless of\n             whether or not they join the therapeutic trial)\n\n          -  Be able to provide informed consent\n\n          -  We will also recruit one family member/caregiver (N = 357) of each participating\n             patient\n\n          -  Consented patients will not be excluded from this study if their family member\n             declines to participate by completing the Cancer Communication Assessment Tool for\n             Families (CCAT-F).
Inclusion:\n\n        A parent trial must :\n\n          -  have a coordinating Center willing to allow their Clinical Sites to participate;\n\n          -  be studying be studying a condition that requires community or health system physician\n             referral\n\n          -  be studying an intervention where the recruitment approach cannot be made directly to\n             minority community members\n\n          -  need to increase recruitment of racially/ethnically diverse participants* to the trial\n             as demonstrated by current trial progress or historical data from other trials in the\n             same disease;\n\n          -  be a Phase II or Phase III trial\n\n          -  be conducted in at least six multiple sites;\n\n          -  expect each Clinical Site to recruit at least 10 participants;\n\n          -  be funded by a sponsor (NIH or pharmaceutical company or other) that has a strong\n             commitment to recruiting racially/ethnically diverse subjects;\n\n          -  be willing to have investigators and coordinators attend a special training meeting\n             (at RECRUIT expense);\n\n          -  require randomization to intervention or control (could be best medical care or active\n             control or placebo or other type of control);\n\n          -  provide transportation costs for trial participants who need assistance in getting to\n             trial sites or use some RECRUIT reimbursement for this purpose.\n\n        The clinical site must\n\n          -  be a funded Clinical Site in the parent trial;\n\n          -  be located in an area where at least 20% of the population within 30 miles in the age\n             group under study in the parent trial are from diverse populations.\n\n        Exclusion Criteria:\n\n          -  site does not agree to be randomized;\n\n          -  investigator or coordinator is under 18 years of age.