[c09aa8]: / clusters / ordered9kclusters / clust_1268.txt

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Other protocol specified criteria
Other protocol specified criteria
Patients must NOT receive concurrent anti-cancer therapy or investigational agent unless specified in protocol
Men who have a female partner of childbearing potential must be willing to use 2 highly effective forms of contraception throughout protocol therapy and for at least an additional 3 months after the last dose of protocol-specified therapy; men who have a pregnant partner must be willing to use a condom during sexual activity throughout protocol therapy and for 3 months after the last dose of protocol-specified therapy
Patients who received systemic corticosteroids within 28 days of enrollment on this protocol, except as specified, are not eligible
Laboratory data as specified below:
Meets protocol-specified criteria for qualification and contraception
Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
History of exposure to the protocol specified doses of anthracyclines
Patients must not have received any of the specified therapies as stated in the protocol in the time period prior to registration
Patients must complete all mandatory tests listed in section 4.0 within the specified time frames.
Patients with prior therapy, other than therapy specified above
Additional graft selection criteria specified in section 2.5
Meet protocol-specified lab requirements
Some protocol specified treatments prior to the first dose of study drug.
Subject in whom there is bleeding at the specified area for each surgical procedure after any applicable conventional means for hemostasis are attempted as specified by the intraoperative protocol;
Patients must complete all required pre-entry tests listed in section 4.0 within the specified time frames.
Patients must complete all required pre-entry tests within the specified time frames
All races and ethnicities are eligible and no upper limit of age is specified
Current significant cardiac conduction abnormalities and hypokalemia as specified in the protocol.
Meet the clinical laboratory criteria as specified in the protocol
Use of investigational drug, other than the study medications specified by the protocol, within 30 days of transplantation
Radiotherapy within 2 weeks before the start of protocol-specified therapy.
Woman of childbearing potential and is not willing to use 2 highly effective methods of contraception while receiving protocol-specified therapy and for an additional 24 hours after the last dose of protocol-specified therapy.
Male who has a female partner of childbearing potential, and is not willing to use 2 highly effective forms of contraception while receiving protocol-specified therapy and for at least an additional 24 hours after the last dose of protocol-specified therapy.
Male who has a pregnant partner, and is not willing to use a condom during sexual activity while receiving protocol-specified therapy and for 3 months after the last dose of protocol-specified therapy.
Concurrent treatment for cancer except agents specified within the treatment protocol
Receiving other anti-cancer or investigational therapy during study treatment, apart from those agents specified in the study protocol
PHASE I: Patients must meet pre-entry requirements as specified
The patient must be able to have fiducial markers implanted into the pancreatic tumor, and receive radiation regimen as specified in the protocol
Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol
Subjects must complete all required tests listed in the protocol within the specified time frames
Able to return for treatment and follow-up as specified in the protocol
Laboratory data as specified below:
Patients who are not able to receive protocol specified radiation therapy
Subject does not meet protocol-specified washout periods for prior treatments
Prior history of specific mutations (specified in the protocol) in the tumor at the time of any previous assessment.
Radiotherapy as specified in the protocol
History of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment.
Patients must not have received any of the specified therapies as stated in the protocol in the time period prior to registration
Eligible for intensive cytarabine/daunorubicin (7+3) chemotherapy specified
Use of concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol
Received any of the following within the specified time frame prior to administration of study medication:
Prior anti-tumor therapies must have been completed within time periods specified in the protocol prior to DNX-2401 injection
All laboratory assessments should be performed within 21 days of initiation of protocol therapy unless otherwise specified
Subject must be willing and able to take pazopanib with a low-fat meal every day as specified in the protocol
Patients must meet pre-entry requirements as specified
No concomitant anti-cancer therapy unless specified above
Patients must meet the pre-entry requirements specified
Patients who have met the pre-entry requirements specified
Patients must have met the pre-entry requirements as specified
Coagulation panel within protocol-specified parameters
Patients who have met the pre-entry requirements specified
Any concurrent therapy for BM other than the specified treatment in this study
Prior standard or investigational anti-cancer therapy as specified in protocol
Have clinically acceptable laboratory screening results within certain limits specified below:
Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol
Females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the study protocol
Requirement for any excluded medication as specified in protocol
Anticipated use of chemotherapy or radiotherapy not specified in the study protocol while on study
Patients who have met the pre-entry requirements specified in Section 7.0
Agree to return for all follow-up evaluations and procedures specified in the protocol
Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.
Representative tumor specimens as specified by the protocol
Meet the clinical laboratory criteria as specified in the protocol
Representative tumor specimens as specified by the protocol
Use of any of the following medications or procedures within the specified timeframe:
Measurable disease as specified in study protocol
Meet the clinical laboratories criteria as specified in the protocol
Concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in this protocol
Patients must be within certain limits for protocol-specified laboratory tests
Patients must meet pre-entry requirements as specified
Known active cardiovascular disease condition as specified in protocol
Use of concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol
No prior treatment with systemic anti-cancer therapy for SCCHN, unless protocol specified criteria are met
Use of investigational drug, other than the study medications specified by the protocol, within 30 days of transplantation
Tumor MET amplified by protocol-specified centralized testing.
Contraindication to receive vincristine or any planned protocol-specified chemotherapy
Use of investigational drug, other than the study medications specified by the protocol, within 30 days of transplantation
Laboratory data as specified:
Concomitant use of prohibited therapy (specified in protocol)
Patients must not have received the therapies indicated below for the specified time period prior to the first day of administration of protocol therapy on this study:
Prior cancer vaccines are not allowed, with the exception as specified in protocol
History of autoimmune disease with caveats as specified in protocol
Concurrent anticancer treatment with any agent other than iniparib and any co-administered chemotherapeutic agent(s) specified on the parental study protocol are not permitted throughout the course of the study.
Measurable disease as specified in study protocol
Has measurable disease as specified in study protocol
Use of concomitant chemotherapy, investigational agents, radiation therapy, or immunotherapy other than as specified in the protocol
DISEASE CHARACTERISTICS: Histologically confirmed, locally advanced adenocarcinoma of the\n prostate, including: Bulky primary tumors confined to the prostate (clinical Stage T2c)\n Primary tumors extending beyond the capsule (clinical Stage T3-4) No common iliac or\n para-aortic nodal involvement Regional lymph node involvement below the common iliac level\n allowed Positive nodes on imaging studies must be biopsied by FNA or surgical sampling PSA\n no more than 150 (mandatory) No distant metastases\n\n PATIENT CHARACTERISTICS: Age: At least 50 Performance status: Karnofsky 70-100%\n Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No prior or\n concurrent second cancer except basal cell skin cancer No major medical or psychiatric\n illness that would prevent completion of treatment or interfere with follow-up\n\n PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior\n chemotherapy Endocrine therapy: No prior hormonal therapy Radiotherapy: No prior\n radiotherapy Surgery: No prior radical surgery for carcinoma of the prostate
Receiving or plans to receive concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy other than is specified in the protocol
The patient is enrolled on a COG trial that utilizes unrelated donor HSCT and requires that patients be transplanted using an approach specified by the protocol that is in conflict with the approach specified in this protocol
Participant is receiving standard \7+3\ induction chemotherapy regimen as specified in the protocol;
Menopausal status not specified
Additional endoscopic restrictions as specified in the Clinical Investigation Plan
Willing to provide mandatory biospecimens as specified in the protocol
History of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol specified imaging sessions
Presenting with one of the four conditions specified below
Requires prohibited treatment (i.e., non-protocol specified anticancer pharmacotherapy, surgery or conventional radiotherapy for treatment of malignant tumor).
Anticipated use of concomitant chemotherapy (other than the protocol-specified agents), immunotherapy, or radiation therapy
Location of cancer not specified
Has met protocol-specified criteria for qualification and contraception
Has history or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters