Any concurrent chemotherapy, immune therapy, biologic, hormonal therapy for cancer treatment
Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use
Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
Patients must not be planning treatment with other systemic anti-cancer agents (e.g., chemotherapy, hormonal therapy, immunotherapy) or other treatments not part of protocol-specified anti-cancer therapy including concurrent investigational agents of any type
Patients must NOT receive concurrent anti-cancer therapy or investigational agent unless specified in protocol
No other planned concurrent investigational agents or other tumor directed therapy (chemotherapy, radiation) while on study
Patients may not be receiving other therapeutic investigational agents or be receiving concurrent anticancer therapy other than standard androgen deprivation therapy; concurrent treatment with agents to prevent skeletal-related events (such as zoledronic acid or denosumab) will be allowed as long as it was initiated prior to study entry
Concurrent anticancer therapy (including other investigational agents) with the exception of hormone therapy for prostate cancer.
Need for concurrent other cytoreductive chemotherapy
Concurrent enrollment in another clinical study, unless in follow-up period or it is an observational study
Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
Concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib and/or lenalidomide.
Concurrent participation in another therapeutic clinical trial
2. Any concurrent chemotherapy, radiotherapy, immunotherapy, or biologic therapy for cancer treatment. Concurrent use of hormones for non-cancer related conditions is acceptable (e.g., insulin for diabetes & hormone replacement therapy). Local treatment of isolated lesions for palliative intent is acceptable;
Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed
Concurrent enrollment in another therapeutic clinical trial.
Concurrent treatment with a prohibited medication.
Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted therapy, immunotherapy, or biological agents
No other concurrent investigational agents or other meningioma-directed therapy (chemotherapy, radiation) while on study
Concurrent participation in another therapeutic clinical trial.
Concurrent use of other investigational agents
Concurrent therapy with any other investigational drug
Concurrent immunotherapy is allowed
Concurrent or Intercurrent Illness:
Patients may not receive any concurrent investigational agents while on study
Patients may not receive any cancer-directed concurrent therapy, such as concurrent chemotherapy, radiotherapy, or hormonal therapy while on study
Concurrent use of any other investigational agents
Patients who are receiving concurrent investigational therapy;
Concurrent administration of any other investigational agents
Concurrent administration of other anti-cancer therapy during the course of this study is not allowed; note that concurrent use of supportive care medications (e.g. anti-resorptive agents, pain medications) is allowed
Subject receiving concurrent chemotherapeutics or investigational agents within 30 days of study entry, including gliadel wafers or gliasite application.
Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
Concurrent exposure to any commercially available agents known to be active against SMM and MM
Concurrent use of any other anti-cancer agents or treatments or any other investigational agents
Concurrent use of any other anti-cancer agents or treatments or any other investigational agents
Concurrent administration of other cancer specific therapy or investigational agents during the course of this study is not allowed
Concurrent administration of other cancer specific therapy during the course of this study is not allowed
Concurrent treatment with any other investigational therapeutic agents
Concurrent administration of other cancer specific therapy during the course of this study is not allowed
The subject must have completed RT with concurrent TMZ at least 12 weeks prior to the planned start of treatment on this study UNLESS there is pathological verification of recurrent tumor and at least 4 weeks have elapsed since the end of RT with concurrent TMZ.
Concurrent use of hypoglycemic agents or any systemic therapy for melanoma; palliative limited-field radiation therapy will be allowed
Concurrent brain directed therapy (beyond SRS and NovoTTF-100M as per protocol)
Patients receiving any other concurrent anticancer or investigational therapy
Concurrent enrollment in another interventional trial
Concurrent treatment with other experimental treatments for NSCLC while on the study
Concurrent administration of other cancer specific therapy during the course of this study is not allowed
Prior or concurrent antineoplastic agents (chemotherapy)
No other concurrent chemotherapeutic or investigational agents for this cancer. However, concurrent glucocorticoids are allowed;
Concurrent therapy with other systemic anti-neoplastic or investigational agents
Concurrent anticancer therapy; however, radiotherapy is allowed
Eligible for otherwise curative treatment or undergoing concurrent therapy
Patients must be having concurrent chemotherapy
Participation in another concurrent treatment protocol
Concurrent participation in other investigational drug trials.
Planned concurrent chemotherapy or anti-tumor agent during PCI
Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational\r\n* NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Concurrent therapy: no other concurrent anticancer or investigational therapy permitted except as noted above
Receiving concurrent investigational therapy
Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 2 weeks of trial entry (signing of the informed consent form)
Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)
History of concurrent second cancers requiring active, ongoing systemic treatment.
Other concurrent chemotherapy, immunotherapy, radiotherapy, 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)
Any concurrent medications which could interfere with the trial
Concurrent use of other anti-cancer agents or treatment
Concurrent chronic systemic immunotherapy, chemotherapy or hormone therapy
Concurrent use of other anti-cancer agents or treatments
Known substance abuse or receiving concurrent treatment with non-permitted drugs.
Concurrent serious infection
Concurrent treatment with any chemotherapeutic agent
Concurrent systemic steroid therapy
No other concurrent investigational agents are allowed
Other concurrent chemotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Concurrent use of other investigational agents
Concurrent use of another anti-cancer drug including an investigational anti-cancer agent
Concurrent systemic steroid therapy
Presence of any condition or concurrent requirement for treatment with agents known to result in immune deficiency.
Receiving concurrent immunotherapy or chemotherapy
Presence of concurrent second cancer (active, not history)
Patients who are receiving any other investigational or concurrent anticancer treatment (chemotherapy, radiotherapy, immunotherapy, cytokine therapy except erythropoietin) at the time of enrollment except for testosterone lowering therapy in men with prostate cancer
No concurrent XRT or chemotherapy is allowed
Concurrent systemic steroid therapy; (NOTE: Patients with recurrent glioblastoma who require steroids for clinical indications are eligible)
Concurrent use of other anti-cancer agents or treatments.
Concurrent systemic steroid therapy.
Is receiving concurrent chemotherapy, investigational drug, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non–cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
Concurrent chemotherapy or targeted anti-cancer agents, other than intrathecal therapy
Other concurrent chemotherapy, or any ancillary therapy considered investigational ? 14 days prior to study registration; NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
MEDICAL HISTORY AND CONCURRENT DISEASES
Concurrent brain-directed therapy
Induction chemotherapy prior to concurrent chemoradiation is allowed
Concurrent enrollment in another study unless it is an observational (e.g. non-interventional) study.
Enrollment in a concurrent clinical study.
Patients may not be receiving any other investigational agents, or concurrent biological therapy, chemotherapy, or radiation therapy
Concurrent treatment with non-permitted drugs and other interventions.
Patients already receiving hypomethylating agents will be allowed to enroll on the protocol and receive concurrent treatment with vitamin C
Uncontrolled concurrent serious illness
Concurrent participation in another therapeutic or imaging clinical trial.
Concurrent participation in another therapeutic treatment trial
Patients receiving any concurrent chemotherapy, radiotherapy, immunotherapy, or biologic, or hormonal therapy for cancer (concurrent use of hormones for noncancer-related conditions [e.g., insulin for diabetes and hormone replacement therapy] is acceptable) Patients must have completed any previous cancer-related treatments before enrolment. The following intervals between the end of the prior treatment and first dose of study drug must be observed:
Concurrent anticancer therapy (including other investigational agents) with the exception of hormone therapy for breast or prostate cancer; patients that have received treatment for a different cancer previously and have been disease-free for less than one year are excluded
Patients requiring concurrent administration of valproic acid are not eligible for this trial
Concurrent use of other anti-cancer agents or treatments
Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment
Concurrent systemic corticosteroids, cytokines, and immunomodulatory therapy (e.g. interferons)
Concurrent use of other anticancer agents including chemotherapy, targeted therapy, radiotherapy or immunotherapy not otherwise specified in the protocol
Other concurrent chemotherapy, immunotherapy, radiotherapy or investigational therapy except for hormonal therapy (e.g., tamoxifen, etc.).
Concurrent radiation sensitizing medications concurrent with radiation, per treatment physician
Patients receiving concurrent corticosteroids at the time protocol therapy is initiated other than for physiologic maintenance treatment
Concurrent administration of other anti-cancer therapy within 14 days of starting protocol therapy and during the course of this study
Concurrent use of other anti-cancer agents or treatments
Other concurrent chemotherapy, immunotherapy, or any ancillary antitumor therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation)
Concurrent treatment with bisphosphonates or denosumab is required
No concurrent chemotherapy or targeted small molecule therapy
Patients that receive concurrent chemotherapy with the exception of concurrent vincristine
Any concurrent chemotherapy, investigational product (IP), biologic, or hormonal therapy for cancer treatment; concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable
Concurrent, malignant disease for which patient is on active therapy
Concurrent anti-cancer therapy other than the ones specified in the protocol is not permitted during study participation; bisphosphonates or denosumab are allowed
Any known concurrent RAF or PIK3CA mutation
Concurrent therapy with approved or investigational anticancer therapeutics.
No concurrent therapy with approved or investigational anticancer therapeutics
Uncontrolled concurrent serious illness
Concurrent systemic steroid therapy
Any concurrent chemotherapy, investigational product (IP), biologic or hormonal therapy for cancer treatment; concurrent use of hormonal therapy for non-cancer-related conditions (e.g. hormone replacement therapy) is acceptable
Prior or concurrent treatment with any anticancer agent for the same cancer diagnosis
Any concurrent anticancer therapy
FOR ALL PHASES (Ib AND II): Concurrent therapy with any other non-protocol anti-cancer therapy
FOR ALL PHASES (Ib AND II): Concurrent diagnosis of pheochromocytoma
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration [FDA] approved indication and in the context of a research investigation)
DONOR: Receiving any investigational agents, or concurrent biological, chemotherapy, immunosuppression or radiation therapy
Use of any other concurrent investigational agents or anticancer agents including hormonal therapy, except in the case of prostate cancer patients who are being treated anti-androgen or bone targeting therapies.
Concurrent adjuvant endocrine therapy and bone-modifying agents is allowed
Patients receiving other concurrent cancer therapy including chemotherapy, immunotherapy, or biologic therapy
Prior/concurrent radiation therapy allowed
Concurrent use of restricted agents
Concurrent treatment with any chemotherapeutic agent.
Concurrent treatment with a non-permitted drug
Patients may not be on a concurrent clinical trial, unless approved by PI.
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
Concurrent treatment for cancer except agents specified within the treatment protocol
More than one concurrent, malignant disease
Concurrent enrollment on another investigational therapy
Chemotherapy concurrent with SBRT is not allowed
Patients must not be planning to receive any concurrent cytotoxic chemotherapy, surgery or radiation therapy during protocol treatment
Concurrent participation in another therapeutic clinical trial.
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration [FDA] approved indication and in the context of a research investigation); \r\n* NOTE: in AML, the concurrent use of hydroxyurea to help control proliferative counts is allowed throughout the treatment protocol; \r\n* NOTE: in TCL, patients may use topical emollients or corticosteroids, acetic acid soaks, etc. to control pruritis and prevent infection; no topical chemotherapy is allowed (no topical nitrogen mustard)
Patients may not be receiving any other investigational agents, or concurrent biological therapy, chemotherapy, or radiation therapy
Patients may not be receiving any other investigational agents, or concurrent biological therapy, chemotherapy, or radiation therapy
Other concurrent chemotherapy, or any ancillary therapy considered investigational; NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Concurrent treatment with any other anti-leukemia agent
Patients may not be receiving any other investigational agents, or concurrent parenteral biological, chemotherapy, or radiation therapy; oral chemotherapeutic agents or biologics - for example ruxolitinib therapy (either past or current exposure) - is allowed
Prior or concurrent systemic anticancer therapy for BC (immunotherapy, hormonotherapy, biologic/targeted therapy, chemotherapy, investigational agents).
Concurrent treatment with a non-permitted drug
Concurrent chemotherapy, hormonal therapy, immunotherapy regimens, or radiation therapy, standard or investigational
Concurrent treatment with other anti-cancer therapy is not permitted
Concurrent treatment with any other anticancer therapy
Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
Concurrent use of conventional or investigational anticancer agents, except hydroxyurea
Patients on concurrent anti-cancer therapy, unless specifically agreed to by the patient's medical oncologist and consenting professional
Concurrent disease - patients under treatment for concurrent medical conditions will be eligible for protocol treatment if, in the opinion of the physician responsible for hyperthermia treatment that the concurrent medical condition will neither interfere with the process of the treatment or patient assessments nor add significantly to the risks or complications of the treatment
Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable
Patients receiving concurrent chemotherapy, radiation therapy, or immunotherapy for AML
Concurrent systemic steroid therapy
Any concurrent chemotherapy, biologic or hormonal therapy for cancer treatment is not permitted within 28 days of registration\r\n* Note: Prior immunotherapy is not permitted\r\n* Note: Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
Concurrent systemic steroid therapy
Serious concurrent medical condition including CNS disorders.
Concurrent administration of any other anti-tumor therapy
Any concurrent chemotherapy, immunotherapies or biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable; in addition, local treatment (eg, by local surgery or radiotherapy) of isolated lesions for palliative intent is acceptable beyond the first cycle with prior consultation and in agreement with the principal investigator (PI)
Concurrent enrollment in another clinical trial, unless in a follow-up period or it is an observational study
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g. insulin for diabetes and hormone replacement therapy) is acceptable
No concurrent chemotherapy
Concurrent systemic steroid therapy
Any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment, concurrent use of hormonal therapy for non–cancer-related conditions (e.g., hormone replacement therapy) is acceptable
Patients may not be receiving any other investigational agents, or concurrent biological therapy, chemotherapy, or radiation therapy
Any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy
No prior treatment for primary advanced (stage III or IV) epithelial ovarian, primary peritoneal, or fallopian tube carcinoma such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy, surgery, and/or other concurrent agents or therapies
Concurrent use of other investigational agents or Optune™ device
Concurrent therapy\r\n* The concurrent use of bevacizumab is allowed if previously initiated for tumor progression or symptomatic management; prior temozolomide or other cytotoxic chemotherapy is allowed
Other concurrent chemotherapy, immunotherapy, radiotherapy, 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)
Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; Note: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Concurrent anticancer therapy (including other investigational agents)
Patients with concurrent cytotoxic chemotherapy or radiation therapy
Patients who are participating in a concurrent treatment protocol
Patients who are participating in a concurrent treatment protocol
Use of any other concurrent investigational agents or anticancer agents including hormonal therapy, except in the case of prostate cancer patients who are being treated with LHRH agonist at the time of trial entry
Concurrent enrollment in another clinical study, unless in a follow-up period or the study is an observational or non-interventional study
Concurrent treatment with any anticancer agent, including chemotherapy, immunotherapy, or biologic therapy; in breast cancer patients, concurrent use of hormonal therapy (but not trastuzumab) is acceptable provided hormonal therapy was initiated more than 30 days prior to treatment on this study
Concurrent diagnosis of pheochromocytoma
Patients receiving concurrent anti-cancer treatment (chemotherapy, investigational agents, immunotherapy, endocrine therapy, or Optune®…)
Plans for concurrent anticancer therapy except as permitted
Concurrent systemic steroid therapy
Patients must not receive concurrent systemic or topical steroids or other skin directed therapy while on study
SECOND COHORT: Concurrent therapy with enzalutamide will be permitted and is a requirement for enrollment
Concurrent use of any other investigational agents
Be eligible for curative-intent concurrent chemoradiation therapy
Note: Concurrent and/or adjuvant chemotherapy does not make a patient ineligible; participation in a concurrent treatment protocol does not make a patient ineligible
Concurrent treatment with another anti-estrogen
Prior use of platinum or paclitaxel for stage IV non-small cell lung cancer (NSCLC) or concurrent use of other anticancer approved or investigational agents
Patient with any significant concurrent illness
Receiving concurrent anti-cancer treatment (excluding radiation therapy), either approved or investigational
Current or planned use of other investigational agents, or concurrent biological chemotherapy, or radiation therapy during the study treatment period
Current or planned use of other investigational agents, or concurrent biological, chemotherapy, or radiation therapy during the study treatment period
Patients cannot tolerate concurrent chemotherapy
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nAny concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable; NOTE: local treatment of isolated lesions for palliative intent is acceptable (e.g., by local surgery or radiotherapy)
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAny concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable; NOTE: Local treatment of isolated lesions for palliative intent is acceptable (e.g., by local surgery or radiotherapy)
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nConcurrent enrollment in another clinical study, unless it is an observational non-interventional clinical study or the follow-up of an interventional study; any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable; NOTE: Local treatment of isolated lesions for palliative intent is acceptable (e.g., by local surgery or radiotherapy)
Concurrent use of bosentan
Concurrent administration of any other antitumor therapy.
Is receiving concurrent anti-cancer therapy for metastatic disease
Concurrent use of other anticancer approved or investigational agents is not allowed.
Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy; may have received an experimental agent prior to enrolling in the trial
Patients may not receive concurrent treatment with other investigational or commercial agent(s) for treatment of their breast cancer
Concurrent chemotherapy is allowed, but not required
Concurrent therapy with approved or investigational anticancer therapy
No concurrent anticancer chemotherapy or local therapy
Concurrent treatment with other investigational drugs or anti-cancer therapy.
Other concurrent chemotherapy, immunotherapy, radiotherapy, 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)
Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; NOTE: local treatment of isolated lesions, excluding target lesions, for palliative intent is acceptable (e.g., by local ablation, surgery or radiotherapy)
Concurrent use of other anti-cancer agents or experimental treatments
Patients receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy
Concurrent systemic steroid therapy
Concurrent systemic steroid therapy
Plans during the trial to receive any other (non-trial) investigational agents, or concurrent biological, chemotherapy, or radiation therapy; (chemotherapy for white blood count control is permitted)
Concurrent chemotherapy, radiotherapy, or any ancillary therapy for treatment of multiple myeloma; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Other concurrent chemotherapy, immunotherapy, radiotherapy, 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)
Previous or concurrent systemic or targeted chemotherapy is allowed
No other concurrent anticancer therapy
Participation in another concurrent treatment protocol
Concurrent systemic steroid therapy
The presence of a concurrent non-appendiceal metastatic cancer
Must be no anticipated need for concurrent radiation therapy during protocol treatment.
Participation in another concurrent treatment protocol
Patients may not be receiving any other concurrent chemotherapy, immunotherapy, or radiotherapy
Planned concurrent WBRT
Concurrent malignancies
Concurrent use of other anti-cancer agents or treatments
Concurrent use of other anti-cancer agents or experimental treatments
Concurrent use of any other investigational agents
Patients taking any other concurrent approved or investigational anti-cancer therapy (e.g. chemotherapy, immunotherapy, targeted or biologic therapy)
Suitability for concurrent chemoradiation therapy per treating physician's assessment
Patients may not receive concurrent chemotherapy, radiotherapy or immunotherapy, nor have received any investigational agents within 7 days prior to drug sensitivity screening
Medical history and concurrent diseases:
Patients can be undergoing concurrent systemic therapy, such as temozolomide, at the discretion of their treating oncologist
Induction chemotherapy prior to concurrent chemoradiation allowed
Patient with concurrent use of complementary or alternative medicines
Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation
Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational\r\n* NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Patients must have completed any previous cancer-related treatments before enrolment. Any concurrent chemotherapy [Chemotherapy washout within 21 days or 5 half-lives (whichever is shorter) from enrolment], radiotherapy, immunotherapy, or biologic, or hormonal therapy for cancer excludes the patient (concurrent use of hormones for noncancer-related conditions [eg, insulin for diabetes and hormone replacement therapy] is acceptable),
Concurrent serious infection
Use of concurrent gemcitabine-based chemotherapy during radiotherapy
Patients who are participating in a concurrent treatment protocol
Concurrent enrollment in any other study using an investigational drug
The use of other concurrent investigational agents will not be allowed
Concurrent use of other anti-cancer agents or treatments.
See Disease Characteristics PRIOR CONCURRENT THERAPY:
Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation
Concurrent participation in any interventional clinical trial.
Previous or concurrent cancer except
Other concurrent chemotherapy or any ancillary therapy considered investigational\r\n* NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Other concurrent chemotherapy, immunotherapy, radiotherapy or investigational therapy.
Concurrent NSAID therapy; washout period of 7 days
Concurrent enrollment in another clinical study
Concurrent adjuvant cancer therapy.
Concurrent participation in another therapeutic clinical trial
Concurrent therapy with approved or investigational anticancer therapeutic other than steroids
Chronic adrenal failure or is receiving concurrent long-term corticosteroid therapy.
Patients can be undergoing concurrent systemic therapy, such as temozolomide, at the discretion of their treating oncologist.
Concurrent treatment with any other anticancer therapy
Concurrent use of anticholinergics
Concurrent use of anti-seizure drugs, with the exception of gabapentin for treatment of neuropathy
Concurrent anti-cancer therapy
Concurrent active malignancy with expected survival of less than 1 year. For example, candidates with treated skin cancers, prostate cancer, breast cancer, etc. without metastatic disease are candidates for therapy since their expected survival exceeds that of relapsed or refractory AML. All subjects with concurrent malignancies will be reviewed by the principal investigator (PI) prior to enrollment.
Concurrent conditions as listed in the protocol.
Previous or concurrent cancer that is distinct from tumor for which the patient is enrolled in study, with exceptions
Subject is receiving concurrent chemotherapy or biologic or hormonal therapy for cancer treatment; Note: Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes) is acceptable
Concurrent use of other anticancer approved or investigational agents is not allowed.
Concurrent systemic steroid therapy
Concurrent use of other anti-cancer agents or experimental treatments
Concurrent use of other investigational agents
Excluded therapies and medications, previous and concomitant\r\n* Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment (regorafenib)\r\n* Prior use of regorafenib\r\n* Concurrent use of chemotherapy, radiotherapy or another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)\r\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication\r\n* Use of any herbal remedy (e.g. St. John’s wort [Hypericum perforatum])
Concurrent administration of any other investigational agent considered to have potential efficacy in the treatment of breast cancer
Has any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for invasive malignancy within 2 years. Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable.
Concurrent treatment with other experimental drugs or any other systemic anticancer therapy (due to unknown drug-vaccine potential interactions)
Prior or concurrent use of trastuzumab
Any concurrent treatment that would compromise the study including but not limited to:
Other concurrent chemotherapy, immunotherapy, radiotherapy, 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)
ARM A: Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy
ARM B: Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy
Concurrent investigational agent or anticancer therapy\r\n* Note: megestrol [Megace] if used as an appetite stimulant is allowed\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)
Concurrent diagnosis of pheochromocytoma
Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are allowed while on protocol treatment
Any other concurrent investigational agent or chemotherapy, radiotherapy, hormonotherapy, or immunotherapy. Exceptions are long-term hormonals for prostate (eg, goserelin) and octreotide for neuroendocrine malignancies
Any other concurrent chemotherapy, radiotherapy, or immunotherapy.
Other concurrent chemotherapy, immunotherapy, radiotherapy, 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)
Concurrent use of any other investigational agents
Other concurrent chemotherapy, immunotherapy, radiotherapy 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)
Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
Other concurrent chemotherapy or any ancillary therapy considered investigational\r\n* NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Current or planned use of other investigational agents, or concurrent biological, chemotherapy, or radiation therapy during the study treatment period
Receiving other concurrent anticancer therapy (including chemotherapy, radiation, hormonal treatment, or immunotherapy, but excluding corticosteroids) within 7 days prior to the ASCT or planning to receive any of these treatments prior to the last study visit on day +100
Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 28 days prior to registration
Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
Concurrent use of rifampin or ketoconazole
Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
Concurrent treatment with any other anti-neoplastic drug or concurrent participation in another therapeutic clinical trial
Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
Patients receiving any other investigational agents, or concurrent chemotherapy, radiation therapy, or immunotherapy
Concurrent administration of any other investigational agents
Concurrent treatment with any other anti-neoplastic drug or concurrent participation in another therapeutic clinical trial
Patient is receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
Patients must not be receiving any other concurrent therapy considered to be investigational; patients must not be planning to receive any radiotherapy (except localized radiation for palliative care); patients must not be planning to receive any concurrent chemotherapy, immunotherapy, radiotherapy or other treatment with curative intent
Concurrent enrollment in another clinical study, except for non-interventional, observational studies
Concurrent chemotherapy
Concurrent systemic steroid therapy
Concurrent chemotherapy or biologic therapy
Concurrent treatment with other investigational agents is not permitted
Patients may receive no other concurrent chemotherapy or radiation therapy during this trial
Other concurrent chemotherapy, immunotherapy, radiotherapy, 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); Note: concomitant use of zoledronic acid, pamidronate or denosumab is allowed (and can be initiated while patients are on study therapy at investigator discretion)
Patient must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol treatment
Concurrent hormonal contraceptive use
No concurrent hormonal oral contraceptive use
Serious concurrent illness or clinically relevant active infection as defined in the protocol
Concurrent treatment with any cytotoxic therapy
Patients receiving concurrent immunotherapy, or radiotherapy
No prior or concurrent systemic or radiation therapy for the treatment of myeloma
Prior or concurrent use of erythropoietin is disallowed
Prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted
Uncontrolled concurrent illness;
Plan to administer concurrent radiation therapy now or for progressive symptoms during treatment
Unstable or serious concurrent medical conditions in the previous 6 months.
Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment
Concurrent anticancer treatment or immunosuppressive agents
Concurrent, recent (? 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or
Concurrent therapy with any other investigational drug
Concurrent use of other investigational agents.
Concurrent therapy given to treat cancer
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
Is taking concurrent (or within 4 week prior to registration) chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). Supportive care measures are allowed
Concurrent chemotherapy
While patients randomized to the standard arm (Arm B, 30-33 fractions) may receive concurrent chemotherapy with carboplatin/taxol at their treating physician’s discretion, patients enrolled to the experimental arm (Arm A, 15 fractions) cannot be treated with concurrent chemoradiation and must not have plans for concurrent chemoradiation therapy; sequential chemotherapy (prior to or after radiotherapy) is allowed for either arm
Concurrent treatment with other investigational drugs.
Concurrent therapeutic intervention (including radiation therapy and NovoTTF).
Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
Concurrent, recent (? 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
Concurrent participation in an investigational drug trial with therapeutic intent
Concurrent treatment with hormone replacement therapy is permitted at the discretion of the treating physician; patients who have been taking hormonal/hormone blocking agents for breast cancer or breast cancer prevention or other indication are eligible; use of anti-hormonal agents (tamoxifen, medroxyprogesterone, aromatase inhibitors) is permitted at the discretion of the treating physician; documentation of concurrent medications is required
Prior or concurrent malignant disease unless cured for more than five years.
Any concurrent therapy for BM other than the specified treatment in this study
Concurrent investigational therapy or investigational therapy within 4 weeks of start of afatinib therapy
Concurrent, recent (? 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or
Concurrent treatment with a non permitted drug
Anti-tumor therapy within 28 days of study drug dosing; concurrent use of hormone therapy for breast or prostate cancer is permitted
Concurrent spironolactone use
SUB-PROTOCOL AIM A: Concurrent use of any other approved or investigational anticancer agents which would be considered as a treatment for the primary neoplasm
Patients may not receive any other concurrent investigational agents while on study
No concurrent herbal or unconventional therapy
Concurrent participation in other studies that could affect the primary endpoint
Concurrent hormone replacement therapy
Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy.
Subjects with any previously untreated or concurrent cancer that is distinct in primary site or
EXCLUSION FOR TREATMENT: Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation
Participation in concurrent clinical trials evaluating treatment intervention(s)
Concurrent use of other anti-cancer agents or treatments
Has a serious concurrent medical condition such as:
Concurrent participation in another therapeutic clinical trial.
Concurrent adjuvant cancer therapy
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) study.
Concurrent, malignant disease for which patient is on active therapy
Concurrent use of another investigational drug or device therapy (ie, outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form).
Concurrent participation in any other investigational study
Concurrent treatment with anticoagulation medication, unless approved by Sponsor
Concurrent systemic steroid therapy
Medical History and Concurrent Diseases
Concurrent chemotherapy, hormonal therapy, immunotherapy regimens, or radiation therapy, standard or investigational
Receiving concurrent chemotherapy, biologic therapy, radiotherapy, or other investigational therapy
Concurrent therapy with any other investigational anticancer agent
Concurrent use of other anti-cancer agents or anti-cancer treatments
Concurrent treatment with other investigational agents
Concurrent anti-cancer treatment in another investigational trial
Other concurrent chemotherapy, immunotherapy, radiotherapy, 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)
Concurrent usage of other investigational agents, chemotherapy, or hormone therapy; prior chemotherapy, hormonal therapy, targeted therapy, and investigational agents are allowed but all toxicities grade >= 2 must have resolved by the time of study commencement (except alopecia)
History of concurrent second cancers requiring active, ongoing systemic treatment.
Concurrent treatment with non-permitted drugs and other interventions
Patients for whom concurrent Adriamycin or gemcitabine chemotherapy is planned, unless on a concurrent protocol (such as a COG sponsored protocol)
Concurrent anti-cancer therapy (chemotherapy, definitive radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment; concurrent therapy with bisphosphonates or denosumab for bone metastases is allowed; palliative radiation to non-target lesions is also allowed
Concurrent use of another investigational drug or device (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)
Patient is participating in a concurrent treatment protocol
Patients who are receiving any other investigation agents or concurrent anticancer therapy are NOT eligible for participation; previous systemic treatment and/or radiation therapy is allowed with a 14 day washout period prior to registration
Concurrent use of any other anti-cancer treatments or any other investigational agents
Concurrent treatment with any anticancer agent outside of this protocol
Concurrent or planned concurrent treatment with anticoagulants such as Coumadin or heparin, except to maintain patency of in dwelling catheters
Any concurrent chemotherapy, investigational product , biologic, or hormonal therapy for cancer treatment.
Prior or concurrent therapy with somatostatin analogs is permitted for patients with secretory NET
Concurrent cancer therapy is not permitted.
Patients receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents) other than temozolomide
Concurrent treatment with commercial agents or other agents with the intent to treat the participant’s malignancy, including endocrine therapy, chemotherapy, and/or targeted therapy, with the exception of bisphosphonates and GnRH agonists
Concurrent use of any other anti-cancer agents or treatments or any other study agents
Concurrent anti-platelet therapy
Concurrent anti-coagulation therapy
Other concurrent experimental or investigational drugs
Prior chemotherapy, radiation therapy, concurrent chemoradiation are allowed if used for treatment of non-metastatic disease
Excluded therapies and medications, previous and concomitant:\r\n* Concurrent anti-cancer therapy (chemotherapy, surgery, immunotherapy, biologic therapy, anti-HER2 targeting therapies, or tumor embolization) other than Ra 223 dichloride; concurrent external beam radiation therapy is permitted\r\n* Prior use of Ra-223 dichloride\r\n* Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)
Concurrent use of other anti-cancer agents or treatments
Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer treatment;
Concurrent anti-cancer therapy, including chemotherapy agents, targeted agents, or biological agents not otherwise specified in this protocol
Concurrent use of any other investigational agents.
Concurrent use of any other approved or investigational anticancer agents, including hormonal agents
Use of investigational agents or concurrent anti-cancer treatment within the last 4 weeks of registration
Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
Other concurrent chemotherapy, immunotherapy, radiotherapy, 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)
Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer treatment
Concurrent treatment with any systemic chemotherapeutic agent
Concurrent therapy with approved or investigational anticancer therapeutic
Concurrent therapy with approved or investigational anticancer therapeutic
Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 21 days of trial entry (signing of the informed consent form)
Concurrent anti-cancer therapy (chemotherapy, definitive radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment; concurrent therapy with bisphosphonates or denosumab for bone metastases is allowed; palliative radiation to non-target lesions is also allowed
Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
Concurrent maintenance corticosteroids;
Other concurrent investigational agents;
No other concurrent anticancer therapies or agents
Research participants receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
Concurrent neurodegenerative disease,
Concurrent therapy with other investigational agents
Concurrent investigational therapy given to treat cancer or concurrent participation in another clinical trial involving anti-cancer investigational drug.
Recommendation to undergo concurrent chemoradiation, as determined by the treating physician
Prior or concurrent treatment with Avastin (bevacizumab)
Concurrent anti-cancer treatment in another investigational trial
Concurrent use of other anti-cancer agents or treatments
Concurrent therapy with protocol-defined excluded medications
Concurrent treatment with a non-permitted drug
Concurrent anticancer treatment or concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 30 days before the start of trial treatment. Short-term administration of steroids (that is, for allergic reactions or the management of immune-related adverse events [irAE]) is allowed
Any concurrent anticancer therapy, excluding hormonal therapy for prostate or breast cancer
Patients receiving any concurrent immunosuppressants
Participants may not be receiving any other investigational agents; concurrent treatment with bisphosphonates or denosumab is allowed
Participants receiving any other cancer directed concurrent therapy; such as concurrent chemotherapy, radiotherapy, or hormonal therapy; concurrent treatment with bisphosphonates/denosumab is allowed but should be started before starting treatment on study
Concurrent treatment with other investigational or anti-neoplastic agents
Concurrent use of other investigational agents
Patients will be excluded if they are not planning to receive concurrent temozolomide
Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)
Concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Participation in concurrent investigational studies
Concurrent administration of any other anti-tumor therapy
Patient receiving any concurrent chemotherapy
Concurrent cytotoxic or immunosuppressive therapy for non-malignant disease (e.g., for rheumatoid arthritis or lupus)
Concurrent therapy with any other investigational agent
Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)
Concurrent use of aspirin > 100 mg daily
Concurrent use of other anti-cancer agents or treatments
Concurrent uncontrolled illness not related to cancer, including but not limited to:
Patient receiving any concurrent chemotherapy
Patients who are receiving any other investigational agents or concurrent anticancer therapy are NOT eligible for participation; previous systemic treatment is allowed with a 2 week washout period prior to registration
Patient is participating in a concurrent treatment protocol
Concurrent use of other anti-cancer agents or treatments
Concurrent treatment with any other anticancer therapy
Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
Concurrent adjuvant immunotherapy, chemotherapy, or radiotherapy
Concurrent cytotoxic or immunosuppressive therapy for non-malignant disease (e.g., for rheumatoid arthritis or lupus)
concurrent use of anti-coagulant drugs
Concurrent chemotherapy, or targeted anti-cancer agents, other than hydroxyurea
ANY concurrent investigational agents
Treatment plan to include delivery of concurrent chemoradiotherapy
Serious concurrent illness:
Concurrent anticancer therapy (including other investigational agents), with the exception of hormone therapy for prostate cancer
Concurrent treatment with commercial agents or other agents with the intent to treat the participant’s malignancy, including endocrine therapy, chemotherapy, and/or targeted therapy, with the exception of bisphosphonates and GnRH agonists
Patient receiving any concurrent chemotherapy
No concurrent methotrexate, thiotepa, cytarabine, or investigational agents
Patients in cohort 2 being treated with concurrent HER2 therapy must have undergone treatment with the concurrent HER2 therapy selected by their attending physician for at least 3 weeks prior to initiation on this study
Concurrent use of other anti-cancer therapy including chemotherapy agents, targeted agents, or biological agents not otherwise specified in this protocol
Concurrent use of any other investigational product
Concurrent use of other anti-cancer agents or treatments
Patients who are receiving any cancer-directed concurrent therapy, such as concurrent chemotherapy, radiotherapy, or hormonal therapy while on study; concurrent treatment with bisphosphonates and denosumab is allowed for bony metastases but should be started before the first dose of neratinib
Prior or concurrent exposure to approved or investigational multiple myeloma treatments (concurrent treatment with bone-protecting agents (eg, bisphosphonates, denosumab), or steroids (not exceeding 10 mg prednisone per day or equivalent) are only allowed if given in a stable dose and for a nonmalignant condition; concurrent treatment with erythropoietin-stimulating agents (ESAs) are not allowed.)
Concurrent chemotherapy or biologic therapy
Concurrent systemic steroid therapy
Patients receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy
Patients must be registered on the study within 5 weeks of completion of concurrent chemoradiation
Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Concurrent treatment with other investigational agents(s)
Concurrent use of other anti-cancer agents or treatments.
Most concurrent second malignancies
Concurrent investigational therapy delivered over the period of treatment or observation (28 days post-RT) for dose limiting toxicity
Concurrent or planned radiation, hormonal, chemotherapeutic, experimental or targeted biologic therapy
Receiving concurrent endocrine, cytotoxic, or biologic agent(s) or within time limits specified above prior to study day 1
Other concurrent chemotherapy, immunotherapy, radiotherapy, 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); patients should have recovered from any immunotherapy, chemotherapy, or radiation therapy related toxicities
Prior or concurrent chemotherapy, radiotherapy, or immunotherapy for CLL
Patient has concurrent use of other anti-cancer agents or treatments
Concurrent use of other anti-cancer agents or treatments
Patients may not be receiving any other experimental agents and/or any other concurrent anticancer agents or therapies except hormonal maintenance
Requirement to receive other concurrent chemotherapy (excluding combination therapy defined in original protocol), immunotherapy, radiotherapy, or any other investigational drug while on study. Palliative radiotherapy is allowed provided that:
Concurrent use of other anti-cancer agents or treatment or concurrent radiation to the pelvis; palliative radiation to areas outside the pelvis is allowed
Non-protocol concurrent hormonal therapy is not allowed
Concurrent chemotherapy is not allowed
concurrent treatment on another therapeutic clinical trial
Concurrent uncontrolled illness not related to cancer, including but not limited to:
Concurrent treatment with a non-permitted drug.
Concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib
Any other prior, concurrent or planned chemotherapy, immunotherapy, radiotherapy, device, or investigational therapy for this cancer other than those specified in this study.
No concurrent enrollment in another therapeutic protocol for the same diagnosis
Subject must understand that while they are on study they cannot have any concurrent curative therapy for their cancer other than what is outlined in the protocol
Use of any other concurrent investigational agents or anticancer agents except for hormonal therapy as outlined in inclusion criteria
Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation
Concurrent use of valproic acid is not allowed
Concurrent use of other anti-cancer agents or treatments
Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer
Concurrent enrollment in another clinical study, unless in a follow-up period or it is an observational study
Concurrent systemic or inhaled steroid therapy
Concurrent systemic steroid therapy
Other concurrent chemotherapy, immunotherapy, radiotherapy, or an ancillary therapy considered investigational
No concurrent growth factors unless vital for the patient
No other concurrent investigational treatment
No other concurrent anticancer agents
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration [FDA] approved indication and in the context of a research investigation)
Concurrent administration of herbal preparations.
Concurrent metastatic solid tumors
Concurrent participation in another therapeutic clinical trial
Other concurrent anticancer chemotherapy
Other concurrent investigational therapy (utilized for a non-FDA-approved indication and in the context of a research investigation).
Concurrent use of other anti-cancer agents or treatments
Concurrent participation in another therapeutic clinical trial;
Concurrent participation in another therapeutic clinical trial
Patients receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents, radiation or immunotherapy) within 4 weeks of the first dose of the study drug
Receiving any other concurrent cytotoxic, biologic agent(s) or investigational agent; NOTE: Concurrent intrathecal chemotherapy for CNS prophylaxis allowed per institutional standards
Concurrent non-hematologic malignancies requiring treatment.
Concurrent ongoing administration of systemic therapy (e.g. chemotherapy), or radiation therapy.
Concurrent therapy with approved or investigational anticancer therapeutic other than steroids
Planned concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment
Concurrent use of another investigational drug or device during, or within 3 weeks of starting study treatment
Other concurrent anti-tumor, chemotherapy, hormonal therapy, immunotherapy regimens or radiation therapy, standard or investigational
Concurrent use of any other investigational agents on a clinical trial
Other concurrent chemotherapy
Concurrent therapy with any other non-protocol anti-cancer therapy
Concurrent use of another investigational drug or device during, or within 3 weeks of starting study treatment
A concurrent skin rash or skin condition requiring treatment with a prescription medication
Concurrent neoplasia requiring cytotoxic therapy
Concurrent anticancer therapy
Concurrent systemic steroid therapy
Concurrent systemic steroid therapy
are receiving concurrent chemotherapy, radiotherapy, immunotherapy, biological or hormonal treatment for cancer.
Patient must not undergo concomitant radiotherapy, chemotherapy or immunotherapy; patient must not be in concurrent study with other investigational agents
Is receiving any other concurrent systemic tumor therapy, including hormonal agents and HER-2 inhibitors
No concurrent cytochrome P450 3A4 inducers
No other concurrent investigational agents
Concurrent therapy for cancer
Concurrent systemic steroid therapy
Concurrent neoplasia requiring cytotoxic therapy
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have any other significant concurrent illness
Patients who are receiving any other investigational agents with the intent to treat myeloma; permitted concurrent therapies include:\r\n* Bisphosphonates
Requirement for concurrent systemic glucocorticoid therapy at greater than physiologic replacement doses
Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
Patients are allowed to be on another study concurrent with this protocol
Concurrent treatment with other anti-cancer therapy
Other concurrent chemotherapy, immunotherapy, radiotherapy, 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) with the exception of intravesical therapy at the time of TURBT
Exclusionary concurrent medical conditions:
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, receipt of last dose of an approved anticancer therapy within 21 days
Concurrent participation in another therapeutic treatment trial.
Concurrent cancer chemotherapy, radiotherapy or surgery
Concurrent serious infection
Concurrent participation in another therapeutic clinical trial.
Concurrent use of QT-prolonging medication
Concurrent treatment for cancer
Concurrent use of systemic steroids
Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
Concurrent use of other investigational agents or other prostate cancer therapies (e.g., androgen deprivation therapy)
Concurrent therapy with approved or investigational anticancer therapeutic other than steroids
Concurrent systemic steroid therapy
Uncontrolled concurrent illness
No concurrent anti-cancer treatment (including topical agents such as imiquimod) or investigational agents
Concurrent therapy with any other non-protocol anti-cancer therapy
Concurrent treatment with other anticancer therapy
Patient has concurrent use of anti-neoplastic agents including investigational therapy
No concurrent systemic chemotherapy or anticancer biologic therapy is allowed. Note: Patients on hormonal treatment for breast cancer or prostate cancer may continue on treatment and enter into study.
Other concurrent chemotherapy, immunotherapy, radiotherapy, 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)
Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Concurrent use of other anti-cancer agents or treatments, including other investigational agents
Concurrent anti-cancer cytotoxic chemotherapy
Concurrent use of other anti-cancer agents or treatments
Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
No concurrent radiotherapy or chemotherapy may be given to the patient during the administration of the study drug
Patients who require concurrent treatment with any medications or substances that have significant proarrhythmic potential are ineligible
Concurrent or Intercurrent Illness:
Patients on concurrent anti-cancer therapy other than that allowed in the study
Concurrent anti-cancer therapy (chemotherapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment (regorafenib)
Patient is receiving concurrent treatment with other investigational agents not allowed as part of the combination regimen in the parental study protocol.
Concurrent systemic steroid therapy
Concurrent enrollment in another investigational clinical study
Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment
Concurrent immunotherapy, chemotherapy, or radiation therapy for duration of subject participation on study
Concurrent therapy with other anti-neoplastic or experimental agents
Medical History and Concurrent Diseases
Concurrent use of other anti-cancer agents or treatments
Patients receiving concurrent investigational drugs
Subjects undergoing concurrent chemotherapy, radiation therapy, immunotherapy are excluded
Must be able to take concurrent aspirin 325 mg daily
Concurrent treatment with relevant doses of systemic glucocorticosteroids.
Significant concurrent disease.
Concurrent investigational drugs
Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment
Subjects who are considered to require concurrent therapy with another influenza antiviral medication.
Concurrent use of other anti-cancer agents or treatments
Receiving concurrent treatment with other anticancer therapy
Concurrent therapy with any other non-protocol anti-cancer therapy
Patients who are participating in a concurrent treatment protocol
Concurrent anticancer therapy (including other investigational agents)
Concurrent anti-androgen therapy
Patients on concurrent anti cancer therapy other than that allowed in the study.
Concurrent bisphosphonate treatment
Requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy (except for pain control) or any other investigational drug while on this study.
Concurrent use of investigational agents
Actively receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
Concurrent therapy with approved or investigational anticancer therapeutic other than steroids
Concurrent systemic steroid therapy
Concurrent systemic steroid therapy
Have a concurrent major debilitating illness,
Concurrent use of bupropion
Previous or concurrent use of flibanserin
Not have: concurrent use of ethyol; severe cognitive compromise; known history of central nervous system (CNS) disease (e.g. brain metastases, seizure disorder); concurrent use of amifostine, concurrent abdominal radiotherapy; concurrent use of quinolone antibiotic therapy; chronic alcoholism (as determined by the investigator); known hypersensitivity to olanzapine; known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months; history of uncontrolled diabetes mellitus (stable insulin dose and/or stable oral hypoglycemic agent permitted); or have planned chemotherapy or radiation during the 7 days following study initiation
Receiving concurrent radiation therapy
Concurrent use of somatostatin
Are receiving concurrent radiation therapy (RT)
Concurrent systemic corticosteroid therapy;
Subjects who have concurrent illness requiring systemic corticosteroid use other than the planned dexamethasone during conditioning therapy
Concurrent endocrine therapy permissible
Other concurrent malignancies except skin cancer
Concurrent breast related radiation therapy is allowed
Patients are eligible regardless of concurrent enrollment on protocol 13-492 (Predictors of Chemotherapy Toxicity in Older Adults)
BRAIN CANCER: Status post concurrent radiation therapy and daily temozolomide
Subjects with significant concurrent medical complications that in the judgment of the principal investigator(s) could affect the patient's ability to complete the planned trial; there are no therapy restrictions or restrictions regarding the use of other investigational agents
Concurrent chemotherapy
Patients undergoing concurrent cytotoxic chemotherapy and radiation therapy (concurrent Herceptin and/or tamoxifen/aromatase inhibitor allowed)
Concurrent participation in another chemoprevention trial
Concurrent therapy with an investigational agent
Planned concurrent chemotherapy or antitumoral agent during PCI
Concurrent radiation therapy or chemotherapy
Concurrent radiation, chemotherapeutic, or investigational therapy other than transplant related therapy
Concurrent enrollment in LCCC 1404
Scheduled to receive concurrent administration of fluoropyrimidine chemotherapy (fluorouracil [5-FU] or capecitabine) during radiation therapy
Is not receiving concurrent cytotoxic chemotherapy and/or radiation therapy at time of enrollment AND, if randomized, is not anticipated that the participant will need to receive concurrent cytotoxic chemotherapy and/or radiation therapy at any time during the aim 1 intervention
Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)
Concurrent antiandrogen therapy allowed but not required
Prior/concurrent radiation allowed
Concurrent use of any other anti-cancer agents or treatments or any other study agents
Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable.
No prior treatment involving irradiation, hormonal therapy, immunotherapy, investigational therapy, and/or other concurrent agents or therapies for ovarian cancer
Patients receiving concurrent additional biologic therapy
Concurrent anti-cancer therapy
Patients requiring concurrent administration of valproic acid are also excluded
Concurrent therapy with approved or investigational anticancer therapeutics
Recommended to undergo IMRT or PBT of the pelvis with concurrent chemotherapy
No concurrent use of chronic systemic steroids (defined as currently on more than 1 week of treatment)
Concurrent participation in other investigational studies allowed
Concurrent use of other anti-cancer agents or treatments
Concurrent chemotherapy (biologic agents are allowed)
Concurrent diuretic use
Be receiving concurrent radiotherapy or interferon.
Concurrent participation in other experimental studies that could affect the primary endpoint
Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
Uncontrolled serious concurrent illness
Patients with evidence of concurrent adenocarcinoma-in-situ
Concurrent participation in another clinical trial
Concurrent use of hormonal contraception or hormone replacement therapy
Concurrent use of immunosuppressant medications
Concurrent therapy with investigational agents
History of concurrent second cancers requiring active, ongoing systemic treatment.
Concurrent therapy with other seizurogenic medications.
Other concurrent clinically active malignant disease, requiring treatment
Patients who will undergo standard radiation therapy with concurrent cisplatin-based chemotherapy for cervical cancer
Concurrent systemic therapy for prostate cancer with investigational agents.
Diagnosis of cervical cancer of any stage that will be treated with radiation therapy and concurrent chemotherapy
Completion of treatment with standard radiation (with or without concurrent therapy)
Concurrent enrollment in another clinical study where they are receiving non-standard salvage chemotherapy, (i.e., concurrent enrollment is allowable if the patient is receiving standard salvage chemotherapy and research imaging is allowed)
Concurrent therapy will be allowed
No concurrent chemotherapy
Patients who are participating in a concurrent treatment protocol
Concurrent treatment with chemotherapy, molecule-selective, biological, or radiotherapeutic agent
Received treatment with chemotherapy, radiation, or biologic cancer therapy within 14 days of first protocol treatment; prior and concurrent hydroxyurea is permitted
Concurrent enrollment in another therapeutic investigational study or prior therapy with ibrutinib or other BTK inhibitors
Participating in a concurrent clinical trial or has participated in another clinical trial with an investigational compound within the past 30 days
Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted agents, biological agents, immunotherapy, or investigational agents not otherwise specified in this protocol
concurrent NSAID treatments while undergoing treatment
Concurrent disease or condition that interferes with participation or safety
Patients who will be treated with radiation therapy or concurrent chemoradiation therapy
Medical History and Concurrent Diseases