Clinical Trials Search
A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)
S0820
- Eligibility:Click Here to View
*MCRC is not participating in the PK substudy
*Check for eligibility to DCP-001*-History of Stage 0-III colon or rectal adenocarcinoma that has been treated per standard care with resection alone or in combination with RT or chemotherapy. Treatment must have been completed 30d prior to registration.
-Patients must be registered 180-456 days of primary resection.
-Patients must show no evidence of disease (NED) based on post-op colonoscopy and CT scans.
-Patients must not have known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer or IBD
-Patients with a personal history of large bowel colorectal resection greater than 40cm are not eligible.
-Patients with significant hearing loss are not eligible.
-Zubrod PS must be 0-1
-Patients must not be expecting to receive RT or additional chemotherapy.
-Patients must not be receiving or plan to receive concomitant steroids, NSAIDs, nor anticoagulants on a regular or predictable intermittent basis.
- Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study
S0931
- Eligibility:Click Here to View
-Histologically or cytologically confirmed renal cell carcinoma(clear cell or non-clear cell but collecting duct or medullary carcinomas are excluded).
-Must be considered either intermediate high-risk or very high-risk disease. Patients with microvascular invasion of the renal vein of any grade or stage (with no mets) are also eligible.
-No history of distant metastases or current evidence or residual or metastatic disease
-Have undergone a full surgical resection (radical nephrectomy or partial nephrectomy) including removal of all clinically positive nodes. Surgical margins must be negative. Patients with positive renal vein margins are eligible unless there is invasion of the renal vein wall at the margin (provided no other margins are positive).
-Patients with bilateral renal tumors may be eligible.
-No prior anticancer therapy for renal cell carcinoma including systemic therapy in the adjuvant or neoadjuvant setting, immunotherapy, investigational therapy, surgical metastasectomy, or radiotherapy
-No concurrent chronic treatment with systemic steroids or another immunosuppressive agent
-Zubrod performance status 0-1. Patients must have recovered from any surgery-related complications - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)
S1001
- Eligibility:Click Here to View
*Credentials required. Check your site's credentialing status.
CURRENT SITES CREDENTIALED:
SJMH*Sites cannot order Zevalin until their site questionnaire and radioactive materials license are submitted.*
-Patients must have biopsy-proven de-novo Diffuse Large B-Cell Lymphoma.
-Patients with primary mediastinal lympohoma or testicular lymphoma are not eligible.
-Patients with prior or simultaneous diagnosis of indolent lymphoma are not eligible.
-Post-transplant lymphoproliferative disorder with DLBCL morphology is ineligible.
-Patients must have non-bulky Stage I or II disease. Patients who are upstaged to stage III or IV based on FDG-PET only are also eligible.
-Patients must not have clinical evidence of CNS involvement by lymphoma.
-Patients may have either measurable or evaluable limited-stage DLBCL. Patients rendered free of measurable or evaluable disease by virtue of biopsy (resection) are also eligible.
-The lymphoma must express the CD20 antigen
-Patients must not have received prior chemotherapy, RT, or antibody therapy for lymphoma
-Patients must have Zubrod PS 0-2Second Registration Eligibility:
-Patients must have completed 3 cycles of R-CHOP with no evidence of disease progression
-If PET-negative on central review, patients must be planning to begin further treatment within 35d of the start of C3 of R-CHOP. If PET-positive based on central review, it is important for patients to plan to initiate IFRT followed by Zevalin within 35d of the start of C3 of R-CHOP. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
A Phase III, Randomized Clinical Trial of Standard Adjuvant
Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer
S1007
- Eligibility:Click Here to View
The QOL substudy is permanently closed to accrual effective 12/01/12.
Patients who do not know their Oncotype DX score will submit tissue for screening. The result must be less than or equal to 25 for the patient to be eligible.
-Histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast cancer with positive ER and/or PR receptor status and negative HER-2 status.
-Patients with multifocal, multicentric and synchronous bilateral breast cancers are allowed.
-Patients will have undergone axillary staging by sentinel node biopsy or axillary LN dissection. Patients must have at least one, but no more than 3 known positive LNs. Patients with micrometastases only are not eligible.
-Patients must not have inflammatory breast cancer and must not have metastatic
-Patients with prior diagnosis of contralateral DCIS are eligible if they underwent a mastectomy or lumpectomy with WBRT. Patients with a prior diagnosis of ipsilateral DCIS or invasive breast cancer who received RT are not eligible.
-Patients must have had either breast-conserving surgery with planned RT or total mastectomy. Margins must be clear.
-If oncotype DX score is already known, it must not be greater than 25.
-Men are not eligible for this study.
-Zubrod PS must be 0-2.
-Patients must not have already begun chemotherapy or endocrine therapy for their breast cancer
-Patients must not require chronic treatment with systemic steroids or other immunosuppressive agents.
-Patients must not have received an AI or SERM within 5 years - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer (NSABP B-53)
S1207 (NSABP B-53)
- Eligibility:Click Here to View
*BAHO Specimen submission is terminated*
-Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive ER and/ or PR status, and negative HER2, for whom standard adjuvant endocrine therapy is planned.
-Patients must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, synchronous bilateral, and primary inflammatory breast cancers are allowed.
-Patients must be high risk defined as one of the following:
--Completion of adjuvant chemotherapy and pathologically negative axillary nodes, and a tumor measuring greater than or equal to 2 cm in greatest diameter, and an Oncotype DX® recurrence score greater than 25 (completed as standard of care)
--Completion of adjuvant chemotherapy, and pathologically 1-3 positive axillary lymph nodes, and an Oncotype DX® RS greater than 25 or tumor tissue with pathological grade III
--Completion of adjuvant chemotherapy and pathologically 4 or more positive axillary lymph nodes independent of the Oncotype DX® RS in the primary tumor
--Completion of neoadjuvant chemotherapy and 4 or more positive nodes pathologically determined prior to or after chemotherapy
-Patients must have completed either breast-conserving surgery or total mastectomy, with negative margins and appropriate axillary staging
--Patients who had breast-conserving surgery must have completed WBRT
--Patients with greater than or equal to 4 positive lymph nodes must have completed breast/chest wall and nodal-basin radiation therapy before randomization; omission of radiation therapy is not allowed in this high-risk population of patients
-Patients must have a PS of 0-2 by Zubrod criteria
-Patients must have completed standard neoadjuvant or adjuvant taxane and/or anthracycline based chemotherapy prior to randomization; patients must be registered within 21 weeks after completion of chemotherapy; patients may have started endocrine therapy at any time after the diagnosis of the current breast cancer
-Patients must not be receiving or planning to receive trastuzumab
-Patients must not have prior exposure to mTOR inhibitors (rapamycin, everolimus, temsirolimus, deforolimus) - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM) (S1211 aka CA204-101)
S1211 (aka CA204-101)
- Eligibility:Click Here to View-Patients must have newly diagnosed active multiple myeloma (MM)
-Patients must have high-risk MM based on one or more of the following criteria at the time of initial diagnosis (prior to any chemotherapy):
--Poor-risk genomic signature according to the University of Arkansas 70-gene model (available clinically as MyPRS score, Signal Genetics, Inc.)
--Translocation (14;16), and/or translocation (14;20), and/or deletion (17p) by FISH or cytogenetics
--Primary plasma cell leukemia (defined by either = 2,000 plasma cells/mL of peripheral blood, or 20% on a manual differential count)
--Serum lactate dehydrogenase (LDH) greater than or equal to 2 X IULN
--1q21 amplification by FISH
--High risk by the SKY92 signature
-Patients with non-secretory MM or known amyloidosis are not eligible
-Patients must have measurable disease (prior to initiation of first induction course for patients with prior therapy)
-Patients may have received one prior cycle of any noninvestigational chemotherapy. Prior chemotherapy must have been completed within 56d prior to registration and all toxicities must have resolved to less than or equal to grade 1. Prior treatment with dexamethasone must have been less than or equal to a total of 14d in duration and less than or equal to a total dose of 360mg.
-Patients may have received prior RT for symptomatic localized bone lesions or impending spinal cord compression only. Must have been completed at least 14d prior to registration and toxicities resolved to less than or equal to grade 1.
-Patients must not have active involvement of the central nervous system (CNS) with MM (by clinical evaluation).
-Zubrod PS must be 0-2.
- Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Sensitive Prostate Cancer
S1216
- Eligibility:Click Here to View
*Credentialing required. Please check your site's credentialing status.
CURRENT SITES CREDENTIALED:
St. Alphonsus, SJMO, SJMH, St. John Hosp., Sparrow, Macomb, Saginaw, Lehigh Valley-There are two patient populations eligible for the study:
--Patients who have not started any therapy with LHRH agonist or antagonist (Early Induction Group)
--Patients who have already started therapy with LHRH agonist or antagonist within the 30 days prior to registration (Late Induction Group).
-Patients must be registered within 30 days of first injection of the LHRH agonist or antagonist.
-All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate.
-All patients must have distant metastatic disease as evidenced by soft tissue and/or bony metastases prior to initiation of androgen deprivation therapy.
-Patients with known brain metastases are not eligible.
-Patients who are deemed to have high-risk or extensive metastatic, hormone sensitive prostate cancer per "clinical judgment" of the treating physician are eligible for enrollment if they are unsuitable candidates for docetaxel or if they have declined docetaxel therapy.
-Patients may have received prior androgen deprivation therapy- neoadjuvant and/or adjuvant setting only-but it must not have lasted for more than 36 months. Single or combination therapy allowed. At least 6 months must have elapsed since completion of the therapy and serum testosterone must be greater than 50ng/mL (non-castrate levels) for early induction patients.
-Patients must not have received prior and/or must not have any plans for receiving concomitant therapy with ketoconazole, aminoglutethimide or abiraterone acetate, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed.
-Patients must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer. Prior cytotoxic chemotherapy with curative intent in the neoadjuvant/adjuvant setting is allowed, but at least 2 years must have elapsed since completion.
-Patients may have received prior surgery.
-Patients may have received or plan to receive concurrent bone targeting agents that do not have an effect on PSA.
-For the late induction group, patients must have had no more than 30d of prior castration for their disease prior to registration. If the patient was on an antiandrogen, the patient must be willing to switch over to bicalutamide or TAK-700. If the method of castration was LHRH antagonists, the patient must be willing to switch to an LHRH agonist.
-Patients must have a PSA greater than or equal to 2 ng/mL.
-Zubrod PS must be 0-2; PS of 3 will be allowed if from bone pain only. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) with Dexamethasone for Multiple Myeloma Patients with Relapsed or Refractory Disease
S1304
- Eligibility:Click Here to View
Initial Registration Eligibility:
-Patients must have a confirmed diagnosis of symptomatic multiple myeloma and must be relapsed or refractory.
-Patients must have measurable disease.
-Patients must have received at least one prior regimen of chemotherapy for symptomatic multiple myeloma; patients may not have more than six (6) previous regimens of therapy for the disease; prior chemotherapy must have been completed at least 21 days prior to registration.
-For study purposes, a regimen is defined as follows:
--An anti-myeloma therapy used at the time of initial diagnosis or documented disease progression which is given with the intent to decrease disease burden.
--Any maintenance therapy used after an Induction should be considered part of that Induction regimen.
--Use of any agent or combination of agents more than once during the patient's disease history for separate documented disease progressions will be counted as separate regimens.
--In cases of autologous stem cell transplant, the entire induction + stem cell mobilization + conditioning + planned maintenance should be considered one regimen.
-Patients may not have received any prior carfilzomib treatment.
-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.
-Patients with non-secretory MM or known primary amyloidosis are not eligible.
-Patients must have Zubrod performance status 0-2.
-Patients may have received palliative XRT for local disease control with no curative intent.Crossover Eligibility:
-Patient must have been eligible for and initially randomized to low dose carfilzomib, begun cycle 2 of treatment, and progressed prior to completing 12 cycles of protocol therapy.
-At least 14 days and no more than 28 days must have elapsed between the last day of treatment on prior arm and registration to crossover.
-Patients must have recovered from all non-hematologic toxicities to less than or equal to grade 2 and from all hematologic toxicities to less than or equal to grade 3.
-Patients must not have received any dose reduction for toxicity in the last cycle of treatment, immediately preceding progression. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
A Randomized Phase II Study of CO-eXpression ExtrapolatioN (COXEN)-Directed Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer
S1314
- Eligibility:Click Here to View-Patients must have histologically proven urothelial carcinoma of the bladder. Those with mixed histology, including a component of urothelial carcinoma, are eligible. Pure small cell carcinoma, pure adenocarcinoma, and pure squamous cell carcinoma are excluded.
-Patients must have Stage cT2-T4a N0 M0 disease. To exclude non-bulky/low-risk tumors, subjects must have documented muscle invasion with at least one of the following:
--Disease measuring at least 10 mm on cross-sectional imaging. Bladder thickening on imaging, by itself, is not adequate.
--The presence of tumor-associated hydronephrosis.
-Patients must be planning to receive a cystectomy from a urologist who has performed at least 50 cystectomies in the past 3 years, and the urologist must plan to remove at least 12 lymph nodes as part of surgery.
-Patients must have a PS of 0-1
-Patients must not have received previous systemic cytotoxic chemotherapy for urothelial carcinoma.-Patients must not have received previous systemic anthracycline (intravesical anthracycline is allowed).
-Patients must not have peripheral neuropathy greater than or equal to Grade 2.
-Patients must have tumor tissue from transurethral resection of the bladder tumor(TURBT) available for submission that is sufficient for COXEN testing. The diagnostic TURBT sample must have been obtained within 56 days prior to
registration.
- Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map) (upd 11/18/15)
S1400
- Eligibility:Click Here to View
All sites have complied with Revision #3 training.
Screening Eligibility:
-Patients must have pathologically proven squamous cell carcinoma of the lung
-Disease must be stage IV or recurrent. Mixed histologies are not allowed.
-Patients can be screened at progression on prior treatment (at least one line previous was platinum based; must have progressed after most recent line; if received platinum-based for stage I-III, PD must have occurred within a year of that therapy) OR
-Patients can be pre-screened prior to progression on first-line treatment (must have had at least 1 dose of a first-line platinum-based chemotherapy regimen for stage IV)
-Patients must not have received docetaxel for Stage IV disease
-Patients must have adequate tumor tissue available and agree to have this tissue submitted for profiling and C-MET IHC.
-Patients must not have a known EGFR mutation or ALK fusion.
-Patients must have Zubrod performance status 0- 1
-Pts must be willing to provide prior smoking hx.Sub-study Eligibility (common criteria for all sub-studies):
-Patients whose biomarker profiling results indicate the presence of EGFR mutation or EML4/ALK fusion are NOT eligible.
-Patients must not have received RT within 28d of registration
-Patients must not have received any prior systemic chemotherapy or IND within 21d prior to registration
-Patients must have measurable disease
-Patients must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 28 days following treatment, AND (2) pt has no residual neurological dysfunction and has been off corticosteroids for at least 14 days prior to randomization.See substudies for individual substudy additional eligibility criteria.
- Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.