Clinical Trials Search
A Randomized Phase II/III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
RTOG 1008
- Eligibility:Click Here to View
*Credentials may be required depending on treatment modality. Please check your site's credentialing status.*
CURRENT SITES CREDENTIALED:
SJMH, Livonia, Saginaw, Macomb, St. Alphonsus, Oakland, St. John, LVHN
-Pathologically proven diagnosis of a malignant major salivary gland tumor or malignantminor salivary gland tumor of the head and neck of the following histologic subtypes:
--intermediate-grade adenocarcinoma or mucoepidermaoid carcinoma
--high-grade adenocarcinoma or mucoepidermoid carcinoma or salivary duct carcinoma
--high-grade acinic cell carcinoma or adenoid cystic carcinoma
-Patients must have had surgincal resection with curative intent within the past 8 weeks
-Pathologic stage T3-4 or N1-3 or T1-2, N0 with close or microscopically positive surgical margin
-Patients must NOT have metastatic disease
-Zubrod PS must be 0-1
-Patients must NOT have macroscopic disease after surgery
-Patients must not have had prior systemic chemotherapy or RT for salivary gland malignancy
-Patients must not have significant pre-existing hearing loss
- Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck (RTOG-1216)
RTOG 1216
- Eligibility:Click Here to View
*Credentialing required. Please check your site's credentialing status.*
CURRENT SITES CREDENTIALED:
Livonia, SJMH, Saginaw, Holy Cross, Sparrow
-Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity, oropharynx (p16 negative), larynx, or hypopharynx
-Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to registration
-Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension or invasive cancer seen at the primary tumor resection margins
-Pathologic stage III or IV head and neck squamous cell carcinoma (HNSCC)
-No distant metastases
-Zubrod performance status must be 0-1
-Patients with feeding tubes are eligible for the study
-Mandatory tissue submission for epidermal growth factor receptor (EGFR) analysis and for oropharyngeal cancer patients, human papilloma virus (HPV) analyssis
-Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0 resected differentiated thyroid carcinoma, who are eligible.
-No prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
-No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
A Randomized Phase III Trial of CC-5-13 (lenalidomide, NSD-703813) and Low Dose Dexamethasone (LLD) versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant
S0777
- Eligibility:Click Here to View**Please check test schedule carefully. All individual labs must be back and can take 5-7 days to get results. Please call if you have any questions.**
**If for SJMH, SPECIFICALLY order cytogenetics report when ordering a bone marrow. This test is no longer standard.**
**This protocol is randomized through the OPEN system. Please be sure investigator is assigned specifically to your instituion for credit if MD has not registered on this protocol previosly.**
***see memo on timing of bone marrow biopsies***8/27/08
Patients must have newly diagnosed multiple myeloma (Section 4.1) with measurable disease within 28 days prior to reg. Pts with non-secretory MM are not eligible unless baseline serum freelite is elevated. Pts must not have prior chemotherapy or radiotherapy to more than half of pelvis. Prior steroid treatment allowed if it was less than 2 wks duration. No prior bortezomib or lenalidomide treatment allowed. Pts must be at least 18 yrs of age. Pts must have Zubrod PS 0-3. Pts must have adequate marrow function (Section 5.5). Pts must be offered participation in Myeloma Specimen Repository. Institutions must submit local cytogenetics analysis and FISH report. Pts must be treated for pathologic fractures, pneumonia or symptomatic hyperviscosity prior to reg if present at diagnosis. Pts must have creatinine clearance > 30 cc/min within 28 days prior to reg. Pts must not have uncontrolled, active infection requiring IV antibiotics, NYHA Class III or IV heart failure, myocardial infarction within the last 6 months, history of treatment for clinically significant ventricular cardiac arrhythmias, poorly controlled hypertension or poorly controlled diabetes mellitus. Pts must undergo EKG within 28 days prior to reg. Pts must not have history of chronic obstructive or chronic pulmonary disease and must have adequate pulmonary function (Section 5.12) within 42 days prior to reg. Patients must have negative Hep B, Hep C and HIV test within 28 days prior to reg. Treatment-sensitive HIV infection pts will be eligible if immunological and virologic indices are indicative of favorable long-term survival on basis of HIV infection and life expectancy is limited by MM, not HIV. Pts must not have history of cerebral vascular accident with persistent neurologic deficits. Pts must be able to take aspirin 325 mg daily (or enoxaparin 40 mg SQ daily). Females of childbearing potential must have negative serum or urine pregnancy test with sensitivity of at least 50 mIU/mL 10-14 days prior to and again within 24 hours prior to starting lenalidomide; must agree to abstinence from heterosexual intercourse or begin two acceptable methods of birth control at least 4 weeks before starting lenalidomide. Men must agree not to father a child and to use a condom if he or partner is of child bearing potential. Pts must be counseled a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Pts must not have prior malignancy except adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the pt has been disease-free for five yrs. - 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 Response Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging
S0816
- Eligibility:Click Here to View
**This study will be closed to accrual effective 12/01/12**
***All PET/CT imaging must be done on an integrated/hybrid PET/CT machine (a single machine must be used for both PET and CT portions. Pt CAN NOT move between two different machines for images and then have images fused). Confirmation with radiology department and subsequent documentation prior to enrollment that PET and CT portions were done on a single integrated machine will be required. Image submission post enrollment is also required for protocol participation***
DISEASE CHARACTERISTICS:
Histologically confirmed classical Hodgkin lymphoma (i.e., nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted)
Previously untreated stage III or IV disease
No nodular lymphocyte predominant disease
Bidimensionally measurable disease
Adequate biopsy samples from original diagnostic specimen must be available for pathologic review
Tissue obtained from core biopsies allowed
No tissue obtained from needle aspirations or cytologies
Must have known HIV status
No multi-drug resistant HIV infection, CD4 counts 350/mcL, or other concurrent AIDS-defining conditions in HIV-positive patients
HIV-positive patients with CD4 counts = 350/mcL allowed
Must have undergone unilateral or bilateral bone marrow biopsy within the past 42 days
PATIENT CHARACTERISTICS:
Zubrod performance status 0-2
Serum erythrocyte sedimentation rate, LDH, hemoglobin, albumin, WBC, and lymphocytes measured within the past 28 days
Not pregnant or nursing
Fertile patients must use effective contraception during and for = 6 months after completion of study therapy
No significant cardiac abnormalities as assessed by MUGA scan or ECHO AND cardiac ejection fraction = 45% in patients with a history of hypertension or cardiac symptoms
Hepatitis B-negative (i.e., hepatitis B surface antigen-negative or anti-hepatitis B core antigen-negative)
Patients immune to or immunized against hepatitis B (i.e., anti-hepatitis B surface antibody-positive) are eligible
Hepatitis C-negative (i.e., anti-hepatitis C antibody-negative)
No significant lung disease with abnormal lung function tests (i.e., DLCO > 25% below predicted after correction for hemoglobin) unless attributable to lymphoma
No requirement for continuous supplemental oxygen therapy
No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
No prior solid organ transplantation - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
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\r\nEndocrine 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.