Spots Global Cancer Trial Database for Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
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Trial Identification
Brief Title: Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
Official Title: A Phase III Trial To Evaluate The Safety And Efficacy Of Specific Immunotherapy, Recombinant Idiotype Conjugated To KLH With GM-CSF, Compared To Non-Specific Immunotherapy, KLH With GM-CSF, In Patients With Follicular Non-Hodgkin's Lymphoma
Study ID: NCT00017290
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill cancer cells. It is not yet known which regimen of chemotherapy combined with vaccine therapy is more effective for non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy followed by vaccine therapy plus sargramostim in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.
Detailed Description: OBJECTIVES: * Compare the time to tumor progression in patients with stage III or IV follicular B-cell non-Hodgkin's lymphoma treated with cyclophosphamide, prednisone, and vincristine followed by immunotherapy with keyhole limpet hemocyanin with or without autologous tumor-derived immunoglobulin idiotype and adjuvant sargramostim (GM-CSF). * Compare the efficacy of these immunotherapy regimens in terms of converting patients with partial response or unconfirmed complete response to clinical complete response. * Compare the safety and toxic effects of these immunotherapy regimens in this patient population. * Compare the time to treatment failure and survival of patients treated with these regimens. * Correlate the induction of idiotype-specific immune response with clinical benefits of achieving molecular remission in these patients. * Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients receive cyclophosphamide IV over 30-40 minutes and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for 8 courses. At 6 months after completion of chemotherapy, patients maintaining partial response (PR), complete response (CR), or unconfirmed complete response (CRU) receive immunotherapy. Patients are stratified according to participating center and baseline disease status (PR vs CR/CRU). Patients are randomized to one of two treatment arms. * Arm I: Patients receive autologous tumor-derived immunoglobulin idiotype conjugated to keyhole limpet hemocyanin (KLH) subcutaneously (SC) on day 1 and adjuvant sargramostim (GM-CSF) SC on days 1-4 of weeks 0, 4, 8, 12, 16, 20, and 24. * Arm II: Patients receive KLH alone SC on day 1 and GM-CSF SC on days 1-4 of weeks 0, 4, 8, 12, 16, 20, and 24. Quality of life is assessed prior to first immunization, at 2-8 weeks after completion of immunizations, and then every 6 months for 30 months. Patients are followed every 3 months for 1 year and then every 6 months thereafter. Patients also enroll in a long-term follow-up study for an additional 5 years. PROJECTED ACCRUAL: A total of 360 patients (240 in arm I and 120 in arm II) will be accrued from the 480 patients biopsied for this study within 15-18 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
SuperGen, Incorporated, Dublin, California, United States
California Cancer Care, Inc., Greenbrae, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, United States
Rocky Mountain Cancer Centers - Midtown, Denver, Colorado, United States
Shands Cancer Center at the University of Florida Health Science Center, Gainesville, Florida, United States
Mountain States Tumor Institute - Boise, Boise, Idaho, United States
Rush Cancer Institute at Rush University Medical Center, Chicago, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, United States
Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
New York Weill Cornell Cancer Center at Cornell University, New York, New York, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
Cancer Institute at Oregon Health and Science University, Portland, Oregon, United States
Sarah Cannon Cancer Center at Centennial Medical Center, Nashville, Tennessee, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada
Contact Details
Name: David Hinds
Affiliation: Genitope Corporation
Role: STUDY_CHAIR
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