Spots Global Cancer Trial Database for Vaccine Therapy Compared With Interferon Alfa in Treating Patients With Stage III Melanoma
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Trial Identification
Brief Title: Vaccine Therapy Compared With Interferon Alfa in Treating Patients With Stage III Melanoma
Official Title: A Prospective, Randomized, Open-Label, Comparative Clinical Trial in Post-Surgical Melanoma Patients With Either DNP-Modified Autologous Tumor Vaccine or Interferon Alpha-2b
Study ID: NCT00003715
Conditions
Study Description
Brief Summary: RATIONALE: Vaccines made from a person's melanoma cells may make the body build an immune response to kill tumor cells. Interferon alfa may interfere with the growth of the cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of melanoma vaccine with that of interferon alfa-2b in treating patients who have stage III melanoma that has spread to regional lymph nodes following surgery.
Detailed Description: OBJECTIVES: I. Compare the relapse-free and overall survival rates in patients with stage III melanoma treated with autologous tumor vaccine versus interferon alfa-2b as postsurgical adjuvant therapy. II. Compare the safety and tolerability of these regimens in this patient population. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to number of metastatic lymph node sites (1 vs more than 1), number of positive lymph nodes in a single site (none vs 1 or more), presence of intransit metastases (yes vs no), and evidence of extranodal extension (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive autologous tumor cell vaccine intradermally once a week for 7 weeks followed by a booster injection at 6 months. BCG is given concurrently with vaccine as an immune-stimulator for doses 2-8. Patients also receive cyclophosphamide 6 days after the first vaccine injection. Arm II: Patients receive interferon alfa-2b IV for 5 consecutive days a week for 4 weeks followed by maintenance doses given subcutaneously 3 times a week for 48 weeks. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 386-425 patients will be accrued for this study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer and Blood Institute of the Desert, Rancho Mirage, California, United States
Yale Comprehensive Cancer Center, New Haven, Connecticut, United States
Columbia - HCA Cancer Research Network, North Miami Beach, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Georgia Cancer Specialists, Decatur, Georgia, United States
University of Illinois at Chicago, Chicago, Illinois, United States
Lutheran General Cancer Care Center, Park Ridge, Illinois, United States
James Graham Brown Cancer Center, Louisville, Kentucky, United States
Cancer and Hematology Centers of Western Michigan, Grand Rapids, Michigan, United States
Hubert H. Humphrey Cancer Center, Robbinsdale, Minnesota, United States
Midwest Oncology Consortium, Kansas City, Missouri, United States
Jersey Shore Cancer Center, Neptune, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Herbert Irving Comprehensive Cancer Center, New York, New York, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Palmetto Hematology/Oncology Associates, Spartanburg, South Carolina, United States
Contact Details
Name: Karen Doak
Affiliation: AVAX Technologies
Role: STUDY_CHAIR
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