Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma
- Conditions
- Stage IV MelanomaStage III MelanomaRecurrent Melanoma
- Registration Number
- NCT00003647
- Lead Sponsor
- Vical
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or without immunotherapy in treating patients who have stage III or stage IV melanoma.
- Detailed Description
OBJECTIVES: I. Demonstrate either an improvement in the median time to disease progression by at least 2 months with no decrease in the rate of objective clinical response OR an improvement by at least 15% in the rate of objective clinical response with no decrease in the median time to disease progression in patients with stage III or IV melanoma receiving dacarbazine with Allovectin-7 when compared with patients receiving dacarbazine alone.
II. Determine the benefits, risks, and side effects of these regimens in this patient population.
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to sex, age, and spread of disease (cutaneous or nodal vs visceral disease). Patients are randomized to one of two treatment arms.
Arm I: Patients receive dacarbazine IV over 1 hour on day 0. Arm II: Patients receive treatment as in arm I. Patients also receive Allovectin-7 intratumorally on days 3 and 10.
Patients with stable or responding disease may receive additional courses every 28 days.
Patients are followed every 4 months.
PROJECTED ACCRUAL:
A total of 280 patients (140 in each arm) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
Oncology and Hematology Associates
🇺🇸Westwood, Kansas, United States
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Kaiser Permanente-Southern California Permanente Medical Group
🇺🇸San Diego, California, United States
Franklin Square Hospital Center
🇺🇸Baltimore, Maryland, United States
Virginia Piper Cancer Institute
🇺🇸Minneapolis, Minnesota, United States
Arena Oncology Associates
🇺🇸Great Neck, New York, United States
Mid Dakota Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
Providence Hospital Cancer Center
🇺🇸Southfield, Michigan, United States
Mid-Ohio Oncology/Hematology, Inc.
🇺🇸Columbus, Ohio, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
North Memorial Health Care
🇺🇸Robbinsdale, Minnesota, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Scripps Memorial Hospitals-Stevens Cancer Center - Encinitas
🇺🇸Encinitas, California, United States
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Georgia Cancer Specialists, P.C.
🇺🇸East Point, Georgia, United States
Georgia Cancer Specialists
🇺🇸Decatur, Georgia, United States
Cancer Care Center
🇺🇸New Albany, Indiana, United States
Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Cancer Care Center for Southern Indiana
🇺🇸Bloomington, Indiana, United States
St. Francis Medical Center
🇺🇸Honolulu, Hawaii, United States
Lucille Parker Markey Cancer Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Louisiana State University School of Medicine
🇺🇸New Orleans, Louisiana, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
Billings Interhospital Oncology Project
🇺🇸Billings, Montana, United States
Missouri Baptist Cancer Center
🇺🇸Saint Louis, Missouri, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Park Nicollet Clinic
🇺🇸St. Louis Park, Minnesota, United States
HemOnCare, P.C.
🇺🇸Brooklyn, New York, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Toledo Clinic, Inc.
🇺🇸Toledo, Ohio, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Danville Hematology and Oncology, Inc.
🇺🇸Danville, Virginia, United States
Cancer Treatment Centers of America in Hampton Roads
🇺🇸Portsmouth, Virginia, United States