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Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™
RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with malignant melanoma.
OBJECTIVES: * Determine the response in patients with in-transit cutaneous malignant melanoma treated with active immunotherapy comprising polyvalent melanoma vaccine (Canvaxin™). OUTLINE: This is an open-label, multicenter study. Patients receive polyvalent melanoma vaccine (Canvaxin™) subcutaneously to the armpit and groin areas every 2 weeks for approximately 10 weeks (5 doses) and then every 4 weeks for up to approximately 1 year of total treatment (total of 15 doses). Patients with no evidence of response at week 24 receive no further treatment. Patients whose disease continues to respond after completion of study treatment are eligible for a new study in which they will continue treatment with polyvalent melanoma vaccine (Canvaxin™). After completion of study treatment, patients are followed at 30 days. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States
John Wayne Cancer Institute at Saint John's Health Center
Santa Monica, California, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
CCOP - Dayton
Dayton, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
LDS Hospital
Salt Lake City, Utah, United States
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Start Date
July 1, 2005
Last Updated
December 19, 2013
polyvalent melanoma vaccine
BIOLOGICAL
Lead Sponsor
CancerVax Corporation
NCT04079166
NCT04911998
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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