Vaccine Therapy in Treating Patients With Malignant Melanoma
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™|
- Response [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128583
|United States, California|
|Comprehensive Cancer Center at Desert Regional Medical Center|
|Palm Springs, California, United States, 92262|
|John Wayne Cancer Institute at Saint John's Health Center|
|Santa Monica, California, United States, 90404|
|United States, Florida|
|Lakeland Regional Cancer Center at Lakeland Regional Medical Center|
|Lakeland, Florida, United States, 33804-1057|
|H. Lee Moffitt Cancer Center and Research Institute at University of South Florida|
|Tampa, Florida, United States, 33612-9497|
|United States, Ohio|
|CCOP - Dayton|
|Dayton, Ohio, United States, 45429|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|United States, Texas|
|Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas|
|Dallas, Texas, United States, 75390|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|United States, Utah|
|Salt Lake City, Utah, United States, 84143|
|Australia, New South Wales|
|Sydney Cancer Centre at Royal Prince Alfred Hospital|
|Sydney, New South Wales, Australia, 2050|
|Princess Alexandra Hospital|
|Brisbane, Queensland, Australia, 4102|
|Study Chair:||Linda Strause||CancerVax Corporation|