Vaccine Therapy in Treating Patients With Stage IV Melanoma
- Conditions
- Melanoma (Skin)
- Registration Number
- NCT00042783
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine therapy may be effective in treating stage IV melanoma.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.
- Detailed Description
OBJECTIVES:
* Determine the feasibility of treating patients with stage IV melanoma with D1/3-MAGE-3-His fusion protein with SB-AS02B adjuvant.
* Determine the clinically confirmed response rates (partial and complete responses) of patients treated with this regimen.
* Determine the 6-month progression-free survival rate of patients treated with this regimen.
* Determine the qualitative and quantitative toxic effects of this regimen in these patients.
* Determine immune responses in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive D1/3-MAGE-3-His fusion protein emulsified in SB-AS02B adjuvant intramuscularly once every 3 weeks for a total of 12 weeks (4 injections). In the absence of disease progression or unacceptable toxicity, patients receive a second 12-week course beginning at week 16.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- 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 (7)
Arizona Cancer Center at University of Arizona Health Sciences Center
πΊπΈTucson, Arizona, United States
USC/Norris Comprehensive Cancer Center and Hospital
πΊπΈLos Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
πΊπΈLos Angeles, California, United States
Barbara Ann Karmanos Cancer Institute
πΊπΈDetroit, Michigan, United States
Veterans Affairs Medical Center - Biloxi
πΊπΈBiloxi, Mississippi, United States
CCOP - Columbia River Oncology Program
πΊπΈPortland, Oregon, United States
University of Washington School of Medicine
πΊπΈSeattle, Washington, United States
Arizona Cancer Center at University of Arizona Health Sciences CenterπΊπΈTucson, Arizona, United States