Vaccine Therapy in Treating Patients With Melanoma
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of melanoma vaccine in treating patients who have melanoma.
Biological: HPV 16 E7:12-20 peptide vaccine
Biological: gp100 antigen
Biological: incomplete Freund's adjuvant
Procedure: conventional surgery
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial to Determine the Immune Response to a Mutated gp100 Mela|
|Study Start Date:||April 1999|
|Study Completion Date:||July 2003|
- Determine the toxic effects of gp100:209-217 (210M) and human papilloma virus (HPV)-16 E7(12-20) peptide vaccine in patients with primary melanoma at least 1 mm thick.
- Determine the T-cell response to modified self-gp100:209-217 (210M) peptide and unmodified parental gp100 peptide in these patients.
- Determine the T-cell response to the control HLA-A2.1-restricted cytotoxic T-lymphocyte epitope of HPV-16 E7(12-20) in these patients.
- Determine whether analysis of antigen-specific T cells using specific HLA-A2/peptide tetramers is an effective method for monitoring the immune response in patients undergoing peptide vaccination compared to ELISPOT, LDA, and measurement of intracellular cytokine production (fastimmune).
- Compare induction of primary peptide-specific T-cell immune responses to self gp100 peptide versus foreign E7 peptide in these patients.
- Compare immune response induced by vaccinating every 2 weeks for 6 months (13 vaccinations) vs every 3 weeks for 6 months (9 vaccinations) in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gp100:209-217 (210M) and HPV-16 E7(12-20) peptides mixed with Montanide ISA-51 subcutaneously at the site of the primary melanoma and in the extremities and abdomen. Vaccinations continue every 2 weeks for 6 months (13 total injections).
- Arm II: Patients receive vaccinations as in arm I every 3 weeks for 6 months (9 total injections).
Patients undergo sentinel lymph node biopsy and possible wide local excision approximately 10 days after the second vaccination.
Patients are followed every 3 months for 6 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter until recurrence.
PROJECTED ACCRUAL: A total of 36 patients (18 per arm) will be accrued for this study within 14 months.
|United States, Oregon|
|Earle A. Chiles Research Institute at Providence Portland Medical Center|
|Portland, Oregon, United States, 97213-2967|
|Study Chair:||John W. Smith, MD||Providence Cancer Center, Earle A. Chiles Research Institute|