Vaccine Therapy in Treating Patients With Recurrent or Refractory Metastatic Melanoma
|ClinicalTrials.gov Identifier: NCT00019383|
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : June 20, 2013
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Giving the vaccine with interleukin-2 or sargramostim may help kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of peptide vaccine with or without adjuvant interleukin-2 or sargramostim in treating patients who have recurrent or refractory metastatic melanoma.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: aldesleukin Biological: incomplete Freund's adjuvant Biological: sargramostim Biological: tyrosinase peptide Biological: tyrosinase-related protein-1||Phase 2|
- Determine whether patients with refractory metastatic melanoma undergo partial or complete response to peptides specific to their HLA-antigen, either alone or when combined with 1 of 3 adjuvants.
- Evaluate the immunologic response to the peptide alone or when combined with 1 of 3 adjuvants in these patients.
OUTLINE: Patients are stratified by HLA status (A1 vs A3 vs A24 vs A31).
Patients are assigned to 1 of 4 vaccine groups:
- Group 1 (HLA-A1 positive): Patients receive tyrosinase:240-251.
- Group 2 (HLA-A3 positive): Patients receive gp100:17-25. (closed to accrual 5/17/2000)
- Group 3 (HLA-A24 positive): Patients receive tyrosinase:206-214.
- Group 4 (HLA-A31 positive): Patients receive tyrosinase related protein-1. Each peptide vaccine is separately emulsified in Montanide ISA-51 and administered subcutaneously into the thigh. Patients are treated with peptide vaccine alone or combined with 1 of 3 possible adjuvants (interleukin-2 (IL-2) IV, IL-2 delayed IV, or sargramostim (GM-CSF) SQ) depending on the time of entry into study and response to treatment.
At least 4 to 6 patients are accrued for the peptide alone cohort before beginning accrual on the other cohorts. Any patient who experiences unacceptable toxicity due to adjuvant therapy is taken off study. If a second patient develops unacceptable toxicity, that schedule of peptide administration is discontinued.
Patients exhibiting stable, minor, mixed, or partial response may receive up to 12 additional courses.
Patients are followed for 4-6 weeks.
PROJECTED ACCRUAL: A maximum of 457 patients will be accrued for this study over 3.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Immunization of Patients With Metastatic Melanoma Using Immunodominant Peptides From the Tyrosinase Protein or Tyrosinase Related Protein-1 (TRP1)|
|Study Start Date :||January 1998|
|Study Completion Date :||June 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019383
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Steven A. Rosenberg, MD, PhD||NCI - Surgery Branch|