Immunization of Patients With Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201
- Compare the efficacy of gp100:209-217(210M) peptide and MART-1:26-35(27L) peptide
administered with or without high-dose interleukin-2 (IL-2) in patients with metastatic
melanoma who are HLA-A0201 positive.
- Determine the efficacy of these peptides in patients who cannot receive IL-2.
- Compare the efficacy of IL-2 with or without these peptides in patients who need
immediate treatment with IL-2.
- Determine the efficacy of MART-1:26-35(27L) peptide in patients who have received prior
- Compare the immunologic response experienced by patients who have received peptide,
with or without IL-2, as measured by changes in T-cell precursors from before to after
- Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a partially randomized study.
Patients are assigned to 1 of 4 treatment groups based on disease status and prior therapy.
- Group A (eligible to receive interleukin-2 (IL-2) but not in immediate need; no prior
immunization with gp100 or MART-1 antigen): Patients are randomized to 1 of 2 treatment
- Arm I: Patients receive gp100 and MART-1 peptides emulsified in Montanide ISA-51
(ISA-51) subcutaneously (SC) on day 1. (Arm I closed as of 10/30/02).
- Arm II: Patients receive both peptides as in arm I on day 1 and high-dose IL-2 IV
over 15 minutes every 8 hours on days 2-5 (for up to 12 doses). (Arm II closed as
- Group B (ineligible to receive IL-2 due to other debilitating disease): Patients
receive treatment as in group A, arm I.
- Group C (need immediate IL-2 therapy due to extensive and rapid progression of
disease): Patients receive treatment as in group A, arm II. (Group C closed as of
- Group D (prior immunization with gp100 antigen): Patients receive modified
MART-1:26-35(27L) peptide emulsified in ISA-51 SC on day 1.
Treatment in all groups repeats every 3 weeks for 4 courses. Patients who achieve a minor,
mixed, or partial response may receive up to 12 additional courses. Patients who achieve
complete response receive 2 additional courses.
Patients are followed at 4-6 weeks.
PROJECTED ACCRUAL: A total of 103 patients (15-25 for group A, arm I; 19-33 for group A, arm
II; and 15 each for groups B, C, and D) will be accrued for this study within 1 year.
Primary Purpose: Treatment
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch
United States: Federal Government
|Surgery Branch||Bethesda, Maryland 20892|