Immunization of Patients With Metastatic Melanoma Using a Class II Restricted Peptide From the GP100 Antigen and Class I Restricted Peptides From the GP100 and MART-1 Antigens

Trial Information

Immunization of Patients With Metastatic Melanoma Using a Class II Restricted Peptide From the GP100 Antigen and Class I Restricted Peptides From the GP100 and MART-1 Antigens

OBJECTIVES:

- Determine the clinical response to immunization using gp100:44-59 antigen peptide plus
gp100:209-217 (210M) and MART-1:26-35 (27L) antigen peptides in patients with
metastatic melanoma who are HLA-DRB1*0401 and HLA-A0201 positive.

- Determine the clinical response to immunization using gp100:44-59 antigen peptide alone
in patients with metastatic melanoma who are HLA-DRB1*0401 positive but HLA-A0201
negative.

- Determine the immunologic response in patients treated with these regimens as measured
by changes in T-cell precursors from before to after treatment.

- Evaluate the toxicity profiles of these regimens in these patients.

OUTLINE: Patients are assigned to one of three immunization groups based on HLA-A0201 status
and prior gp100:209-217 (210M) antigen peptide immunization:

- Group 1 (HLA-A0201 positive and no prior gp100:209-217 [210M] antigen peptide):
Patients receive gp100:44-59 and gp100:209-217 (210M) antigen peptides emulsified
together in Montanide ISA-51 (ISA-51) subcutaneously (SC) and gp100:44-59 and
MART-1:26-35 (27L) antigen peptides emulsified together in ISA-51 SC.

- Group 2 (HLA-A0201 positive and prior gp100:209-217 [210M] antigen peptide): Patients
receive treatment as in group 1.

- Group 3 (HLA-A0201 negative and no prior gp100:209-217 [210M] antigen peptide):
Patients receive gp100:44-59 antigen peptide emulsified in ISA-51 SC alone.

- All groups: Treatment repeats every 3 weeks for 4 doses in the absence of disease
progression or unacceptable toxicity. Patients with complete response after 4 doses
receive a maximum of 2 additional doses. Patients with stable disease or minor, mixed,
or partial response after 4 doses receive a maximum of 12 additional doses. Patients
with no response after 4 doses receive immunization with the same peptides and
interleukin-2 IV over 15 minutes every 8 hours for a maximum of 12 doses beginning 1
day after each immunization.

Patients are followed at 3-4 weeks.

PROJECTED ACCRUAL: A total of 45-75 patients (15-25 per immunization group) will be accrued
for this study within 2 years.