Trial Information

Summary: Phase II Trial for the Evaluation of the Efficacy of Vaccination with Synthetic Melanoma Peptides Administered with GM-CSF-in-adjuvant in Patients with Advanced Melanoma HIC #10049

This is an open-label, single dose phase II study of a vaccine comprising class I MHC-restricted melanoma-associated peptides, and a class II MHC-restricted tetanus helper peptide, administered in GM-CSF-in-adjuvant

Regimen:

The vaccines will be administered over a 6-week period (weeks 0, 1, 2, 4, 5, and 6). All patients will receive four class I MHC-restricted synthetic peptides (1 each restricted to HLA-A1 and A3, 2 restricted to HLA-A2) and a class II MHC-restricted tetanus helper peptide. All vaccines will contain GM-CSF-in-adjuvant and will be administered intradermally and subcutaneously.

For the first three vaccinations (weeks 0, 1, and 2), the vaccine will be split and administered at two sites: the vaccination site and the replicate vaccination site. The immunologic response at the replicate vaccination site will be evaluated at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel node biopsy methods and will be referred to as the sentinel immunized node (SIN).

The patient’s clinical and radiological response will be evaluated at week 12 and confirmed at week 18. At this time, patients who have stable disease, partial response, or complete response will be eligible for 18 additional booster vaccinations. The booster vaccines will be administered at the primary vaccination site for 6 cycles; during each cycle the vaccine will be administered once each week for 3 weeks. The 6 cycles will be administered over a period of 1 year and 9 months.

Inclusion criteria:

Patients who have been diagnosed, by cytologic or histologic examination, with advanced metastatic melanoma (AJCC stage III or stage IV). Patients with mucosal or ocular melanoma are also eligible for this study. Expression of HLA-A1, -A2 or -A3. Tumor must express either gp100 (for patients HLA-A2+ or HLA-A3+) or tyrosinase (for patients HLA-A1+ or HLA-A2+) by immunohistochemistry. Patients must have measurable disease to be eligible for this study. ECOG performance status 0-1, Serology (within 6 months prior to study entry) HIV negative (antibody screening) and Hepatitis C negative, Age 18 years or older at the time of study entry, Patients with brain metastases may be eligible if all of the following are true:

• The total number of brain metastases ever is less than or equal to 3.
• The brain metastases have been completely removed by surgery or have been treated completely by stereotactic radiosurgery
• No brain metastasis is greater than 2 cm in diameter at the time of protocol entry
• There has been no evident growth of any brain metastasis since treatment.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.