Trial Information

Summary: Evaluation of the Safety and Immunogenicity of Vaccination with Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells, in Patients with Advanced Melanoma HIC #10464 IND# 10825

This is an open label, phase I/II dose escalation study. Patients will receive 6 class II MHC-restricted synthetic melanoma peptides at each vaccination. The three doses to be tested are 200 µ, 400 µ, and 800 µ of each peptide. Assessment of the safety and immunogenicity of a vaccine comprising multiple synthetic melanoma peptides for helper T-cells. Each vaccination will be administered over a 6-week period (days 1, 8, 15, 29, 36, 43). Maximum accrual for this study will be 38 patients.

On days 1, 8, and 15, the peptide dose will be split between two vaccine sites, the primary vaccination site and the replicate vaccination site. The response at the replicate vaccination site will be evaluated at a 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).

Inclusion Criteria:

• Patients who have been diagnosed with AJCC stage IV cutaneous or mucosal melanoma.
• 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 radiotherapy. Stereotactic radiotherapy, such as gamma knife, can be used up to 1 week prior to study entry.
  • There has been no evident growth of any brain metastasis since treatment
  • No treated brain metastasis is greater than 2 cm in diameter at the time of protocol entry
• Patients must have at least two intact axillary and/or inguinal lymph node basins.
• All patients must have:
  • ECOG performance status of 0 or 1
• Laboratory parameters as follows:
  • HLA-DR1, -DR4, -DR11, -DR13, or -DR15+
  • ANC > 1000/mm3, and Platelets < 100,000/mm3 and Hgb > 9 g/dL
  • Hepatic:
    • AST, ALT, bilirubin, and alkaline phosphatase up to 2.5 x upper limits of normal (ULN)
  • Renal:
    • Creatinine up to 1.5 x ULN
  • Serology:
    • HIV negative (antibody screening), Hepatitis C negative
  • Diabetic patients must have a HGBA1C level of < 7%

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