Melanoma (Skin) Clinical Trial
Official title:
Treatment Of Patients With Metastatic Melanoma Using Recombinant Vaccinia And Fowlpox Viruses Encoding The Tyrosine Antigen In Combination With Interleukin-2
RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells.
Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with
interleukin-2 in treating patients who have metastatic melanoma.
OBJECTIVES:
- Determine the response rate (partial response or complete remission) in patients with
metastatic melanoma treated with vaccinia-tyrosinase vaccine, fowlpox-tyrosinase
vaccine, and high-dose interleukin-2.
- Determine the immunologic response, measured by the reactivity of CD4+ and CD8+ T cells
and serum immunoglobulins against tyrosinase and melanoma cells, in patients treated
with this regimen.
OUTLINE: Patients receive vaccinia-tyrosinase vaccine intramuscularly (IM) on day 1 followed
by fowlpox-tyrosinase vaccine IM on days 15 and 29. Patients then receive high-dose
interleukin-2 (IL-2) IV over 15 minutes every 8 hours beginning on day 30 for up to 12 doses
and again beginning approximately 3 weeks after the initial dose. Patients with stable
disease or a minor, mixed, or partial response may receive additional courses of
fowlpox-tyrosinase vaccine (2 doses) and IL-2 as above in the absence of disease progression
or unacceptable toxicity. Patients with a complete response (CR) receive 1 additional course
beyond achieving CR.
Patients are followed annually for at least 5 years.
PROJECTED ACCRUAL: A total of 19-35 patients will be accrued for this study within 2 years.
;
Masking: Open Label, Primary Purpose: Treatment
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