Immunization of Patients With Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen

OBJECTIVES:

• Determine efficacy of recombinant fowlpox and vaccinia viruses encoding tyrosinase antigen, administered with or without low-dose interleukin-2 (IL-2), in terms of response, in patients with metastatic melanoma.
• Compare the response rate in patients to this vaccination administered with high-dose IL-2 to that in similar patients on previous trials treated with high-dose IL-2 alone.
• Determine the immunological response in patients treated with this regimen.

OUTLINE: This is a randomized study. Patients are randomized to one of three treatment arms.

• Arm I: Patients receive recombinant fowlpox vaccine IM on day 1 followed 4 weeks later by recombinant vaccinia vaccine IM. Treatment repeats for a minimum of 4 vaccinations.
• Arm II: Patients receive vaccinations as in arm I plus low-dose interleukin-2 (IL-2) subcutaneously daily on days 2-13 after each vaccination.
• Arm III: Patients receive vaccinations as in arm I plus high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 after each vaccination.

Patients with stable disease or a minor, mixed, or partial response after four immunizations (1 course) may receive a second course of the same regimen beginning 4-6 weeks after the first course. After the second course, patients with tumor regression may continue to receive treatment in the absence of unacceptable toxicity until best response is achieved.