Immunization of Patients With Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen
- 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.
Patients are followed at 4-6 weeks.
PROJECTED ACCRUAL: A total of 73 patients (13-20 for arm I, 13-20 for arm II, and 19-33 for
arm III) will be accrued for this study within 2 years.
Allocation: Randomized, Primary Purpose: Treatment
Suzanne L. Topalian, MD
NCI - Surgery Branch
United States: Federal Government
|Surgery Branch||Bethesda, Maryland 20892|