Trial Information

PHASE I TRIAL IN PATIENTS WITH METASTATIC MELANOMA OF IMMUNIZATION WITH A RECOMBINANT FOWLPOX VIRUS ENCODING THE GP100 MELANOMA ANTIGEN

OBJECTIVES: I. Evaluate the toxicity, immunologic reactivity, and possible therapeutic
efficacy of immunization with recombinant fowlpox virus encoding the gp100 melanoma antigen
administered alone or with interleukin-2 in patients with metastatic melanoma.

OUTLINE: This is a dose-escalation study. Patients receive recombinant fowlpox virus
encoding the gp100 melanoma antigen (FPV-gp100) IV or intramuscularly to rotating sites or
fowlpox virus encoding modified gp100 melanoma antigen IV every 2 weeks for 4 vaccinations.
Treatment continues for a maximum of 2 courses in the absence of disease progression.
Cohorts of 3-9 patients receive escalating doses of FPV-gp100 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients develop dose-limiting toxicity. Patients in 3 of 5 cohorts also receive
interleukin-2 (IL-2) within 12 hours of FPV-gp100. One cohort receives IL-2 subcutaneously
daily on days 1-5 and days 8-12. A second cohort receives low-dose IL-2 IV over 15 minutes
every 8 hours on days 2-8. A third cohort receives high-dose IL-2 IV over 15 minutes every 8
hours on days 2-6. Patients in cohorts 4 and 5 receive FPV-gp100 alone and, if no response
is observed after 2 courses, may receive 2 courses of IL-2 alone every 8 hours for 5 days,
approximately 2 weeks apart. A separate cohort of 3-9 patients receives modified FPV-gp100.
If no response is observed after 2 courses, IL-2 may be administered as in cohorts 4 and 5.
Patients are followed at 28 days after the second immunization with FPV-gp100.

PROJECTED ACCRUAL: A maximum of 91 patients will be accrued for this study.