Immunization of Patients With Metastatic Melanoma Using a Recombinant Fowlpox Virus Encoding a GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
- Compare the clinical response in patients with metastatic melanoma treated with
immunization with recombinant fowlpox vaccine administered either intravenously or
intramuscularly, with or without interleukin-2 (IL-2).
- Compare the immune response in patients before and after treatment with these regimens.
- Compare the toxicity profile of these regimens in these patients.
OUTLINE: This is a partially randomized study. Patients are randomized to 1 of 3 treatment
- Cohort 1: Patients receive recombinant fowlpox virus encoding gp100 peptide (fowlpox
vaccine) IV once every 4 weeks for up to 4 doses. (Closed to accrual as of 6/21/02.)
- Cohort 2: Patients receive fowlpox vaccine intramuscularly (IM) once every 4 weeks for
up to 4 doses. (Closed to accrual as of 6/21/04.)
- Cohort 3 (for patients in need of immediate interleukin-2 [IL-2] and those with disease
progression after treatment in cohorts 1 or 2): Patients receive fowlpox vaccine either
IV or IM* once every 4 weeks for 4 doses and IL-2 IV every 8 hours for a maximum of 12
doses beginning 24 hours after fowlpox vaccine.
NOTE: *The IM route of administration was selected as the preferred route of administration
from cohorts 1 and 2
- Expanded cohort 2 (open to accrual 7/19/02): Patients receive fowlpox vaccine IM once
every 4 weeks for up to 4 doses. Upon disease progression, patients receive fowlpox
vaccine as above and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours
after fowlpox vaccine. (Closed to accrual 12/4/03.) In all cohorts, 3-4 weeks after the
last injection, patients achieving a complete remission may receive a maximum of an
additional 2 courses of therapy. Patients with responding disease may receive repeat
vaccinations for up to 8 courses. Patients with no response or progressive disease in
cohorts not receiving IL-2 may be treated with fowlpox vaccine and IL-2 as in cohort 3.
Patients who are randomized to receive IL-2 may not receive additional IL-2 therapy.
PROJECTED ACCRUAL: A maximum of 84 patients (24 in cohorts 1 and 2, 19-33 in cohort 3, and
27 in expanded cohort 2) will be accrued for this study within 1 year.
Masking: Open Label, Primary Purpose: Treatment
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|