Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Recurrent Metastatic Melanoma
RATIONALE: Vaccines made from an antigen combined with a modified virus may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy with interleukin-2 may kill more tumor cells.
PURPOSE: Phase I trial to compare the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have recurrent metastatic melanoma that has not responded to previous therapy.
Biological: fowlpox virus vaccine vector
Biological: gp100 antigen
|Study Design:||Primary Purpose: Treatment|
|Official Title:||PHASE I TRIAL IN PATIENTS WITH METASTATIC MELANOMA OF IMMUNIZATION WITH A RECOMBINANT FOWLPOX VIRUS ENCODING THE GP100 MELANOMA ANTIGEN|
|Study Start Date:||August 1996|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019175
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Steven A. Rosenberg, MD, PhD||NCI - Surgery Branch|