Melanoma (Skin) Clinical Trial
Official title:
Phase II Trial of the Effects of Interferon Alfa-2b on the Immunogenicity of a Polyvalent Melanoma Antigen Vaccine in Patients With Stage III Malignant Melanoma
RATIONALE: Vaccines may make the body build an immune response and kill tumor cells.
Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Interferon
alfa-2b may interfere with the growth of tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus
interleukin-2 with or without interferon alfa-2b in treating patients who have stage III
melanoma.
OBJECTIVES: I. Determine the effect of interferon alfa-2b on the potentiation of
antimelanoma antibodies and cellular immune responses induced by immunization to a
polyvalent melanoma vaccine and interleukin-2 in patients with stage III malignant melanoma.
II. Determine the optimal dose of interferon that will maximally stimulate these responses
in these patients. III. Determine the toxicity of this regimen in these patients.
OUTLINE: This is a randomized study. Patients are randomized into a vaccine treated control
arm or to receive one of two doses of interferon alfa-2b plus vaccine. All patients receive
polyvalent melanoma vaccine incorporated into interleukin-2 liposomes. The vaccine is
administered intradermally every 2 weeks for 8 weeks, monthly for 3 months, and then every 3
months for a total of 2 years or until disease progression. Patients assigned to arms II or
III also receive interferon alfa-2b subcutaneously, at one of two doses, three times a week
for 2 years. Patients are followed for survival.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 18 months.
;
Allocation: Randomized, Primary Purpose: Treatment
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