RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining interferon alfa plus radiation therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of interferon alfa plus radiation therapy in treating patients who have stage III or recurrent melanoma that has been removed by surgery.
OBJECTIVES: I. Determine the effectiveness and toxicity of adjuvant radiotherapy given concurrently with interferon alfa to patients with stage III or recurrent melanoma. OUTLINE: This is a multicenter study. Patients receive interferon alfa IV over 20 minutes daily for 5 consecutive days a week for 4 weeks. Patients then receive radiotherapy on days 2 and 4 and interferon alfa subcutaneously (SQ) on days 1, 3, and 5 for 2.5 weeks. Interferon alfa SQ continues 3 times a week for 10 months in the absence of disease progression or unacceptable toxicity. Patients are followed every month for 3 months, then every 3 months for 2 years, then every six months until year 5, and then annually thereafter. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 2.75 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Interferon alfa as outlined in treatment arm.
Radiation therapy as outlined in treatment arm.
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Overall Response Rate (ORR)
Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Time frame: Study Duration: 7 years
Number of Participants with Adverse Events
Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.
Time frame: Study Duration: 7 years
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