Spots Global Cancer Trial Database for Post-Operative Adjuvant Radiotherapy With Concurrent Interferon-Alfa

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Trial Identification

Brief Title: Post-Operative Adjuvant Radiotherapy With Concurrent Interferon-Alfa

Official Title: The Florida Melanoma Trial: A Phase I/II Trial of Post-Operative Adjuvant Radiotherapy With Concurrent Interferon-Alfa in the Treatment of Advanced Stage III Melanoma: Study Site & Coordinating Center

Study ID: NCT00005615

Conditions

Melanoma (Skin)

Interventions

Interferon alfa

Radiation therapy

Study Description

Brief Summary: 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.

Detailed Description: 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.