Post-Operative Adjuvant Radiotherapy With Concurrent Interferon-Alfa

Phase 1

Completed

• Conditions: Melanoma (Skin)
• Interventions: Biological: Interferon alfa; Radiation: Radiation therapy

• Registration Number: NCT00005615
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Study Timeline

• Study Start: 1997-07
• Study First Submitted: 2000-05-02
• Study First Submitted QC: 2004-04-01
• Study First Posted: 2004-04-02
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-21
• Last Update Posted: 2012-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interferon Alfa Plus Radiation	Interferon alfa	Combined Therapy: interferon alfa plus radiation therapy. 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.
Interferon Alfa Plus Radiation	Radiation therapy	Combined Therapy: interferon alfa plus radiation therapy. 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.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	Study Duration: 7 years	Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	Study Duration: 7 years	Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.

Trial Locations

Locations (2)

Sylvester Cancer Center, University of Miami; 🇺🇸 Miami, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States