Interferon Alfa-2b With or Without Radiation Therapy in Treating Patients With Melanoma That Has Metastasized to Lymph Nodes in the Neck, Under the Arm, or in the Groin
- Conditions
- Melanoma (Skin)
- Registration Number
- NCT00003444
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Interferon alfa-2b may interfere with the growth of cancer cells. It is not yet known whether giving radiation therapy with interferon alfa-2b is more effective than giving interferon alfa-2b alone in treating melanoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus interferon alfa-2b with that of interferon alfa-2b alone in treating patients who have melanoma that has metastasized to lymph nodes in the neck, under the arm, or in the groin.
- Detailed Description
OBJECTIVES: I. Evaluate the effectiveness of postoperative hypofractionated radiotherapy in combination with high dose interferon in preventing regional relapse in patients with malignant melanoma with any number of nodes with clinical extracapsular extension or previous nodal basin recurrence. II. Evaluate the effectiveness of this therapy in prolonging relapse free and overall survival in this patient population. III. Evaluate the toxicity of this therapy in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to prior nodal basin recurrence, site of disease, and extracapsular extension. Following surgery, patients are randomized to receive either interferon alfa-2b alone or five treatments of radiotherapy followed by interferon alfa-2b. Patients receive radiotherapy 2 days a week for 2.5 weeks. Patients receive interferon alfa-2b IV over 20 minutes daily for 5 days for a total of 28 days, followed by subcutaneous injections 3 times a week for 48 weeks. Patients are followed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: Approximately 167 patients will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 167
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Lakeside)
🇺🇸Chicago, Illinois, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
New England Medical Center Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Scroll for more (13 remaining)Emory University Hospital - Atlanta🇺🇸Atlanta, Georgia, United States