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NCT00003444 Clinical Trial

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

Melanoma (Skin) Clinical Trial

Official title:
A Prospective Randomized Phase III Clinical Trial Assessing the Role of Post-Operative Radiotherapy Plus Adjuvant Interferon Alpha-2b in Patients With Cervical, Axillary, and Inguinal Nodal Metastasis From Cutaneous Melanoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00003444
Other study ID # CDR0000066472
Secondary ID E-3697
Status Completed
Phase Phase 3
First received
Last updated
Start date March 29, 1999

Study information
Verified date June 2023
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 167
Est. completion date
Est. primary completion date September 2003
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 120 Years
Eligibility DISEASE CHARACTERISTICS: Histologically documented malignant melanoma in node(s) meeting one or more of the following criteria: 1 or more lymph nodes found to contain metastatic melanoma with gross evidence of extracapsular nodal extension Nodal recurrence at the site of previous lymphadenectomy All gross cancer removed with negative margins Prior node biopsy allowed if complete nodal dissection performed Parotid involvement outside a node allowed No distant metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 125,000/mm3 Hematocrit at least 33% Hepatic: AST no greater than 2 times upper limit of normal (ULN) LDH no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Bilirubin no greater than 2 times ULN If LDH or alkaline phosphatase are above normal, CT or MRI of liver required Renal: Creatinine no greater than 1.8 mg/dL BUN no greater than 33 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior or concurrent malignancies within 2 years, except any carcinoma in situ, lobular carcinoma of the breast in situ, carcinoma in situ of the cervix, atypical melanocytic hyperplasia or Clark I melanoma in situ, or basal or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interferon Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head and neck, axillary, or inguinal areas Surgery: See Disease Characteristics Recovered from prior surgery

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• recombinant interferon alfa

Radiation:
• radiation therapy

Locations
Country Name City State
United States Veterans Affairs Medical Center - Albany Albany New York
United States Emory University Hospital - Atlanta Atlanta Georgia
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States New England Medical Center Hospital Boston Massachusetts
United States CCOP - Cedar Rapids Oncology Project Cedar Rapids Iowa
United States Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois
United States Veterans Affairs Medical Center - Chicago (Lakeside) Chicago Illinois
United States Ireland Cancer Center Cleveland Ohio
United States CCOP - Geisinger Clinical and Medical Center Danville Pennsylvania
United States CCOP - Central Illinois Decatur Illinois
United States Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia
United States CCOP - Duluth Duluth Minnesota
United States Veterans Affairs Medical Center - East Orange East Orange New Jersey
United States CCOP - Northern New Jersey Hackensack New Jersey
United States Hackensack University Medical Center Hackensack New Jersey
United States CCOP - Kalamazoo Kalamazoo Michigan
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee Wisconsin
United States CCOP - Illinois Oncology Research Association Peoria Illinois
United States University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania
United States UPMC St. Margaret Pittsburgh Pennsylvania
United States Riverview Medical Center Red Bank New Jersey
United States CCOP - Metro-Minnesota Saint Louis Park Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Eastern Cooperative Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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