Expired Study
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Decatur, Illinois 62526


Purpose:

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

CDR0000066472


NCT ID:

NCT00003444


Secondary ID:

E-3697


Study Acronym:


Brief Title:

Interferon Alfa-2b With or Without Radiation Therapy in Treating Patients With Melanoma That Has Metastasized to Lymph Nodes in the Neck, Under the Ar


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Eastern Cooperative Oncology Group


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Primary Purpose: Treatme


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

167


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Maury M. Rosenstein, MD
Study Chair
UPMC Cancer Center at UPMC St. Margaret

Study Dates

Start Date:October 1998
Primary Completion Date:September 2003
Primary Completion Type:Actual
Verification Date:January 2010
Last Changed Date:January 26, 2010
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:recombinant interferon alfa
Intervention Type:Radiation
Name:radiation therapy

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Eastern Cooperative Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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