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Home > "I" Clinical Trials Conditions > 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

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



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

For Condition: Stage 4 Melanoma,stage 3 melanoma,Recurrent Melanoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MauryRosenstein,  Study Chair,  Eastern Cooperative Oncology Group

CCOP - Geisinger Clinical and Medical Center
Danville,  Pennsylvania,  17822-2001
United States
 

Veterans Affairs Medical Center - Albany
Albany,  New York,  12208
United States
 

CCOP - Northern New Jersey
Hackensack,  New Jersey,  07601
United States
 

Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago,  Illinois,  60611
United States
 

CCOP - Duluth
Duluth,  Minnesota,  55805
United States
 

Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago,  Illinois,  60611
United States
 

New England Medical Center Hospital
Boston,  Massachusetts,  02111
United States
 

CCOP - Central Illinois
Decatur,  Illinois,  62526
United States
 

CCOP - Metro-Minnesota
St. Louis Park,  Minnesota,  55416
United States
 

Medical College of Wisconsin
Milwaukee,  Wisconsin,  53226
United States
 

CCOP - Kalamazoo
Kalamazoo,  Michigan,  49007-3731
United States
 

UPMC St. Margaret
Pittsburgh,  Pennsylvania,  15215
United States
 

CCOP - Illinois Oncology Research Association
Peoria,  Illinois,  61602
United States
 

Emory University Hospital - Atlanta
Atlanta,  Georgia,  30322
United States
 

Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee,  Wisconsin,  53295
United States
 

Beth Israel Deaconess Medical Center
Boston,  Massachusetts,  02215
United States
 

Ireland Cancer Center
Cleveland,  Ohio,  44106-5065
United States
 

Veterans Affairs Medical Center - East Orange
East Orange,  New Jersey,  07018-1095
United States
 

Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur,  Georgia,  30033
United States
 

Riverview Medical Center
Red Bank,  New Jersey,  07701
United States
 

University of Pittsburgh Cancer Institute
Pittsburgh,  Pennsylvania,  15213
United States
 

CCOP - Cedar Rapids Oncology Project
Cedar Rapids,  Iowa,  52403-1206
United States
 

Hackensack University Medical Center
Hackensack,  New Jersey,  07601
United States
 


Additional Information:
Study ID Numbers:
  CDR0000066472;  E-3697
Study Start Date: October 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003444

Other Stage 3 Melanoma Studies:
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2. Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers

3. Vaccine Therapy in Treating Patients With Melanoma

4. Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg

5. Interferon alfa Following Surgery in Treating Patients With Stage III Melanoma

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