Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Interferon alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	10 to 70	NCI	MDA-ID-95196 MDA-DM-95196, NCI-G96-1089, NCT00002882

Objectives

1. Compare the efficacy of postoperative adjuvant therapy with interferon alfa-2b (IFN-A) administered subcutaneously with or without IV induction vs concurrent biochemotherapy including cisplatin, vinblastine, DTIC, IFN-A and IL-2 and in melanoma patients with regional lymph node metastases that have been surgically resected.
2. Determine the relative toxic effects associated with adjuvant therapy with IFN-A and concurrent biochemotherapy including cisplatin, vinblastine, DTIC, IFN-A, and IL-2 and their effect on the quality of life.
3. Determine the prognostic value of detection of melanoma cells in the peripheral blood using RT/PCR for tyrosinase mRNA.

Entry Criteria

Disease Characteristics:

• Histologically diagnosed malignant melanoma with regional lymph node metastases
• Undergone complete lymph node dissection and free of any residual tumor
• No greater than 90 days from diagnosis of regional lymph nodes metastases
• No distant or resected in-transit metastases

Prior/Concurrent Therapy:

Biologic therapy:

• No prior immunotherapy with interferon or IL-2
• No concurrent immunomodulators

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• No concurrent steroids

Radiotherapy:

• Prior adjuvant local radiotherapy allowed for head and neck

Surgery:

• No greater than 8 weeks after definitive surgery for lymph node metastases

Other:

• No concurrent nonsteroid anti-inflammatory drugs, or other prostaglandin synthetase inhibitors

Patient Characteristics:

Age:

• 10 to 66
• 66 to 70 if in excellent physical condition

Performance status:

• 0-2

Life expectancy:

• At least 12 months

Hematopoietic:

• Hemoglobin greater than 10 g/dL
• WBC greater than 3,000/mm³
• Platelet count greater than 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.2 mg/dL

Renal:

• Creatinine no greater than 1.5 mg/dL

Other:

• No serious intercurrent illness that would compromise tolerance of therapy and long term survival
• Must be able to participate in follow up for minimum of 5 years
• No second malignancy except:
  • In situ cervical cancer
  • Basal or squamous skin cancer
• Must be able to physically and emotionally tolerate biochemotherapy
• No history of pulmonary or cardiac dysfunction, e.g., cardiac rhythm disturbance, congestive heart failure, coronary bypass, or impaired cardiac ejection fraction

Expected Enrollment

A total of 200 patients (100 patients in each arm) will be entered.

Outline

This is a randomized study. All patients are stratified according to prognostic factors.

Patients are randomly allocated to 1 of 2 treatment options. Treatment 1 uses interferon alfa-2b (IFN-A) therapy, and treatment 2 includes adjuvant biochemotherapy.

Patients who are randomized to IFN-A will be further stratified and randomized to one of two interferon schedules.

• Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.
• Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks.

Adjuvant biochemotherapy begins immediately after registration on the study. Cisplatin is given IV on days 1-4; vinblastine is given IVPB on days 1-4; dacarbazine (DTIC) is given IVPB on day 1; IFN-A is given subcutaneously on days 1-5; IL-2 is given by continuous infusion for a total of 96 hours on days 1-4. Each course of therapy is repeated every 21 days for 4 courses. Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy.

Kim KB, Legha SS, Gonzalez R, et al.: A randomized phase III trial of biochemotherapy versus interferon-alpha-2b for adjuvant therapy in patients at high risk for melanoma recurrence. Melanoma Res 19 (1): 42-9, 2009.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Agop Bedikian, MD, Protocol chair		Ph: 713-792-2921; 800-392-1611 Email: abedikia@mdanderson.org

Registry Information
Official Title		ADJUVANT THERAPY FOR MELANOMA PATIENTS WITH REGIONAL LYMPH NODE METASTASES WITH INTERFERON ALFA-2B VS. BIOCHEMOTHERAPY USING CISPLATIN + VINBLASTINE + DTIC + INTERFERON PLUS IL-2
Trial Start Date		1995-11-21
Registered in ClinicalTrials.gov		NCT00002882
Date Submitted to PDQ		1995-11-21
Information Last Verified		2004-04-08
NCI Grant/Contract Number		P30-CA16672

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