Interferon Alfa-2b in Treating Patients With Melanoma and Early Lymph Node Metastasis

Melanoma (Skin) Clinical Trial

Official title: A Multicenter Trial of Adjuvant Interferon Alfa-2b for Melanoma Patients With Early Lymph Node Metastasis Detected by Lymphatic Mapping and Sentinel Lymph Node Biopsy

Status Completed

Clinical Trial Summary

RATIONALE: Interferon alfa-2b may interfere with the growth of cancer cells.

PURPOSE: Randomized phase III trial to study the effectiveness of interferon alfa-2b in treating patients who have melanoma with early lymph node metastasis.

Clinical Trial Description

OBJECTIVES:

• Compare the efficacy of regional lymphadenectomy with or without adjuvant high-dose interferon alfa-2b on disease-free survival and overall survival of patients with invasive cutaneous melanoma with early or submicroscopic sentinel lymph node metastasis detected by histology or immunohistochemistry or by polymerase chain reaction (PCR).

• Compare the effect of lymphadenectomy vs observation on disease-free survival and overall survival of patients with submicroscopic sentinel lymph node metastasis detected only by PCR.

• Determine the recurrence rate and survival of patients with submicroscopic sentinel lymph node metastasis detected only by PCR.

• Determine the positive and negative predictive value of reverse transcriptase PCR analysis of sentinel lymph nodes and peripheral blood to identify patients at risk for recurrence and death.

OUTLINE: This is a randomized, multicenter study. Patients in the randomized portions of Protocols A and B are stratified according to tumor thickness (1-2 mm vs 3-4 mm vs greater than 4 mm) and tumor ulceration (yes vs no).

All patients undergo wide local tumor excision with lymphatic mapping and sentinel node biopsy. Patients with tumors with ambiguous drainage patterns undergo lymphoscintigraphy prior to tumor excision. Patients with evidence of metastatic melanoma in the sentinel node(s) by routine histology, serial sectioning, or immunohistochemistry and who have undergone a prior regional lymph node dissection proceed to protocol A.

• Protocol A: Patients with metastasis in a single sentinel node with no evidence of extracapsular extension and no metastatic disease in nonsentinel nodes are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive adjuvant high-dose interferon alfa-2b IV 5 days a week for 4 weeks, then subcutaneously 3 times a week for 48 weeks.

• Arm II: Patients undergo observation. Patients with metastases in more than one sentinel node with evidence of extracapsular extension or metastasis in any nonsentinel node receive adjuvant high-dose interferon alfa-2b as in arm I.

Patients with no evidence of sentinel node(s) metastases by routine histology, serial sectioning, and immunohistochemistry and are negative by polymerase chain reaction (PCR) analysis are observed.

• Protocol B: Patients with positive sentinel node(s) by PCR analysis are randomized to one of three treatment arms.

• Arm I: Patients undergo observation.

• Arm II: Patients undergo lymph node dissection.

• Arm III: Patients undergo lymph node dissection followed by adjuvant high-dose interferon alfa-2b IV 5 days a week for 4 weeks.

Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 5 years. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

• NCT number: NCT00004196
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Status: Completed
• Phase: Phase 3
• Start date: October 1999
• Completion date: November 2007