Interferon Alfa-2b in Treating Patients With Melanoma and Early Lymph Node Metastasis
Condition: Melanoma (Skin)
MeSH terms: Melanoma; Lymphatic Metastasis
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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.
    

Intervention name(s): recombinant interferon alfa; lymphangiography; Observation
Intervention type(s): Biological; Procedure; Drug
Intervention MeSH terms: Interferons; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: stage I melanoma; stage II melanoma; stage III melanoma