High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma

Running, not enrolling · Phase 3

Conditions studied: Melanoma (Skin)

In brief

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically. PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.

Key facts

Study ID

NCT00003641

Run by

ECOG-ACRIN Cancer Research Group

People needed

1150

Starts

1999-03-25

Expected to finish

2026-12-01

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed primary melanoma of cutaneous origin
• Stage II (T3 N0 M0 1.5-4.0 mm Breslow depth)
• Clinically negative regional lymph node pathologic status unknown OR
• Histologically negative regional lymph nodes
• Stage III (T4 N0 M0)
• Greater than 4.0 mm Breslow depth OR
• Stage III (T1-4 N1)
• One lymph node positive microscopically
• Patients must meet at least 1 of the following criteria:
• T2b N0 - primary melanoma 1.01-2.0 mm with ulceration, node negative
• T3a-b N0 - primary melanoma 2.01-4.0 mm with and without ulceration, node negative
• T4a-b N0 - primary melanoma > 4.0 mm with or without ulceration, node negative
• T1a N1a-2a (microscopic) - primary melanoma of any thickness with microscopically positive lymph node (any number)
• Patients with a positive sentinel node should undergo complete lymphadenectomy of the nodal basin prior to study
• Must complete all primary therapy (wide excision with or without lymphadenectomy) and be randomized in this study within 84 days of wide excision
• Must have undergone an adequate wide excision of the primary lesion
• Age 18 and over (For ECOG patients only, patients must be >=10 years)
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1
• Adequate hematopoietic, hepatic, and renal function based on the following tests:
• White blood cell (WBC) cout at least 3,000/mm\^3
• Platelet count at least 125,000/mm\^3
• Hematocrit at least 30%
• Bilirubin no greater than 2 times upper limit of normal (ULN)
• Aspartate aminotransferase (AST), lactate dehydrogenase (LDH), and alkaline phosphatase no greater than 2 times ULN
• If lactate dehydrogenase or alkaline phosphatase is above normal, a contrast-enhanced computed tomography (CT) scan or Magnetic resonance imaging (MRI) of the liver is required to document the absence of tumor

You may not qualify if…

• Clinical, radiological/laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease
• Clinically palpable lymphadenopathy
• Evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that would preclude study participation
• Other significant medical or surgical condition, or any medication or treatment regimens, that would interfere with study participation
• Pregnant or nursing
• Other history of invasive melanoma
• Autoimmune disorders or conditions of immunosuppression
• History of active ischemic heart disease
• Cerebrovascular disease
• Congestive heart failure (New York Heart Association class III or IV heart disease)
• Prior or concurrent chemotherapy
• Prior immunotherapy including tumor vaccines, interferon, interleukins, levamisole, or other biologic response modifiers for melanoma
• Concurrent systemic corticosteroids including oral steroids (i.e., prednisone, dexamethasone), topical steroid creams or ointments, or any steroid-containing inhalers
• Prior or concurrent radiotherapy
• Other concurrent immunosuppressive medications

Where it is running

• University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States
• Arizona Cancer Center at University of Arizona Health Sciences Center — Tucson, Arizona, United States
• Hembree Mercy Cancer Center at St. Edward Mercy Medical Center — Fort Smith, Arkansas, United States
• Arkansas Cancer Research Center at University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Kaiser Permanente - Deer Valley — Antioch, California, United States
• Alta Bates Summit Comprehensive Cancer Center — Berkeley, California, United States
• Peninsula Medical Center — Burlingame, California, United States
• Southern California Permanente Medical Group — Downey, California, United States
• Kaiser Permanente - Fremont — Fremont, California, United States
• Marin Cancer Institute at Marin General Hospital — Greenbrae, California, United States
• Kaiser Permanente Medical Center - Hayward — Hayward, California, United States
• Loma Linda University Cancer Institute at Loma Linda University Medical Center — Loma Linda, California, United States
• Kaiser Permanente Medical Center - Oakland — Oakland, California, United States
• Veterans Affairs Medical Center - Palo Alto — Palo Alto, California, United States
• Kaiser Permanente Medical Center - Redwood City — Redwood City, California, United States
• Kaiser Permanente Medical Center - Richmond — Richmond, California, United States
• Kaiser Permanente Medical Center - Roseville — Roseville, California, United States
• Sutter Cancer Center at Roseville Medical Center — Roseville, California, United States
• Sutter Cancer Center — Sacramento, California, United States
• South Sacramento Kaiser-Permanente Medical Center — Sacramento, California, United States
• Kaiser Permanente Medical Center - Sacramento — Sacramento, California, United States
• Kaiser Permanente Medical Office -Vandever Medical Office — San Diego, California, United States
• Naval Medical Center - San Diego — San Diego, California, United States
• Kaiser Permanente Medical Center - San Francisco Geary Campus — San Francisco, California, United States
• UAB Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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