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NCT00003641

PHASE3

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

Sponsor: ECOG-ACRIN Cancer Research Group

View on ClinicalTrials.gov

Summary

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.

Official title: Phase III Randomized Study of Four Weeks of High Dose Interferon Alfa-2b in Stage T2bN0, T3a-bN0, T4a-bN0, and T1-4, N1a,2a (Microscopic) Melanoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1150

Start Date

1999-03-25

Completion Date

2026-05-26

Last Updated

2026-09-29

Healthy Volunteers

Conditions

Melanoma (Skin)

Interventions

BIOLOGICAL

interferon alfa-2b

Given IV

OTHER

observation

Patients undergo observation for 4 weeks.

Inclusion Criteria: * 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 * Blood urea nitrogen (BUN) no greater than 33 mg/dL OR Creatinine no greater than 1.8 mg/dL * No other concurrent or prior malignancies within the past 5 years except: * Cancer in situ * Lobular carcinoma in situ of the breast * Carcinoma in situ of the cervix * Atypical melanocytic hyperplasia or Clark 1 melanoma in situ * Basal or squamous cell skin cancer * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study Exclusion Criteria: * 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

Locations (533)

UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

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

California Pacific Medical Center - California Campus

San Francisco, California, United States

Kaiser Permanente Medical Center - Santa Teresa

San Jose, California, United States

Kaiser Foundation Hospital - San Rafael

San Rafael, California, United States

Sutter Health - Western Division Cancer Research Group

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara Kiely Campus

Santa Clara, California, United States

Kaiser Permanente Medical Center - Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente Medical Center - South San Francisco

South San Francisco, California, United States

Stanford Cancer Center

Stanford, California, United States

Kaiser Permanente Medical Facility - Stockton

Stockton, California, United States

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, United States

Sutter Solano Medical Center

Vallejo, California, United States

Kaiser Permanente Medical Center - Walnut Creek

Walnut Creek, California, United States

Aurora Presbyterian Hospital

Aurora, Colorado, United States

Boulder Community Hospital

Boulder, Colorado, United States

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

St. Anthony Central Hospital