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
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
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.
OBJECTIVES:
Primary Objective:
Secondary Objectives:
OUTLINE: This is a randomized study. Patients are stratified by pathologic lymph node status (known vs unknown),lymph node staging procedures(sentinel lymph node procedure vs. elective lymph node dissection vs. no lymphadenectomy), Breslow depth (<= 1.0 mm vs. 1.01-2.0 mm vs. 2.01-4.0 mm vs > 4.0 mm), ulceration of the primary lesion (yes vs. no vs. unknown), and disease stage (lymph node positive [N1, N2a] vs. lymph node negative [N0]). Patients are randomized into one of two treatment arms in a 1:1 ratio.
Quality of life is assessed before treatment, at day 22, every 3 months for 2 years, and then every 6 months for 3 years.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter until 15 years after randomization.
PROJECTED ACCRUAL: A total of 1,420 patients will be accrued for this study over 5 years.
Inclusion Criteria:
Histologically confirmed primary melanoma of cutaneous origin
Stage II (T3 N0 M0 1.5-4.0 mm Breslow depth)
Stage III (T4 N0 M0)
Stage III (T1-4 N1)
Patients must meet at least 1 of the following criteria:
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:
No other concurrent or prior malignancies within the past 5 years except:
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after study
Exclusion Criteria:
Tucson, Arizona 85724-5024, United States
Fort Smith, Arkansas 72903, United States
Little Rock, Arkansas 72205, United States
Loma Linda, California 92354, United States
San Francisco, California 94115, United States
Santa Clara, California 95051, United States
South San Francisco, California 94080, United States
Grand Junction, Colorado 81502, United States
Hartford, Connecticut 06105, United States
Stamford, Connecticut 06904, United States
Daytona Beach, Florida 32114, United States
Fort Lauderdale, Florida 33308, United States
Lakeland, Florida 33805, United States
Miami, Florida 33136, United States
Pensacola, Florida 32514, United States
Atlanta, Georgia 30322, United States
Savannah, Georgia 31405, United States
Chicago, Illinois 60611-3013, United States
Libertyville, Illinois 60048, United States
Beech Grove, Indiana 46107, United States
Indianapolis, Indiana 46202-5289, United States
La Porte, Indiana 46350, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Wichita, Kansas 67214, United States
Shreveport, Louisiana 71130-3932, United States
Scarborough, Maine 04074, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Columbia, Missouri 65203, United States
St Louis, Missouri 63141, United States
Billings, Montana 59101, United States
Missoula, Montana 59807, United States
Grand Island, Nebraska 68803, United States
Omaha, Nebraska 68198-6805, United States
Lebanon, New Hampshire 03756-0002, United States
Manchester, New Hampshire 03102, United States
Flemington, New Jersey 08822, United States
New Brunswick, New Jersey 08903, United States
Voorhees Township, New Jersey 08043, United States
East Syracuse, New York 13057, United States
Lake Success, New York 11042, United States
Manhasset, New York 11030, United States
Charlotte, North Carolina 28232-2861, United States
Charlotte, North Carolina 28233-3549, United States
Greensboro, North Carolina 27403-1198, United States
Columbus, Ohio 43210-1240, United States
Portland, Oregon 97213-2967, United States
Portland, Oregon 97227, United States
Allentown, Pennsylvania 18105, United States
Hershey, Pennsylvania 17033-0850, United States
Philadelphia, Pennsylvania 19104-4283, United States
Philadelphia, Pennsylvania 19107-5541, United States
Reading, Pennsylvania 19612-6052, United States
Scranton, Pennsylvania 18510, United States
Wilkes-Barre, Pennsylvania 18711, United States
Williamsport, Pennsylvania 17701, United States
Sioux Falls, South Dakota 57117-5039, United States
Kingsport, Tennessee 37662, United States
Murray, Utah 84157, United States
Seattle, Washington 98122-4307, United States
Seattle, Washington 98195, United States
Yakima, Washington 98902, United States
Charleston, West Virginia 25302, United States
Huntington, West Virginia 25701, United States
Morgantown, West Virginia 26506, United States
Parkersburg, West Virginia 26102, United States
Eau Claire, Wisconsin 54701, United States
Elkhorn, Wisconsin 53121, United States
Green Bay, Wisconsin 54301-3526, United States
Green Bay, Wisconsin 54311, United States
Madison, Wisconsin 53792-6164, United States
Manitowoc, Wisconsin 54221-1450, United States
Summit, Wisconsin 53066, United States
Westmead, New South Wales 2145, Australia
Kelowna, British Columbia V1Y 5L3, Canada
Oshawa, Ontario L1G 2B9, Canada