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

Primary Purpose

Melanoma (Skin)

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

interferon alfa-2b

observation

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage II melanoma, stage III melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UAB Comprehensive Cancer Center
University of South Alabama Mitchell Cancer Institute
Arizona Cancer Center at University of Arizona Health Sciences Center
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Kaiser Permanente - Deer Valley
Alta Bates Summit Comprehensive Cancer Center
Peninsula Medical Center
Southern California Permanente Medical Group
Kaiser Permanente - Fremont
Marin Cancer Institute at Marin General Hospital
Kaiser Permanente Medical Center - Hayward
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Kaiser Permanente Medical Center - Oakland
Veterans Affairs Medical Center - Palo Alto
Kaiser Permanente Medical Center - Redwood City
Kaiser Permanente Medical Center - Richmond
Kaiser Permanente Medical Center - Roseville
Sutter Cancer Center at Roseville Medical Center
Sutter Cancer Center
South Sacramento Kaiser-Permanente Medical Center
Kaiser Permanente Medical Center - Sacramento
Kaiser Permanente Medical Office -Vandever Medical Office
Naval Medical Center - San Diego
Kaiser Permanente Medical Center - San Francisco Geary Campus
California Pacific Medical Center - California Campus
Kaiser Permanente Medical Center - Santa Teresa
Kaiser Foundation Hospital - San Rafael
Sutter Health - Western Division Cancer Research Group
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Kaiser Permanente Medical Center - Santa Rosa
Kaiser Permanente Medical Center - South San Francisco
Stanford Cancer Center
Kaiser Permanente Medical Facility - Stockton
Kaiser Permanente Medical Center - Vallejo
Sutter Solano Medical Center
Kaiser Permanente Medical Center - Walnut Creek
Aurora Presbyterian Hospital
Boulder Community Hospital
Penrose Cancer Center at Penrose Hospital
St. Anthony Central Hospital
Kaiser Permanente - Denver
Porter Adventist Hospital
Presbyterian - St. Luke's Medical Center
St. Joseph Hospital
Rose Medical Center
CCOP - Colorado Cancer Research Program
Swedish Medical Center
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
North Colorado Medical Center
Kaiser Permanente - Lafayette
Sky Ridge Medical Center
Hope Cancer Care Center at Longmont United Hospital
McKee Medical Center
St. Mary - Corwin Regional Medical Center
North Suburban Medical Center
Exempla Lutheran Medical Center
Praxair Cancer Center at Danbury Hospital
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Eastern Connecticut Hematology and Oncology Associates
Carl and Dorothy Bennett Cancer Center at Stamford Hospital
Tunnell Cancer Center at Beebe Medical Center
CCOP - Christiana Care Health Services
Herbert D. Kerman Regional Oncology Center - Daytona Beach
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Baptist Cancer Institute - Jacksonville
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
CCOP - Mount Sinai Medical Center
University of Miami Sylvester Comprehensive Cancer Center - Miami
Sacred Heart Cancer Center at Sacred Heart Hospital
West Florida Cancer Institute at West Florida Hospital - Pensacola
All Children's Hospital
Florida Cancer Specialists - Sarasota Downtown
Kaplan Cancer Center at St. Mary's Medical Center
Piedmont Hospital
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Winship Cancer Institute of Emory University
Northside Hospital Cancer Center
Saint Joseph's Hospital of Atlanta
CCOP - Atlanta Regional
MBCCOP - Medical College of Georgia Cancer Center
WellStar Cobb Hospital
John B. Amos Cancer Center
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Veterans Affairs Medical Center - Atlanta (Decatur)
Northeast Georgia Medical Center
Gwinnett Medical Center
Kennestone Cancer Center at Wellstar Kennestone Hospital
Southern Regional Medical Center
Harbin Clinic Cancer Center - Medical Oncology
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Kaiser Permanente - Moanalua Medical Center and Clinic
Rush-Copley Cancer Care Center
Hematology Oncology Associates of Illinois - Berwyn
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Hematology and Oncology Associates
Saint Joseph Hospital
Decatur Memorial Hospital Cancer Care Institute
Crossroads Cancer Center
Evanston Hospital
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Kellogg Cancer Care Center
Hinsdale Hematology Oncology Associates
Midwest Center for Hematology/Oncology
North Shore Oncology and Hematology Associates, Limited - Libertyville
La Grange Oncology Associates - Geneva
Cancer Care and Hematology Specialists of Chicagoland - Niles
Swedish-American Regional Cancer Center
Hematology Oncology Associates - Skokie
Carle Cancer Center at Carle Foundation Hospital
CCOP - Carle Cancer Center
St. Francis Hospital and Health Centers - Beech Grove Campus
Elkhart Clinic, LLC
Michiana Hematology-Oncology, PC - Elkhart
Elkhart General Hospital
Indiana University Melvin and Bren Simon Cancer Center
William N. Wishard Memorial Hospital
Howard Community Hospital
Center for Cancer Therapy at LaPorte Hospital and Health Services
Michiana Hematology Oncology PC - La Porte
Saint Anthony Memorial Health Centers
Michiana Hematology-Oncology, PC - South Bend
Saint Joseph Regional Medical Center
Cancer Center at Ball Memorial Hospital
Medical Consultants, PC at Ball Memorial Cancer Center
Michiana Hematology Oncology PC - Plymouth
Reid Hospital & Health Care Services
CCOP - Northern Indiana CR Consortium
Memorial Hospital of South Bend
South Bend Clinic
McFarland Clinic, PC
Cedar Rapids Oncology Associates
Mercy Regional Cancer Center at Mercy Medical Center
Medical Oncology and Hematology Associates - West Des Moines
Genesis Regional Cancer Center at Genesis Medical Center
Genesis Medical Center - West Campus
Mercy Capitol Hospital
CCOP - Iowa Oncology Research Association
John Stoddard Cancer Center at Iowa Methodist Medical Center
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Medical Oncology and Hematology Associates at Mercy Cancer Center
Mercy Cancer Center at Mercy Medical Center - Des Moines
John Stoddard Cancer Center at Iowa Lutheran Hospital
McCreery Cancer Center at Ottumwa Regional
Siouxland Hematology-Oncology Associates, LLP
Mercy Medical Center - Sioux City
St. Luke's Regional Medical Center
Covenant Cancer Treatment Center
Hospital District Sixth of Harper County
Cancer Center of Kansas, PA - Chanute
Cancer Center of Kansas, PA - Dodge City
Cancer Center of Kansas, PA - El Dorado
Cancer Center of Kansas - Fort Scott
Cancer Center of Kansas-Independence
Cancer Center of Kansas, PA - Kingman
Lawrence Memorial Hospital
Cancer Center of Kansas, PA - Liberal
Cancer Center of Kansas, PA - Newton
Menorah Medical Center
Saint Luke's Hospital - South
Cancer Center of Kansas, PA - Parsons
Cancer Center of Kansas, PA - Pratt
Cancer Center of Kansas, PA - Salina
Tammy Walker Cancer Center at Salina Regional Health Center
Shawnee Mission Medical Center
Cotton-O'Neil Cancer Center
Cancer Center of Kansas, PA - Wellington
Associates in Womens Health, PA - North Review
Cancer Center of Kansas, PA - Medical Arts Tower
Cancer Center of Kansas, PA - Wichita
CCOP - Wichita
Via Christi Cancer Center at Via Christi Regional Medical Center
Cancer Center of Kansas, PA - Winfield
Cancer Care at Our Lady of Bellefonte Hospital
Drs. Carrol, Sheth, Raghavan
Tulane Cancer Center Office of Clinical Research
Ochsner Health Center - Bluebonnet
Louisiana State University Health Sciences Center - Monroe
CCOP - Ochsner
Ochsner Cancer Institute at Ochsner Clinic Foundation
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
DeCesaris Cancer Institute at Anne Arundel Medical Center
Greater Baltimore Medical Center Cancer Center
Union Hospital Cancer Program at Union Hospital
Tufts-NEMC Cancer Center
Beth Israel Deaconess Medical Center
Hickman Cancer Center at Bixby Medical Center
Saint Joseph Mercy Cancer Center
CCOP - Michigan Cancer Research Consortium
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Barbara Ann Karmanos Cancer Institute
Green Bay Oncology, Limited - Escanaba
Genesys Hurley Cancer Institute
Hurley Medical Center
Van Elslander Cancer Center at St. John Hospital and Medical Center
Dickinson County Healthcare System
Foote Memorial Hospital
Borgess Medical Center
West Michigan Cancer Center
Bronson Methodist Hospital
Haematology-Oncology Associates of Ohio and Michigan, PC
Sparrow Regional Cancer Center
St. Mary Mercy Hospital
Community Cancer Center of Monroe
Mercy Memorial Hospital - Monroe
Michiana Hematology Oncology PC - Niles
St. Joseph Mercy Oakland
Mercy Regional Cancer Center at Mercy Hospital
William Beaumont Hospital - Royal Oak Campus
Seton Cancer Institute at Saint Mary's - Saginaw
Lakeland Regional Cancer Care Center - St. Joseph
Lakeside Cancer Specialists, PLLC
St. John Macomb Hospital
MeritCare Bemidji
Fairview Ridges Hospital
Mercy and Unity Cancer Center at Mercy Hospital
Duluth Clinic Cancer Center - Duluth
CCOP - Duluth
Miller - Dwan Medical Center
St. Luke's Hospital Cancer Care Center
Fairview Southdale Hospital
Fergus Falls Medical Group, PA
Mercy and Unity Cancer Center at Unity Hospital
Hutchinson Area Health Care
HealthEast Cancer Care at St. John's Hospital
Minnesota Oncology Hematology, PA - Maplewood
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Hennepin County Medical Center - Minneapolis
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
CentraCare Clinic - River Campus
Coborn Cancer Center
CCOP - Metro-Minnesota
Park Nicollet Cancer Center
Regions Hospital Cancer Care Center
United Hospital
St. Francis Cancer Center at St. Francis Medical Center
Ridgeview Medical Center
Willmar Cancer Center at Rice Memorial Hospital
Minnesota Oncology Hematology, PA - Woodbury
University of Mississippi Cancer Clinic
Saint Luke's Hospital
Ellis Fischel Cancer Center at University of Missouri - Columbia
Children's Mercy Hospital
Truman Medical Center - Hospital Hill
Saint Luke's Cancer Institute at Saint Luke's Hospital
St. Joseph Medical Center
North Kansas City Hospital
Heartland Hematology Oncology Associates, Incorporated
CCOP - Kansas City
Research Medical Center
Saint Luke's East - Lee's Summit
Liberty Hospital
Heartland Regional Medical Center
Saint Joseph Oncology, Incorporated
Missouri Baptist Cancer Center
Arch Medical Services, Incorporated at Center for Cancer Care and Research
CCOP - Cancer Research for the Ozarks
St. John's Regional Health Center
Hulston Cancer Center at Cox Medical Center South
CCOP - Montana Cancer Consortium
Hematology-Oncology Centers of the Northern Rockies - Billings
Northern Rockies Radiation Oncology Center
Billings Clinic - Downtown
Bozeman Deaconess Cancer Center
St. James Healthcare Cancer Care
Big Sky Oncology
Great Falls Clinic - Main Facility
Sletten Cancer Institute at Benefis Healthcare
Northern Montana Hospital
St. Peter's Hospital
Glacier Oncology, PLLC
Kalispell Medical Oncology at KRMC
Montana Cancer Specialists at Montana Cancer Center
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
Cancer Resource Center - Lincoln
CCOP - Missouri Valley Cancer Consortium
Immanuel Medical Center
Alegant Health Cancer Center at Bergan Mercy Medical Center
Creighton University Medical Center
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Norris Cotton Cancer Center at Catholic Medical Center
Hunterdon Regional Cancer Center at Hunterdon Medical Center
CCOP - Northern New Jersey
Hackensack University Medical Center Cancer Center
Cancer Institute of New Jersey at Hamilton
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
Frederick R. and Betty M. Smith Cancer Treatment Center
Cancer Institute of New Jersey at Cooper - Voorhees
University of New Mexico Cancer Center
CCOP - Hematology-Oncology Associates of Central New York
Charles R. Wood Cancer Center at Glens Falls Hospital
Monter Cancer Center of the North Shore-LIJ Health System
CCOP - North Shore University Hospital
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Long Island Jewish Medical Center
Stony Brook University Cancer Center
SUNY Upstate Medical University Hospital
Randolph Hospital
Blumenthal Cancer Center at Carolinas Medical Center
Presbyterian Cancer Center at Presbyterian Hospital
Duke Comprehensive Cancer Center
Wayne Memorial Hospital, Incorporated
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Leo W. Jenkins Cancer Center at ECU Medical School
Annie Penn Cancer Center
CCOP - MeritCare Hospital
MeritCare Broadway
Akron Children's Hospital
Summa Center for Cancer Care at Akron City Hospital
Barberton Citizens Hospital
Mary Rutan Hospital
Wood County Oncology Center
Mercy Cancer Center at Mercy Medical Center
Aultman Cancer Center at Aultman Hospital
Adena Regional Medical Center
Christ Hospital Cancer Center
Charles M. Barrett Cancer Center at University Hospital
Case Comprehensive Cancer Center
MetroHealth Cancer Care Center at MetroHealth Medical Center
North Coast Cancer Care - Clyde
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Riverside Methodist Hospital Cancer Care
CCOP - Columbus
Grant Medical Center Cancer Care
Mount Carmel Health - West Hospital
Doctors Hospital at Ohio Health
Dayton Children's - Dayton
Grandview Hospital
Good Samaritan Hospital
David L. Rike Cancer Center at Miami Valley Hospital
Samaritan North Cancer Care Center
CCOP - Dayton
Grady Memorial Hospital
Community Cancer Center
Hematology Oncology Center
Blanchard Valley Medical Associates
Middletown Regional Hospital
Wayne Hospital
Charles F. Kettering Memorial Hospital
Fairfield Medical Center
St. Rita's Medical Center
Lima Memorial Hospital
Strecker Cancer Center at Marietta Memorial Hospital
Northwest Ohio Oncology Center
St. Luke's Hospital
Knox Community Hospital
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Fisher-Titus Medical Center
St. Charles Mercy Hospital
Toledo Clinic - Oregon
North Coast Cancer Care, Incorporated
Community Hospital of Springfield and Clark County
Flower Hospital Cancer Center
Mercy Hospital of Tiffin
Toledo Hospital
St. Vincent Mercy Medical Center
Medical University of Ohio Cancer Center
CCOP - Toledo Community Hospital
St. Anne Mercy Hospital
Toledo Clinic, Incorporated - Main Clinic
UVMC Cancer Care Center at Upper Valley Medical Center
Fulton County Health Center
Mount Carmel St. Ann's Cancer Center
Clinton Memorial Hospital
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Genesis - Good Samaritan Hospital
Cleo Craig Cancer Research Clinic
Oklahoma University Cancer Institute
Cancer Care Associates - Mercy Campus
Legacy Mount Hood Medical Center
Providence Milwaukie Hospital
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Providence Cancer Center at Providence Portland Medical Center
Adventist Medical Center
CCOP - Columbia River Oncology Program
Providence St. Vincent Medical Center
Legacy Emanuel Hospital and Health Center and Children's Hospital
Northwest Cancer Specialists at Rose Quarter Cancer Center
Salem Hospital Regional Cancer Care Services
Legacy Meridian Park Hospital
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
St. Luke's Cancer Network at St. Luke's Hospital
Lehigh Valley Hospital - Muhlenberg
Geisinger Cancer Institute at Geisinger Health
Geisinger Hazleton Cancer Center
Penn State Children's Hospital
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Lancaster General Hospital
Lewistown Hospital
Abramson Cancer Center of the University of Pennsylvania
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
St. Christopher's Hospital for Children
Allegheny Cancer Center at Allegheny General Hospital
UPMC Cancer Centers
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Guthrie Cancer Center at Guthrie Clinic Sayre
Mercy Hospital Cancer Center - Scranton
Hematology and Oncology Associates of Northeastern Pennsylvania
Geisinger Medical Group - Scenery Park
Mount Nittany Medical Center
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Susquehanna Cancer Center at Divine Providence Hospital
York Cancer Center at Apple Hill Medical Center
Rapid City Regional Hospital
Avera Cancer Institute
Medical X-Ray Center, PC
Sanford Cancer Center at Sanford USD Medical Center
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
East Tennessee Children's Hospital
Center for Biomedical Research
Vanderbilt-Ingram Cancer Center
Harrington Cancer Center
Medical City Dallas Hospital
University of Texas Health Science Center at San Antonio
Methodist Children's Hospital of South Texas
CCOP - Scott and White Hospital
American Fork Hospital
Sandra L. Maxwell Cancer Center
Logan Regional Hospital
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Utah Valley Regional Medical Center - Provo
Dixie Regional Medical Center - East Campus
LDS Hospital
Utah Cancer Specialists at UCS Cancer Center
Huntsman Cancer Institute at University of Utah
University of Virginia Cancer Center
Danville Regional Medical Center
Fredericksburg Oncology, Incorporated
Southwest Virginia Regional Cancer Center at Wellmonth Health
St. Joseph Cancer Center
Olympic Hematology and Oncology
Providence Centralia Hospital
St. Francis Hospital
Columbia Basin Hematology
Skagit Valley Hospital Cancer Care Center
Providence St. Peter Hospital Regional Cancer Center
Harrison Poulsbo Hematology and Onocology
Good Samaritan Cancer Center
Minor and James Medical, PLLC
Group Health Central Hospital
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Polyclinic First Hill
University Cancer Center at University of Washington Medical Center
Cancer Care Northwest - Spokane South
Evergreen Hematology and Oncology, PS
Franciscan Cancer Center at St. Joseph Medical Center
Allenmore Hospital
CCOP - Northwest
MultiCare Regional Cancer Center at Tacoma General Hospital
St. Clare Hospital
Southwest Washington Medical Center Cancer Center
Legacy Salmon Creek Medical Center
Wenatchee Valley Medical Center
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
West Virginia University Health Sciences Center - Charleston
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Schiffler Cancer Center at Wheeling Hospital
Fox Valley Hematology and Oncology - East Grant Street
Aurora Memorial Hospital of Burlington
Marshfield Clinic - Chippewa Center
Center for Cancer Treatment & Prevention at Sacred Heart Hospital
Marshfield Clinic Cancer Care at Regional Cancer Center
Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
Oncology Alliance - Franklin
Oncology Alliance, SC - Milwaukee - East
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay Oncology, Limited at St. Mary's Hospital
St. Mary's Hospital Medical Center - Green Bay
St. Vincent Hospital Regional Cancer Center
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
UW Cancer Center Johnson Creek
Oncology Alliance - Kenosha South
Gundersen Lutheran Center for Cancer and Blood
Dean Medical Center - Madison
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Holy Family Memorial Medical Center Cancer Care Center
Bay Area Cancer Care Center at Bay Area Medical Center
Vince Lombardi Cancer Clinic - Marinette
Marshfield Clinic - Marshfield Center
Saint Joseph's Hospital
Aurora Advanced Healthcare East Mequon Clinic
Medical Consultants, Limited
Oncology Alliance, SC - Milwaukee - South
Medical College of Wisconsin Cancer Center
Marshfield Clinic - Lakeland Center
Green Bay Oncology, Limited - Oconto Falls
Aurora Health Center - Racine
Ministry Medical Group at Saint Mary's Hospital
Marshfield Clinic - Indianhead Center
Vince Lombardi Cancer Clinic - Sheboygan
Marshfield Clinic at Saint Michael's Hospital
Saint Michael's Hospital Cancer Center
Green Bay Oncology, Limited - Sturgeon Bay
Aurora Medical Center
Vince Lombardi Cancer Clinic - Two Rivers
Aurora Health Center - Waukesha
Marshfield Clinic - Wausau Center
Oncology Alliance, SC - Milwaukee - West
Diagnostic and Treatment Center
Marshfield Clinic - Weston Center
Marshfield Clinic - Wisconsin Rapids Center
Rocky Mountain Oncology
Welch Cancer Center at Sheridan Memorial Hospital
Westmead Institute for Cancer Research at Westmead Hospital
Cross Cancer Institute at University of Alberta
British Columbia Cancer Agency - Centre for the Southern Interior
BCCA - Fraser Valley Cancer Centre
British Columbia Cancer Agency - Vancouver Cancer Centre
British Columbia Cancer Agency - Vancouver Island Centre
CancerCare Manitoba
Nova Scotia Cancer Centre
Royal Victoria Hospital of Barrie
Margaret and Charles Juravinski Cancer Centre
London Regional Cancer Program at London Health Sciences Centre
R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa
St. Catharines General Hospital at Niagara Health System
Edmond Odette Cancer Centre at Sunnybrook
Princess Margaret Hospital
Trillium Health Centre - Mississauga Site
Windsor Regional Cancer Centre at Windsor Regional Hospital
Hopital Notre-Dame du CHUM
McGill Cancer Centre at McGill University
CHUM - Hotel Dieu Hospital
Allan Blair Cancer Centre at Pasqua Hospital
Pretoria Academic Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Observation

Interferon Alfa-2b

Arm Description

Patients undergo observation for 4 weeks.

Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.

Outcomes

Primary Outcome Measures

5-year Relapse-free Survival Rate

Relapse-free survival (RFS) was defined as time from randomization to disease relapse or death from any cause, whichever occurred first. Patients without disease relapse were censored at last disease assessment date known of free of relapse. Kaplan-Meier method was used to estimate 5-year RFS rate in the intent-to-treat (ITT) patients.

Secondary Outcome Measures

5-year Overall Survival Rate

Overall survival (OS) was defined as time from randomization to death from any cause. Patients still alive were censored at last known alive date. Kaplan-Meier method was used to estimate 5-year OS rate in the ITT patients.

Full Information

NCT ID

NCT00003641

First Posted

November 1, 1999

Last Updated

June 13, 2023

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI), SWOG Cancer Research Network, Cancer and Leukemia Group B, NCIC Clinical Trials Group, Children's Oncology Group

1. Study Identification

Unique Protocol Identification Number

NCT00003641

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 25, 1999 (Actual)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI), SWOG Cancer Research Network, Cancer and Leukemia Group B, NCIC Clinical Trials Group, Children's Oncology Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

OBJECTIVES: Primary Objective: Compare the effect of high-dose interferon alfa-2b treatment on the relapse-free survival of patients with stage II or III resected malignant melanoma. Secondary Objectives: Compare the effect of this treatment regimen on overall survival of these patients. Assess the toxicity of this treatment in these patients. Compare the effect of treatment on quality of life. 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. Arm I (observation): Patients undergo observation for 4 weeks. Arm II (Interferon Alfa-2b): Patients receive high-dose interferon alfa-2b intravenously (IV) over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma (Skin)

Keywords

stage II melanoma, stage III melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Observation

Arm Type

Other

Arm Description

Patients undergo observation for 4 weeks.

Arm Title

Interferon Alfa-2b

Arm Type

Experimental

Arm Description

Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.

Intervention Type

Biological

Intervention Name(s)

interferon alfa-2b

Other Intervention Name(s)

recombinant interferon alfa, Intron-A, IFN-α 2b, NSC # 377523

Intervention Description

Given IV

Intervention Type

Other

Intervention Name(s)

observation

Other Intervention Name(s)

clinical observation

Intervention Description

Patients undergo observation for 4 weeks.

Primary Outcome Measure Information:

Title

5-year Relapse-free Survival Rate

Description

Time Frame

assessed every 3 months for 2 years, every 6 months for 3 years

Secondary Outcome Measure Information:

Title

5-year Overall Survival Rate

Description

Time Frame

assessed every 3 months for 2 years, every 6 months for 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: