S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Children's Oncology Group
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00006237
First received: September 11, 2000
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether interferon alfa is more effective with or without combination chemotherapy and interleukin-2 for melanoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy consisting of cisplatin, vinblastine, and dacarbazine, plus interleukin-2, in treating patients who have melanoma.


Condition Intervention Phase
Melanoma (Skin)
Biological: interleukin-2
Biological: filgrastim
Biological: interferon alfa
Drug: cisplatin
Drug: dacarbazine
Drug: vinblastine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Trial of High Dose Interferon Alfa 2-b Versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients With High Risk Melanoma

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • 5-year Overall Survival [ Time Frame: Every three months for a year, every six months for years 2-5, annual for years 5-10 ] [ Designated as safety issue: No ]
    Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.

  • 5-year Relapse-Free Survival [ Time Frame: Every three months for the first year, every 6 months for years 2-5, annually for years 6-10 ] [ Designated as safety issue: No ]
    Measured from date of registration to date of first observation of progressive disease or death due to any cause.


Secondary Outcome Measures:
  • Toxicity [ Time Frame: While on treatment, patients on the HDIFN arm were assessed weekly for the 1st month, then every 2 weeks for the 2nd month, then every 3 months therafter; patients on the biochemo arm were assessed daily for the 1st 5 days, then weekly thereafter. ] [ Designated as safety issue: Yes ]
    Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event


Enrollment: 432
Study Start Date: August 2000
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients receive interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity.
Biological: interferon alfa
Given IV and subcutaneously
Experimental: Arm II
Patients receive cisplatin IV over 30 minutes followed by vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 1 hour on day 1, interleukin-2 IV over 96 hours on days 1-4, and interferon alfa SC on days 1-5, 8, 10, and 12. In addition, patients receive filgrastim (G-CSF) SC on days 6-15. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Biological: interleukin-2
Given IV
Other Name: aldesleukin
Biological: filgrastim
Given subcutaneously
Biological: interferon alfa
Given IV and subcutaneously
Drug: cisplatin
Given IV
Drug: dacarbazine
Given IV
Drug: vinblastine
Given IV

Detailed Description:

OBJECTIVES:

  • Compare the overall survival and disease-free survival of patients with high-risk melanoma treated with interferon alfa vs cisplatin, vinblastine, and dacarbazine plus interferon alfa and interleukin-2.
  • Compare the toxic effects of these treatment regimens in these patients.
  • Determine the relationship between minimal residual disease (MRD) status at 12 weeks and 52 weeks and overall survival of patients treated with these regimens.
  • Compare the effects of these treatment regimens on the MRD status of these patients.
  • Determine the relationship between clinical characteristics (number of involved lymph nodes, ulcerated primary, and extracapsular extension) and MRD in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal status (N1 or N2 vs N3), degree of lymph node involvement (micrometastases only vs any macrometastases, including satellite/in-transit metastases), and ulceration of the primary tumor (yes vs no vs unknown primary). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive cisplatin IV over 30 minutes followed by vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 1 hour on day 1, interleukin-2 IV over 96 hours on days 1-4, and interferon alfa SC on days 1-5, 8, 10, and 12. In addition, patients receive filgrastim (G-CSF) SC on days 6-15. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 410 patients (205 per treatment arm) will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven melanoma of cutaneous origin or from unknown primary at initial presentation of primary or first clinically detected nodal or satellite/in-transit recurrence

    • No distant metastases
    • No melanoma of ocular, mucosal, or other non-cutaneous origin
  • One of the following criteria must apply for patients with newly diagnosed melanoma OR a previously diagnosed primary with current subsequent, clinical, regional nodal disease and/or satellite/in-transit disease:

    • Ulcerated primary melanoma with 1 or more involved lymph nodes (micro/occult or macro/clinically overt)
    • Non-ulcerated or unknown primary melanoma with one macro/clinically overt lymph node metastasis, including a single matted nodal mass

      • No non-ulcerated or unknown primary tumor and a single micrometastatic lymph node
    • Non-ulcerated melanoma with two or more lymph node metastases (micro/occult or macro/clinically overt) and/or matted nodes
    • Any satellite/in transit metastasis with or without lymph node involvement
  • Patients with recurrent disease must have recurrent disease in the regional nodal basin of a prior complete lymphadenectomy
  • Multiple regional nodal basin involvement allowed if they are appropriate anatomic drainage basins for primary site
  • Patients must be disease free at time of enrollment based on the following surgical criteria:

    • Patients at initial presentation of melanoma must undergo adequate wide excision of primary lesion
    • Patients with previously diagnosed melanoma must have all disease resected with pathologically negative margins and no disease at primary site or second resection of primary
    • Full lymphadenectomy required of all patients including those with positive sentinel nodes or positive satellite/in-transit metastasis
  • No more than 56 days since prior lymphadenectomy OR surgery to remove recurrent disease after prior complete lymphadenectomy
  • Must be willing to participate in minimal residual disease studies if registered on the study on 3/1/2003 or later

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2 times ULN
  • LDH and alkaline phosphatase no greater than 2 times ULN (above normal value requires a contrast-enhanced CT scan or MRI of liver)
  • No known recent hepatitis positivity by PCR

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 75 mL/min

Cardiovascular:

  • No congestive heart failure
  • No coronary artery disease
  • No serious cardiac arrhythmia
  • No prior myocardial infarction
  • Normal cardiac stress test required if any of the following are present:

    • Over age 50
    • Abnormal EKG
    • History of cardiac disease

Pulmonary:

  • No symptomatic pulmonary disease

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No autoimmune disorders or conditions of immunosuppression
  • No other prior malignancy within the past 5 years except the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • Carcinoma in situ of the cervix
    • Adequately treated stage I or II cancer in remission
  • HIV negative
  • No known AIDS or HIV-1 associated complex

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy, including interferon, interleukin, levamisole, or other biologic response modifiers
  • No other concurrent biologic therapy

Chemotherapy:

  • No prior chemotherapy (including infusion or perfusion therapy)
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent systemic corticosteroids or topical steroid creams
  • Concurrent steroid antihistamines allowed if no alternative
  • No concurrent hormonal therapy

Radiotherapy:

  • No prior radiotherapy

    • Prior postlumpectomy radiotherapy for breast cancer allowed
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • No concurrent surgery

Other:

  • No concurrent anti-hypertensive medications (arm II only)
  • No concurrent immunosuppressive agents
  • No other concurrent anticancer therapy
  • Antihistamines allowed if no alternative medication suitable
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006237

  Hide Study Locations
Locations
United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Arizona
Banner Thunderbird Medical Center
Glendale, Arizona, United States, 85306
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016-7710
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
United States, Arkansas
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Ft. Smith, Arkansas, United States, 72903
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Eden Medical Center
Castro Valley, California, United States, 94546
Saint Rose Hospital
Hayward, California, United States, 94545
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
Highland General Hospital
Oakland, California, United States, 94602
Valley Care Medical Center
Pleasanton, California, United States, 94588
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States, 95825
Scripps Cancer Center - San Diego
San Diego, California, United States, 92121
Veterans Affairs Medical Center - San Diego
San Diego, California, United States, 92161
Doctors Medical Center - San Pablo Campus
San Pablo, California, United States, 94806
CCOP - Santa Rosa Memorial Hospital
Sana Rosa, California, United States, 95405
United States, Colorado
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States, 06360-2875
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States, 06050
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Florida
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
All Children's Hospital
St. Petersburg, Florida, United States, 33701
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States, 33607
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
United States, Georgia
Winship Cancer Institute of Emory University
Altanta, Georgia, United States, 30322
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Valdosta, Georgia, United States, 31603
United States, Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States, 83712
United States, Illinois
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
Graham Hospital
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Veterans Affairs Medical Center - Chicago Westside Hospital
Chicago, Illinois, United States, 60612
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Mercy Hospital and Medical Center
Chicago, Illinois, United States, 60616
Swedish Covenant Hospital
Chicago, Illinois, United States, 60625
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
Sherman Hospital
Elgin, Illinois, United States, 60120
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Mason District Hospital
Havana, Illinois, United States, 62644
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Midwest Center for Hematology/Oncology
Joliet, Illinois, United States, 60432
Kewanee Hospital
Kewanee, Illinois, United States, 61443
McDonough District Hospital
Macomb, Illinois, United States, 61455
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles, Illinois, United States, 60714
Community Cancer Center
Normal, Illinois, United States, 61761
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
Proctor Hospital
Peoria, Illinois, United States, 61614
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Swedish-American Regional Cancer Center
Rockford, Illinois, United States, 61104-2315
Hematology/Oncology of the North Shore at Gross Point Medical Center
Skokie, Illinois, United States, 60076
Hematology Oncology Associates - Skokie
Skokie, Illinois, United States, 60076
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, United States, 52803
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Kansas
Veterans Affairs Medical Center - Kansas City
Kansas City, Kansas, United States, 64128
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, United States, 67401
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States, 66606
Cotton-O'Neil Cancer Center
Topeka, Kansas, United States, 66606
United States, Louisiana
Louisiana State University Health Sciences Center - Monroe
Monroe, Louisiana, United States, 71210
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States, 71130-3932
United States, Maryland
Union Hospital Cancer Program at Union Hospital
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Tufts-NEMC Cancer Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Hurley Medical Center
Flint, Michigan, United States, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Great Lakes Cancer Institute at McLaren Regional Medical Center
Flint, Michigan, United States, 48532
Metro Health Hospital
Grand Rapids, Michigan, United States, 49506
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Holland Community Hospital
Holland, Michigan, United States, 49423
Dickinson County Healthcare System
Iron Mountain, Michigan, United States, 49801
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
Upper Michigan Cancer Center at Marquette General Hospital
Marquette, Michigan, United States, 49855
Hackley Hospital
Muskegon, Michigan, United States, 49442
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
MeritCare Bemidji
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Miller - Dwan Medical Center
Duluth, Minnesota, United States, 55805
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States, 55805-1983
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Lichfield, Minnesota, United States, 55355
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
HealthEast Cancer Care at St. Joseph's Hospital
St Paul, Minnesota, United States, 55102
Park Nicollet Cancer Center
St. Louis Park, Minnesota, United States, 55416
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
United Hospital
St. Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, Montana
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
Billings Clinic Cancer Center
Billings, Montana, United States, 59107-5100
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Big Sky Oncology
Great Falls, Montana, United States, 59405-5309
Great Falls, Montana, United States, 59405
St. Peter's Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Community Medical Center
Missoula, Montana, United States, 59801
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States, 68848-1990
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
Booker Cancer Center at Riverview Medical Center
Red Bank, New Jersey, United States, 07701
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Lovelace Medical Center - Gibson
Albuquerque, New Mexico, United States, 87108
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
Adirondack Cancer Care - Glens Falls
Glens Falls, New York, United States, 12801
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
MeritCare Broadway
Fargo, North Dakota, United States, 58122
United States, Ohio
Mercy Cancer Center at Mercy Medical Center
Canton, Ohio, United States, 44708
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
CCOP - Columbus
Columbus, Ohio, United States, 43215
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Community Oncology Group at Cleveland Clinic Cancer Center
Independence, Ohio, United States, 44131
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
St. Rita's Medical Center
Lima, Ohio, United States, 45801
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Mercy Medical Center
Springfield, Ohio, United States, 45504
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Cleveland Clinic - Wooster
Wooster, Ohio, United States, 44691
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
United States, Oregon
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States, 97227
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland, Oregon, United States, 97210
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Adventist Medical Center
Portland, Oregon, United States, 97216
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Salem Hospital Regional Cancer Care Services
Salem, Oregon, United States, 97309-5014
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Central Pennsylvania Hematology and Medical Oncology Associates, PC
Lemoyne, Pennsylvania, United States, 17043
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134-1095
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Carolina
Roper St. Francis Cancer Center at Roper Hospital
Charleston, South Carolina, United States, 29401
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States, 29203
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
University of Tennessee Cancer Institute - Memphis
Memphis, Tennessee, United States, 38104
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Harrington Cancer Center
Amarillo, Texas, United States, 79106
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234-6200
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104
Wilford Hall Medical Center
Lackland AFB, Texas, United States, 78236
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113-1100
United States, Virginia
Martha Jefferson Hospital Cancer Care Center
Charlottesville, Virginia, United States, 22901
United States, Washington
Auburn Regional Center for Cancer Care
Auburn, Washington, United States, 98002
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Providence Centralia Hospital
Centralia, Washington, United States, 98531-9027
St. Francis Hospital
Federal Way, Washington, United States, 98003
Skagit Valley Hospital Cancer Care Center
Mt. Vernon, Washington, United States, 98273
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States, 98506-5166
Good Samaritan Cancer Center
Puyallup, Washington, United States, 98372
Harborview Medical Center
Seattle, Washington, United States, 98104
Polyclinic First Hill
Seattle, Washington, United States, 98122
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Group Health Central Hospital
Seattle, Washington, United States, 98112
Minor and James Medical, PLLC
Seattle, Washington, United States, 98104
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Franciscan Cancer Center at St. Joseph Medical Center
Tacoma, Washington, United States, 98405-3004
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States, 98405
St. Clare Hospital
Tacoma, Washington, United States, 98499
Allenmore Hospital
Tacoma, Washington, United States, 98405
CCOP - Northwest
Tacoma, Washington, United States, 98405
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98668
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801-2028
United States, West Virginia
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, United States, 25304
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States, 26102
United States, Wisconsin
Fox Valley Hematology and Oncology - East Grant Street
Appleton, Wisconsin, United States, 54911-3496
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Sponsors and Collaborators
Southwest Oncology Group
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Children's Oncology Group
Investigators
Study Chair: Lawrence E. Flaherty, MD Barbara Ann Karmanos Cancer Institute
Principal Investigator: John A. Thompson, MD Seattle Cancer Care Alliance
Principal Investigator: John T. Vetto, MD, FACS OHSU Knight Cancer Institute
Study Chair: Michael B. Atkins, MD Beth Israel Deaconess Medical Center
Principal Investigator: John M. Kirkwood, MD University of Pittsburgh
Study Chair: Frank Haluska, MD, PhD Massachusetts General Hospital
Principal Investigator: Alberto S. Pappo, MD Texas Children's Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00006237     History of Changes
Obsolete Identifiers: NCT00546416
Other Study ID Numbers: CDR0000068162, U10CA032102, S0008, CALGB-500002, ECOG-S0008, COG-S0008
Study First Received: September 11, 2000
Results First Received: August 20, 2012
Last Updated: November 15, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
stage III melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Cisplatin
Interferons
Vinblastine
Interleukin-2
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014