AzTrials
AzTrials

Melanoma (Skin)Phase 3NCT00006237

S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma

A Phase 3 study testing interleukin-2, filgrastim and interferon alfa in people with Melanoma (Skin), run by SWOG Cancer Research Network at 297 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin)
What is being tested?
interleukin-2, filgrastim and interferon alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
432 participants
Where
297 sitesin 2 countries
Study dates
Aug 2000to Jul 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

297 sites in 2 countries.

297 sites in 2 countries

United States296 sites

  • Lovelace Medical Center - Gibson

    Albuquerque, New Mexico, 87108

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-5636

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Winship Cancer Institute of Emory University

    Altanta, Georgia, 30322

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Fox Valley Hematology and Oncology - East Grant Street

    Appleton, Wisconsin, 54911-3496

  • Auburn Regional Center for Cancer Care

    Auburn, Washington, 98002

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • MeritCare Bemidji

    Bemidji, Minnesota, 56601

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic Cancer Center

    Billings, Montana, 59107-5100

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

    Birmingham, Alabama, 35294

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • Tufts-NEMC Cancer Center

    Boston, Massachusetts, 02111

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Graham Hospital

    Canton, Illinois, 61520

  • Mercy Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Eden Medical Center

    Castro Valley, California, 94546

  • Providence Centralia Hospital

    Centralia, Washington, 98531-9027

  • Roper St. Francis Cancer Center at Roper Hospital

    Charleston, South Carolina, 29401

  • West Virginia University Health Sciences Center - Charleston

    Charleston, West Virginia, 25304

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Martha Jefferson Hospital Cancer Care Center

    Charlottesville, Virginia, 22901

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • Veterans Affairs Medical Center - Chicago Westside Hospital

    Chicago, Illinois, 60612

  • Mercy Hospital and Medical Center

    Chicago, Illinois, 60616

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • MetroHealth Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Palmetto Health South Carolina Cancer Center

    Columbia, South Carolina, 29203

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210-1240

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Mercy Capitol Hospital

    Des Moines, Iowa, 50307

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Sherman Hospital

    Elgin, Illinois, 60120

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital Cancer Program at Union Hospital

    Elkton MD, Maryland, 21921

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Evanston Northwestern Healthcare - Evanston Hospital

    Evanston, Illinois, 60201-1781

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • MeritCare Broadway

    Fargo, North Dakota, 58122

  • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center

    Farmington, Connecticut, 06360-2875

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Great Lakes Cancer Institute at McLaren Regional Medical Center

    Flint, Michigan, 48532

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234-6200

  • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

    Fort Smith, Arkansas, 72903

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Banner Thunderbird Medical Center

    Glendale, Arizona, 85306

  • Adirondack Cancer Care - Glens Falls

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Metro Health Hospital

    Grand Rapids, Michigan, 49506

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301-3526

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Mason District Hospital

    Havana, Illinois, 62644

  • Saint Rose Hospital

    Hayward, California, 94545

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Community Oncology Group at Cleveland Clinic Cancer Center

    Independence, Ohio, 44131

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • Dickinson County Healthcare System

    Iron Mountain, Michigan, 49801

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Midwest Center for Hematology/Oncology

    Joliet, Illinois, 60432

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Kansas, 64128

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Central Pennsylvania Hematology and Medical Oncology Associates, PC

    Lemoyne, Pennsylvania, 17043

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • Meeker County Memorial Hospital

    Lichfield, Minnesota, 55355

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • Upper Michigan Cancer Center at Marquette General Hospital

    Marquette, Michigan, 49855

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Tennessee Cancer Institute - Memphis

    Memphis, Tennessee, 38104

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36652-2144

  • Louisiana State University Health Sciences Center - Monroe

    Monroe, Louisiana, 71210

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Hackley Hospital

    Muskegon, Michigan, 49442

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

    New Britain, Connecticut, 06050

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Cancer Care and Hematology Specialists of Chicagoland - Niles

    Niles, Illinois, 60714

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Green Bay Oncology, Limited - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • Providence St. Peter Hospital Regional Cancer Center

    Olympia, Washington, 98506-5166

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois, 61350

  • Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26102

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Saint Jude Midwest Affiliate

    Peoria, Illinois, 61637

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134-1095

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016-7710

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

  • Valley Care Medical Center

    Pleasanton, California, 94588

  • Legacy Good Samaritan Hospital & Comprehensive Cancer Center

    Portland, Oregon, 97210

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • Adventist Medical Center

    Portland, Oregon, 97216

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Legacy Emanuel Hospital and Health Center and Children's Hospital

    Portland, Oregon, 97227

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Good Samaritan Cancer Center

    Puyallup, Washington, 98372

  • Booker Cancer Center at Riverview Medical Center

    Red Bank, New Jersey, 07701

  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Swedish-American Regional Cancer Center

    Rockford, Illinois, 61104-2315

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Kaiser Permanente Medical Center - Oakland

    Sacramento, California, 95825

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • HealthEast Cancer Care at St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Salem Hospital Regional Cancer Care Services

    Salem, Oregon, 97309-5014

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • Primary Children's Medical Center

    Salt Lake City, Utah, 84113-1100

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78207

  • Scripps Cancer Center - San Diego

    San Diego, California, 92121

  • Veterans Affairs Medical Center - San Diego

    San Diego, California, 92161

  • Doctors Medical Center - San Pablo Campus

    San Pablo, California, 94806

  • CCOP - Santa Rosa Memorial Hospital

    Sana Rosa, California, 95405

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Polyclinic First Hill

    Seattle, Washington, 98122

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • St. Francis Cancer Center at St. Francis Medical Center

    Shakopee, Minnesota, 55379

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences

    Shreveport, Louisiana, 71130-3932

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center, PC

    Sioux Falls, South Dakota, 57105

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Hematology Oncology Associates - Skokie

    Skokie, Illinois, 60076

  • Hematology/Oncology of the North Shore at Gross Point Medical Center

    Skokie, Illinois, 60076

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • St. Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Mercy Medical Center

    Springfield, Ohio, 45504

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • Geisinger Medical Group - Scenery Park

    State College, Pennsylvania, 16801

  • Mount Nittany Medical Center

    State College, Pennsylvania, 16803

  • Green Bay Oncology, Limited - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Franciscan Cancer Center at St. Joseph Medical Center

    Tacoma, Washington, 98405-3004

  • Allenmore Hospital

    Tacoma, Washington, 98405

  • CCOP - Northwest

    Tacoma, Washington, 98405

  • MultiCare Regional Cancer Center at Tacoma General Hospital

    Tacoma, Washington, 98405

  • St. Clare Hospital

    Tacoma, Washington, 98499

  • St. Joseph's Cancer Institute at St. Joseph's Hospital

    Tampa, Florida, 33607

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Cotton-O'Neil Cancer Center

    Topeka, Kansas, 66606

  • St. Francis Comprehensive Cancer Center

    Topeka, Kansas, 66606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724-5024

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Pearlman Comprehensive Cancer Center at South Georgia Medical Center

    Valdosta, Georgia, 31603

  • Southwest Washington Medical Center Cancer Center

    Vancouver, Washington, 98668

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Fox Chase Virtua Health Cancer Program at Virtua West Jersey

    Voorhees Township, New Jersey, 08043

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010-2970

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

  • Kaplan Cancer Center at St. Mary's Medical Center

    West Palm Beach, Florida, 33407

  • Mount Carmel St. Ann's Cancer Center

    Westerville, Ohio, 43081

  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

  • HealthEast Cancer Care at Woodwinds Health Campus

    Woodbury, Minnesota, 55125

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota, 55125

  • Cleveland Clinic - Wooster

    Wooster, Ohio, 44691

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

Australia1 site

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6001

Other trials in Australia

About this study

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

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.

Read the 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.

Conditions
Melanoma (Skin)
Being tested
interleukin-2, filgrastim, interferon alfa, cisplatin, dacarbazine
Keywords
stage III melanoma, recurrent melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • interleukin-2Biological

    Also called aldesleukin

    Given IV

  • filgrastimBiological

    Given subcutaneously

  • interferon alfaBiological

    Given IV and subcutaneously

  • cisplatinDrug

    Given IV

  • dacarbazineDrug

    Given IV

  • vinblastineDrug

    Given IV

Study groups in NCT00006237
Study groupRoleWhat they receive
Arm IActive comparatorPatients 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.
Receives: Biological: interferon alfa
Arm IIExperimentalPatients 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.
Receives: Biological: interleukin-2; Biological: filgrastim; Biological: interferon alfa; Drug: cisplatin; Drug: dacarbazine; Drug: vinblastine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 5-year Overall Survival

    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.

    Measured: Every three months for a year, every six months for years 2-5, annual for years 5-10

  2. 5-year Relapse-Free Survival

    Measured from date of registration to date of first observation of progressive disease or death due to any cause.

    Measured: Every three months for the first year, every 6 months for years 2-5, annually for years 6-10

Secondary outcomes (1)

  1. Toxicity

    Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 2000
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
432 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006237
Sponsor's protocol ID
S0008
Other IDs
U10CA032102, S0008, CALGB-500002, ECOG-S0008, COG-S0008
Status last verified
Mar 2015
First submitted
11 Sep 2000
Last updated
25 Mar 2015
Data monitoring committee
Yes

Publications

  • Flaherty LE, Othus M, Atkins MB, Tuthill RJ, Thompson JA, Vetto JT, Haluska FG, Pappo AS, Sosman JA, Redman BG, Moon J, Ribas A, Kirkwood JM, Sondak VK. Southwest Oncology Group S0008: a phase III trial of high-dose interferon Alfa-2b versus cisplatin, vinblastine, and dacarbazine, plus interleukin-2 and interferon in patients with high-risk melanoma--an intergroup study of cancer and leukemia Group B, Children's Oncology Group, Eastern Cooperative Oncology Group, and Southwest Oncology Group. J Clin Oncol. 2014 Nov 20;32(33):3771-8. doi: 10.1200/JCO.2013.53.1590. Epub 2014 Oct 20.

    PubMed 25332243

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing interleukin-2, filgrastim and interferon alfa in people with Melanoma (Skin), run by SWOG Cancer Research Network at 297 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 297 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5-year Overall Survival (time frame: Every three months for a year, every six months for years 2-5, annual for years 5-10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006237, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.

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