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S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma

Primary Purpose

Melanoma (Skin)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

interleukin-2

filgrastim

interferon alfa

cisplatin

dacarbazine

vinblastine

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Mobile Infirmary Medical Center
Banner Thunderbird Medical Center
Banner Good Samaritan Medical Center
CCOP - Western Regional, Arizona
Phoenix Children's Hospital
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
Eden Medical Center
Saint Rose Hospital
Rebecca and John Moores UCSD Cancer Center
Highland General Hospital
Alta Bates Summit Medical Center - Summit Campus
CCOP - Bay Area Tumor Institute
Valley Care Medical Center
Kaiser Permanente Medical Center - Oakland
Scripps Cancer Center - San Diego
Veterans Affairs Medical Center - San Diego
Doctors Medical Center - San Pablo Campus
CCOP - Santa Rosa Memorial Hospital
Poudre Valley Hospital
Front Range Cancer Specialists
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
Eastern Connecticut Hematology and Oncology Associates
Tunnell Cancer Center at Beebe Medical Center
CCOP - Christiana Care Health Services
Children's National Medical Center
Baptist Cancer Institute - Jacksonville
All Children's Hospital
St. Joseph's Cancer Institute at St. Joseph's Hospital
Kaplan Cancer Center at St. Mary's Medical Center
Winship Cancer Institute of Emory University
Veterans Affairs Medical Center - Atlanta (Decatur)
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Rush-Copley Cancer Care Center
St. Joseph Medical Center
Graham Hospital
Memorial Hospital
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Hematology and Oncology Associates
University of Illinois Cancer Center
Veterans Affairs Medical Center - Chicago Westside Hospital
Mercy Hospital and Medical Center
Swedish Covenant Hospital
Sherman Hospital
Eureka Community Hospital
Evanston Northwestern Healthcare - Evanston Hospital
Galesburg Clinic, PC
Galesburg Cottage Hospital
Mason District Hospital
Hopedale Medical Complex
Midwest Center for Hematology/Oncology
Joliet Oncology-Hematology Associates, Limited - West
Kewanee Hospital
McDonough District Hospital
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Cancer Care and Hematology Specialists of Chicagoland - Niles
BroMenn Regional Medical Center
Community Cancer Center
Community Hospital of Ottawa
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Cancer Treatment Center at Pekin Hospital
Proctor Hospital
CCOP - Illinois Oncology Research Association
Oncology Hematology Associates of Central Illinois, PC - Peoria
Methodist Medical Center of Illinois
OSF St. Francis Medical Center
Saint Jude Midwest Affiliate
Illinois Valley Community Hospital
Perry Memorial Hospital
Swedish-American Regional Cancer Center
Hematology Oncology Associates - Skokie
Hematology/Oncology of the North Shore at Gross Point Medical Center
St. Margaret's Hospital
Carle Cancer Center at Carle Foundation Hospital
CCOP - Carle Cancer Center
Elkhart General Hospital
Howard Community Hospital
Center for Cancer Therapy at LaPorte Hospital and Health Services
Saint Anthony Memorial Health Centers
CCOP - Northern Indiana CR Consortium
Memorial Hospital of South Bend
Saint Joseph Regional Medical Center
McFarland Clinic, PC
Genesis Regional Cancer Center at Genesis Medical Center
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
Holden Comprehensive Cancer Center at University of Iowa
Veterans Affairs Medical Center - Kansas City
Tammy Walker Cancer Center at Salina Regional Health Center
Cotton-O'Neil Cancer Center
St. Francis Comprehensive Cancer Center
Louisiana State University Health Sciences Center - Monroe
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Union Hospital Cancer Program at Union Hospital
Tufts-NEMC Cancer Center
Boston University Cancer Research Center
Beth Israel Deaconess Medical Center
Saint Joseph Mercy Cancer Center
CCOP - Michigan Cancer Research Consortium
University of Michigan Comprehensive Cancer Center
Battle Creek Health System Cancer Care Center
Mecosta County Medical Center
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
Great Lakes Cancer Institute at McLaren Regional Medical Center
Butterworth Hospital at Spectrum Health
CCOP - Grand Rapids
Lacks Cancer Center at Saint Mary's Health Care
Metro Health Hospital
Van Elslander Cancer Center at St. John Hospital and Medical Center
Holland Community Hospital
Dickinson County Healthcare System
Foote Memorial Hospital
Borgess Medical Center
West Michigan Cancer Center
Bronson Methodist Hospital
Sparrow Regional Cancer Center
Upper Michigan Cancer Center at Marquette General Hospital
Hackley Hospital
William Beaumont Hospital - Royal Oak Campus
Seton Cancer Institute at Saint Mary's - Saginaw
Lakeland Regional Cancer Care Center - St. Joseph
Munson Medical Center
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
Fairview Southdale Hospital
Mercy and Unity Cancer Center at Unity Hospital
Hutchinson Area Health Care
Meeker County Memorial Hospital
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
CCOP - Metro-Minnesota
St. Francis Cancer Center at St. Francis Medical Center
HealthEast Cancer Care at St. Joseph's Hospital
Park Nicollet Cancer Center
Regions Hospital Cancer Care Center
United Hospital
Ridgeview Medical Center
HealthEast Cancer Care at Woodwinds Health Campus
Minnesota Oncology Hematology, PA - Woodbury
Children's Mercy Hospital
CCOP - Kansas City
CCOP - Montana Cancer Consortium
Hematology-Oncology Centers of the Northern Rockies - Billings
Northern Rockies Radiation Oncology Center
St. Vincent Healthcare Cancer Care Services
Billings Clinic Cancer 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
St. Peter's Hospital
Glacier Oncology, PLLC
Kalispell Medical Oncology at KRMC
Kalispell Regional Medical Center
Community Medical Center
Guardian Oncology and Center for Wellness
Montana Cancer Specialists at Montana Cancer Center
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Good Samaritan Cancer Center at Good Samaritan Hospital
Cancer Resource Center - Lincoln
CCOP - Missouri Valley Cancer Consortium
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Booker Cancer Center at Riverview Medical Center
Cancer Institute of New Jersey at Cooper - Voorhees
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Lovelace Medical Center - Gibson
University of New Mexico Cancer Center
CCOP - Hematology-Oncology Associates of Central New York
Adirondack Cancer Care - Glens Falls
SUNY Upstate Medical University Hospital
Presbyterian Cancer Center at Presbyterian Hospital
Duke Comprehensive Cancer Center
Wayne Memorial Hospital, Incorporated
CCOP - MeritCare Hospital
MeritCare Broadway
Mercy Cancer Center at Mercy Medical Center
Adena Regional Medical Center
Charles M. Barrett Cancer Center at University Hospital
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland Clinic Taussig Cancer Center
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Riverside Methodist Hospital Cancer Care
CCOP - Columbus
Grant Medical Center Cancer Care
Mount Carmel Health - West Hospital
Doctors Hospital at Ohio Health
Grady Memorial Hospital
Community Oncology Group at Cleveland Clinic Cancer Center
Fairfield Medical Center
St. Rita's Medical Center
Strecker Cancer Center at Marietta Memorial Hospital
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Mercy Medical Center
Community Hospital of Springfield and Clark County
Mount Carmel St. Ann's Cancer Center
Cleveland Clinic - Wooster
Genesis - Good Samaritan Hospital
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
Salem Hospital Regional Cancer Care Services
Legacy Meridian Park Hospital
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Geisinger Cancer Institute at Geisinger Health
Penn State Cancer Institute at Milton S. Hershey Medical Center
Central Pennsylvania Hematology and Medical Oncology Associates, PC
Lewistown Hospital
St. Christopher's Hospital for Children
UPMC Cancer Centers
Geisinger Medical Group - Scenery Park
Mount Nittany Medical Center
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Roper St. Francis Cancer Center at Roper Hospital
Palmetto Health South Carolina Cancer Center
CCOP - Greenville
Avera Cancer Institute
Medical X-Ray Center, PC
Sanford Cancer Center at Sanford USD Medical Center
Thompson Cancer Survival Center
University of Tennessee Cancer Institute - Memphis
Vanderbilt-Ingram Cancer Center
Harrington Cancer Center
Brooke Army Medical Center
Cook Children's Medical Center - Fort Worth
Wilford Hall Medical Center
University of Texas Health Science Center at San Antonio
CCOP - Scott and White Hospital
Huntsman Cancer Institute at University of Utah
Primary Children's Medical Center
Martha Jefferson Hospital Cancer Care Center
Auburn Regional Center for Cancer Care
St. Joseph Cancer Center
Olympic Hematology and Oncology
Providence Centralia Hospital
St. Francis Hospital
Skagit Valley Hospital Cancer Care Center
Providence St. Peter Hospital Regional Cancer Center
Good Samaritan Cancer Center
Fred Hutchinson Cancer Research Center
Harborview Medical 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
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
Wenatchee Valley Medical Center
West Virginia University Health Sciences Center - Charleston
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Fox Valley Hematology and Oncology - East Grant Street
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
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Bay Area Cancer Care Center at Bay Area Medical Center
Green Bay Oncology, Limited - Oconto Falls
Green Bay Oncology, Limited - Sturgeon Bay
Welch Cancer Center at Sheridan Memorial Hospital
Princess Margaret Hospital for Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I

Arm II

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

5-year Relapse-Free Survival

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

Secondary Outcome Measures

Toxicity

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

Full Information

NCT ID

NCT00006237

First Posted

September 11, 2000

Last Updated

March 5, 2015

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI), Eastern Cooperative Oncology Group, Cancer and Leukemia Group B, Children's Oncology Group

1. Study Identification

Unique Protocol Identification Number

NCT00006237

Brief Title

S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

August 2000 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI), Eastern Cooperative Oncology Group, Cancer and Leukemia Group B, 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. 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.

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.

6. Conditions and Keywords

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

Melanoma (Skin)

Keywords

stage III melanoma, recurrent melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

432 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Active Comparator

Arm Description

Arm Title

Arm II

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

interleukin-2

Other Intervention Name(s)

aldesleukin

Intervention Description

Given IV

Intervention Type

Biological

Intervention Name(s)

filgrastim

Intervention Description

Given subcutaneously

Intervention Type

Biological

Intervention Name(s)

interferon alfa

Intervention Description

Given IV and subcutaneously

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

dacarbazine

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

vinblastine

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

5-year Overall Survival

Description

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.

Time Frame

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

Title

5-year Relapse-Free Survival

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Toxicity

Description

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

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: