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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Interleukin-2 and Interferon alfa in Treating Patients With Metastatic Melanoma  Combination Chemotherapy With or Without Interleukin-2 and Interferon alfa in Treating Patients With Metastatic Melanoma
Combination Chemotherapy With or Without Interleukin-2 and Interferon alfa in Treating Patients With Metastatic Melanoma
For Condition: Stage 4 Melanoma
Status: No longer recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI),Southwest Oncology Group,Cancer and Leukemia Group B
Synopsis: RATIONALE: 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. Interferon alfa may interfere with the growth of tumor cells. It is not yet known whether combination chemotherapy plus interleukin-2 and interferon alfa is more effective than combination chemotherapy alone for metastatic melanoma. PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without interleukin-2 and interferon alfa in treating patients who have metastatic melanoma that cannot be treated by surgery.
Details: OBJECTIVES: - Compare response rate, duration of response, and survival rate in patients with metastatic malignant melanoma treated with cisplatin, vinblastine, and dacarbazine with or without interleukin-2 and interferon alfa-2b. - Determine the toxic effects of these regimens in this patient population. OUTLINE: This is a randomized study. Patients are stratified according to performance status (0 vs 1), prior interferon (yes vs no), and number of involved sites. Patients are randomized to one of two treatment arms. - Arm I: Patients receive cisplatin IV over 30 minutes daily immediately followed by vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 60 minutes on day 1 following vinblastine. - Arm II: Patients receive treatment as in arm I. Patients also receive interleukin 2 (IL-2) IV continuously on days 1-4 and interferon alfa-2b subcutaneously (SC) daily before IL-2 on days 1-4 and after IL-2 on day 5, followed by filgrastim (G-CSF) (SC) daily on days 7-16. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 6 weeks, every 3 months for 18 months, every 6 months for 18 months, and then annually for 2 years. PROJECTED ACCRUAL: A total of 482 patients will be accrued for this study within 3.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed surgically incurable metastatic malignant melanoma - Measurable disease - No active brain metastases or edema - No leptomeningeal disease - No ocular melanoma PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT less than 3 times the upper limit of normal unless due to liver metastases Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance at least 75 mL/min Cardiovascular: - No congestive heart failure - No symptoms of coronary artery disease - No serious cardiac arrhythmias - No prior myocardial infarction on EKG - Normal cardiac stress test required for the following: - Over 50 years of age - Abnormal EKG - Prior history of cardiac disease Pulmonary: - No symptomatic pulmonary disease - FEV1 greater than 2.0 L OR at least 75% predicted if over 50 years of age or with history of pulmonary symptoms Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No significant infection - HIV negative - No other prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No organ allografts - No significant disease other than malignancy - No seizure disorder PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior interleukin-2 therapy for metastatic disease - At least 4 weeks since prior vaccine therapy - At least 4 weeks since prior adjuvant immunotherapy Chemotherapy: - No prior chemotherapy for disease Endocrine therapy: - No concurrent corticosteroids Radiotherapy: - No prior radiation therapy to measurable disease site unless disease is clearly progressive - At least 4 weeks since prior radiation therapy for local control or palliation and recovered Surgery: - Recovered from prior surgery Other: - No prior systemic therapy for metastatic disease - At least 3 months since definitive therapy for brain metastases
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelAtkins, Study Chair, New England Medical Center
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5048
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
United States
CCOP - Dayton
Kettering, Ohio, 45429
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
OHSU Cancer Institute
Portland, Oregon, 97239
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
CCOP - Columbia River Program
Portland, Oregon, 97225
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799
United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-8852
United States
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45267-0501
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813-2424
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7845
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Additional Information:
Study ID Numbers: CDR0000065617; E-E3695,CLB-509802,SWOG-E3695
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003027
Other Stage 4 Melanoma Studies:
1. Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
2. Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma
3. Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma
4. Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma
5. Vaccine Therapy in Treating Patients With Metastatic Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Illinois Clinical Trials
Other Maywood Clinical Trials
Combination Chemotherapy With or Without Interleukin-2 and Interferon alfa in Treating Patients With Metastatic Melanoma
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