A Randomized Phase III Trial of Concurrent Biochemotherapy With Cisplatin, Vinblastine, Dacarbazine, IL-2 and Interferon A-2B Versus Cisplatin, Vinblastine, Dacarbazine Alone in Patients With Metastatic Malignant Melanoma
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Overall survival
No
Michael B. Atkins, MD
Study Chair
Tufts Medical Center
United States: Food and Drug Administration
CDR0000065617
NCT00003027
October 1997
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
Chao Family Comprehensive Cancer Center | Orange, California 92868 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
University of California Davis Medical Center | Sacramento, California 95817 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Loyola University Medical Center | Maywood, Illinois 60153 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
David Grant Medical Center | Travis Air Force Base, California 94535 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
Tulane University School of Medicine | New Orleans, Louisiana 70112 |
Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Veterans Affairs Medical Center - Albany | Albany, New York 12208 |
CCOP - Columbus | Columbus, Ohio 43206 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Columbia River Program | Portland, Oregon 97213 |
CCOP - Greenville | Greenville, South Carolina 29615 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Swedish Cancer Institute | Seattle, Washington 98104 |
MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix, Arizona 85012 |
Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock, Arkansas 72205 |
Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
Veterans Affairs Medical Center - West Los Angeles | Los Angeles, California 90073 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
Dwight David Eisenhower Army Medical Center | Fort Gordon, Georgia 30905-5650 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines, Illinois 60141 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
Boston Medical Center | Boston, Massachusetts 02118 |
Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
Providence Hospital - Southfield | Southfield, Michigan 48075-9975 |
Veterans Affairs Medical Center - Biloxi | Biloxi, Mississippi 39531-2410 |
Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
University of Rochester Medical Center | Rochester, New York 14642 |
Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
Oklahoma Medical Research Foundation | Oklahoma City, Oklahoma 73104 |
Veterans Affairs Medical Center - Oklahoma City | Oklahoma City, Oklahoma 73104 |
OHSU Cancer Institute | Portland, Oregon 97239 |
Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
Veterans Affairs Medical Center - Charleston | Charleston, South Carolina 29401-5799 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Veterans Affairs Medical Center - Houston | Houston, Texas 77030 |
Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
Madigan Army Medical Center | Tacoma, Washington 98431-5048 |