Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma
OBJECTIVES: I. Demonstrate either an improvement in the median time to disease progression
by at least 2 months with no decrease in the rate of objective clinical response OR an
improvement by at least 15% in the rate of objective clinical response with no decrease in
the median time to disease progression in patients with stage III or IV melanoma receiving
dacarbazine with Allovectin-7 when compared with patients receiving dacarbazine alone.
II. Determine the benefits, risks, and side effects of these regimens in this patient
population.
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified
according to sex, age, and spread of disease (cutaneous or nodal vs visceral disease).
Patients are randomized to one of two treatment arms.
Arm I: Patients receive dacarbazine IV over 1 hour on day 0. Arm II: Patients receive
treatment as in arm I. Patients also receive Allovectin-7 intratumorally on days 3 and 10.
Patients with stable or responding disease may receive additional courses every 28 days.
Patients are followed every 4 months.
PROJECTED ACCRUAL:
A total of 280 patients (140 in each arm) will be accrued for this study.
Interventional
Primary Purpose: Treatment
Cherie Smith
Study Chair
Vical
United States: Food and Drug Administration
CDR0000066736
NCT00003647
July 1998
September 2002
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
Mount Sinai School of Medicine | New York, New York 10029 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
Beth Israel Medical Center | New York, New York 10003 |
Virginia Piper Cancer Institute | Minneapolis, Minnesota 55407 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Lucille Parker Markey Cancer Center, University of Kentucky | Lexington, Kentucky 40536-0093 |
Franklin Square Hospital Center | Baltimore, Maryland 21237 |
Lutheran General Hospital | Park Ridge, Illinois 60068 |
Kaiser Permanente-Southern California Permanente Medical Group | San Diego, California 92120 |
Louisiana State University School of Medicine | New Orleans, Louisiana 70112-2822 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Mount Sinai Comprehensive Cancer Center | Miami Beach, Florida 33140 |
Providence Hospital Cancer Center | Southfield, Michigan 48075 |
Georgia Cancer Specialists | Decatur, Georgia 30033 |
Danville Hematology and Oncology, Inc. | Danville, Virginia 24541 |
Park Nicollet Clinic | St. Louis Park, Minnesota 55416 |
Mid Dakota Clinic, P.C. | Bismarck, North Dakota 58501 |
Toledo Clinic, Inc. | Toledo, Ohio 43623 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Cancer Care Center for Southern Indiana | Bloomington, Indiana 47403 |
Comprehensive Blood and Cancer Center | Bakersfield, California 93309 |
Scripps Memorial Hospitals-Stevens Cancer Center - Encinitas | Encinitas, California 92023 |
Washington Cancer Institute | Washington, District of Columbia 20010 |
Georgia Cancer Specialists, P.C. | East Point, Georgia 30344 |
St. Francis Medical Center | Honolulu, Hawaii 96817 |
Cancer Care Center | New Albany, Indiana 47150 |
Oncology and Hematology Associates | Westwood, Kansas 66205 |
North Memorial Health Care | Robbinsdale, Minnesota 55422 |
Billings Interhospital Oncology Project | Billings, Montana 59101 |
HemOnCare, P.C. | Brooklyn, New York 11235 |
Arena Oncology Associates | Great Neck, New York 11021 |
Mid-Ohio Oncology/Hematology, Inc. | Columbus, Ohio 43222 |
Cancer Treatment Centers of America in Hampton Roads | Portsmouth, Virginia 23704 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |