A Phase II Evaluation of DMAP Plus GM-CSF in the Treatment of Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
OBJECTIVES:
- Determine the antitumor activity of dacarbazine, mitomycin, doxorubicin, and cisplatin
plus sargramostim (GM-CSF) in patients with advanced, persistent, or recurrent
leiomyosarcoma of the uterus.
- Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: Patients receive dacarbazine IV over 2 hours, followed by mitomycin IV over 2-5
minutes, doxorubicin IV over 2-5 minutes, and cisplatin IV over 2 hours on day 1. Patients
also receive sargramostim (GM-CSF) subcutaneously (SC) once every 12 hours on days -6 to -3
before the first chemotherapy course and then on days 2-15 and 23-26 of all chemotherapy
courses. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity. Patients achieving stable disease receive a maximum of 4 courses. Patients
achieving complete or partial response receive a maximum of 6 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 12-28
months.
Interventional
Primary Purpose: Treatment
Harry J. Long, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000069308
NCT00033644
March 2002
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
State University of New York Health Sciences Center - Stony Brook | Stony Brook, New York 11790-7775 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
University of Oklahoma College of Medicine | Oklahoma City, Oklahoma 73190 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Tacoma General Hospital | Tacoma, Washington 98405 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
Tuft-New England Medical Center | Boston, Massachusetts 02111 |
Cooper University Hospital | Camden, New Jersey 08103 |
Barrett Cancer Center | Cincinnati, Ohio 45267-0502 |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |