Spots Global Cancer Trial Database for Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus
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Trial Identification
Brief Title: Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus
Official Title: A Phase II Evaluation of DMAP Plus GM-CSF in the Treatment of Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
Study ID: NCT00033644
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus sargramostim in treating patients who have advanced, persistent, or recurrent cancer of the uterus.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
University of Colorado Cancer Center, Denver, Colorado, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States
Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States
Tuft-New England Medical Center, Boston, Massachusetts, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Cooper University Hospital, Camden, New Jersey, United States
State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Barrett Cancer Center, Cincinnati, Ohio, United States
University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
University of Texas Medical Branch, Galveston, Texas, United States
Tacoma General Hospital, Tacoma, Washington, United States
Norwegian Radium Hospital, Oslo, , Norway
Contact Details
Name: Harry J. Long, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
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