Sarcoma Clinical Trial
Official title:
A Phase II Evaluation of DMAP Plus GM-CSF in the Treatment of Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
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.
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.
;
Primary Purpose: Treatment
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