Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer
Recruitment status was: Active, not recruiting
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 I/II trial to study the effectiveness of topotecan plus sargramostim in treating patients who have advanced cancer.
|Unspecified Adult Solid Tumor, Protocol Specific||Biological: sargramostim Drug: topotecan hydrochloride||Phase 1 Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I/II Study of Topotecan (SKF 104864) With Recombinant GM-CSF (Sargramostim) Used as a Priming Agent in Advanced Malignancies|
|Study Start Date:||September 1996|
OBJECTIVES: I. Identify a priming schedule of sargramostim (GM-CSF) that reduces the percentage of progenitor cells in cycle at the time of chemotherapy administration in patients with advanced malignancies. II. Determine the maximum tolerated dose and toxic effects of topotecan when administered with sargramostim in these patients. III. Conduct a preliminary assessment of the activity of this topotecan regimen in these patients.
OUTLINE: This is a dose escalation study of topotecan. Patients receive priming with sargramostim (GM-CSF) on days -4 through -2. On day 0, topotecan IV is administered over 30 minutes. Cohorts of 6 patients receive escalating doses of topotecan. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity (DLT). Sargramostim resumes on day 1 following topotecan, and continues for 5 days or until sufficient hematologic recovery. The next course of topotecan is given 48 hours later. Treatment repeats every 6 weeks for 4 courses. Patients are followed every 3 months for the first year, then every 6 months thereafter.
PROJECTED ACCRUAL: 15-25 patients will be accrued for the duration of 18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002950
|United States, Connecticut|
|Yale Comprehensive Cancer Center|
|New Haven, Connecticut, United States, 06520-8028|
|Study Chair:||Thomas J. Rutherford, MD, PhD||Yale University|