A Phase I Study of High Dose Topotecan With Filgrastim and Peripheral Blood Stem Cell Support for Patients With Refractory Malignancies
- Determine the maximum tolerated dose, toxicities, and preliminary antitumor activity of
escalating doses of topotecan, with filgrastim (G-CSF) and peripheral blood stem cell
support, when administered to patients with refractory malignancies for which no
effective therapy exists.
OUTLINE: This is a dose-escalation study.
Prior to stem cell harvesting, patients receive 1-2 courses of mobilizing salvage
After stem cell harvest, high-dose topotecan is administered according to an escalating
dosage scale. Topotecan is given over 30 minutes daily for three days. A minimum of 3
patients are entered at each dose level. The MTD is defined as the dose immediately below
that at which 2 patients experience dose limiting toxicity.
Peripheral blood stem cells (PBSC) are infused at least 24 hours after treatment with
topotecan is complete. Filgrastim (G-CSF) is administered subcutaneously beginning on the
day PBSC are infused and continuing until blood counts recover.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: Not specified
Primary Purpose: Treatment
Mario Sznol, MD
United States: Federal Government
|Yale Comprehensive Cancer Center
|New Haven, Connecticut 06520-8028