High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of drugs and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of high-dose topotecan and peripheral stem cell transplantation in treating patients with refractory cancer.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: topotecan hydrochloride
Procedure: bone marrow ablation with stem cell support
Procedure: peripheral blood stem cell transplantation
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of High Dose Topotecan With Filgrastim and Peripheral Blood Stem Cell Support for Patients With Refractory Malignancies|
|Study Start Date:||October 1996|
|Study Completion Date:||January 2004|
|Primary Completion Date:||January 2004 (Final data collection date for primary outcome measure)|
- 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 chemotherapy.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002948
|United States, Connecticut|
|Yale Comprehensive Cancer Center|
|New Haven, Connecticut, United States, 06520-8032|
|Study Chair:||Mario Sznol, MD||Yale University|