DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of DX-8951f in treating children who have advanced solid tumors or lymphomas that have not responded to previous therapy.
|Brain and Central Nervous System Tumors Lymphoma Unspecified Childhood Solid Tumor, Protocol Specific||Biological: filgrastim Drug: exatecan mesylate||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Dose Escalation Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Pediatric Patients With Advanced Solid Tumors and Lymphomas|
|Study Start Date:||September 1999|
|Study Completion Date:||April 2004|
|Primary Completion Date:||April 2004 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of exatecan mesylate (DX-8951f) with and without filgrastim (G-CSF) in pediatric patients with advanced solid tumors or lymphomas.
- Determine the toxic effects, including dose-limiting toxicity, of exatecan mesylate in these patients.
- Determine the pharmacokinetics of exatecan mesylate in these patients.
- Determine the recommended dose of exatecan mesylate for phase II study.
- Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of exatecan mesylate (DX-8951f). Patients are stratified according to prior treatment (minimally treated vs heavily treated).
Patients receive exatecan mesylate IV over 30 minutes daily for 5 days. Patients in dose levels 5 and above also receive filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing for at least 7 days or until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of exatecan mesylate with and without G-CSF until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 45 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004212
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105-2794|
|United States, Texas|
|Children's Medical Center of Dallas|
|Dallas, Texas, United States, 75235|
|Institute for Drug Development|
|San Antonio, Texas, United States, 78245-3217|
|Study Chair:||Robert L. DeJager, MD, FACP||Daiichi Sankyo Inc.|