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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
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.
OBJECTIVES: * 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.
Age
0 - 21 years
Sex
ALL
Healthy Volunteers
No
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Institute for Drug Development
San Antonio, Texas, United States
Start Date
September 1, 1999
Primary Completion Date
April 1, 2004
Completion Date
April 1, 2004
Last Updated
May 16, 2012
filgrastim
BIOLOGICAL
exatecan mesylate
DRUG
Lead Sponsor
Daiichi Sankyo
NCT05139017
NCT06337318
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