DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas

Phase 1

Completed

• Conditions: Brain and Central Nervous System Tumors; Lymphoma; Unspecified Childhood Solid Tumor, Protocol Specific

• Registration Number: NCT00004212
• Lead Sponsor: Daiichi Sankyo

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1999-09
• Study First Submitted: 2000-01-28
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-15
• Last Update Posted: 2012-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

Children's Medical Center of Dallas; 🇺🇸 Dallas, Texas, United States

Institute for Drug Development; 🇺🇸 San Antonio, Texas, United States

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States