NCT00021216

Bortezomib in Treating Children With Advanced Solid Tumors

A Phase I Study Of PS-341 In Pediatric Patients With Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of bortezomib in treating children who have advanced solid tumors that have not responded to previous treatment.

Detailed description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of bortezomib in pediatric patients with refractory solid tumors. II. Determine the dose-limiting toxicity and other toxic effects of this regimen in these patients. III. Preliminarily determine the antitumor activity of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. If dose-limiting toxicity in the form of myelosuppression occurs in stratum I, dose escalation continues with patients meeting the qualifications for stratum II. PROJECTED ACCRUAL: Approximately 24-36 patients will be accrued for this study.

Conditions

• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	bortezomib	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2001-11-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2003-01-27
• Last updated: 2015-04-15

Locations

1 site across 1 country: United States