NCT00077467

Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia

A Phase I Study of PS-341 (Velcade, Bortezomib) in Pediatric Patients With Refractory/Recurrent Leukemias

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

Summary

This phase I trial is studying the side effects and best dose of bortezomib in treating young patients with refractory or recurrent leukemia. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

Detailed description

OBJECTIVES: Primary I. Determine the maximum tolerated dose and recommended phase II dose of bortezomib in children with refractory or recurrent leukemia. II. Determine the toxic effects of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. Secondary I. Determine, preliminarily, the antitumor activity of this drug in these patients. II. Determine, preliminarily, the biologic activity of this drug in these patients. OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients receive bortezomib IV over 3-5 seconds 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. PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 1.5-36 months.

Conditions

• Blastic Phase Chronic Myelogenous Leukemia
• Childhood Acute Promyelocytic Leukemia (M3)
• Recurrent Childhood Acute Lymphoblastic Leukemia
• Recurrent Childhood Acute Myeloid Leukemia

Interventions

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

Timeline

• Start date: 2004-01-01
• Primary completion: 2006-03-01
• First posted: 2004-02-12
• Last updated: 2013-06-05

Locations

1 site across 1 country: United States