NCT00085111

Bevacizumab in Treating Young Patients With Refractory Solid Tumors

A Phase I Study of Bevacizumab in Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 bevacizumab in treating young patients with refractory solid tumors. Monoclonal antibodies, such as bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the maximum tolerable dose (MTD) of bevacizumab by dose escalation to a maximum of 15mg/kg, even if MTD is not reached, administered as an intravenous infusion, every 2 weeks to children with refractory solid tumors. II. To determine the dose-limiting toxicities (DLT) and other toxicities of bevacizumab given on this schedule. III. To characterize the pharmacokinetic behavior of bevacizumab in children with refractory cancer. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of bevacizumab within the confines of a phase I study. II. To assess the biologic activity of bevacizumab by measuring levels of total serum VEGF, and parallel angiogenic markers V-CAM-1, ICAM-1, bFGF, and TSP-1 at baseline and at time points post therapy. III. To explore the biologic effect of bevacizumab on circulating endothelial cells (CECs) and circulating endothelial cell precursors (CECPs). IV. To determine in archival tumor tissue the expression of VEGF by immunohistochemistry and/or real time PCR. OUTLINE: This is a dose-escalation, multicenter study. Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bevacizumab 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.

Conditions

• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BIOLOGICAL	bevacizumab	Given IV

Timeline

• Start date: 2003-12-01
• Primary completion: 2005-10-01
• First posted: 2004-06-11
• Last updated: 2013-06-05

Locations

1 site across 1 country: United States