NCT00622414

Aflibercept in Treating Young Patients With Relapsed or Refractory Solid Tumors

A Phase I Study of VEGF Trap (NSC# 724770, IND# 100137) in Children With Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (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 aflibercept in treating young patients with relapsed or refractory solid tumors. Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) or recommended phase II dose (RPTD) of aflibercept administered intravenously every 14 days in children with relapsed or refractory solid tumors. II. To estimate the MTD or RPTD of aflibercept administered intravenously every 21 days in these patients. III. To define and describe the toxicities of intravenous aflibercept administered on a 14-day and 21-day schedule, respectively. IV. To characterize the pharmacokinetics of intravenous aflibercept in these patients. SECONDARY OBJECTIVES: I. To define, preliminarily, the antitumor activity of intravenous aflibercept within the confines of a phase I study. OUTLINE: This is a multicenter study. PART 1: Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days for 2 years in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive aflibercept until the maximum tolerated dose (MTD) is determined. PART 2: Patients receive aflibercept as in part 1 at 150% of the MTD determined in part 1. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Blood samples are collected prior to treatment on day 1 of courses 1, 2, and 5 or 6 for pharmacokinetic studies. After completion of study treatment, patients are followed for at least 30 days.

Conditions

• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BIOLOGICAL	ziv-aflibercept	Given IV

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-02-01
• First posted: 2008-02-25
• Last updated: 2014-02-24

Locations

6 sites across 1 country: United States