Clinical Trial: Pazopanib Hydrochloride in Treating Young Patients With Solid Tumors That Have Relapsed or Not Responded to Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I Study of Pazopanib as a Single Agent for Children With Relapsed or Refractory Solid Tumors

Brief Summary: This phase I trial is studying the side effects and best dose of pazopanib hydrochloride in treating young patients with solid tumors that have relapsed or not responded to treatment. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Estimate the maximum-tolerated dose and/or recommended phase II dose of pazopanib hydrochloride in pediatric patients with relapsed or refractory solid tumors.

II. Define and describe the toxicities of this regimen in these patients. III. Characterize the pharmacokinetics of pazopanib hydrochloride in these patients.

SECONDARY OBJECTIVES:

I. Preliminarily define the antitumor activity of pazopanib hydrochloride within the confines of a phase I study.

II. Evaluate changes in tumor vascular permeability following initiation of pazopanib hydrochloride and correlate these changes with clinical outcome by dynamic contrast-enhanced MRI.

OUTLINE: This is a multicenter study dose-escalation study.

Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Patients accrued after the maximum-tolerated dose (MTD) of pazopanib hydrochloride has been determined receive pazopanib hydrochloride as an oral suspension.

Some patients undergo dynamic contrast-enhanced MRI at baseline and periodically during study. Blood samples are collected at baseline and periodically during study for pharmacokinetic studies.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Maximum-tolerated dose of pazopanib hydrochloride defined as the maximum dose at which fewer that one-third of patients experience DLT [ Time Frame: 28 days ]
    Graded using the NCI CTCAE version 4.0.
  • Adverse events according to NCI CTCAE version 4.0 [ Time Frame: Up to 30 days after completion of study treatment ]
  • Pharmacokinetics of pazopanib hydrochloride [ Time Frame: Baseline, days 15, 22, and 27 of course 1 and day 1 of odd courses ]
    Summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).


Original Primary Outcome:

  • Maximum-tolerated dose and/or recommended phase II dose of pazopanib hydrochloride
  • Adverse events according to NCI CTCAE v. 3.0
  • Pharmacokinetics


Current Secondary Outcome: Overall response to pazopanib hydrochloride according to RECIST criteria [ Time Frame: Up to 30 days after completion of study treatment ]

The overall response assessment takes into account response in both target and non-target lesions, the appearance of new lesions and normalization of markers.


Original Secondary Outcome: Overall response to pazopanib hydrochloride according to RECIST criteria

Information By: National Cancer Institute (NCI)

Dates:
Date Received: June 27, 2009
Date Started: June 2009
Date Completion:
Last Updated: September 27, 2013
Last Verified: September 2013