Pazopanib Hydrochloride in Treating Young Patients With Solid Tumors That Have Relapsed or Not Responded to Treatment
|ClinicalTrials.gov Identifier: NCT00929903|
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : September 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Childhood Central Nervous System Choriocarcinoma Childhood Central Nervous System Embryonal Tumor Childhood Central Nervous System Germ Cell Tumor Childhood Central Nervous System Germinoma Childhood Central Nervous System Mixed Germ Cell Tumor Childhood Central Nervous System Teratoma Childhood Central Nervous System Yolk Sac Tumor Metastatic Childhood Soft Tissue Sarcoma Recurrent Childhood Brain Stem Glioma Recurrent Childhood Central Nervous System Embryonal Tumor Recurrent Childhood Soft Tissue Sarcoma Recurrent Childhood Visual Pathway Glioma Unspecified Childhood Solid Tumor, Protocol Specific||Drug: pazopanib hydrochloride Other: pharmacological study||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Pazopanib as a Single Agent for Children With Relapsed or Refractory Solid Tumors|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||April 2013|
Experimental: Treatment (pazopanib hydrochloride)
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.
Drug: pazopanib hydrochloride
Other: pharmacological study
Other Name: pharmacological studies
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929903
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, Illinois|
|Lurie Children's Hospital-Chicago|
|Chicago, Illinois, United States, 60614|
|United States, Indiana|
|Indiana University Medical Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|C S Mott Children's Hospital|
|Ann Arbor, Michigan, United States, 48109|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Children's Hospital of Pittsburgh of UPMC|
|Pittsburgh, Pennsylvania, United States, 15224|
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Julia Glade-Bender||COG Phase I Consortium|