Sunitinib in Treating Young Patients With Refractory Solid Tumors
Summary
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth and by blocking blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of sunitinib in treating young patients with refractory solid tumors.
Description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended phase II dose of sunitinib malate in pediatric patients with refractory solid tumors.
- Determine the toxicity of this regimen in these patients.
- Characterize the pharmacokinetics of this regimen in these patients.
- Evaluate the tolerability and pharmacokinetic profile of sunitinib malate capsule contents sprinkled over applesauce or yogurt using the recommended phase II dose.
Secondary
- Determine, preliminarily, the antitumor effects of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study (part A) followed by a pediatric-friendly formulation study (part B).
- Part A:
Patients receive oral sunitinib malate once daily on days 1-28 days. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of sunitinib malate 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.
- Part B:
Patients receive sunitinib malate capsule contents sprinkled over applesauce or yogurt once daily on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. After the first course, patients may switch to capsule formulation for convenience.
NOTE: Patients will not receive sunitinib malate on day 2 of the first course to allow for pharmacokinetic testing.
Blood is collected on days 1, 7, 14, 21, and 28 of course 1 for pharmacokinetic studies using liquid chromatography/mass spectrometry.
After completion of study treatment, patients are followed up for 30 days.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Study Design
Primary Purpose: Treatment
Conditions
Unspecified Childhood Solid Tumor, Protocol Specific
Intervention
sunitinib malate, mass spectrometry, pharmacological study
Location
UAB Comprehensive Cancer Center
Birmingham
Alabama
United States
35294
Status
Recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00387920
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Tandem Mass Spectrometry
A mass spectrometry technique using two (MS/MS) or more mass analyzers. With two in tandem, the precursor ions are mass-selected by a first mass analyzer, and focused into a collision region where they are then fragmented into product ions which are then characterized by a second mass analyzer. A variety of techniques are used to separate the compounds, ionize them, and introduce them to the first mass analyzer. For example, for in GC-MS/MS, GAS CHROMATOGRAPHY-MASS SPECTROMETRY is involved in separating relatively small compounds by GAS CHROMATOGRAPHY prior to injecting them into an ionization chamber for the mass selection.
Gas Chromatography-mass Spectrometry
A microanalytical technique combining mass spectrometry and gas chromatography for the qualitative as well as quantitative determinations of compounds.
Mass Spectrometry
An analytical method used in determining the identity of a chemical based on its mass using mass analyzers/mass spectrometers.
Spectrometry, Mass, Electrospray Ionization
A mass spectrometry technique used for analysis of nonvolatile compounds such as proteins and macromolecules. The technique involves preparing electrically charged droplets from analyte molecules dissolved in solvent. The electrically charged droplets enter a vacuum chamber where the solvent is evaporated. Evaporation of solvent reduces the droplet size, thereby increasing the coulombic repulsion within the droplet. As the charged droplets get smaller, the excess charge within them causes them to disintegrate and release analyte molecules. The volatilized analyte molecules are then analyzed by mass spectrometry.
Spectrometry, Mass, Secondary Ion
A mass-spectrometric technique that is used for microscopic chemical analysis. A beam of primary ions with an energy of 5-20 kiloelectronvolts (keV) bombards a small spot on the surface of the sample under ultra-high vacuum conditions. Positive and negative secondary ions sputtered from the surface are analyzed in a mass spectrometer in regards to their mass-to-charge ratio. Digital imaging can be generated from the secondary ion beams and their intensity can be measured. Ionic images can be correlated with images from light or other microscopy providing useful tools in the study of molecular and drug actions.
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