Sunitinib in Treating Young Patients With Refractory Solid Tumors
Condition: Central Nervous System Metastases; 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; Recurrent Childhood Central Nervous System Embryonal Tumor; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasms; Neoplasms, Germ Cell and Embryonal; Teratoma; Endodermal Sinus Tumor; Choriocarcinoma; Germinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial is studying the side effects and best dose of sunitinib in treating young
      patients with refractory solid tumors. 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.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine the maximum tolerated dose (MTD) and recommended phase II dose of sunitinib
      malate in pediatric patients with refractory solid tumors.

      II. Determine the toxicity of this regimen in these patients. III. Characterize the
      pharmacokinetics of this regimen in these patients. IV. Evaluate the tolerability and
      pharmacokinetic profile of sunitinib malate capsule contents sprinkled over applesauce or
      yogurt using the recommended phase II dose.

      SECONDARY OBJECTIVES:

      I. Determine, preliminarily, the antitumor effects of this regimen in these patients.

      II. Describe changes in peripheral blood monocyte counts, circulating endothelial cells, and
      plasma angiogenic factors during treatment with sunitinib malate.

      III. Explore changes in tumor vascular permeability using dynamic contrast-enhanced
      (DCE)-magnetic resonance imaging (MRI) in patients receiving sunitinib malate.

      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 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.
    

Intervention name(s): sunitinib malate; pharmacological study; dynamic contrast-enhanced magnetic resonance imaging; laboratory biomarker analysis
Intervention type(s): Drug; Other; Procedure; Other
Intervention description(s): Given orally; Correlative studies; Undergo DCE-MRI; Correlative studies
Other intervention name(s): SU11248; sunitinib; Sutent; pharmacological studies; DCE-MRI
Intervention MeSH terms: Sunitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment