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Investigator(s):
Elizabeth Fox, M.D. Principal Investigator Phone: 301-402-6641 foxb@mail.nih.gov
Referral Contact(s):
Pediatric Oncology  Phone: 1-877-624-4878 (Toll free)

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Primary Eligibility:

• Histologically confirmed solid tumor
• Recurrent or refractory disease
• Measurable or evaluable disease
• Primary CNS tumors or known CNS metastases allowed
• No known bone marrow metastatic disease
• No tumors involving the pleural surface
• Recovered from prior therapy
• No prior sunitinib
• No prior anthracycline
• No prior radiotherapy to a radiation field that included the heart
• ≥ 3 months since prior stem cell transplant or rescue (without total-body irradiation) and no evidence of graft-vs-host disease
• No concurrent CYP3A4 inducing or inhibiting medications
• No concurrent antithrombotic or antiplatelet agents
• ≥ 2 and ≤ 21 years of age
• Karnofsky performance status 50–100% (> 10 years of age) OR Lansky 50–100% (≤ 10 years of age)
• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³ (transfusion independent)
• Hemoglobin ≥ 8 g/dL (transfusions allowed)
• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age/gender
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
• ALT ≤ 2.5 x ULN
• Albumin ≥ 2 g/dL
• Adequate cardiac and pancreatic function
• Body surface area ≥ 0.5 m²
• Blood pressure within ULN
• Not pregnant or nursing; fertile patients must use effective contraception
• No medical condition that would preclude study participation
• Able to swallow sunitinib malate capsules
• No history of allergic reaction attributed to sunitinib malate or component of sunitinib malate capsules

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Study Outline:

This is a multicenter, dose-escalation study.

• Patients receive oral sunitinib malate once daily on Days 1–28
• Treatment repeats every 42 days for up to 9 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
• Blood is collected on Days 1, 7, 14, 21, and 28 of course 1 for pharmacokinetic studies
• After completion of study treatment, patients are followed for 30 days

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/8/09
Updated: 5/14/09