Sunitinib in Treating Young Patients With Refractory Solid Tumors

Completed · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00387920

Run by

National Cancer Institute (NCI)

People needed

35

Starts

2006-10-01

Last updated by the study team

2014-01-28

Who can join

Age: 2 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed solid tumor (not required for patients with intrinsic brain stem tumors or optic pathway gliomas)
• Recurrent or refractory disease
• Measurable or evaluable disease
• No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
• Patients with metastatic bone marrow disease are eligible but are not evaluable for hematologic toxicity
• Must not be refractory to red blood cell or platelet transfusions
• Primary CNS tumors or known CNS metastases allowed
• Neurological deficits must have been relatively stable for ≥ 1 week before study enrollment
• No imaging evidence of prior intracranial hemorrhage
• No evidence of new CNS hemorrhage on baseline MRI obtained within 14 days before study enrollment (ECHO gradient MRI sequences per institutional guidelines required for evaluation of CNS hemorrhage)
• The presence of small punctuate CNS hemorrhage on these scans will exclude a patient from participation
• No known bone marrow metastatic disease
• No tumors involving the pleural surface
• Karnofsky performance status (PS) 50-100% (> 10 years of age) OR Lansky PS 50-100% (≤ 10 years of age)
• Absolute neutrophil count ≥ 1,000/mm³*
• Platelet count ≥ 100,000/mm³ (transfusion independent)*
• Hemoglobin ≥ 8.0 g/dL (transfusions allowed)*
• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age/gender as follows:
• No greater than 0.8 mg/dL (2 to 5 years of age)
• No greater than 1 mg/dL (6 to 9 years of age)
• No greater than 1.2 mg/dL (10 to 12 years of age)
• No greater than 1.5 mg/dL (male) OR 1.4 mg/dL (female) (13 to 15 years of age)
• No greater than 1.7 mg/dL (male) OR 1.4 mg/dL (female) (≥ 16 years of age)
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for liver metastases)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Childrens Hospital of Orange County — Orange, California, United States
• UCSF-Mount Zion — San Francisco, California, United States
• University of California San Francisco Medical Center-Parnassus — San Francisco, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• C S Mott Children's Hospital — Ann Arbor, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Hospital for Sick Children — Toronto, Ontario, Canada
• Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.