GDC-0449 in Treating Young Patients With Medulloblastoma That is Recurrent or Did Not Respond to Previous Treatment

Completed · Phase 1

Conditions studied: Recurrent Childhood Medulloblastoma

In brief

This phase I trial is studying the side effects and best dose of GDC-0449 in treating young patients with medulloblastoma that is recurrent or did not respond to previous treatment. GDC-0449 may be effective in treating young patients with medulloblastoma.

Key facts

Study ID

NCT00822458

Run by

National Cancer Institute (NCI)

People needed

34

Starts

2009-01-01

Last updated by the study team

2014-04-02

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed medulloblastoma, including posterior fossa primitive neuroectodermal tumor (PNET)
• Recurrent, progressive, or refractory to standard therapy
• No known curative therapy exists
• Neurological deficits allowed provided they are stable for ≥ 1 week prior to study entry
• No atypical teratoid/rhabdoid tumor or supratentorial PNET
• Karnofsky performance status (PS) 60-100% (for patients > 16 years of age) OR Lansky PS 60-100% (for patients ≤ 16 years of age)
• ANC ≥ 1,000/μL*
• Platelet count ≥ 100,000/μL (transfusion independent)*
• Hemoglobin ≥ 8.0 g/dL (RBC transfusion allowed)*
• Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age as follows:
• ≤ 0.8 mg/dL (for patients ≤ 5 years of age)
• ≤ 1.0 mg/dL (for patients 6 to 10 years of age)
• ≤ 1.2 mg/dL (for patients 11 to 15 years of age)
• ≤ 1.5 mg/dL (for patients > 15 years of age)
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
• ALT/AST ≤ 2.5 times ULN for age
• Serum albumin ≥ 2.5 g/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile female patients must use 2 effective methods of contraception during and for 12 months following study treatment
• Fertile male patients must use effective barrier contraception during and for 12 months following study treatment
• Body surface area > 0.67 m\^2 and ≤ 2.5 m\^2
• Able to swallow capsules
• No malabsorption syndrome or other condition that would interfere with enteral absorption
• No history of congestive heart failure

Where it is running

• UCSF-Mount Zion — San Francisco, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Pediatric Brain Tumor Consortium — Memphis, Tennessee, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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