A Phase II Clinical Trial Evaluating the Efficacy and Safety of GDC-0449 in Children with Recurrent or Refractory Medulloblastoma

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Research

Brain Tumors

Protocol

PBTC32: A Phase II Clinical Trial Evaluating the Efficacy and Safety of GDC-0449 in Children with Recurrent or Refractory Medulloblastoma

Diseases

Brain Tumor : Recurrent or refractory medulloblastoma

Description

Subjects taking part in this research study have a type of brain tumor called medulloblastoma that is growing or has come back (recurred). Because there has been a major challenge in finding an effective treatment that these tumors will respond to, this study is testing GDC-0449 given once daily based on data available on the recently conducted Phase I study. We are using GDC-0449 because it seems to block a gene that is thought to be involved in the development of brain tumors.

This Phase II study has been designed to demonstrate the clinical benefit of GDC-0449 in children with recurrent medulloblastoma. This study will seek to describe the efficacy, response and side effects of the drug in patients with recurrent or refractory medulloblastoma.

Objectives

To see what effects (good or bad) GDC-0449 has on the patient and on the patient’s tumor
To learn how the body processes GDC-0449 by studying fluids of the body and brain tumor tissue in the laboratory
To measure levels of certain cells and proteins in the blood to see if changes are related to how the brain tumor responds to GDC-0449

Eligibility

Patient must be at least 3 years of age (greater than or equal to 3 years) and at most 21 (less than or equal to 21 years) on the date of registration.
Patients with recurrent and/or refractory diagnosis of medulloblastoma
Female patients of childbearing potential must not be pregnant or breast-feeding.
Patients receiving any other anticancer or investigational drug therapy are not eligible for the study
Patients with history of congestive heart failure or malabsorption syndrome are not eligible for the study
Patients will not be eligible for the study if they are unable to swallow capsules

For current eligibility status of this clinical study, referring physician and patient’s family may contact St. Jude’s Brain Tumor Team at (901) 595-2544 or (901) 595-4599.

Contact

Amar Gajjar, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Phone: 901-595-2544 or 901-595-4599
FAX: 901-595-5353

Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
Phone: 901-595-2544
Fax: 901-595-5353
Email: tabatha.doyle@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

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