Phase I and Pharmacokinetic Study of Enzastaurin (LV317615) in Children and Adolescents with Refractory Primary CNS Tumors

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Research

Protocol

PBTC23: Phase I and Pharmacokinetic Study of Enzastaurin (LV317615) in Children and Adolescents with Refractory Primary CNS Tumors

Diseases

Brain Tumor : Brain tumors

Description

Subjects taking part in this research study have a brain tumor that is growing or has come back (recurred). Because there are few effective treatments for this type of cancer, this study is testing an experimental drug called enzastaurin. Enzastaurin has been studied in adults with a variety of types of cancer including brain tumors but enzastaurin has not yet been studied in children. The purpose of testing new experimental drugs such enzastaurin is to find a drug that may be useful in treating children with brain tumors.

This is called a Phase I study because the goal is to find the highest dose of enzastaurin that can be given safely to children therefore not all people will receive the same dose of the study drug. Enzastaurin is being used because it seems to block the formation and growth of blood vessels that tumors need to grow and survive. The study will review how children tolerate taking enzastaurin, and it will also review how well the drug works in children with brain tumors.

Objectives

To find highest does without causing severe side effects
See what effects (good or bad) Enzastaurin has on the participant or the participant’s tumor
To learn how the body processes Enzastaurin by studying the fluids of the body

Eligibility

21 years of age or less
Adequate bone marrow, liver and kidney functions
Participant has no previous treatment with Enzastaurin
No active infection or unstable medical condition
Participant is able to perform ordinary tasks and daily activities as defined in study guidelines
Participant meets other requirements defined in the study

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Amar Gajjar, MD
Director of Neuro Oncology
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
TEL: 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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