PBTC-004 Abstract for Health Professionals

Study Title: Phase I Study of Intrathecal SpartajectTM-Busulfan in Children with Neoplastic Meningitis

Description:

The alkylating agent busulfan is an extremely hydrophobic compound that precludes intravenous (IV) or intrathecal (IT) administration. Spartajectš -Busulfan is a phospholipid-encapsulated form of busulfan that can be easily dispersed in water and hence makes it amenable to IT or IV therapy. This phase I study of IT Spartajectš -Busulfan is designed to evaluate the toxicity and pharmacokinetics of administering this drug intrathecally in children with refractory leptomeningeal disease from primary malignant brain tumors, acute lymphoblastic leukemia, and lymphoma.

Objectives:

  1. To determine the qualitative and quantitative toxicity of intrathecal SpartajectTM-Busulfan when administered to children and adolescents with a refractory CNS malignancy.
  2. To determine the maximum-tolerated dose (MTD) of intrathecal SpartajectTM -Busulfan that can be recommended for subsequent phase II studies.
  3. To determine the cerebrospinal fluid (CSF) and serum pharmacokinetics of SpartajectTM-Busulfan following IT administration.

Rationale:

The following factors favor the use of intrathecal busulfan in children with leptomeningeal disease from primary malignant brain tumors:

Eligibility Criteria:

Contact:

Study Chair Study Co-Chair

Gururangan, Sri, MRCP (UK)
The Brain Tumor Center at Duke
Duke University Medical Center
047 Baker House, DUMC Box 3624
Durham, NC 27710

Friedman, Henry, MD
Duke University Medical Center
Dept. of Pediatrics, Medicine & Surgery
Trent Drive
Durham, NC 27710


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