PBTC-003 Abstract for Health Professionals

Study Title: Phase I Trial of Escalating Oral Doses of SCH 66336 in Pediatric Patients with Refractory or Recurrent Brain Tumors

Description:

This is a phase I trial for patients 21 years of age or less, with recurrent or progressive brain tumors. It is a collaborative study of the Pediatric Brain Tumor Consortium.

SCH 66336 will be given twice daily without breaks, approximately every 12 hours. A course is defined as 4 weeks of therapy, for a total of 13 courses (one year). Patients on enzyme inducing anticonvulsant drugs (EIACD) are not eligible.

SCH 66336 Dose Escalation Table – Doses given BID

Dose Level

Dose (mg/m2)

Daily Dose (mg/m2)

1

90

180

2

115

230

3

150

300

4

200

400

5

260

520


Objectives:

  1. To establish the qualitative and quantitative toxicity of SCH 66336 when administered to children and adolescents with a refractory CNS malignancy.
  2. To establish the maximum-tolerated dosage (MTD) of SCH 66336.
  3. To investigate which clinical and laboratory studies are needed to monitor or alter therapy to prevent unacceptable toxicity.
  4. To describe the pharmacokinetics of SCH 66336 with this route of administration.
  5. To describe the activity of SCH 66336 with this route of administration using in vitro assays of patient white blood cell farnesyl transferase inhibition and inhibition of prelamin A farnesylation in buccal mucosa cells.
  6. To obtain preliminary information about the efficacy of SCH 66336.

Eligibility Criteria:

Contact:

Study Chair Study Co-Chair

Kieran, Mark W., MD, PhD
Dana-Farber Cancer Institute
Department of Pediatrics
44 Binney Street
Boston, MA 02115

Packer, Roger, MD
Children's National Medical Center
Department of Neurology
111 Michigan Avenue, NW
Washington, DC 20010


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