Neuroblastoma Clinical Trial
Official title:
Phase I and Pharmacokinetic Study of Enzastaurin (LY317615) in Children and Adolescents With Refractory Primary CNS Tumors
RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of enzastaurin in
treating young patients with refractory primary brain tumors.
OBJECTIVES:
Primary
- To estimate the maximum tolerated dose (MTD) and/or recommend a phase II dose of
enzastaurin hydrochloride in children with recurrent or refractory CNS tumors who are
not receiving enzyme-inducing anticonvulsants.
- To further characterize the pharmacokinetics and toxicity of the recommended phase II
dose of enzastaurin hydrochloride given twice daily in these patients.
Secondary
- To characterize the pharmacokinetics of enzastaurin hydrochloride at the recommended
phase II dose given once a day or twice a day in children.
- To document and describe toxicities associated with enzastaurin hydrochloride.
- To document antitumor activity in children with recurrent or refractory CNS tumors.
- To explore changes in MR perfusion scans obtained within 15 ± 2 days after initiation
of enzastaurin hydrochloride therapy as compared to baseline and to correlate these
changes with clinical outcome.
- To evaluate a panel of biological surrogate markers in this patient population at
baseline and following enzastaurin hydrochloride administration.
OUTLINE: This is a multicenter study.
Patients receive oral enzastaurin hydrochloride once daily until the maximum tolerated dose
(MTD) is determined. Patients then receive enzastaurin hydrochloride at the MTD twice daily
on days 1-28. Treatment repeats every 28 days for 13 courses in the absence of disease
progression or unacceptable toxicity. Patients may receive 13 additional courses (for a
total of 26 courses) of oral enzastaurin hydrochloride if the patient is benefitting from
the treatment and the investigator and subject agree to continue treatment.
Patients undergo blood sample collection periodically for pharmacokinetic studies.
After completion of study treatment, patients are followed periodically.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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