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Investigator(s):
Howard A. Fine, M.D. Principal Investigator Phone: 301-402-6298 hfine@mail.nih.gov
Referral Contact(s):
Charisse Garcia, R.N. Research Nurse Phone: 301-402-6298 Fax: 301-480-2246 Toll free: 866-251-9686 garciacr@mail.nih.gov	Julie Peretti, R.N. Research Nurse Phone: 301-402-6298 Fax: 301-480-2246 Toll free: 866-251-9686 jperetti@mail.nih.gov	Tracy Cropper, R.N. Research Nurse Phone: 301-496-8250 Fax: 301-480-2246 Toll free: 866-251-9686 tcropper@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed primary brain tumor, including any of the following:
  • Malignant glioma, including any of the following subtypes: glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, malignant glioma not otherwise specified
  • Primitive neuroectodermal tumors of the CNS
  • Progressive low-grade glioma
  • Radiographically diagnosed brain stem glioma
• Recurrent or refractory disease
  • Progressive disease after standard treatment allowed
  • Unequivocal evidence of tumor progression by MRI or CT scan
  • Steroid dosage stable for ≥ 5 days
• Failed prior radiotherapy
• No prior treatment with platinum-based therapy
• Recovered from all prior therapy
• Karnofsky performance status ≥ 60
• WBC ≥ 3,000/mm³, absolute neutrophil count ≥ 1,500/mm³, platelet count ≥ 100,000/mm³, hemoglobin ≥ 10 g/dL (transfusion allowed)
• SGOT ≤ 2 x upper limit of normal (ULN), bilirubin ≤ 2 x ULN
• Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
• No illness that would preclude study participation
• No clinically significant symptomatic arrhythmia requiring treatment
• Not pregnant or nursing; fertile patients must use effective contraception during and for 3–6 months after completion of study treatment
• No known allergy to mannitol

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Study Outline:

This is a dose-escalation study of carboplatin in combination with enzastaurin. Patients are stratified according to concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) (yes vs. no).

• All patients receive a 7-day lead-in treatment period (Cycle 1) consisting of a loading dose of single-agent, oral enzastaurin on Day 1, followed by enzastaurin once daily beginning on Day 2 in order to achieve steady-state pharmacokinetics of enzastaurin
• Patients receive oral enzastaurin hydrochloride once daily on Days 1–35 (only Cycle 1 is 35 days) and carboplatin IV over 30 minutes on Day 8 of Course 1
• Patients receive oral enzastaurin once daily on Days 1–28 and carboplatin IV over 30 minutes on Day 1 in all subsequent courses
• Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
• Cohorts of 4–12 patients receive escalating doses of carboplatin; enzastaurin dosing remains the same for all dose levels depending on what group the patient is in
• Patients undergo blood collection on Days 1,7,8, and 9 and between weeks 4–5 of Course 1
• Blood is also collected for research purposes on Days 1,7, and 28 of each course

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 3/5/09
Updated: 5/14/09