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Sponsored by: |
National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00112788 |
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 patients with recurrent gliomas.
Condition | Intervention | Phase |
Brain and Central Nervous System Tumors |
Drug: enzastaurin hydrochloride |
Phase I |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | Enzastaurin Enzastaurin Hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial of Enzastaurin (LY317615) in Patients With Recurrent Gliomas |
Estimated Enrollment: | 42 |
Study Start Date: | May 2005 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drug (EIAED) (e.g., phenytoin, carbamazepine, or trileptal) use (yes vs no).
Cohorts of 12 patients receive escalating doses of enzastaurin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 4 of 12 patients experience dose-limiting toxicity.
Cohorts of 6 patients receive escalating doses of enzastaurin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed within 2 weeks.
PROJECTED ACCRUAL: Approximately 42 patients (approximately 24 in stratum 1 and 12 in stratum 2) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant glioma, including any of the following:
Recurrent disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No QTc with Bazett's correction that is unmeasurable OR QTc ≥ 460 msec by ECG
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Prior surgical resection of recurrent or progressive tumor allowed provided patient has recovered
Other
United States, Maryland | |||||
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |||||
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | Howard A. Fine, MD | NCI - Neuro-Oncology Branch |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Web site for additional information 
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Featured trial article 
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Study ID Numbers: | CDR0000429472, NCI-05-C-0136 |
First Received: | June 2, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00112788 |
Health Authority: | United States: Food and Drug Administration |
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