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NCT00049127 · ClinicalTrials.gov registry record · Phase 1
Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor
A Phase 1 study of Adult Anaplastic Oligodendroglioma and Adult Mixed Glioma, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 20
- Study locations
NCT00049127: Completed Phase 1 study of Adult Anaplastic Oligodendroglioma and Adult Mixed Glioma, sponsored by Alliance for Clinical Trials in Oncology.
NCT00049127 is a Phase 1 study of Adult Anaplastic Oligodendroglioma and Adult Mixed Glioma that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 64 participants, above the 49-participant average among 7 other Adult Anaplastic Oligodendroglioma trials with a reported enrollment target (31% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00049127, a Phase 1 study of Adult Anaplastic Oligodendroglioma and Adult Mixed Glioma, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I/II trial is studying the side effects and best dose of imatinib mesylate and to see how well it works in treating patients with a recurrent brain tumor that has not responded to previous surgery and radiation therapy. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
Primary Outcome
The proportion of successes will be estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 90% confidence interval estimated using the Duffy-Santer algorithm. Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), \>25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Pharmacological Study
- DRUG Imatinib Mesylate
Study Locations (20)
Illinois
- Rush - Copley Medical Center - Aurora
- Bromenn Lifecare Center - Bloomington
- Saint Joseph Medical Center - Bloomington
- Graham Hospital Association - Canton
- Memorial Hospital - Carthage
- Eureka Hospital - Eureka
- Galesburg Cottage Hospital - Galesburg
- Illinois CancerCare Galesburg - Galesburg
- Western Illinois Cancer Treatment Center - Galesburg
- Mason District Hospital - Havana
- Hopedale Medical Complex - Hospital - Hopedale
- Joliet Oncology-Hematology Associates Limited - Joliet
- Kewanee Hospital - Kewanee
- Mcdonough District Hospital - Macomb
- Garneau, Stewart C MD (UIA Investigator) - Moline
- Porubcin, Michael MD (UIA Investigator) - Moline
- Sharis, Christine M MD (UIA Investigator) - Moline
Arizona
- Mayo Clinic in Arizona - Scottsdale
Connecticut
- Saint Francis Hospital and Medical Center - Hartford
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2003-06 |
| Est. Completion | 2019-09-01 |
| Phase | Phase 1 |
What the finished NCT00049127 record still lists
NCT00049127 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, above the 49-participant average among 7 other Adult Anaplastic Oligodendroglioma trials with a reported enrollment target (31% higher).
The record links to 4 conditions, with Adult Anaplastic Oligodendroglioma appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00049127 names 20 study sites across 4 states, led by Illinois, Arizona, Connecticut.
Frequently Asked Questions
What is clinical trial NCT00049127 about?
NCT00049127 is a clinical study titled "Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor". This phase I/II trial is studying the side effects and best dose of imatinib mesylate and to see how well it works in treating patients with a recurrent brain tumor that has not responded to previous surgery and radiation therapy. Imatinib mesylate may stop the growth of tumor cells by blocking the ...
What is the current status of trial NCT00049127?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2003-06. Estimated completion is 2019-09-01.
What conditions does trial NCT00049127 study?
This clinical trial studies the following conditions: Adult Anaplastic Oligodendroglioma, Adult Mixed Glioma, Recurrent Adult Brain Neoplasm, Adult Oligodendroglioma.
What interventions are being tested in trial NCT00049127?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), Imatinib Mesylate (DRUG).
Who is sponsoring clinical trial NCT00049127?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00049127 being conducted?
This trial has 20 study locations across Arizona, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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