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Sponsors and Collaborators: |
Duke University Novartis Pharmaceuticals |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00615927 |
Primary objective:
Secondary objectives:
Condition | Intervention | Phase |
---|---|---|
Glioblastoma Gliosarcoma |
Drug: Imatinib Mesylate & Hydroxyurea |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study of Imatinib Mesylate Plus Hydroxyurea in the Treatment of Patients With Recurrent / Progressive Grade II Low-Grade Glioma |
Estimated Enrollment: | 64 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Pts w gr II astrocytoma
|
Drug: Imatinib Mesylate & Hydroxyurea
Imatinib administered orally on daily. Imatinib is local irritant & must be taken in sitting position; mini of 2hrs should be allowed between last drug intake & going to bed. Imatinib doses 400mg/600mg administered once daily, whereas daily doses of 800mg/> administered as equally divided dose taken twice day. Dose for imatinib: Pts not receiving p450-inducing antiepileptic drugs: 400 mg/day. Pts receiving p450-inducing antiepileptic drugs: 500 mg twice day. It is recommended that pts take their prescribed imatinib mesylate at same time that they take their prescribed hydroxyurea, however, 30-60min interval between agents is acceptable if required for practical/other compliance issues. Hydroxyurea administered orally twice day. Dosing will begin on day 1 of cycle 1 & continue daily. Drug is approximately 80 percent bioavailable. Dose will be 500mg twice day for all pts. |
B: Experimental
Pts w oligodendroglioma/oligoastrocytomas
|
Drug: Imatinib Mesylate & Hydroxyurea
Imatinib administered orally on daily. Imatinib is local irritant & must be taken in sitting position; mini of 2hrs should be allowed between last drug intake & going to bed. Imatinib doses 400mg/600mg administered once daily, whereas daily doses of 800mg/> administered as equally divided dose taken twice day. Dose for imatinib: Pts not receiving p450-inducing antiepileptic drugs: 400 mg/day. Pts receiving p450-inducing antiepileptic drugs: 500 mg twice day. It is recommended that pts take their prescribed imatinib mesylate at same time that they take their prescribed hydroxyurea, however, 30-60min interval between agents is acceptable if required for practical/other compliance issues. Hydroxyurea administered orally twice day. Dosing will begin on day 1 of cycle 1 & continue daily. Drug is approximately 80 percent bioavailable. Dose will be 500mg twice day for all pts. |
This is an open-label, single stage, uncontrolled, non-randomized ph II study of continuous, daily doses of imatinib mesylate & hydroxyurea in adult pts w progressive/recurrent gr II LGG. Treatment cycle is defined as imatinib mesylate & hydroxyurea administered daily for 28 days for purpose of scheduling evaluations. All pts who receive 1/>doses of either imatinib mesylate/hydroxyurea will be evaluable for toxicity, whereas all pts who receive mini of 14 consecutive days of study regimen will be evaluable for response. Pts who discontinue therapy prior to receiving 14 consecutive days of study regimen will be regarded as ineligible for evaluation of response & will be replaced.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Duke University Health System | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | David A. Reardon, MD | Duke University Health System |
Responsible Party: | Duke University Health System ( David A. Reardon, MD ) |
Study ID Numbers: | 7262-07-7R2 |
Study First Received: | February 3, 2008 |
Last Updated: | November 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00615927 |
Health Authority: | United States: Institutional Review Board |
Gliosarcoma Glioblastoma GBM Imatinib Mesylate Gleevec Hydroxyurea Droxia |
Hydrea Hydroxycarbamide Imatinib Brain tumor Malignant brain tumor Recurrent glioblastoma multiforme Progressive glioblastoma multiforme |
Glioblastoma Astrocytoma Hydroxyurea Recurrence Imatinib Brain Neoplasms Neuroectodermal Tumors |
Glioblastoma multiforme Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Gliosarcoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Antisickling Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Hematologic Agents Enzyme Inhibitors |
Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Neoplasms, Neuroepithelial Nucleic Acid Synthesis Inhibitors |