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Sponsors and Collaborators: |
Duke University Novartis Pharmaceuticals |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00613132 |
Primary objective To determine maximum tolerated dose & dose limiting toxicity of imatinib mesylate & RAD001 when combined w fixed doses of hydroxyurea among pts w recurrent GBM who are on & not on enzyme-inducing anti-convulsants including pts not on anti-epileptic drugs Secondary objective To assess safety & tolerability of imatinib mesylate in combo w RAD001 & hydroxyurea in this population To characterize single-dose & repeated-dose pharmacokinetic profiles of imatinib mesylate & RAD001 combo therapy in this pt population.
To assess antiangiogenic effects, pre- and post-treatment, of imatinib mesylate, RAD001 & hydroxyurea combo therapy, using DCE-MRI to evaluate changes in extent of vascular permeability, perfusion & relative tumor blood volume; to explore assessment of tumor cellularity & tumor cell death by changes in DWI-MRI as quantitated by apparent diffusion coefficient maps.
Condition | Intervention | Phase |
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Glioblastoma Gliosarcoma |
Drug: Gleevec, RAD001, and Hydroxyurea |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Phase I Dose Escalation of Gleevec in Combination With RAD001 Plus Hydroxyurea for Patients With Recurrent Malignant Glioma |
Estimated Enrollment: | 72 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Pts receiving EIACDs
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Drug: Gleevec, RAD001, and Hydroxyurea
Dose of Gleevec will be 400 mg in 1st cohort & will be increased to 600 mg po/day & then to 400 mg bid in successive cohorts. Prescribed dose should be administered orally, w large glass of water. Pts should not eat large or high fat meal within 1 hour before or after gleevec dosing. Doses of 600 mg or less should be administered once daily, whereas doses greater than 600 mg should be administered as equal doses twice day. It is recommended that pts take their prescribed Gleevec at same time that they take their prescribed RAD001 & hydroxyurea, however, 30-60 minute interval between agents is acceptable if required for practical or other compliance issues.
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2: Experimental
Pts not receiving EIACDs
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Drug: Gleevec, RAD001, and Hydroxyurea
Dose of Gleevec will be 400 mg in 1st cohort & will be increased to 600 mg po/day & then to 400 mg bid in successive cohorts. Prescribed dose should be administered orally, w large glass of water. Pts should not eat large or high fat meal within 1 hour before or after gleevec dosing. Doses of 600 mg or less should be administered once daily, whereas doses greater than 600 mg should be administered as equal doses twice day. It is recommended that pts take their prescribed Gleevec at same time that they take their prescribed RAD001 & hydroxyurea, however, 30-60 minute interval between agents is acceptable if required for practical or other compliance issues.
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This is open-label, single center, 1-arm ph I dose-escalation study of continuous, daily doses of imatinib mesylate & RAD001 administered orally in combination w fixed doses of hydroxyurea in adult pts w recurrent or relapsing glioblastoma multiforme. Study format includes classical "3+3" dose escalation design to determine MTD & DLT of imatinib mesylate + RAD001 when combined w hydroxyurea among GBM pts. Pts will be stratified based on whether they who are receiving EIACD & each stratum will independently dose escalate. Additionally, study will characterize safety, tolerability, biologic activity, & pharmacokinetic profile of this combo therapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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: | 7020-07-32 |
Study First Received: | January 29, 2008 |
Last Updated: | November 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00613132 |
Health Authority: | United States: Food and Drug Administration |
Glioblastoma Gliosarcoma GBM Brain tumor RAD0001 Hydroxyurea Gleevec Imatinib |
Droxia Everolimus Hydrea Hydroxycarbamide Recurrent GBM Imatinib mesylate Glioblastoma multiforme |
Everolimus Glioblastoma Astrocytoma Hydroxyurea Recurrence Imatinib Brain Neoplasms Neuroectodermal Tumors |
Methamphetamine Glioblastoma multiforme Neoplasms, Germ Cell and Embryonal Neuroepithelioma Amphetamine Glioma Gliosarcoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Antisickling Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Hematologic Agents |
Enzyme Inhibitors Immunosuppressive Agents Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Neoplasms, Neuroepithelial Nucleic Acid Synthesis Inhibitors |