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Ph II Imatinib Mesylate + Hydroxyurea in Treatment for Pts w Recurrent/Progressive Meningioma

2014-08-27 03:33:08 | BioPortfolio

Summary

Primary objective To evaluate activity of imatinib mesylate & hydroxyurea among pts w recurrent meningioma as measured by 6 month progression free survival.

Secondary objectives To evaluate time to progression, overall survival & objective response rate among pts w recurrent meningioma treated with imatinib + hydroxyurea To assess safety & tolerability of imatinib mesylate + hydroxyurea in this population.

Description

This is an open-label, 2-stage, uncontrolled, non-randomized phase II study of continuous, daily doses of imatinib mesylate & hydroxyurea in adult pts with recurrent or relapsing meningioma. Treatment cycle is defined as imatinib mesylate & hydroxyurea administered daily for 28 days for purpose of scheduling evaluations. All pts who receive 1 or more doses of either imatinib mesylate or hydroxyurea will be evaluable for toxicity, whereas all pts who receive minimum 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.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Glioblastoma

Intervention

Imatinib Mesylate and Hydroxyurea

Location

Duke University Health System
Durham
North Carolina
United States
27710

Status

Active, not recruiting

Source

Duke University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:33:08-0400

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Medical and Biotech [MESH] Definitions

A tyrosine kinase inhibitor and ANTINEOPLASTIC AGENT that inhibits the BCR-ABL kinase created by chromosome rearrangements in CHRONIC MYELOID LEUKEMIA and ACUTE LYMPHOBLASTIC LEUKEMIA, as well as PDG-derived tyrosine kinases that are overexpressed in gastrointestinal stromal tumors.

Benign and malignant central nervous system neoplasms derived from glial cells (i.e., astrocytes, oligodendrocytes, and ependymocytes). Astrocytes may give rise to astrocytomas (ASTROCYTOMA) or glioblastoma multiforme (see GLIOBLASTOMA). Oligodendrocytes give rise to oligodendrogliomas (OLIGODENDROGLIOMA) and ependymocytes may undergo transformation to become EPENDYMOMA; CHOROID PLEXUS NEOPLASMS; or colloid cysts of the third ventricle. (From Escourolle et al., Manual of Basic Neuropathology, 2nd ed, p21)

An antineoplastic agent that inhibits DNA synthesis through the inhibition of ribonucleoside diphosphate reductase.

Natural product isolated from Streptomyces pilosus. It forms iron complexes and is used as a chelating agent, particularly in the mesylate form.

A pyrimidine and thiazole derived ANTINEOPLASTIC AGENT and PROTEIN KINASE INHIBITOR of BCR-ABL KINASE. It is used in the treatment of patients with CHRONIC MYELOID LEUKEMIA who are resistant or intolerant to IMATINIB.

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