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Efficacy and Safety of Imatinib Mesylate Plus Hydroxyurea (HU) in Patients With Recurrent Glioblastoma Multiforme (GBM)

NCT00290771 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2011-05-16

Study results available
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Summary

This was an investigational study to assess the objective overall response (OOR) rate (complete response \[CR\] + partial response \[PR\]) of imatinib mesylate and hydroxyurea (hydroxycarbamide) combination therapy in patients with recurrent glioblastoma multiforme (brain tumors). This study also evaluated the duration of tumor response (as per MacDonald criteria), clinical benefit, progression-free survival rate at 6 and 12 months, and the survival rate at 12 and 24 months.

Conditions

  • Recurrent Glioblastoma Multiforme (GBM)

Interventions

DRUG

Imatinib tablets

Imatinib was supplied as 100 and 400 mg tablets by Novartis.

DRUG

Hydroxyurea capsules

Hydroxyurea was supplied locally as 500 mg capsules.

Sponsors & Collaborators

Principal Investigators

  • David Reardon, Dr. · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00290771 on ClinicalTrials.gov