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Ph I Zactima + Imatinib Mesylate & Hydroxyurea for Pts w Recurrent Malignant Glioma

NCT00613054 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2012-12-05

No results posted yet for this study

Summary

Primary Objective To determine maximum tolerated dose \& dose limiting toxicity of Zactima when combined w standard dosing of imatinib mesylate \& hydroxyurea among pts w recurrent malignant glioma who are on \& not on enzyme-inducing anti-epileptic drugs Secondary Objectives To assess safety \& tolerability of Zactima + imatinib mesylate \& hydroxyurea To evaluate pharmacokinetics of Zactima among MG pts on \& not on enzyme inducing anti-epileptic drugs (EIAEDs) when combo w imatinib mesylate \& hydroxyurea To evaluate pharmacokinetics of imatinib mesylate among MG pts on \& not on EIAEDs when combo w Zactima \& hydroxyurea Exploratory Objective To evaluate for evidence of anti-tumor activity of study regimen among recurrent malignant glioma (RMG) pts including radiographic response rate, 6-month progression free survival (PFS) rate \& median PFS

Conditions

Interventions

DRUG

Zactima, Gleevec, Hydroxyurea

Pts will start treatment on day 1 of cycle 1 w Zactima, imatinib mesylate \& hydroxyurea. All 3 agents administered in continuous daily, oral manner. Imatinib mesylate dose 400 mg/day for pts not on EIAEDs \& 1000 mg/day for pts on EIAEDs based on previous studies demonstrating that pts on EIAEDs require significantly higher doses of imatinib mesylate \& that such doses are safe \& well tolerated. Dose of hydroxyurea 500 mg twice day. Dose level of Zactima will be increased in successive cohorts of pts as described below. Cohorts of 3-6 pts will accrue at each dose level until MTD is defined. Each cohort will consist of a mini of 3 newly enrolled pts. Intra-patient dose escalation is not permitted. Cohorts may be expanded at any dose level for further elaboration of safety \& pharmacokinetic parameters as required. Treatment cycle is defined as daily administration of Zactima + imatinib mesylate \& hydroxyurea for 28 days for purpose of scheduling evaluations.

Sponsors & Collaborators

Principal Investigators

  • Annick Desjardins, MD, FRCPC · Duke Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-03-31
Completion
2009-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT00613054 on ClinicalTrials.gov