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Comparison of Two Dosing Regimens of Temozolomide in Patients With Progressive or Recurrent Glioblastoma

NCT00941460 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2014-08-15

No results posted yet for this study

Summary

For patients with progressive or recurrent glioblastoma there is no standard therapy. One strategy is re-exposure to temozolomide in a higher dose. This increase in dosing can be done by 2 regimens. Aim of this study is to compare these 2 dosing regimens concerning toxicity. In study arm A patients receive temozolomide for one week, followed by a week without temozolomide. In study arm B patients receive temozolomide for three weeks, followed by a week without temozolomide. The regimen that is less toxic will be selected for further evaluations.

Conditions

Interventions

DRUG

Temozolomide in both arms

initial dose 120 mg/m2 in arm A

DRUG

Temozolomide in both arms

initial dose 80 mg/m2 in arm B

Sponsors & Collaborators

  • Essex Pharma GmbH

    collaborator INDUSTRY

  • Prof. Dr. Wolfgang Wick

    lead OTHER

Principal Investigators

  • Michael Weller, Prof. Dr. · University of Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Austria
  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT00941460 on ClinicalTrials.gov