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Temodal in Newly Diagnosed Glioblastoma Multiforme
NCT00003464Phase 2
Key facts
- Status
- Completed
- Start
- Sep 1997
- Countries
- 1
- Sponsor
- Duke University
- Modality
- Small Molecules
- Drugs
- temozolomide
- Conditions
- glioblastoma multiforme (GBM)
01
Overview
Phase 2, open-label, single-arm trial of temozolomide in glioblastoma multiforme (GBM), sponsored by Duke University. Primary endpoint: Antitumor Activity. Started Sep 1997; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Temodal Treatment
Temodal (temozolomide) administered before and after radiation therapy.
03
Who it enrols
Adults with newly diagnosed, histologically proven supratentorial malignant glioblastoma multiforme not requiring immediate radiation therapy.
04
Endpoints
Primary
Antitumor Activity
Secondary
Correlation of MGMT Activity and Response
Correlation of DNA Mismatch Repair and Response
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