Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma

Status unconfirmed · Phase 2

Conditions studied: Newly Diagnosed Supratentorial Malignant Glioma

In brief

To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide

Key facts

Study ID

NCT00283543

Run by

Kentuckiana Cancer Institute

People needed

40

Starts

2002-09-01

Expected to finish

2008-04-01

Last updated by the study team

2007-10-31

Who can join

Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• MRI showing unilateral supratentorial cerebral tumor
• surgical tx within 4 weeks of baseline MRI
• KPS 60% or higher
• moderate to high grade malignant glioma

You may not qualify if…

• prior cytoreductive surgery for moderate or high grade glioma
• prior CNS radiotherapy
• prior chemo for this glioma
• more than one focus of tumor or tumor crossing the midline per MRI
• life expectancy less than 12 months
• sensitivity to temozolomide, nitrosoureas, or Gliadel wafer

Where it is running

• Kentuckiana Cancer Institute — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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