Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma

A Phase II Study of Radiation With Concomitant and Then Sequential Temozolomide in Patients With Newly Diagnosed Supratentorial Malignant Glioma Who Have Undergone Surgery With Gliadel Wafer Insertion

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00283543

Enrollment

Registered

2006-01-30

Start date

2002-09-30

Completion date

2008-04-30

Last updated

2007-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly Diagnosed Supratentorial Malignant Glioma

Keywords

Glioma, Gliadel Wafer

Brief summary

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

Detailed description

A phase II study of radiation with concomitant and then sequential Temozolomide in patients with newly diagnosed supratentorial malignant glioma who have undergone surgery with Gliadel wafer insertion. To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and limited field radiation therapy with concomitant Temozolomide followed by Temozolomide alone in patients undergoing initial surgery for newly diagnosed unifocal moderate to high grade glioma.

Interventions

DRUGGliadel Wafer

DRUGTemozolomide

PROCEDURELimited field radiation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 72 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
To determine the safety and efficacy of Gliadel 3.85% wafers	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026