Trials / Unknown
UnknownNCT00283543
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Kentuckiana Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 72 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gliadel Wafer | |
| DRUG | Temozolomide | |
| PROCEDURE | Limited field radiation |
Timeline
- Start date
- 2002-09-01
- Completion
- 2008-04-01
- First posted
- 2006-01-30
- Last updated
- 2007-10-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00283543. Inclusion in this directory is not an endorsement.