Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma

Newly Diagnosed Supratentorial Malignant Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00283543
• Other study ID #: 1068016
• Secondary ID: 128-02
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 26, 2006
• Last updated: October 30, 2007
• Start date: September 2002
• Est. completion date: April 2008

Study information

• Verified date: October 2007
• Source: Kentuckiana Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 72 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioma
• Newly Diagnosed Supratentorial Malignant Glioma

Intervention

Drug:
• Gliadel Wafer

• Temozolomide

Procedure:
• Limited field radiation

Locations

Country	Name	City	State
United States	Kentuckiana Cancer Institute	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Kentuckiana Cancer Institute	Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and efficacy of Gliadel 3.85% wafers