Back to resultsRadiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma
Primary Purpose
Newly Diagnosed Supratentorial Malignant Glioma
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gliadel Wafer
Temozolomide
Limited field radiation
Sponsored by
About this trial
This is an interventional treatment trial for Newly Diagnosed Supratentorial Malignant Glioma focused on measuring Glioma, Gliadel Wafer
Eligibility Criteria
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
Sites / Locations
- Kentuckiana Cancer Institute
Outcomes
Primary Outcome Measures
To determine the safety and efficacy of Gliadel 3.85% wafers
Secondary Outcome Measures
Full Information
NCT ID
NCT00283543
First Posted
January 26, 2006
Last Updated
October 30, 2007
Sponsor
Kentuckiana Cancer Institute
Collaborators
Eisai Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00283543
Brief Title
Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Kentuckiana Cancer Institute
Collaborators
Eisai Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newly Diagnosed Supratentorial Malignant Glioma
Keywords
Glioma, Gliadel Wafer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gliadel Wafer
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Type
Procedure
Intervention Name(s)
Limited field radiation
Primary Outcome Measure Information:
Title
To determine the safety and efficacy of Gliadel 3.85% wafers
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato V. LaRocca, MD
Organizational Affiliation
Kentuckiana Cancer Institute
Official's Role
Study Director
Facility Information:
Facility Name
Kentuckiana Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma
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