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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


Phase 2
18 Years
72 Years
Open (Enrolling)
Both
Newly Diagnosed Supratentorial Malignant Glioma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the safety and efficacy of Gliadel 3.85% wafers

Principal Investigator

Renato V. LaRocca, MD

Investigator Role:

Study Director

Investigator Affiliation:

Kentuckiana Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

1068016

NCT ID:

NCT00283543

Start Date:

September 2002

Completion Date:

April 2008

Related Keywords:

  • Newly Diagnosed Supratentorial Malignant Glioma
  • Glioma
  • Gliadel Wafer
  • Glioma

Name

Location

Kentuckiana Cancer InstituteLouisville, Kentucky  40202