Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma

Kentuckiana Cancer Institute40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Newly Diagnosed Supratentorial Malignant Glioma

Interventions

Gliadel WaferDRUG

TemozolomideDRUG

Limited field radiationPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 72 Years

Medical Language ↔ Plain English

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

Locations (1)

Kentuckiana Cancer Institute

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

To determine the safety and efficacy of Gliadel 3.85% wafers

Data from ClinicalTrials.gov

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