Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma

Kentuckiana Cancer Institute

Status and phase: Unknown; Phase 2

Conditions: Newly Diagnosed Supratentorial Malignant Glioma

Treatments: Procedure: Limited field radiation; Drug: Gliadel Wafer; Drug: Temozolomide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00283543

1068016

128-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)