Clinical Trials
Glioblastoma Multiforme
An open-label, phase I trial to study side effects and the best dose of AT-101 to give with temozolomide with or without radiation therapy
Primary Objective
- To determine the maximum tolerated dose of AT-101 when administered with radiotherapy and concurrent temozolomide
- To determine the maximum tolerated dose of AT-101 when administered with adjuvant temozolomide after standard radiotherapy and concurrent temozolomide
Secondary Objective
- To assess the toxicity of these treatment regimens
- To assess and describe the pharmacokinetics of AT-101
- To preliminarily determine the therapeutic activities of these regimens
- To determine the relationship between these regimens and cellular and molecular features identified in tumor biopsy specimens
Key Inclusion Criteria
- Adults with histologically confirmed supratentorial Grade IV astrocytoma (glioblastoma multiforme)
- Completed surgery within the past 6 weeks (group I)
- Received radiotherapy and concomitant temozolomide at least 4 weeks but no more than 7 weeks before the start of study treatment
- Patients must be on a stable corticosteroid regimen
- Patients must have the following characteristics
- Karnofsky score 60%-100%
- Adequate hematologic, liver, and renal function
- Ability to swallow oral medication
Location and Contact Information
This study is currently being conducted at multiple sites within the United States.
Trial Identification Number
NCT00390403