NCT00498927

Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma

A Phase II Trial of Continuous Low-Dose Temozolomide for Patients With Recurrent Malignant Glioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent glioblastoma multiforme or other malignant glioma.

Detailed description

OBJECTIVES: Primary * Determine the progression-free survival rate at 6 months in patients with recurrent glioblastoma multiforme or other malignant glioma treated with temozolomide. Secondary * Determine the overall survival of patients treated with this drug. OUTLINE: Patients receive oral temozolomide once daily in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and every 2 months for 2 years for evaluation of markers of neo-angiogenesis. Samples are analyzed by protein expression, reverse-transcriptase PCR, ELISA, and western blot. (Samples are no longer being collected and tested as of 1/12/09)

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	temozolomide
GENETIC	protein expression analysis
GENETIC	reverse transcriptase-polymerase chain reaction
OTHER	diagnostic laboratory biomarker analysis
OTHER	immunoenzyme technique

Timeline

• Start date: 2007-06-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2007-07-11
• Last updated: 2016-02-29
• Results posted: 2016-02-29

Locations

1 site across 1 country: United States