Temozolomide in Treating Patients With Anaplastic Oligodendroglioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00003465|
Recruitment Status : Completed
First Posted : March 12, 2004
Last Update Posted : June 20, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with anaplastic oligodendroglioma.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: temozolomide||Phase 2|
OBJECTIVES: I. Determine the activity of temozolomide in patients with newly diagnosed, progressive, or recurrent anaplastic oligodendroglioma. II. Determine the toxicity of this drug in this patient population.
OUTLINE: Patients are stratified according to disease characteristics (newly diagnosed anaplastic oligodendroglioma versus recurrent anaplastic oligodendroglioma). Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days. Patients with progressive or recurrent disease (at baseline) continue treatment in the absence of disease progression or unacceptable toxicity. Patients with newly diagnosed disease continue treatment for a maximum of 4 courses before radiotherapy in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive an additional 6 courses after completion of radiotherapy. (Radiotherapy is not part of study treatment.) Patients are followed every 8 weeks for 2 years.
PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Official Title:||Phase II Treatment of Adults With Newly Diagnosed, Progressive or Recurrent Primary Malignant Anaplastic Oligodendroglioma With Temodal|
|Study Start Date :||March 1998|
|Actual Study Completion Date :||February 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003465
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Henry S. Friedman, MD||Duke University|