Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
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|ClinicalTrials.gov Identifier: NCT00079092|
Recruitment Status : Completed
First Posted : March 9, 2004
Last Update Posted : April 19, 2017
RATIONALE: Thalidomide may stop the growth of malignant glioma by stopping blood flow to the tumor. Drugs used in chemotherapy, such as procarbazine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with procarbazine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving thalidomide together with procarbazine works in treating patients with recurrent or progressive malignant glioma.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: procarbazine hydrochloride Drug: thalidomide||Phase 2|
- Determine the response rate in patients with recurrent or progressive malignant glioma treated with thalidomide and procarbazine.
- Determine the progression-free survival of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral procarbazine once daily on days 1-5 and oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then before every odd course.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Of Thalidomide And Procarbazine In Adults With Recurrent/Progressive Gliomas|
|Actual Study Start Date :||January 2004|
|Primary Completion Date :||March 21, 2006|
|Study Completion Date :||March 21, 2006|
- Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion
- Progression-free survival by CT scan, MRI, and follow up form at baseline, pre-odd cycles, and study completion
- Overall survival by follow-up form at study completion
- Quality of life by FACT-Br, FACIT-F and Karnofsky performance status (PS) at baseline, pre-odd cycles, and study completion
- Toxicity by evaluation form at baseline, pre-odd cycles, and study completion
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): NCT00079092
|United States, Illinois|
|CCOP - Central Illinois|
|Decatur, Illinois, United States, 62526|
|United States, North Carolina|
|CCOP - Southeast Cancer Control Consortium|
|Goldsboro, North Carolina, United States, 27534-9479|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, South Carolina|
|CCOP - Greenville|
|Greenville, South Carolina, United States, 29615|
|CCOP - Upstate Carolina|
|Spartanburg, South Carolina, United States, 29303|
|Principal Investigator:||Glenn J. Lesser, MD||Wake Forest University Health Sciences|
|Study Chair:||Edward G. Shaw, MD||Wake Forest University Health Sciences|
|Principal Investigator:||Volker W. Stieber, MD||Wake Forest University Health Sciences|