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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | March 8, 2004 | ||||||||||||
| Last Updated Date | August 20, 2009 | ||||||||||||
| Start Date ICMJE | January 2004 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Current Primary Outcome Measures ICMJE |
Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion | ||||||||||||
| Change History | Complete list of historical versions of study NCT00079092 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma | ||||||||||||
| Official Title ICMJE | A Phase II Trial Of Thalidomide And Procarbazine In Adults With Recurrent/Progressive Gliomas | ||||||||||||
| Brief Summary | 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. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
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. |
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| Study Phase | Phase II | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Treatment, Open Label | ||||||||||||
| Condition ICMJE | Brain and Central Nervous System Tumors | ||||||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||||||
| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Estimated Enrollment ICMJE | 55 | ||||||||||||
| Completion Date | |||||||||||||
| Primary Completion Date | |||||||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Other
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00079092 | ||||||||||||
| Responsible Party | |||||||||||||
| Study ID Numbers ICMJE | CDR0000354204, CCCWFU-91202, NCI-6358 | ||||||||||||
| Study Sponsor ICMJE | Wake Forest University Baptist Medical Center | ||||||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Wake Forest University Baptist Medical Center | ||||||||||||
| Verification Date | August 2009 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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