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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 24, 2003 | ||||
| Last Updated Date | April 9, 2009 | ||||
| Start Date ICMJE | March 2004 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Progression-free survival at 6 months [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Progression-free survival at 6 months | ||||
| Change History | Complete list of historical versions of study NCT00052650 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Response (complete and partial response) [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Response (complete and partial response) | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent High-Grade Gliomas | ||||
| Official Title ICMJE | A Phase II Study Of Peginterferon Alpha-2B (PEG-INTRON) And Thalidomide In Adults With Recurrent High Grade Gliomas | ||||
| Brief Summary | RATIONALE: Biological therapies such as PEG-interferon alfa-2b use different ways to stimulate the immune system and stop cancer cells from growing. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if PEG-interferon alfa-2b is more effective with or without thalidomide in treating recurrent high-grade gliomas. PURPOSE: This phase II trial to study the effectiveness of PEG-interferon alfa-2b and thalidomide in treating patients who have recurrent high-grade gliomas. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to type of glioma (glioblastoma multiforme vs anaplastic glioma). Patients receive PEG-interferon alfa-2b subcutaneously once weekly and oral thalidomide once daily for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Active Control | ||||
| 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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 64 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| 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
Surgery
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 | NCT00052650 | ||||
| Responsible Party | Howard A. Fine, NCI - Neuro-Oncology Branch | ||||
| Study ID Numbers ICMJE | CDR0000258609, NCI-03-C-0002, NABTC-0201 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2008 | ||||
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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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