Carboxyamidotriazole Plus Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
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| First Received Date ICMJE | December 10, 1999 | ||||
| Last Updated Date | May 1, 2012 | ||||
| Start Date ICMJE | May 2000 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00004146 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Carboxyamidotriazole Plus Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme | ||||
| Official Title ICMJE | Phase II Clinical and Pharmacologic Study of Radiation Therapy and CAI (Carboxy-amido Triazole) in Adults With Newly Diagnosed Glioblastoma Multiforme | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of carboxyamidotriazole plus radiation therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme. |
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| Detailed Description | OBJECTIVES: I. Determine overall survival rate and duration of disease free progression in patients with newly diagnosed supratentorial glioblastoma multiforme treated with carboxyamidotriazole and radiotherapy. II. Evaluate the toxicities of this combination regimen in this patient population. III. Determine the correlations between pharmacokinetic parameters and toxicity and/or drug activity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive induction therapy consisting of radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks followed by carboxyamidotriazole alone daily for 4 weeks. Patients continue on oral carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for survival. PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study over 1.5 years. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Primary Purpose: Treatment | ||||
| Condition ICMJE | Brain and Central Nervous System Tumors | ||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Mikkelsen T, Lush R, Grossman SA, Carson KA, Fisher JD, Alavi JB, Rosenfeld S. Phase II clinical and pharmacologic study of radiation therapy and carboxyamido-triazole (CAI) in adults with newly diagnosed glioblastoma multiforme. Invest New Drugs. 2006 Nov 1; [Epub ahead of print] | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Histologically confirmed supratentorial glioblastoma multiforme PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 2 months after the study PRIOR CONCURRENT THERAPY: No prior therapy for the brain tumor except surgery No prior antineoplastic agents, including carboxyamidotriazole At least 10 days since prior hepatic enzyme inducing anticonvulsants |
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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 Number ICMJE | NCT00004146 | ||||
| Other Study ID Numbers ICMJE | NABTT-9904 CDR0000067378, U01CA062475, NABTT-9904, JHOC-NABTT-9904 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Sidney Kimmel Comprehensive Cancer Center | ||||
| Study Sponsor ICMJE | Sidney Kimmel Comprehensive Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | Sidney Kimmel Comprehensive Cancer Center | ||||
| Verification Date | May 2012 | ||||
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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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