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Carboxyamidotriazole Plus Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00004146
First received: December 10, 1999
Last updated: May 1, 2012
Last verified: May 2012

December 10, 1999
May 1, 2012
May 2000
January 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00004146 on ClinicalTrials.gov Archive Site
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Carboxyamidotriazole Plus Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
Phase II Clinical and Pharmacologic Study of Radiation Therapy and CAI (Carboxy-amido Triazole) in Adults With Newly Diagnosed Glioblastoma Multiforme

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: carboxyamidotriazole
  • Radiation: radiation therapy
Not Provided
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]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
January 2010   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004146
NABTT-9904 CDR0000067378, U01CA062475, NABTT-9904, JHOC-NABTT-9904
Not Provided
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Tom Mikkelsen, MD Josephine Ford Cancer Center at Henry Ford Hospital
Sidney Kimmel Comprehensive Cancer Center
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP