Spots Global Cancer Trial Database for Carboxyamidotriazole + RT in Treating Patients Newly Diagnosed Supratentorial GBM
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Trial Identification
Brief Title: Carboxyamidotriazole + RT in Treating Patients Newly Diagnosed Supratentorial GBM
Official Title: Phase II Clinical and Pharmacologic Study of Radiation Therapy and CAI (Carboxy-Amido Triazole) in Adults With Newly Diagnosed Glioblastoma Multiforme
Study ID: NCT00004146
Study Description
Brief Summary: 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. Phase II trial to study the effectiveness of carboxyamidotriazole plus radiation therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.
Detailed Description: PRIMARY OBJECTIVES: I. To evaluate overall survival rate in patients administered CAI (carboxyamidotriazole) and radiation therapy to adults with newly diagnosed glioblastoma multiforme. II. To determine the toxicity of CAI when combined with cranial irradiation. III. To estimate correlations between pharmacokinetic parameters, including steady state CAI concentration, with toxicity and/or drug activity in this patient population. IV. To estimate duration of disease free progression with this treatment regime. 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama Birmingham, Birmingham, Alabama, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States
Johns Hopkins University, Baltimore, Maryland, United States
Henry Ford Hospital, Detroit, Michigan, United States
Wake Forest University, Winston-Salem, North Carolina, United States
University of Pennsylavania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Contact Details
Name: Tom Mikkelsen, MD
Affiliation: New Approaches to Brain Tumor Therapy Consortium
Role: PRINCIPAL_INVESTIGATOR
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