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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
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
Overall Survival Rate
estimated period of time event assessed 30 months. event assessed from time of histological diagnosis to death
Time frame: approximately 30 months
Toxicity of CAI When Combined With RT
patients who experienced a grade 3 or higher event considered at least possibly related to CAI
Time frame: pts were reviewed for toxicity while on treatement - median time of 2 months
Correlation Between PK CAI and Toxicity in This pt Population
PK paramenters including steady state CAI concentrations with toxicity/or drug activity
Time frame: during treatment
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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