RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase I/II trial to study the effectiveness BCX-1777 in treating patients who have refractory cutaneous T-cell lymphoma.
OBJECTIVES: * Determine the maximum tolerated dose of BCX-1777 in patients with refractory cutaneous T-cell lymphoma. * Determine the efficacy of this drug in these patients. * Determine the toxicity profile of this drug in these patients. * Correlate plasma concentration of deoxyguanosine with clinical response and toxicity in patients treated with this drug. * Determine the provisional optimal biological dose of this drug in these patients. OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study. * Phase I: Patients receive BCX-1777 IV over 30 minutes every 12 hours on days 1-5 (a total of 9 doses). Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BCX-1777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity. * Phase II: Patients receive treatment as in phase I at the MTD of BCX-1777. Patients (including those who respond to treatment) are followed at 14 and 30 days, monthly for 6 months, every 2 months for 6 months, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for phase I and 40 for phase II) will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.