Phase 1-2 Multi-Center Study of Intravenous BCX-1777 in Patients With Refractory Cutaneous T-Cell Lymphoma (CTCL)
- Determine the maximum tolerated dose of BCX-1777 in patients with refractory cutaneous
- 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.
Masking: Open Label, Primary Purpose: Treatment
Alex Shalaurov, MD, PhD
Inveresk Research Group, Incorporated
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|