BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma
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.
|Study Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase 1-2 Multi-Center Study of Intravenous BCX-1777 in Patients With Refractory Cutaneous T-Cell Lymphoma (CTCL)|
|Study Start Date:||February 2003|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061880
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Alex Shalaurov, MD, PhD||Inveresk Research Group, Incorporated|