BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00061880
- Lead Sponsor
- BioCryst Pharmaceuticals
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
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
University of Alabama at Birmingham Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States