BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00061880|
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : May 30, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: forodesine hydrochloride||Phase 1 Phase 2|
- 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 (Clinical Trial)|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||January 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|