Trials / Completed
CompletedNCT00061880
BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma
Phase 1-2 Multi-Center Study of Intravenous BCX-1777 in Patients With Refractory Cutaneous T-Cell Lymphoma (CTCL)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- BioCryst Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | forodesine hydrochloride |
Timeline
- Start date
- 2003-02-01
- Primary completion
- 2005-01-01
- Completion
- 2008-01-01
- First posted
- 2003-06-06
- Last updated
- 2013-05-30
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00061880. Inclusion in this directory is not an endorsement.