BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma

Phase 1

Completed

• 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.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2003-06-05
• Study First Submitted QC: 2003-06-05
• Study First Posted: 2003-06-06
• Status Verified: 2004-07
• Primary Completion: 2005-01
• Study Completion: 2008-01
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

University of Alabama at Birmingham Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States