Forodesine (BCX-1777) in Treating Patients With Refractory Stage IIA, Stage IIB, Stage III, Stage IVA, or Stage IVB Cutaneous T-Cell Lymphoma
RATIONALE: Forodesine (BCX-1777) may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory stage IIA, stage IIB, stage III, stage IVA, or stage IVB cutaneous T-cell lymphoma.
|Study Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I, Multi-Center, Open-Label, Safety and Pharmacokinetic, Repeat-Dose Study of Oral Forodesine Hydrochloride in Patients With Refractory Cutaneous T-Cell Lymphoma|
|Study Start Date:||November 2004|
|Study Completion Date:||July 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- Determine the safety and efficacy of forodesine (BCX-1777) in patients with refractory stage IIA-IVB cutaneous T-cell lymphoma.
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral forodesine (BCX-1777) once daily on days 1-28. Courses may be repeated in the absence of disease progression or unacceptable toxicity.
Patients are followed periodically.
PROJECTED ACCRUAL: Not specified.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098332
|United States, Alabama|
|Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, Arkansas|
|Burke Pharmaceutical Research|
|Hot Springs, Arkansas, United States, 71913|
|United States, California|
|Stanford Comprehensive Cancer Center - Stanford|
|Stanford, California, United States, 94305|
|United States, Colorado|
|University of Colorado Cancer Center at UC Health Sciences Center|
|Aurora, Colorado, United States, 80045|
|United States, Connecticut|
|Yale Cancer Center|
|New Haven, Connecticut, United States, 06520-8028|
|United States, Florida|
|Cancer and Blood Disease Center|
|Lecanto, Florida, United States, 34461|
|United States, Massachusetts|
|Dana-Farber/Brigham and Women's Cancer Center|
|Boston, Massachusetts, United States, 02115|
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Charles M. Barrett Cancer Center at University Hospital|
|Cincinnati, Ohio, United States, 45219|
|United States, Texas|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|