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

OBJECTIVES:

• 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.