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Lead
BioCryst Pharmaceuticals
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.
PROJECTED ACCRUAL: Not specified.
Human T-cell lymphotrophic virus type I (HTLV-I) negative
HIV negative
No active serious infection not controlled by antibiotics
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No known impaired absorption of the gastrointestinal tract
No other illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
More than 21 days since prior chemotherapy and recovered
Endocrine therapy
Concurrent topical corticosteroids allowed provided patient remains on a stable dose
Radiotherapy
No concurrent radiotherapy
Surgery
Not specified
Other
More than 30 days since prior investigational agents and recovered
No concurrent tanning bed use
No other concurrent therapy for cutaneous T-cell lymphoma
Clareo Health | Forodesine (BCX-1777) in Treating Patients With Refractory Stage IIA, Stage IIB, Stage III, Stage IVA, or Stage IVB Cutaneous T-Cell Lymphoma
