Forodesine (BCX-1777) in Treating Patients With Refractory Stage IIA, Stage IIB, Stage III, Stage IVA, or Stage IVB Cutaneous T-Cell Lymphoma

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

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.

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.

DISEASE CHARACTERISTICS:

• Histologically confirmed cutaneous T-cell lymphoma

  • Refractory to prior treatment
  • Stage IIA, IIB, III, IVA, or IVB disease

• Measurable disease

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Not specified

Hepatic

• AST and/or ALT ≤ 3 times upper limit of normal
• Hepatitis B and/or hepatitis C negative

Renal

• Creatinine clearance ≥ 40 mL/min

Immunologic

• 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