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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioCryst Pharmaceuticals

Criteria

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