RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase II trial to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia or T-cell lymphoma.

Condition	Treatment or Intervention	Phase
acute leukemia adult T-cell leukemia and lymphoma childhood lymphoblastic lymphoma Non-Hodgkin's Lymphoma Prolymphocytic Leukemia	Drug: BCX-1777  Procedure: enzyme inhibitor therapy	Phase II

OBJECTIVES: Primary

• Determine the sustained effectiveness of BCX-1777 (by peripheral blood evaluation and confirmatory bone marrow evaluation) in patients with recurrent or refractory advanced T-cell leukemia or lymphoma.

Secondary

• Determine the safety and tolerability of multiple courses of this drug in these patients.
• Determine the effect of this drug on plasma levels of 2'-deoxyguanosine (dGuo) and red blood cell purine nucleoside phosphorylase (PNP) activity in these patients.
• Correlate the plasma levels of dGuo and PNP with efficacy parameters of this drug in these patients.
• Determine the steady-state pharmacokinetics and pharmacodynamics of this drug in these patients.
• Determine the maintenance of response to and safety of this drug given as long-term therapy in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive BCX-1777 IV over 30 minutes once daily on days 1-5. Treatment repeats every 7 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients who demonstrate a clinically significant response may continue to receive BCX-1777 once daily on days 1 and 4. Treatment repeats every 7 days for 6 courses.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of T-cell leukemia of one of the following types:
• T-cell acute lymphoblastic leukemia
• T-cell prolymphocytic leukemia
• T-cell lymphoma with circulating blasts
• No cutaneous T-cell lymphoma (including Sezary syndrome)
• Failed prior therapy OR relapsed after initial response to prior therapy
• No infrequent subsets of T-cell leukemia or natural killer leukemia (including large granular lymphocyte)
• No rapidly progressing disease with life-threatening, compensated organ function

PATIENT CHARACTERISTICS: Age

• Any age

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

Renal

• Creatinine clearance > 50 mL/min

Other

• No active serious infection uncontrolled by oral or IV antibiotics
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• More than 7 days since prior chemotherapy unless full recovery has occurred

Endocrine therapy

• Concurrent corticosteroids allowed provided the dose is stable during study treatment

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 7 days since prior investigational antileukemic agents unless full recovery has occurred
• No other concurrent anticancer agents

Study ID Numbers:  CDR0000370834; BIOCRYST-BCX1777-T-04-201
Record last reviewed:  September 2004
Record first received:  July 8, 2004
ClinicalTrials.gov Identifier:  NCT00086788
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-01