Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia.

Patients will receive an infusion of BCX-1777 on days 1-5. Treatment may be repeated every week for up to six courses. Patients are not required to be hospitalized for the administration of BCX-1777. Some patients may continue to receive an infusion of BCX-1777 twice a week for 6 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioCryst Pharmaceuticals

Criteria

Inclusion Criteria:

• Documented T-cell leukemia (precursor T-lymphoblastic leukemia/lymphomia or T-PLL)

• Failure to have responded to one or more standard regimens for their disease.

• Performance status of <=2 by Eastern Cooperative Oncology Group (ECOG) criteria

• All ages are eligible

• Life expectancy of at least 3 months

• Adequate liver function (aspartate transaminase [AST] and/or alanine transaminase [ALT] not >3 times upper limits or normal [ULN])

• Adequate kidney function (calculated creatinine clearance >50 mL/min)

• Negative urine pregnancy test within 2 to 7 days prior to the start of study treamtment in females of childbearing potential

• Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study

• Signed informed consent/assent form (ICF) prior to start of any study specific procedures

Exclusion Criteria:

• Patients with known HIV infection or human T-cell leukemia virus type (HTLV-1)

• Patients with known Hepatitis B and/or Hepatitis C active infection

• Patients with active CMV infection

• Tumor-related central nervous system (CNS) leukemia requiring active treatment

• Active serious infection not controlled by oral or IV antibiotics

• Treatment with any investigational anti-leukemic agent or chemotherapy agent within 7 days prior to study entry, unless full recovery from side effects has occurred.

• Rapidly progressive disease with compromised organ function judged to be life-threatening by the investigator

• Concurrent treatment with other anticancer agents (corticosteroid use will not be excluded, but patient must remain on the stable dose)

• Cutaneous T-cell lymphoma (CTCL) diagnosis (including Sezary Syndrome)

• Pregnant and/or lactating women