Status:
COMPLETED
Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia
Lead Sponsor:
BioCryst Pharmaceuticals
Conditions:
Leukemia, T-Cell
Eligibility:
All Genders
Phase:
PHASE2
Brief 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 rec...
Detailed Description
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 rec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00095381
Start Date
March 1 2004
End Date
December 1 2007
Last Update
January 19 2012
Active Locations (24)
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1
Los Angeles, California, United States, 90024
2
Palo Alto, California, United States, 94304
3
Denver, Colorado, United States, 80262
4
Gainesville, Florida, United States, 32611