Trial Search Results
Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia
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.
Stanford is currently not accepting patients for this trial.
- Drug: forodesine hydrochloride (BCX-1777)
- 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
- 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
Ages Eligible for Study
N/A - N/A
Genders Eligible for Study