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

Not Recruiting

Trial ID: NCT00095381

Purpose

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.

Official Title

A Phase II, Multi-Center Open-Label, Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia With an Option of Long-Term Forodesine Hydrochloride (BCX-1777) Use

Stanford Investigator(s)

Eligibility

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

Intervention(s):

drug: forodesine hydrochloride (BCX-1777)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nadeem Mukhtar
6504978815

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