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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2007

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 recurrent or refractory advanced T-cell leukemia.

Interventions

  • Drug: forodesine hydrochloride (BCX-1777)

Clinical Trial Outcome Measures

Primary Measures

  • Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL)

Secondary Measures

  • Safety and tolerability
  • Pharmacokinetics (PK) and Pharmacodynamics (PD)
  • maintenance of response and safety in long-term treatment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • BioCryst Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor

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