Clinical trial NCT00095381: Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia, T-Cell
Keywords: Leukemia, Lymphocytic, T-Cell
Entry Term Lymphocytic Leukemia, T-Cell
T-Cell Leukemia
T-Lymphocytic Leukemia
Leukemia, Lymphocytic, T Cell
T Lymphocytic Leukemia
BCX-1777
forodesine hydrochloride
BioCryst
Lead sponsor: BioCryst Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2004-11-04
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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 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.

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.

Eligibility 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

Primary outcomes:
measure: Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL)
Secondary outcomes:
measure: Safety and tolerability
measure: Pharmacokinetics (PK) and Pharmacodynamics (PD)
measure: maintenance of response and safety in long-term treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Gainesville
country: United States
state: Florida
city: Lecanto
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: New Orleans
country: United States
state: Louisiana
city: Detroit
country: United States
state: Michigan
city: Rolla
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Hackensack
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: New York
country: United States
facility: Weil Medical College of Cornell University
state: New York
city: New York
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Spartanburg
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Abingdon
country: United States
state: Virginia
city: Tbilisi
country: Georgia
Study officials:
References: