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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00095381
Recruitment Status : Completed
First Posted : November 4, 2004
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
BioCryst Pharmaceuticals

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.


Condition or disease Intervention/treatment Phase
Leukemia, T-Cell Drug: forodesine hydrochloride (BCX-1777) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2004
Actual Primary Completion Date : March 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia




Primary Outcome Measures :
  1. Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL)

Secondary Outcome Measures :
  1. Safety and tolerability
  2. Pharmacokinetics (PK) and Pharmacodynamics (PD)
  3. maintenance of response and safety in long-term treatment


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095381


Locations
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United States, California
Los Angeles, California, United States, 90024
Palo Alto, California, United States, 94304
United States, Colorado
Denver, Colorado, United States, 80262
United States, Florida
Gainesville, Florida, United States, 32611
Lecanto, Florida, United States, 34461
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Illinois
Chicago, Illinois, United States, 60611
Chicago, Illinois, United States, 60637
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Louisiana
New Orleans, Louisiana, United States, 70118
United States, Michigan
Detroit, Michigan, United States, 48202
United States, Missouri
Rolla, Missouri, United States, 65401
St. Louis, Missouri, United States, 63110
United States, Nebraska
Omaha, Nebraska, United States, 68198
United States, New Jersey
Hackensack, New Jersey, United States, 07601
United States, New York
Bronx, New York, United States, 10467
Weil Medical College of Cornell University
New York, New York, United States, 10021
New York, New York, United States, 10021
Syracuse, New York, United States, 13210
United States, South Carolina
Spartanburg, South Carolina, United States, 29303
United States, Texas
Austin, Texas, United States, 78701
Houston, Texas, United States, 77030
United States, Virginia
Abingdon, Virginia, United States, 24211
Georgia
Tbilisi, Georgia, GE-380079
Sponsors and Collaborators
BioCryst Pharmaceuticals
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Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00095381    
Obsolete Identifiers: NCT00086788
Other Study ID Numbers: BCX1777-T-04-201
First Posted: November 4, 2004    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012
Keywords provided by BioCryst Pharmaceuticals:
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
Additional relevant MeSH terms:
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Leukemia
Leukemia, T-Cell
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases