Gary Dahl
Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
CompletedStanford Recruiting Status:
CompletedCondition(s):
Intervention(s):
- Drug: Drug: forodesine hydrochloride (BCX-1777)
Phase:
Phase 2Eligibility
Ages Eligible for Study:
Any Age to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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
Key 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
Additional Study Details
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) UseAnticipated start date:
2/15/2006Lead Sponsor:
BioCryst PharmaceuticalsInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
EfficacyPrimary Outcomes:
- Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL)
Secondary Outcomes:
- Safety and tolerability
- Pharmacokinetics (PK) and Pharmacodynamics (PD)
- maintenance of response and safety in long-term treatment
Total Number to be Enrolled:
20Total Number to be Enrolled at Stanford:
3More Information
Secondary ID(s):
- 96802
- BCX1777-T-04-201
- NCT00095381
- PEDSATL0001
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
4/17/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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