Phase I-II Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive (High Grade) T-Cell Malignancies
N/A
N/A
Both
Leukemia, Lymphocytic, Lymphoma
Trial Information
Phase I-II Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive (High Grade) T-Cell Malignancies
Despite the great strides that have been made in improving the outcome with frontline
programs of intensive chemotherapy in patients with aggressive T-cell malignancies, the
prognosis with relapsed or refractory T-cell leukemias or lymphomas is poor. BCX-1777 is a
purine nucleoside phosphorylase (PNP) inhibitor and a potential T-cell target therapy.
The purpose of the phase I portion of the study is to determine the maximum tolerated dose
(MTD) of BCX-1777 and the dose to be studied in the phase II portion of the study.
The purpose of the phase II portion of the study is to determine the safety and efficacy of
BCX-1777 in patients with relapsed or refractory aggressive T-cell malignancies.
Patients who respond to BCX-1777 or have stable disease may be eligible to receive an
additional course of treatment.
Inclusion Criteria:
- Previously treated, relapsed or refractory aggressive T-cell malignancies (leukemias
and lymphomas) histologically proven with measurable disease.
- Capable of only limited self-care, confined to bed or chair more than 50% of waking
hours.
- All ages are eligible. Pediatric patients (<15 years of age) are eligible to be
treated at a dose level previously tested in adults.
- Adequate liver and renal function.
- Patients with prior history of stem cell transplant if they meet all other
eligibility requirements.
- Negative pregnancy test within 72 hours of study treatment in females of childbearing
potential.
- Life expectancy of at least 2 months.
Exclusion:
- Active serious infection not controlled by oral or intravenous antibiotics.
- Treatment with any investigational antileukemic agents or chemotherapy agents in the
last 7 days before study entry, unless full recovery from side-effects has occurred
or patient has rapidly progressive disease judged to be life-threatening by the
investigator.
- Concurrent treatment with other anti-cancer agents.
- Known CNS leukemia or lymphoma requiring intrathecal or craniospinal radiation
therapy. Lumbar puncture not required in asymptomatic patients.
- Pregnant and/or lactating women; or fertile men or women not willing to use
contraception.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Deborah A. Thomas, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
BC-01-02
NCT ID:
NCT00035022
Start Date:
August 2001
Completion Date:
March 2004
Related Keywords:
- Leukemia, Lymphocytic
- Lymphoma
- Leukemia, Lymphoma, T-Cell
- Leukemia
- Leukemia, Lymphoid
- Lymphoma
Name | Location |
|---|---|
| M.D. Anderson Cancer Center | Houston, Texas 77030 |
