Overview
Study of ABT-751 in Patients With Refractory Hematologic Malignancies
Status:
Completed
Completed
Trial end date:
2005-01-01
2005-01-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
ABT-751 is a new antitumor drug that that interferes with cell division. The goal of this clinical research study is to find the highest safe dose of ABT-751 that can be given as a treatment for refractory hematologic malignancies. The safety and side effects of ABT-751 will also be studied.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
M.D. Anderson Cancer Center
Criteria
Inclusion Criteria- Patients with relapsed or refractory acute leukemias (AML, ALL, MDS [RAEB, RAEBT],
CMML in transformation with >/= 10% peripheral blood/bone marrow blasts, CML in blast
crisis), and patients with relapsed/refractory or transformed CLL.
- Signed informed consent indicating that patients are aware of the investigational
nature of this study, and in keeping with the policies of this hospital.
- ECOG performance status = 2.
- Serum direct bilirubin = 2 mg/dL, serum SGOT or SGPT < 3 upper limit of normal,
serum creatinine = 2 mg/dL, unless considered due to organ leukemic involvement.
- Age > 16 years - a separate Phase I study is being conducted in the pediatric
population.
Exclusion Criteria
- Any severe, concurrent disease, infection, or co-morbidity that, in the judgment of
the Investigator, would make the patient inappropriate for study entry.
- Pregnant and/or lactating females.
- Those with documented sulfonamide allergy should be excluded from study participation.