Phase I-II Study of Liposomal Vincristine (VSLI) and Dexamethasone in Relapsed or Refractory Acute Lymphoblastic Leukemia
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of liposomal vincristine given with
dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia
(ALL).
- Determine the efficacy of liposomal vincristine given with dexamethasone in these
patients.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD of VSLI
Subjects had to receive at least 1 course consisting of 4 weekly infusions of VSLI at the assigned drug dose with a minimum 2 weeks of observation after the last VSLI dose to be included in the evaluation of the MTD.
6 weeks
Yes
Deborah Thomas, MD
Principal Investigator
MD Anderson Cancer Center, Department of Hematology/Oncology
United States: Food and Drug Administration
VSLI-06-ALL
NCT00144963
July 2002
August 2006
Name | Location |
---|---|
Emory University | Atlanta, Georgia 30322 |
University of Chicago Medical Center | Chicago, Illinois 60637 |
University of Texas M.D. Anderson Cancer Center | Houston, Texas 77030 |