Clofarabine, Etoposide, and Mitoxantrone for Relapsed and Refractory Acute Leukemias
This will be a phase I study with a standard 3x3 design. Patients will proceed to treatment
through a series of cohorts with the three drugs being delivered over five days beginning
with a dose of Etoposide 100 mg/m2 on days 1-5,Mitoxantrone 8 mg/m2 days 1-3, and
clofarabine at 20 mg/m2 IV on days 2-6. Presuming this and subsequent cohorts are tolerable
and no more than 1 patient per cohort develops DLT, MTD patients will be treated in cohorts
of 3-6 patients up to a final dose level of Etoposide 100 mg/m2 on days 1-5,Mitoxantrone 8
mg/m2 days 1-5, and Clofarabine at 30 mg/m2 IV on days 2-6. Patients failing to enter
remission may receive 4 days of therapy with Etoposide 100 mg/m2 on days 1-4,Mitoxantrone 8
mg/m2 days 1-2 or 1-4,and Clofarabine at 20-30 mg/m2 IV on days 1-4. According to
established definitions for dose limiting toxicity a recommended phase II dose will be
established. After this is established the final cohort will be expanded to 15 patients.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Establish toxicity of Clofarabine in combination with Etoposide and Mitoxantrone for therapy of relapsed or refractory acute leukemias
Days 30-45
Yes
David F. Claxton, MD
Principal Investigator
Penn State College of Medicine
United States: Institutional Review Board
PSHCI 08-096
NCT00882076
March 2009
September 2013
Name | Location |
---|---|
Penn State Hershey Cancer Institute | Hershey, Pennsylvania 17033 |