Phase II Study of Perifosine in Patients With Refractory and Relapsed Leukemia
This is a Phase II study of perifosine in patients with refractory and relapsed leukemia.
After a one time loading dose of 600 mg (150 mg x 4 at least 4 hours apart) during the first
cycle, perifosine will be given orally at 100 mg once a day continuously. Cycles are 28
days in length. Intra-patient dose escalation for the maintenance dose to 150 mg daily will
be done in the second cycle if no non-hematological toxicities beyond grade 0-1 occurred
during the first cycle are observed.
Patients will be assessed for efficacy at the end of each 28 day cycle of therapy, +/- 7
days. Complete remissions, partial remissions and hematological improvements of any kind
will be counted towards an objective response for all diseases.
A maximum total of 37 evaluable patients will be entered in each of two diagnostic groups,
which are being distinguished due to different anticipated rates of accrual. Group 1: AML,
MDS, CML-BP non-lymphoid, CMML, Agnogenic Myeloid Metaplasia (AMM); Group 2: CLL, ALL,
CML-BP lymphoid. A maximum total of 74 patients will be enrolled on the study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (CR + PR)
Every 4 weeks
Frank Giles, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration