Phase II Study of Perifosine in Patients With Refractory and Relapsed Leukemia
This is a Phase II trial designed to determine the efficacy and safety of perifosine in patients with leukemia who develop progressive disease or recurrence while receiving therapy.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Perifosine in Patients With Refractory and Relapsed Leukemia|
- Overall Response Rate (CR + PR) [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
- Time to Tumor Progression [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
- Hematologic Improvement [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: Perifosine Daily
Perifosine Daily Dose
Other Name: perifosine
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.