Phase II Study of Perifosine in Patients With Refractory and Relapsed Leukemia
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|ClinicalTrials.gov Identifier: NCT00391560|
Recruitment Status : Completed
First Posted : October 24, 2006
Last Update Posted : March 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: perifosine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Perifosine in Patients With Refractory and Relapsed Leukemia|
|Study Start Date :||October 2006|
|Primary Completion Date :||October 2010|
|Study Completion Date :||October 2011|
Experimental: Perifosine Daily
Perifosine Daily Dose
- Overall Response Rate (CR + PR) [ Time Frame: Every 4 weeks ]
- Time to Tumor Progression [ Time Frame: Every 4 weeks ]
- Hematologic Improvement [ Time Frame: Every 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391560
|Study Chair:||Frank Giles, MD||M.D. Anderson Cancer Center|