Spots Global Cancer Trial Database for Phase II Study of Perifosine in Patients With Refractory and Relapsed Leukemia

Study Description

Brief Summary: 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.

Detailed Description: 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 74 patients will be enrolled on the study, all of them assigned to the same experimental treatment scheme (arm) described above. 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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