Status:
COMPLETED
Phase II Study of Perifosine in Patients With Refractory and Relapsed Leukemia
Lead Sponsor:
AEterna Zentaris
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable remission. Patients with poor-risk myelodysplasia (MDS) \[i.e. refractory anemia with excess blasts (RAEB-1 or RAEB-2) by WHO classification\] and chronic myelomonocytic leukemia (CMML) are also candidates for this protocol. Relapsed/refractory leukemias include acute non-lymphocytic leukemia (AML) by WHO classification, acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), or chronic myelogenous leukemia (CML) in blast crisis. Patients with agnogenic myeloid metaplasia (AMM) are also eligible.
- ECOG performance status of 0-2
- Sexually active men and women who are not surgically sterile or post menopausal must use acceptable contraceptive methods (physician will discuss acceptable methods) during the time on study and for 4 weeks following the completion of treatment. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this trial.
- In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least five half-lives for noncytotoxic agents. Persistent chronic toxicities from prior chemotherapy must not be greater than grade 1.
- Patients must have the following clinical laboratory values:
- Serum creatinine: \<= 2.0 mg/dl
- Total bilirubin: \<=1.5x the upper limit of normal unless considered due to Gilbert's syndrome
- Alanine aminotransferase (ALT), or aspartate aminotransferase (AST): \<= 3x the upper limit of normal unless considered due to organ leukemic involvement
- Must be able and willing to give written informed consent
- Age equal to or greater than 18 years
Exclusion
- Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure
- Patients with a history of severe hyper-reactive airway system (e.g. active asthma, COPD)
- Patients receiving any other standard or investigational treatment for their hematologic malignancy
- Pregnant and nursing patients are excluded because the effects of perifosine on a fetus or nursing child are unknown.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00391560
Start Date
October 1 2006
End Date
October 1 2011
Last Update
March 14 2018
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