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Phase II Study of Perifosine in Patients With Refractory and Relapsed Leukemia

Phase 2
18 Years
Not Enrolling

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Trial Information

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.

Inclusion Criteria:

- 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 Criteria:

- 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,

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate (CR + PR)

Outcome Time Frame:

Every 4 weeks

Safety Issue:


Principal Investigator

Frank Giles, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:

Perifosine 217



Start Date:

October 2006

Completion Date:

October 2011

Related Keywords:

  • Leukemia
  • refractory leukemia
  • Leukemia