Phase II Study of Perifosine in Patients With Refractory and Relapsed Leukemia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Leukemia	Drug: perifosine	Phase 2

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia

U.S. FDA Resources

Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:

Overall Response Rate (CR + PR) [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	19
Study Start Date:	October 2006
Study Completion Date:	October 2011
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Perifosine Daily Perifosine Daily	Drug: perifosine Perifosine Daily Dose Other Name: perifosine

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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, 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391560

Sponsors and Collaborators

AEterna Zentaris

Investigators

Study Chair:

Frank Giles, MD

M.D. Anderson Cancer Center

More Information

No publications provided

Responsible Party:	AEterna Zentaris
ClinicalTrials.gov Identifier:	NCT00391560 History of Changes
Other Study ID Numbers:	Perifosine 217
Study First Received:	October 20, 2006
Last Updated:	March 4, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by AEterna Zentaris:

refractory leukemia

Additional relevant MeSH terms:

Leukemia
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013