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

NCT00391560 | Completed Phase 2

• 1 other identifier: Perifosine 217
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Leukemia

Keywords

refractory leukemia

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (CR + PR)

  All patients included in the study must be assessed for response to treatment, unless there are major protocol treatment deviations or they are ineligible. Even a 5% response rate would be of interest for this agent, given the different nature and mechanism of action of this compound.

  Every 4 weeks

Secondary Outcomes (2)

• Time to Tumor Progression

  Every 4 weeks

• Hematologic Improvement

  Every 4 weeks

Study Arms (2)

Group 1 on Perifosine

EXPERIMENTAL

Patients with AML, MDS, CML-BP non-lymphoid, CMML, or Agnogenic Myeloid Metaplasia (AMM). 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.

Drug: perifosine

Group 2 on Perifosine

EXPERIMENTAL

Patients with CLL, ALL, or CML-BP lymphoid. 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.

Drug: perifosine

Interventions

perifosine DRUG

Identical intervention in both arms.

Also known as: D-21266, KRX-0401

Group 1 on Perifosine; Group 2 on Perifosine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AEterna Zentaris: lead

MeSH Terms

Conditions

Leukemia

Interventions

perifosine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Frank Giles, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single treatment arm. Two disease related analyses groups, i.e.: Group 1: AML, MDS, CML-BP non-lymphoid, CMML, Agnogenic Myeloid Metaplasia (AMM); Group 2: CLL, ALL, CML-BP lymphoid

Study Record Dates

• First Submitted: October 20, 2006
• First Posted: October 24, 2006
• Study Start: October 1, 2006
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2011
• Last Updated: March 14, 2018

Record last verified: 2012-02