Everolimus, Cytarabine, and Daunorubicin in Treating Patients With Relapsed Acute Myeloid Leukemia

September 16, 2013 updated by: Institut de Recherche Clinique sur les Cancers et le Sang

Phase I Study Evaluating the Chemosensitizing Effect of Everolimus Administered With Cytarabine and Daunorubicin in Patients With Acute Myeloid Leukemia in Relapse

RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Everolimus may help cytarabine and daunorubicin work better by making cancer cells more sensitive to chemotherapy. Giving everolimus together with cytarabine and daunorubicin may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with cytarabine and daunorubicin in treating patients with relapsed acute myeloid leukemia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of everolimus.
  • Determine the toxicity of this regimen.

Secondary

  • Assess the activation of PI3K/AKT and mTORC 1 in leukemic blasts.
  • Evaluate the pharmacokinetics of everolimus at different concentrations.

OUTLINE: This is a multicenter study.

Patients receive primary induction therapy comprising daunorubicin hydrochloride IV on days 1-3, cytarabine IV over 24 hours on day 1, and oral everolimus on days 1 and 7. Patients with more than 5% blasts on day 15 receive a second induction course comprising daunorubicin hydrochloride IV on days 17 and 18 and cytarabine IV twice daily on days 17-20.

After completion of study therapy, patients are followed for 3 months.

Study Type

Interventional

Enrollment (Anticipated)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75674
        • Recruiting
        • Hôpital COCHIN
        • Contact:
          • Sophie Park, MD
          • Phone Number: 33-140-514-543

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Diagnosis of de novo or secondary acute myeloid leukemia meeting the following criterion:

    • Relapse > 1 year after obtaining complete remission (any prior treatment allowed)

Exclusion criteria:

  • Philadelphia chromosome-positive disease in blast crisis
  • FAB M3, M6, or M7 disease

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Life expectancy ≥ 4 weeks
  • Transaminases ≤ 5 times normal
  • Creatinine ≤ 2 times normal
  • Bilirubin ≤ 3 times normal (except if visceral involvement present)
  • Alkaline phosphatase or gamma-glutamyltransferase ≤ 5 times normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients of must use effective contraception during and for ≥ 28 days after completion of study therapy

Exclusion criteria:

  • FEV1 < 30%
  • Active uncontrolled or viral pulmonary infection
  • Serious psychiatric disorders not related to leukemia or any condition that would prohibit comprehension of the study
  • HIV-positive
  • Other concurrent malignancy except noninvasive skin cancer or carcinoma in situ
  • Patients who are incarcerated or under supervision or trusteeship

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

  • See Disease Characteristics

Exclusion criteria:

  • Prior experimental medication within the past 4 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity
Maximum tolerated dose of everolimus

Secondary Outcome Measures

Outcome Measure
Activation of PI3K/AKT and mTORC 1 in leukemic blasts
Pharmacokinetics of everolimus

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherche Clinique sur les Cancers et le Sang

Investigators

  • Sophie Park, MD, Institut de Recherche Clinique sur les Cancers et le Sang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

October 13, 2007

First Submitted That Met QC Criteria

October 13, 2007

First Posted (Estimate)

October 16, 2007

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000564068
  • IRLMS-GOELAMS-RAD001
  • INCA-RECF0476

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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