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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: October 13, 2007
Last updated: September 16, 2013
Last verified: July 2009

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.

Condition Intervention Phase
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: everolimus
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study Evaluating the Chemosensitizing Effect of Everolimus Administered With Cytarabine and Daunorubicin in Patients With Acute Myeloid Leukemia in Relapse

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose of everolimus [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Activation of PI3K/AKT and mTORC 1 in leukemic blasts [ Designated as safety issue: No ]
  • Pharmacokinetics of everolimus [ Designated as safety issue: No ]

Estimated Enrollment: 21
Study Start Date: September 2007
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Detailed Description:



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


  • 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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


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


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


Inclusion criteria:

  • See Disease Characteristics

Exclusion criteria:

  • Prior experimental medication within the past 4 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544999

Hopital Cochin Recruiting
Paris, France, 75674
Contact: Sophie Park, MD    33-140-514-543      
Sponsors and Collaborators
Institut de Recherche Clinique sur les Cancers et le Sang
Investigator: Sophie Park, MD Institut de Recherche Clinique sur les Cancers et le Sang
  More Information

ClinicalTrials.gov Identifier: NCT00544999     History of Changes
Other Study ID Numbers: CDR0000564068  IRLMS-GOELAMS-RAD001  INCA-RECF0476 
Study First Received: October 13, 2007
Last Updated: September 16, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent adult acute myeloid leukemia
secondary acute myeloid leukemia
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on May 04, 2016