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

Primary Purpose

Leukemia

Status
Unknown status
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
cytarabine
daunorubicin hydrochloride
everolimus
laboratory biomarker analysis
pharmacological study
Sponsored by
Institut de Recherche Clinique sur les Cancers et le Sang
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital CochinRecruiting

Outcomes

Primary Outcome Measures

Maximum tolerated dose of everolimus
Toxicity

Secondary Outcome Measures

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

Full Information

First Posted
October 13, 2007
Last Updated
September 16, 2013
Sponsor
Institut de Recherche Clinique sur les Cancers et le Sang
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1. Study Identification

Unique Protocol Identification Number
NCT00544999
Brief Title
Everolimus, Cytarabine, and Daunorubicin in Treating Patients With Relapsed Acute Myeloid Leukemia
Official Title
Phase I Study Evaluating the Chemosensitizing Effect of Everolimus Administered With Cytarabine and Daunorubicin in Patients With Acute Myeloid Leukemia in Relapse
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Institut de Recherche Clinique sur les Cancers et le Sang

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
daunorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
everolimus
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
pharmacological study
Primary Outcome Measure Information:
Title
Maximum tolerated dose of everolimus
Title
Toxicity
Secondary Outcome Measure Information:
Title
Activation of PI3K/AKT and mTORC 1 in leukemic blasts
Title
Pharmacokinetics of everolimus

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Park, MD
Organizational Affiliation
Institut de Recherche Clinique sur les Cancers et le Sang
Facility Information:
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75674
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Park, MD
Phone
33-140-514-543

12. IPD Sharing Statement

Learn more about this trial

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

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