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

NCT ID: NCT00544999

Last Updated: 2013-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Leukemia

Keywords

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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)

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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cytarabine

Intervention Type DRUG

daunorubicin hydrochloride

Intervention Type DRUG

everolimus

Intervention Type DRUG

laboratory biomarker analysis

Intervention Type OTHER

pharmacological study

Intervention Type OTHER

Eligibility Criteria

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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)


* 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


* See Disease Characteristics

Exclusion Criteria

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

PATIENT CHARACTERISTICS:


* 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:


* Prior experimental medication within the past 4 weeks
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Recherche Clinique sur les Cancers et le Sang

OTHER

Sponsor Role lead

Principal Investigators

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Sophie Park, MD

Role:

Institut de Recherche Clinique sur les Cancers et le Sang

Locations

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Hopital Cochin

Paris, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Sophie Park, MD

Role: primary

Other Identifiers

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IRLMS-GOELAMS-RAD001

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0476

Identifier Type: -

Identifier Source: secondary_id

CDR0000564068

Identifier Type: -

Identifier Source: org_study_id