NCT00544999

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 leukemia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Last Updated

September 17, 2013

Status Verified

July 1, 2009

Enrollment Period

2.6 years

First QC Date

October 13, 2007

Last Update Submit

September 16, 2013

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemiasecondary acute myeloid leukemiaadult 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) abnormalitiesadult 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)

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose of everolimus

  • Toxicity

Secondary Outcomes (2)

  • Activation of PI3K/AKT and mTORC 1 in leukemic blasts

  • Pharmacokinetics of everolimus

Interventions

cytarabineDRUG
daunorubicin hydrochlorideDRUG
everolimusDRUG
laboratory biomarker analysisOTHER
pharmacological studyOTHER

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of de novo or secondary acute myeloid leukemia meeting the following criterion:
  • Relapse \> 1 year after obtaining complete remission (any prior treatment allowed)

You may not qualify if:

  • Philadelphia chromosome-positive disease in blast crisis
  • FAB M3, M6, or M7 disease
  • PATIENT CHARACTERISTICS:
  • 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Cochin

Paris, 75674, France

RECRUITING

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, AcuteLeukemia, Monocytic, AcuteCongenital Abnormalities

Interventions

CytarabineDaunorubicinEverolimus

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesSirolimusMacrolidesLactones

Study Officials

  • Sophie Park, MD

    Institut de Recherche Clinique sur les Cancers et le Sang

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2007

First Posted

October 16, 2007

Study Start

September 1, 2007

Primary Completion

April 1, 2010

Last Updated

September 17, 2013

Record last verified: 2009-07

Locations

FR(1)