LeukemiaPhase 1NCT00544999
Everolimus, Cytarabine, and Daunorubicin in Treating Patients With Relapsed Acute Myeloid Leukemia
A Phase 1 study testing cytarabine, daunorubicin hydrochloride and everolimus in people with Leukemia, run by Institut de Recherche Clinique sur les Cancers et le Sang at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leukemia
- What is being tested?
- cytarabine, daunorubicin hydrochloride and everolimus
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Cochin
Paris, 75674
Sophie Park, MD, 33-140-514-543
About this study
Official title: 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.
Read the 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.
- Conditions
- Leukemia
- Being tested
- cytarabine, daunorubicin hydrochloride, everolimus, laboratory biomarker analysis, pharmacological study
- 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)
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute, Leukemia, Monocytic, Acute, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytarabineDrug
daunorubicin hydrochlorideDrug
everolimusDrug
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of everolimus
Toxicity
Secondary outcomes (2)
Activation of PI3K/AKT and mTORC 1 in leukemic blasts
Pharmacokinetics of everolimus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche Clinique sur les Cancers et le Sang
- Sponsor type
- University, hospital or other
- Investigators
- Sophie Park, MD, Institut de Recherche Clinique sur les Cancers et le Sang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544999
- Sponsor's protocol ID
- CDR0000564068
- Other IDs
- IRLMS-GOELAMS-RAD001, INCA-RECF0476
- Status last verified
- Jul 2009
- First submitted
- 13 Oct 2007
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Evaluating the Chemosensitizing Effect of Everolimus Administered With Cytarabine and Daunorubicin in Patients With Acute Myeloid Leukemia in Relapse
- ClinicalTrials.gov ID
- NCT00544999
- Acronym / sponsor ID
- CDR0000564068
- Conditions
- 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)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Institut de Recherche Clinique sur les Cancers et le SangUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Apr 2010 (estimated)
- First posted
- 16 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of de novo or secondary acute myeloid leukemia meeting the following criterion:
- Life expectancy ≥ 4 weeks
- Transaminases ≤ 5 times normal
- Creatinine ≤ 2 times normal
- Bilirubin ≤ 3 times normal (except if visceral involvement present)
Key exclusion criteria (11 listed)
- Philadelphia chromosome-positive disease in blast crisis
- FAB M3, M6, or M7 disease
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cytarabine | Drug | – |
| daunorubicin hydrochloride | Drug | – |
| everolimus | Drug | – |
| laboratory biomarker analysis | Other | – |
| pharmacological study | Other | – |
Primary outcome
Maximum tolerated dose of everolimus
Toxicity
2 secondary outcomes
Activation of PI3K/AKT and mTORC 1 in leukemic blasts
Pharmacokinetics of everolimus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Park, MD
Institut de Recherche Clinique sur les Cancers et le Sang
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cytarabine, daunorubicin hydrochloride and everolimus in people with Leukemia, run by Institut de Recherche Clinique sur les Cancers et le Sang at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of everolimus. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.