Everolimus, Cytarabine, and Daunorubicin in Treating Patients With Relapsed Acute Myeloid Leukemia
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|---|---|
|
Leukemia |
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 |
- Maximum tolerated dose of everolimus [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- 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) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| Hopital Cochin | Recruiting |
| Paris, France, 75674 | |
| Contact: Sophie Park, MD 33-140-514-543 | |
| Investigator: | Sophie Park, MD | Institut de Recherches sur les Leucemies et les Maladies du Sang |
More Information
No publications provided
| 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: | December 13, 2009 |
| 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 Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Cytarabine Everolimus Sirolimus Daunorubicin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic Antifungal Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 23, 2013