Laromustine, Daunorubicin, and Cytarabine in Treating Patients With Acute Myeloid Leukemia
This study has been completed.
Sponsor:
Institut Paoli-Calmettes
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00840684
First received: February 7, 2009
Last updated: May 12, 2011
Last verified: July 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Drugs used in chemotherapy, such as laromustine, daunorubicin, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of laromustine when given together with daunorubicin and cytarabine in treating patients with acute myeloid leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: amsacrine Drug: busulfan Drug: cytarabine Drug: daunorubicin hydrochloride Drug: laromustine Drug: melphalan Drug: mitoxantrone hydrochloride Procedure: allogeneic hematopoietic stem cell transplantation Procedure: autologous hematopoietic stem cell transplantation |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A PHASE I-II MULTICENTER STUDY OF THE CLORETAZINE-DAUNORUBICIN-ARACYTINE COMBINATION FOR THE TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) WITH UNFAVORABLE CYTOGENETICS |
Resource links provided by NLM:
Drug Information available for:
Busulfan
Cytarabine
Melphalan
Melphalan hydrochloride
Daunorubicin
Daunorubicin hydrochloride
Mitoxantrone
Mitoxantrone hydrochloride
Daunorubicin citrate
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Dose-limiting toxicity (phase I) [ Designated as safety issue: Yes ]
- Rate of complete remission (phase II) [ Designated as safety issue: No ]
| Estimated Enrollment: | 135 |
| Study Start Date: | January 2009 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To determine the dose of laromustine that can be combined with daunorubicin hydrochloride and cytarabine in patients with previously untreated acute myeloid leukemia with unfavorable cytogenetics. (Phase I)
- To determine the complete remission rate of this regimen as induction therapy. (Phase II)
Secondary
- To determine the complete response rate.
- To determine the safety profile of this regimen.
- To determine the overall and relapse-free survival.
- To evaluate the prognostic value of the molecular markers FLT3, duplications of MLL, and Evi-1.
OUTLINE: This is a multicenter, phase I dose-escalation study of laromustine followed by a phase II study.
- Induction treatment: Patients receive laromustine IV on day 4, daunorubicin hydrochloride IV on days 1-3, and cytarabine IV continuously on days 1-7. Patients not attaining complete remission (CR) after first induction receive a second induction treatment comprising daunorubicin hydrochloride IV on days 1-3 and cytarabine IV twice daily on days 1-4. Patients in CR after 1 or 2 induction treatments proceed to consolidation treatment.
- Consolidation treatment: Patients receive mini-consolidation treatment comprising amsacrine on day 1 and cytarabine IV twice daily on days 1-5 followed by 2 courses of continuing consolidation treatment comprising mitoxantrone hydrochloride on days 1 and 2 and cytarabine IV over 12 hours on days 1-5.
- Allogeneic or autologous stem cell transplantation: Patients receive busulfan four times daily for 4 days and melphalan followed by allogeneic or autologous stem cell transplantation.
After completion of study treatment, patients are followed periodically for 5 years.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia (AML)
- Untreated disease
- No promyelocytic AML
Unfavorable prognosis, defined as at least one of the following:
- Cytogenetic abnormalities including -5/5q-, -7/7q-, 3q, 11q23, t(6;9), and complex abnormalities (≥ 3 clonal abnormalities), excluding t(9;11)
- Baseline hyperleukocytosis ≥ 100 g/L or progression of leukocytosis or extra-medullary localizations despite treatment with hydroxyurea
- No AML with favorable or intermediate prognosis
- No AML secondary to myelodysplastic syndrome diagnosed within the past 3 months or myeloproliferative syndrome
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Total bilirubin < 35 μmol/L
- Transaminases < 2.5 times upper limit of normal in the absence of leukemia-related abnormalities
- Creatinine < 170 μmol/L OR creatinine clearance ≥ 50 mL/min in the absence of leukemia-related abnormalities
- Not pregnant or nursing
- Normal cardiac function by LVEF (echographic ≥ 40% or isotopic ≥ 50%)
- Affiliated with a social security system
No uncontrolled or severe cardiovascular disease, including any of the following:
- Myocardial infarction within the past 3 months
- Cardiac insufficiency
- Uncontrolled arrhythmia
- No other active cancer within the past year except for basal cell carcinoma of the skin or epithelioma in situ of the cervix
- No patients deprived of freedom or under guardianship (including temporary guardianship)
- No psychological, familial, geographical, or social situations that preclude follow-up
- No other contraindications to study treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior hydroxyurea allowed
- No concurrent disulfiram
- No concurrent participation in another study with an experimental drug
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840684
Locations
| France | |
| Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | |
| Marseille, France, 13273 | |
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
| Principal Investigator: | Norbert Vey, MD | Institut Paoli-Calmettes |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00840684 History of Changes |
| Other Study ID Numbers: | CDR0000634230, IPC-LAM-HR, IPC-2006-007, INCA-RECF0902, EUDRACT-2007-001082-15 |
| Study First Received: | February 7, 2009 |
| Last Updated: | May 12, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adult acute myeloid leukemia with 11q23 (MLL) abnormalities untreated adult acute myeloid leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Amsacrine Busulfan Cytarabine Daunorubicin Melphalan Mitoxantrone Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Antibiotics, Antineoplastic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013