Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
RATIONALE: Drugs used in chemotherapy, such as flavopiridol, cytarabine, and mitoxantrone, 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 II trial is studying the side effects and how well giving flavopiridol together with cytarabine and mitoxantrone works in treating patients with newly diagnosed acute myeloid leukemia.
Drug: mitoxantrone hydrochloride
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Flavopiridol (NSC 649890, IND 46, 211) in Timed Sequential Combination With Cytosine Arabinoside (Ara-C) and Mitoxantrone for Adults With Newly Diagnosed, Previously Untreated, Poor- Risk Acute Myelogenous Leukemia|
- Complete Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/L and a platelet count of 100,000 L, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. A CR must be confirmed 4 to 6 weeks after the initial documentation. If possible, at least one bone marrow biopsy should be performed to confirm the CR.
|Study Start Date:||October 2006|
|Study Completion Date:||August 2009|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Flavopiridol, ara-C, mitoxantrone
alvocib IV Days 1-3
Other Name: flavopiridolDrug: cytarabine
cytarabine IV 72 hr infusion D6-8
Other Name: ara-CDrug: mitoxantrone hydrochloride
Mitoxantrone IV D9
Other Name: novantrone
- Determine the efficacy of flavopiridol, cytarabine, and mitoxantrone hydrochloride, in terms of complete response, in patients with newly diagnosed, poor-risk acute myeloid leukemia.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive flavopiridol IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Beginning 35-63 days after completion of course 1, patients achieving complete or partial remission may receive a second course of treatment as above.
Patients age 50 and over with "core binding factor" acute myeloid leukemia (AML) (e.g., t[8;21], inv, or t[16;16]) achieving a complete remission after course 1 of treatment may receive 3-4 courses of consolidation therapy comprising high-dose cytarabine at the discretion of the investigator.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Judith E. Karp, MD||Sidney Kimmel Comprehensive Cancer Center|