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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00407966 |
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.
Condition | Intervention | Phase |
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Leukemia |
Drug: alvocidib Drug: cytarabine Drug: mitoxantrone hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
Estimated Enrollment: | 25 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
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[16], 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed acute myeloid leukemia (AML), including the following subtypes:
Newly diagnosed de novo or secondary AML with ≥ 1 of the following poor-risk features:
AML with adverse cytogenetics, including any of the following:
No hyperleukocytosis (≥ 50,000 blasts/µL)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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 |
Study ID Numbers: | CDR0000518322, JHOC-J0669 |
Study First Received: | December 4, 2006 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00407966 |
Health Authority: | United States: Food and Drug Administration |
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) secondary acute myeloid leukemia untreated adult acute myeloid leukemia adult acute basophilic leukemia adult acute eosinophilic leukemia adult acute megakaryoblastic leukemia (M7) |
adult acute minimally differentiated myeloid leukemia (M0) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myelomonocytic leukemia (M4) adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) |
Leukemia, Monocytic, Acute Acute myelogenous leukemia Acute myelomonocytic leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Di Guglielmo's syndrome Leukemia, Myelomonocytic, Acute Flavopiridol Leukemia |
Leukemia, Erythroblastic, Acute Neoplasm Metastasis Acute erythroblastic leukemia Mitoxantrone Acute myeloid leukemia, adult Congenital Abnormalities Acute monoblastic leukemia Acute myelocytic leukemia Cytarabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Sensory System Agents Therapeutic Uses Growth Inhibitors Peripheral Nervous System Agents Analgesics Central Nervous System Agents |