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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: | NCT00470197 |
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 a new schedule of more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects, best dose, and best schedule for flavopiridol when given together with cytarabine and mitoxantrone in treating patients with relapsed or refractory acute leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: alvocidib Drug: cytarabine Drug: mitoxantrone hydrochloride Other: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of a Pharmacologically Derived Hybrid Bolus-Infusion Schedule of Flavopiridol (NSC 649890, IND 46,211) Given in Timed Sequential Combination With Cytosine Arabinoside (Ara-C) and Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias |
Estimated Enrollment: | 35 |
Study Start Date: | April 2007 |
Estimated Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of flavopiridol.
Patients receive flavopiridol IV over 30 minutes on days 1, 2, and 3. Patients receive cytarabine IV continuously over 72 hours beginning on day 6 and mitoxantrone hydrochloride IV over 60-120 minutes on day 9. Treatment repeats every 35-63 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Serum and bone marrow samples are collected at baseline, during, and after completion of treatment for future studies. Flavopiridol levels are measured at baseline and on days 1-3 for pharmacokinetics.
PROJECTED ACCRUAL: A total of 35 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:
Pathologically confirmed acute myeloid leukemia or acute lymphoblastic leukemia
Relapsed ≥ 1 time OR refractory disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231-2410 | |
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu |
Study Chair: | Judith E. Karp, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000543443, JHOC-7889 |
Study First Received: | May 3, 2007 |
Last Updated: | February 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00470197 History of Changes |
Health Authority: | Unspecified |
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) recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia 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) adult acute megakaryoblastic leukemia (M7) adult acute minimally differentiated myeloid leukemia (M0) |
Leukemia, Monocytic, Acute Antimetabolites Leukemia, Lymphoid Immunologic Factors Acute Myelomonocytic Leukemia Acute Monoblastic Leukemia Leukemia, Myeloid, Acute Protein Kinase Inhibitors Leukemia Acute Myelocytic Leukemia Acute Erythroblastic Leukemia Acute Myeloid Leukemia, Adult Analgesics Congenital Abnormalities |
Acute Lymphoblastic Leukemia Cytarabine Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid Antiviral Agents Immunosuppressive Agents Recurrence Leukemia, Myelomonocytic, Acute Flavopiridol Leukemia, Erythroblastic, Acute Peripheral Nervous System Agents Mitoxantrone Di Guglielmo's Syndrome |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Protein Kinase Inhibitors Leukemia Sensory System Agents Therapeutic Uses Analgesics Growth Inhibitors |
Cytarabine Neoplasms by Histologic Type Growth Substances Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Flavopiridol Neoplasms Mitoxantrone Peripheral Nervous System Agents Central Nervous System Agents |