Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Relapsed or Refractory Acute Leukemia
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ClinicalTrials.gov Identifier: NCT00470197 |
Recruitment Status :
Completed
First Posted : May 7, 2007
Last Update Posted : September 30, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
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 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) Adult Acute Myelomonocytic Leukemia (M4) Adult Erythroleukemia (M6a) Adult Pure Erythroid Leukemia (M6b) Malignant Neoplasm Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia | Drug: alvocidib Drug: cytarabine Drug: mitoxantrone hydrochloride Other: pharmacological study | Phase 1 |
OBJECTIVES:
I. Determine the toxicities of escalating doses of flavopiridol administered by "hybrid" bolus-infusion schedule and given in timed sequence with cytarabine and mitoxantrone hydrochloride in patients with refractory or relapsed acute leukemia.
II. Determine the incidence of clinical response in patients treated with this regimen.
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | 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 |
Study Start Date : | April 2007 |
Actual Primary Completion Date : | January 2011 |

Arm | Intervention/treatment |
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Experimental: Arm I
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.
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Drug: alvocidib
Given IV
Other Names:
Drug: cytarabine Given IV
Other Names:
Drug: mitoxantrone hydrochloride Given IV
Other Names:
Other: pharmacological study Correlative study
Other Name: pharmacological studies |
- Maximum tolerated dose determined by dose-limiting toxicities graded according to NCI-CTC version 3.0 [ Time Frame: Up to 63 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Pathologically confirmed acute myeloid leukemia or acute lymphoblastic leukemia:
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Relapsed >= 1 time OR refractory disease:
- Patients who fail primary induction therapy or who relapse after achieving complete remission are eligible if they have received =< 3 prior courses of induction/reinduction therapy
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- Relapsed >= 1 time OR refractory disease
- Patients who fail primary induction therapy or who relapse after achieving complete remission are eligible if they have received =< 3 prior courses of induction/reinduction therapy
- No active CNS leukemia
- ECOG performance status 0-2
- AST and ALT =< 5 times upper limit normal (ULN)
- Alkaline phosphatase =< 5 times ULN
- Bilirubin =< 2.0 mg/dL
- Creatinine =< 2.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- LVEF >= 45% by MUGA or ECHO
- No active, uncontrolled infection
- No other life-threatening illness
- No mental deficits and/or psychiatric history that would preclude study compliance
- No active graft-vs-host disease
- Recovered from all prior therapies
- At least 24 hours since prior hydroxyurea, steroids, imatinib mesylate, arsenic trioxide, interferon, or leukapheresis for blast count control
- At least 4 weeks since prior stem cell transplantation (autologous or allogeneic)
- At least 4 days since prior growth factors
- At least 3 weeks since prior chemotherapy, except for non-aplasia producing treatments (e.g., low-dose cyclophosphamide, hydroxyurea, interferon, imatinib mesylate, mercaptopurine, thalidomide, azacitidine, or decitabine)
- No prior flavopiridol
- No other concurrent chemotherapy, radiotherapy, or immunotherapy
- No acute promyelocytic leukemia (M3)
- No hyperleukocytosis with > 50,000 blasts/mm^3

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470197
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287-8936 | |
United States, Wisconsin | |
University of Wisconsin Hospital and Clinics | |
Madison, Wisconsin, United States, 53792 |
Principal Investigator: | Judith Karp | Johns Hopkins University |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00470197 |
Other Study ID Numbers: |
NCI-2009-00243 NCI-2009-00243 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) J06133 CDR0000543443 J06133 ( Other Identifier: Johns Hopkins University ) 7889 ( Other Identifier: CTEP ) U01CA070095 ( U.S. NIH Grant/Contract ) U01CA062491 ( U.S. NIH Grant/Contract ) |
First Posted: | May 7, 2007 Key Record Dates |
Last Update Posted: | September 30, 2013 |
Last Verified: | September 2013 |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Monocytic, Acute Leukemia, Myelomonocytic, Acute Leukemia, Megakaryoblastic, Acute Leukemia, Erythroblastic, Acute Neoplasms by Histologic Type Neoplasms Leukemia, Lymphoid Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Cytarabine Mitoxantrone Alvocidib Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |