Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Relapsed or Refractory Acute Leukemia
Completed · Phase 1
Conditions studied: 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
In brief
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. 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.
Key facts
- Study ID
- NCT00470197
- Run by
- National Cancer Institute (NCI)
- People needed
- 35
- Starts
- 2007-04-01
- Last updated by the study team
- 2013-09-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Pathologically confirmed acute myeloid leukemia or acute lymphoblastic leukemia:
- 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
- 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
Where it is running
- Johns Hopkins University — Baltimore, Maryland, United States
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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