Status:
COMPLETED
Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Relapsed or Refractory Acute Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- No other concurrent chemotherapy, radiotherapy, or immunotherapy
- No acute promyelocytic leukemia (M3)
- No hyperleukocytosis with \> 50,000 blasts/mm\^3
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00470197
Start Date
April 1 2007
Last Update
September 30 2013
Active Locations (2)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287-8936
2
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792