Flavopiridol and Vorinostat in Treating Patients With Relapsed or Refractory Acute Leukemia or Chronic Myelogenous Leukemia or Refractory Anemia
Completed · Phase 1
Conditions studied: Blastic Phase Chronic Myelogenous Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Refractory Anemia With Excess Blasts, Relapsing Chronic Myelogenous Leukemia, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Adult Acute Myeloid Leukemia
In brief
This phase I trial is studying the side effects and best dose of flavopiridol when given together with vorinostat in treating patients with relapsed or refractory acute leukemia or chronic myelogenous leukemia or refractory anemia. Flavopiridol and vorinostat may cause leukemia cells to look more like normal cells, and to grow and spread more slowly. Vorinostat may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving flavopiridol together with vorinostat may be an effective treatment for leukemia or refractory anemia.
Key facts
- Study ID
- NCT00278330
- Run by
- National Cancer Institute (NCI)
- People needed
- 24
- Starts
- 2006-01-01
- Last updated by the study team
- 2013-04-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of one of the following:
- Relapsed or refractory acute leukemia (acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL], or acute leukemia unclassifiable) following at least one prior systemic treatment
- Acute leukemia in a patient 60 years or older (no requirement for prior treatment)
- Acute leukemia that has evolved from a prior myelodysplastic syndrome
- Chronic myelogenous leukemia (CML) in blast crisis following prior imatinib mesylate therapy
- Refractory anemia with excess blasts-2 (RAEB-2)
- No known CNS leukemia
- ECOG performance status 0-2
- WBC < 50,000µL
- Hydroxyurea and/or leukaphereses may be used to lower WBC
- Creatinine =< 1.5 times upper limit of normal (ULN) OR creatinine clearance >= 50 mL/min
- Total bilirubin =< 2 times ULN
- AST/ALT =< 2.5 times ULN
- QTc interval =< 0.470 seconds
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- No other condition that would preclude study participation
- At least 3 weeks since prior treatment (expect leukaphereses)
- No valproic acid therapy within the past 2 weeks
- No prior autologous or allogeneic bone marrow or stem cell transplantation
- No hydroxyurea use within the past 24 hours
- No concurrent treatment with other anti-cancer agents or investigational agents
Where it is running
- Virginia Commonwealth University — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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