Status:
COMPLETED
Flavopiridol and Vorinostat in Treating Patients With Relapsed or Refractory Acute Leukemia or Chronic Myelogenous Leukemia or Refractory Anemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Blastic Phase Chronic Myelogenous Leukemia
Recurrent Adult Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
PRIMARY OBJECTIVE: I. Determine recommended phase II doses for the combination of flavopiridol and vorinostat in patients with acute leukemia, chronic myelogenous leukemia in blast crisis, or refract...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00278330
Start Date
January 1 2006
Last Update
April 2 2013
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298