Flavopiridol and Vorinostat in Treating Patients With Relapsed or Refractory Acute Leukemia or Chronic Myelogenous Leukemia or Refractory Anemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Alvocidib; Vorinostat

Criteria

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