Vorinostat in Treating Patients With Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for their growth. Giving the drug in different ways may kill more cancer cells. This randomized phase II trial is studying two different schedules of vorinostat to see how well they work in treating patients with acute myeloid leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of acute myeloid leukemia (AML), meeting 1 of the following criteria:

• Relapsed AML in the following categories:

• Good-risk cytogenetics [inv(16), t (8;21)] in second relapse or in first relapse following a remission of < 12 months

• Acute promyelocytic leukemia (M3) in second relapse or greater AND must have relapsed following both tretinoin-anthracycline-based therapy and arsenic trioxide-based therapy

• All other relapsed patients are eligible

• Untreated AML in the following categories:

• At least 65 years of age

• Myelodysplastic syndromes-AML (AML with trilineage dysplasia)

• AML with del5Q or monosomy 5, monosomy 7, or complex cytogenetics (≥ 3 cytogenetic abnormalities)

• Refused or ineligible for potentially curative options such as allogeneic stem cell transplantation

• No clinical evidence of CNS or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia

• ECOG performance status (PS) 0-2 or Karnofsky PS ≥ 60%

• Life expectancy ≥ 3 months

• Bilirubin normal unless attributed to hemolysis or Gilbert's disease in the opinion of the investigator

• AST/ALT ≤ 2.5 times upper limit of normal (ULN)

• Creatinine normal OR creatinine clearance ≥ 60 mL/min

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat

• No uncontrolled intercurrent illness, including any of the following:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• Psychiatric illness or social situation that would limit compliance with study requirements

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No known HIV positivity

• More than 4 weeks since prior radiotherapy

• More than 2 weeks since prior valproic acid

• More than 3 weeks since other prior treatment for AML, including hematopoietic growth factors

• Hydroxyurea for WBC > 30,000/mm^3 allowed

• Recovered from prior therapy

• No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), epoetin alfa, or darbepoetin alfa

• No other concurrent investigational agents

• No other concurrent anticancer agents or therapies for this cancer