Status:
COMPLETED
Vorinostat in Treating Patients With Acute Myeloid Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Acute Erythroid Leukemia (M6)
Adult Acute Megakaryoblastic Leukemia (M7)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the toxicity and the proportion of complete remissions associated with two different treatment schedules of vorinostat (SAHA) in patients with acute myeloid leukemia....
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00305773
Start Date
January 1 2006
End Date
January 1 2010
Last Update
May 19 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905