Status:
COMPLETED
Vorinostat and Decitabine in Treating Patients With Relapsed, Refractory, or Poor-Prognosis Hematologic Cancer or Other Diseases
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of vorinostat and decitabine in treating patients with relapsed, refractory, or poor-prognosis hematologic cancer or other diseases. Vorin...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximal tolerated dose (MTD) and dose limiting toxicities (DLT) of vorinostat in combination with Decitabine in patients with relapsed/refractory or poor progn...
Eligibility Criteria
Inclusion
- Patients must have histologically confirmed acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), chronic myelogenous leukemia (CML), myelodysplastic syndrome (MDS) or myeloproliferative disease (MPD)
- Patients with refractory or relapsed acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), chronic myelogenous leukemia (CML), myelodysplastic syndrome (MDS) IPSS intermediate 1 and above and myeloproliferative disease (MPD) will be considered for the study; patients with CML are eligible if they have documented hematologic resistance to imatinib mesylate, or lack of any cytogenetic response to imatinib mesylate after 12 months of therapy; patients with Chronic Myelomonocytic Leukemia (CMML) or Philadelphia negative CML are eligible if their disease is not controlled by standard therapy (e.g. hydroxyurea) or if they show signs of disease progression on standard therapy (blast count \> 5%, platelet count \< 100K); patients with Acute Promyelocytic Leukemia are eligible only if they have progressed after standard chemotherapy, ATRA as well as Arsenic Trioxide therapy; untreated patients older than 60 years of age with AML (except APL) or MDS IPSS intermediate 1 and above, not eligible for standard therapy, are also eligible
- Patients must have been off chemotherapy for 2 weeks (six weeks for nitrosoureas or mitomycin C) prior to entering this study and recovered from the toxic effects of that therapy unless there is evidence of rapidly progressive disease; if there is evidence or rapidly progressive disease, the use of hydroxyurea is allowed prior to starting the clinical trial and during the first cycle of therapy; other histone deacetylase inhibitors, including valproic acid, should be stopped 2 weeks prior to entering this study
- Life expectancy of greater than 8 weeks
- ECOG performance status 0-2
- Total bilirubin =\< 2 mg/dL
- AST(SGOT) or ALT(SGPT) =\< 2.5 X institutional upper limit of normal
- Creatinine =\< 2 mg/dL
- Cardiac ejection fraction \>= 50%
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- Patients may not be receiving any other investigational agents
- Patients with clinical evidence of CNS disease should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat or decitabine
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with vorinostat
- HIV-positive patients receiving combination antiretroviral therapy are ineligible
- Vorinostat should not be taken concomitantly with other HDAC inhibitors or compounds with HDAC inhibitor like activity, such as valproic acid; patients who have received such agents as anti-tumor therapy should not enroll in vorinostat oncology trials; patients who have received such agents for other indications, e.g. epilepsy, may enroll on vorinostat trials after a 30 day washout period
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00357708
Start Date
June 1 2006
Last Update
January 7 2013
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030