Status:
COMPLETED
Decitabine and FR901228 in Treating Patients With Relapsed or Refractory Leukemia, Myelodysplastic Syndromes, or Myeloproliferative Disorders
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of decitabine and FR901228 in treating patients with relapsed or refractory leukemia, myelodysplastic syndromes or myeloproliferative diso...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of decitabine and FR901228 (depsipeptide) in patients with relapsed or refractory leukemia, myelodysplastic s...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following hematologic malignancies:
- Acute myeloid leukemia
- Previously untreated patients \> 60 years of age who are not eligible for front-line therapy are eligible for this study
- Acute lymphoblastic leukemia
- Chronic myelogenous leukemia (CML)
- Documented hematologic resistance to imatinib mesylate OR no cytogenetic response after 12 months of prior treatment with imatinib mesylate
- Philadelphia chromosome-negative CML allowed provided disease is resistant to standard therapy (e.g., hydroxyurea) OR disease progressed (blasts \> 5% and platelet count \< 100,000/mm\^3) during standard therapy
- Myelodysplastic syndromes
- International Prognostic Scoring System risk category ≥ intermediate-1
- Patients who are not eligible for front-line therapy are eligible for this study
- Myeloproliferative disease
- Chronic lymphocytic leukemia
- Failed or progressed during ≥ 1 prior fludarabine-based therapy AND alemtuzmab
- Acute promyelocytic leukemia
- Progressed after prior treatment with standard chemotherapy, tretinoin, and arsenic trioxide
- Chronic myelomonocytic leukemia
- Resistant to standard therapy (e.g., hydroxyurea) OR disease progressed (blasts \> 5% and platelet count \< 100,000/mm\^3) during standard therapy
- Relapsed or refractory disease
- No known brain or meningeal disease
- PATIENT CHARACTERISTICS:
- Age
- Over 18
- Performance status
- ECOG 0-1
- Life expectancy
- More than 8 weeks
- Hepatic
- Bilirubin \< 2 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal
- Renal
- Creatinine \< 2 mg/dL
- Cardiovascular
- QTc \< 500 msec
- LVEF \> 40% by MUGA
- No New York Heart Association class III or IV congestive heart failure
- No myocardial infarction within the past year
- No uncontrolled dysrhythmias
- No uncontrolled angina
- No left ventricular hypertrophy by EKG
- No history of serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- No other significant cardiac disease
- Immunologic
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs
- No ongoing or active infection
- No HIV positivity
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- PRIOR CONCURRENT THERAPY:
- Chemotherapy
- Recovered from prior chemotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) unless there is evidence of rapidly progressive disease
- Radiotherapy
- At least 4 weeks since prior radiotherapy and recovered
- Other
- No concurrent agents that cause QTc prolongation
- No other concurrent investigational or commercial agents or therapies for the malignancy
- No concurrent hydrochlorothiazide
- Concurrent potassium-conserving combinations (e.g., Maxide® or Dyazide®) or other antihypertensive agents allowed
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00114257
Start Date
May 1 2005
Last Update
February 11 2013
Active Locations (1)
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1
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009