Status:
COMPLETED
Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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 decitabine and valproic acid in treating patients with refractory or relapsed acute myeloid leukemia or previously treated chronic lymp...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the minimally effective pharmacological dose (MEPD) of decitabine in patients with refractory or relapsed acute myeloid leukemia or with previously treated chronic ly...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients with AML (Stratum I) or CLL/SLL (Stratum II) will be enrolled
- Patients in stratum I will have one of the following:
- Primary refractory or relapsed (in 1 year or less) disease and not a candidate for potentially curative therapy
- Untreated AML patients who are not candidates for chemotherapy
- Patients in stratum I must have a normal WBC (=\< 10 x 10\^9/L) or a WBC =\< 40 x 10\^9/L that is stable for 1 week (this may be sustained with hydroxyurea prior to starting therapy and during the first 4 days of therapy if clinically indicated)
- Patients in stratum II will have received at least one prior therapy for CLL/SLL that has included a purine analog; patients in stratum II with a history of severe autoimmune disease or requiring therapy with chronic corticosteroids or who have any other specific relative contraindications to receive a purine analog and, therefore, have received another form of therapy that include alkylating agents will be eligible to participate
- Performance status - ECOG 0-2
- At least 12 weeks life expectancy
- Stratum II:
- No uncontrolled autoimmune hemolytic anemia
- No idiopathic thrombocytopenia purpura
- Bilirubin =\< 1.5 mg/dL
- ALT and AST =\< 2 times upper limit of normal
- Creatinine =\< 2.0 mg/dL
- No active infection requiring IV antibiotics
- HIV negative
- No other severe medical condition that would preclude study participation
- No psychiatric condition that would preclude study compliance
- No history of seizures
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- More than 14 days since prior chemotherapy (except hydroxyurea)
- No prior FR901228 (depsipeptide) for step 2 of this study
- No other concurrent chemotherapy
- No concurrent corticosteroids for antiemetic therapy
- No concurrent hormonal therapy except for the following:
- Steroids for treatment of adrenal failure or septic shock
- Insulin for diabetes
- Tamoxifen or equivalent for breast cancer prevention or adjuvant therapy
- Estrogens or progestins for gynecologic indications
- More than 14 days since prior radiotherapy
- No concurrent palliative radiotherapy
- No concurrent anticonvulsant medication, including valproic acid
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00079378
Start Date
February 1 2004
Last Update
September 30 2013
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210