Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed · Phase 1

Conditions studied: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Recurrent Adult Acute Myeloid Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Untreated Adult Acute Myeloid Leukemia

In brief

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 lymphocytic leukemia or small lymphocytic leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Valproic acid may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Combining decitabine with valproic acid may kill more cancer cells.

Key facts

Study ID

NCT00079378

Run by

National Cancer Institute (NCI)

People needed

84

Starts

2004-02-01

Last updated by the study team

2013-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.