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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Azacitidine; Decitabine; Valproic Acid

Criteria

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