A Phase I Study of Depsipeptide in Selected Hematologic Malignancies (NSC 630176)

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of one of the following hematologic malignancies:

- Chronic lymphocytic leukemia (CLL)

- Small lymphocytic lymphoma (SLL) (including Waldenstrom's macroglobulinemia)

- Acute myeloid leukemia (AML)

- Acute lymphoblastic leukemia (ALL)

- Stratum I (CLL and SLL):

- Received at least one prior therapy containing a purine analog OR

- Received another form of therapy (including alkylating agents) due to history of
severe autoimmune disease, requirement for chronic corticosteroid, or other
contraindication to purine analog therapy

- Stratum II (AML and ALL):

- Primary refractory or relapsed leukemia within the past year that is not
amenable to curative therapy

- OR

- Untreated or previously treated poor-risk leukemia defined by any of the
following:

- 65 years of age and over

- Poor-risk candidates for aggressive chemotherapy

- Poor-risk cytogenetics (for AML, karyotype abnormalities other than
t(8;21), inv(16), t(15;17))

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- Stratum I only:

- No uncontrolled autoimmune hemolytic anemia

- No idiopathic thrombocytopenic purpura

- Stratum II only:

- WBC no greater than 10,000/mm^3 OR

- WBC no greater than 40,000/mm^3 that is stable for at least 1 week (may be
sustained by hydroxyurea through the first week of study)

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- ALT and AST no greater than 3 times upper limit of normal

Renal:

- Creatinine less than 2.0 mg/dL

Cardiovascular:

- Ejection fraction at least 50% by MUGA

- No myocardial infarction or unstable angina within the past 6 months

- No prior unstable ventricular or supraventricular cardiac arrhythmias

Other:

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other medical or psychiatric problem that would preclude study

- Stratum I only:

- No active infection requiring oral or IV antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- At least 28 days since prior chemotherapy (except hydroxyurea)

- At least 6 weeks since prior nitrosoureas

- At least 8 weeks since prior UCN-01 (unless plasma UCN-01 level less than 1 uM)

Endocrine therapy:

- See Disease Characteristics

Radiotherapy:

- At least 28 days since prior radiotherapy

Surgery:

- At least 28 days since prior major surgery