Phase I Clinical Evaluation of Bryostatin 1 in Combination With 2-CdA in Patients With Relapsed CLL

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of relapsed chronic lymphocytic leukemia

- Intermediate- or high-risk (stage I-IV) disease

- Intermediate-risk patients must have active disease, defined by at least 1 of the
following criteria:

- Presence of any 1 of the following disease-related B symptoms:

- 10% or more loss of body weight within the past 6 months

- Extreme fatigue

- Fever greater than 100 degrees Fahrenheit without evidence of infection

- Night sweats

- Massive (greater than 6 cm below left costal margin) or progressive splenomegaly

- Massive (greater than 10 cm in longest diameter) or progressive lymphadenopathy

- Progressive lymphocytosis with an increase of more than 50% over a 2-month
period or anticipated doubling time of less than 12 months

- Progressive bone marrow failure as manifested by the development or worsening of
anemia and/or thrombocytopenia

- Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroids

- Failed 1-2 prior front-line regimens

- Failed prior fludarabine

- Ineligible for any known treatment of higher potential efficacy

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Zubrod 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- See Disease Characteristics

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 50,000/mm^3

Hepatic:

- Bilirubin less than 1.5 mg/dL

- Transaminases less than 2.5 times normal

Renal:

- Creatinine less than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No history of severe coronary artery disease, cardiomyopathy, uncontrolled congestive
heart failure, or arrhythmias

Neurologic:

- No prior drug-related neurotoxicity

- No other neurologic disorder

Other:

- Not pregnant or nursing

- Fertile patients must use effective barrier or non-hormonal contraception during and
for 2 months after study participation

- No HIV infection

- No AIDS

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior bone marrow transplantation

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy (8 weeks for mitomycin or nitrosoureas) and
recovered

Endocrine therapy:

- See Disease Characteristics

- No concurrent steroids

- No concurrent hormonal contraceptives

Radiotherapy:

- At least 4 weeks since prior radiotherapy and recovered

Surgery:

- Not specified

Other:

- No other concurrent therapy