PHASE II CLINICAL EVALUATION OF BRYOSTATIN 1 IN PATIENTS WITH RELAPSED NON-HODGKIN'S LYMPHOMA AND CLL

Inclusion Criteria

DISEASE CHARACTERISTICS: One of the following hematologic malignancies that has failed 1
or 2 prior front-line chemotherapy regimens and is ineligible for treatment of higher
potential efficacy: Histologically confirmed chronic lymphocytic leukemia (CLL)
Intermediate- or high-risk (RAI stage I-IV) disease Evidence of active disease required by
at least one of the following for intermediate-risk CLL: One of the following B symptoms:
Weight loss of 10% or more in previous 6 months Extreme fatigue Fever over 100 F without
evidence of infection Night sweats Massive (more than 6 cm below left costal margin) or
progressive splenomegaly Massive (more than 10 cm in longest diameter) or progressive
lymphadenopathy Progressive lymphocytosis with more than 50% increase over 2-month period
or anticipated doubling time of less than 12 months Progressive bone marrow failure as
manifested by development or worsening of anemia and/or thrombocytopenia Autoimmune anemia
and/or thrombocytopenia poorly responsive to corticosteroids Biopsy proven low-,
intermediate-, or high-grade non-Hodgkin's lymphoma Transformed lymphoma allowed
Measurable disease required Re-treatment on this study allowed if disease relapsed after a
complete remission

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy:
At least 12 weeks Hematopoietic: ANC at least 1,500/mm3 (at least 1,000/mm3 in CLL
patients with at least 30% marrow involvement) Platelets at least 100,000/mm3 (at least
50,000/mm3 in CLL patients with at least 30% marrow involvement) Hepatic: Bilirubin less
than 1.5 mg/dL Transaminases less than 2.5 times normal Renal: Creatinine no greater than
1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of
impaired cardiac status, e.g.: Severe coronary artery disease Cardiomyopathy Uncontrolled
congestive heart failure Arrhythmia Other: No known AIDS or HIV infection No second
malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer In situ
cervical cancer Not pregnant or nursing Effective contraception required of fertile
patients during and for 2 months after study

PRIOR CONCURRENT THERAPY: No concurrent therapy Biologic therapy: Not specified
Chemotherapy: See Disease Characteristics At least 4 weeks since chemotherapy (8 weeks
since nitrosoureas or mitomycin) and recovered Endocrine therapy: Not specified
Radiotherapy: At least 4 weeks since radiotherapy and recovered Surgery: Not specified
Other: No prior bone marrow transplant