A Phase I Trial Of UCN-01 And Prednisone In Patients With Refractory Solid Tumors And Lymphomas

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed solid tumor or lymphoma

- Progressive disease after standard therapy

- No other therapy is likely to improve survival

- Prostate cancer patients must have progressed through hormonal therapy with
gonadotropin-releasing hormone (GnRH) agonists and withdrawal of testosterone
receptor antagonists

- Patients must continue on GnRH agonist during study (if orchiectomy has not been
performed) and have castrate testosterone levels

- Brain metastases allowed if treated and the patient has been stable off anti-seizure
medication or steroids for > 6 months

- No local complications from disease requiring urgent therapy (i.e., hydronephrosis,
spinal cord compression, or severe pain requiring improved pain management)

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 3 months

Hematopoietic

- Absolute neutrophil count greater than 1,000/mm^3

- Platelet count greater than 100,000/mm^3

- 12-hour fasting glucose no greater than 110 mg/dL OR

- 12-hour fasting glucose no greater than 140 mg/dL with hemoglobin A1C no greater than
6.5 mg/dL

Hepatic

- PT/PTT no greater than 1.5 times upper limit of normal (ULN)

- Bilirubin no greater than 1.5 times ULN (unless Gilbert's syndrome present)

- AST/ALT no greater than 2.5 times ULN

Renal

- Creatinine clearance greater than 60 mL/min OR

- Creatinine no greater than 1.5 mg/dL

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

Pulmonary

- No interstitial lung disease within the past year

- No requirement for oxygen therapy for hypoxia in the past 6 months

Gastrointestinal

- No diagnosis of duodenal or gastric ulcer

- No severe gastritis within the past 6 months

Other

- HIV negative

- No prior allergic reactions to other indolocarbazoles

- No diabetes or hyperglycemia within the past year that required a diabetic diet, oral
hypoglycemics, or insulin

- No other uncontrolled illness

- No active infection

- No seizure disorder

- No psychiatric illness that would preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after study
therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered

- No prior UCN-01

Endocrine therapy

- See Disease Characteristics

- No other concurrent oral or IV steroids

Radiotherapy

- At least 4 weeks since prior radiotherapy and recovered

Surgery

- See Disease Characteristics

- At least 21 days since prior major surgery

Other

- See Disease Characteristics

- At least 4 weeks since prior investigational agents

- No other concurrent anticancer therapy