INCLUSION CRITERIA:
Histologic diagnosis of a solid tumor or lymphoma confirmed by the Laboratory of Pathology, NCI.
Has already received standard therapy for their malignancy and disease has progressed on this therapy and no other therapies are likely to improve survival.
Age greater than or equal to 18 years.
Prognosis of 3 months or greater.
Patients must have normal organ and marrow function as defined below:
Total Bilirubin less than or equal to 1.5 x ULN (upper limit of normal), unless the patient meets the criteria for Gilbert's Syndrome;
AST less than or equal to 2.5 x ULN, ALT less than or equal to 2.5 X ULN;
Creatinine clearance greater than 60 ml/min (measured via 24 hour urine specimen) or serum creatinine less than or equal to 1.5 mg/dl;
Absolute neutrophil count greater than 1000/mm(3);
Platelet count greater than 100,000/mm(3);
12hr fasting glucose less than or equal to 110 mg/dl OR less than or equal to 140 mg/dl AND Hemoglobin A1C less than or equal to 6.5 mg/dl;
PT/PTT less than or equal to 1.5 x ULN.
ECOG Performance Status 0-2.
Patient able to understand and sign an informed consent document.
Patient able and willing to follow guidelines of clinical protocol including visits to NCI, Bethesda, Maryland for treatment and follow up visits.
Last dose of chemotherapy or radiation therapy was greater than 4 weeks (6 weeks for nitrosourease and mitomycin C) prior to commencement of this protocol and patient has recovered from any toxicities associated with those treatments.
Prostate cancer patients must have progressed through hormonal therapy with GnRH agonists and withdrawal of testosterone receptor antagonists. They must continue GnRH agonist during the trial (if orchiectomy was not performed) and have castrate testosterone levels prior to starting.
The effects of UCN-01 on the developing human fetus are unknow therefore women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier methods) during the study and for a period of 2 months after the last dose of UCN-01 (due to the long half life of this drug).
EXCLUSION CRITERIA:
Due to the tendency of UCN-01 to cause hyperglycemia, patients with a history of diabetes or hyperglycemia within the last 1 year that requires/required a diabetic diet, oral hypoglycemics, or insulin.
Uncontrolled illness including, but not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, seizure disorder, or psychiatric illness that may limit compliance with study requirements. These illnesses may also be exacerbated by UCN-01 and/or prednisone.
Patients with a history of interstitial lung disease within the last 1 year will be excluded because of the pulmonary toxicities seen with UCN- 01.
Patients who have required oxygen therapy for hypoxia due to any cause in the last 6 months will be excluded because of the pulmonary toxicities seen with UCN-01.
Requires oral or IV steroid therapy for any reason as this will interfere with the primary objectives of this study.
Positive serology for HIV because of the increased risk for lethal infections in immunocompromised patients treated with steroids.
Local complications from disease requiring urgent therapy (i.e. hydronephrosis, spinal cord compression, severe pain requiring improved pain management).
Major surgery within the last 21 days.
Treatment of brain metastases within the last 6 months due to the poor prognosis of these patients and difficulty ascertaining the cause of neurologic toxicities. Patients with treated brain metastasis that are stable off anti-seizure medications or steroids for greater than 6 months may be treated at the discretion of the principal investigator.
Pregnancy.
Lactating women who are breast feeding.
Diagnosis of duodenal or gastric ulcer or severe gastritis within the 6 months prior to therapy inception due to the risk of exacerbation of these conditions with prednisone.
Prior treatment with UCN-01.
Use of other investigational agents within 4 weeks of on study date.
History of allergic reactions to other indolocarbazoles.
Warren Grant Magnuson Clinical Center (CC)