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Protocol Number: 02-C-0241 
Patients 18 years of age and older who have either a solid tumor or lymphoma and for whom standard therapy is no longer beneficial may be eligible for this study. Candidates are screened with a medical history and physical examination, electrocardiogram, blood and urine tests, review of pathology slides, CT scans, possibly a bone scan or other imaging tests as needed to evaluate the disease, and possibly a bone marrow biopsy and aspirate. If a tissue specimen is not available for examination, a biopsy (removal of a small piece of tumor tissue) may be needed to confirm the diagnosis. Participants receive treatment in 28-day cycles. During the first 5 days of each cycle, patients take prednisone by mouth. On day 3, they receive UCN-01 through a central venous catheter (plastic tube placed in a large vein). Patients who do not already have a central venous catheter will have one put in. The catheter is placed into a major vein in the chest and can remain in the body for months or can be removed after each treatment is completed. It is placed under local anesthesia by a specially trained physician. For the first cycle, UCN-01 is given over 72 hours; for the remaining cycles, it is given over 36 hours. It is given using a portable infusion device to allow patients more mobility. The first group of three patients enrolled in the study receives the lowest dose of UCN-01. Succeeding groups receive higher dose levels as long as the preceding level is well tolerated. New groups are enrolled at 4-week intervals until the side effects are no longer minimal or the highest tolerated dose of UCN-01 alone found in an earlier study is reached. For the first two cycles patients are hospitalized for 5-7 days so they can be closely monitored for side effects and to collect blood and saliva samples to measure levels of UCN-01 in the body. The remaining cycles can be given on an outpatient basis, although patients must stay in the NIH area while receiving the UCN-01 infusion. As an outpatient, participants have blood drawn weekly and just before starting each cycle. Scans and x-rays are done about every 8 weeks to see if the cancer has changed. The length of treatment depends on the patient's individual response. As long as the side effects are not severe and the cancer is shrinking or remains stable, treatment may continue until two cycles past the best tumor response or longer if the investigators think it will be of benefit.
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National Institutes of Health Clinical Center