UCN-01 (7-Hydroxystaurosporine) to Treat Relapsed T-Cell Lymphomas
Status:
Terminated
Trial end date:
2011-09-27
Target enrollment:
Participant gender:
Summary
This study will examine the effects of an experimental drug called UCN-01
(7-hydroxystaurosporine) on T-cell lymphomas. UCN-01 inhibits the growth of several different
tumor cells, and, in laboratory studies, it has worked particularly well on tumor cells taken
from patients with T cell lymphomas.
Patients 9 years of age and older with T cell lymphoma that has relapsed or is not responding
to chemotherapy may be eligible for this study. Candidates will be screened with a medical
histories and physical examinations, blood and urine tests, electrocardiograms, chest x-rays,
and computed tomography (CT) scans of the chest, abdomen and pelvis. Additional tests may be
done if clinically indicated, such as positron emission tomography (PET) scans, bone marrow
aspirations and biopsies, lumbar punctures (spinal taps) and CT's or magnetic resonance
imaging (MRI) scans if there is evidence of central nervous system disease.
Participants are given UCN-01 in 28-day treatment cycles. The drug is given by vein in a
continuous 72-hour infusion on the first cycle and in 36-hour infusions on subsequent cycles.
The total number of cycles patients receive depends on how well the tumor responds to the
drug and how well the patient tolerates drug side effects. Patients who do well may receive
treatment for up to 1 year. Patients whose disease worsens with treatment or who do not
tolerate the therapy are taken off the study.
Some or all of the screening tests are repeated periodically during the course of treatment
to monitor safety and treatment response. X-rays and scans are done every other treatment
cycle for the first 6 cycles and then, if the cancer is stable or improving, the interval
between these imaging studies is lengthened to every 4 cycles. Patients whose tumors can be
safely biopsied undergo this procedure before entering the study and 3 to 5 days after
completing the first UCN-01 treatment. Biopsies requiring open surgery (e.g., in the chest or
abdomen) are done only if absolutely necessary for medical care. Biopsy tissue, blood, and
other fluids are analyzed for gene and protein studies related to lymphoma research.