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Brief Title: A Phase I Trial of Continuous Infusion UCN-01 in Patients With Refractory Neoplasms
Official Title: A Phase I Trial of Continuous Infusion UCN-01 in Patients With Refractory Neoplasms
Study ID: NCT00001444
Brief Summary: This is a dosage escalation study to estimate the maximum tolerated dose of staurosporine analogue UCN-01. Groups of 3 to 6 patients receive a 72-hours intravenous continuous infusions of UCN-01 from day 1 to day 4 of each cycle the first cycle only, and over 36-hours on subsequent cycles. The side effects are allowed to disappear for up to 28 days. This cycle is repeated after evaluations and follow-ups, which are every 4 weeks, as long as the patient benefits.
Detailed Description: Patients with relapsed or refractory neoplasms will be treated with escalating doses of UCN-01(7-hydroxystaurosporine) a protein kinase C inhibitor which also may affect cyclin-dependent kinase activity, given as a 72 hour infusion. This trial will determine the toxicity associated with the maximally tolerated dose of this drug in patients for whom no other therapeutic approach is deemed to be more useful.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
National Cancer Institute (NCI), Bethesda, Maryland, United States