A Phase I and Pharmacologic Study of UCN-01 (NSC638850)
OBJECTIVES: I. Determine the toxicity profile, dose limiting toxicity, and maximum tolerated
dose of UCN-01 administered as a 3, 2, or 1 hour infusion every 4 weeks for patients with
advanced solid tumor malignancies and chronic lymphoproliferative disorders. II. Investigate
the pharmacokinetics and cellular pharmacodynamics of UCN-01 administered on this schedule
in these patients. III. Obtain preliminary evidence of the antitumor activity of UCN-01 in
this patient population.
OUTLINE: This is dose escalation study. Patients receive UCN-01 by intravenous infusions
over 3, 2 or 1 hour(s) every 4 weeks. The first dose level is administered over 3 hours, the
next dose level is administered over 2 hours, and the next and subsequent dose levels are
administered over 1 hour. One patient is treated at each dose level until unacceptable
toxicity is observed. An additional 2 patients are then entered at that dose level. If dose
limiting toxicity (DLT) is experienced in 1 of 3 patients, 3 additional patients are accrued
at that dose level. If 2 or more patients experience DLT, the maximum tolerated dose has
been surpassed and a total of 6 patients must be treated at the previous dose level. If no
patients develop DLT, the dose is escalated in successive cohorts of 3 patients per dose
level. Patients are followed for 4 weeks after each drug administration before subsequent
patients can be entered at the next higher dose level. Patients are followed for 2 months
after their last dose of UCN-01.
PROJECTED ACCRUAL: Approximately 36 patients will be accrued into this study over 18 months.
Interventional
Primary Purpose: Treatment
Ross C. Donehower, MD
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
JHOC-J9814, CDR0000066221
NCT00003289
June 1998
Name | Location |
---|---|
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |