UCN-01 in Treating Patients With Advanced Cancer
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|ClinicalTrials.gov Identifier: NCT00003289|
Recruitment Status : Completed
First Posted : May 21, 2004
Last Update Posted : August 9, 2010
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of UCN-01 in treating patients with advanced cancer that has not responded to previous treatment.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Unspecified Adult Solid Tumor, Protocol Specific||Drug: 7-hydroxystaurosporine||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I and Pharmacologic Study of UCN-01 (NSC638850)|
|Study Start Date :||June 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003289
|United States, Maryland|
|Johns Hopkins Oncology Center|
|Baltimore, Maryland, United States, 21231|
|Study Chair:||Ross C. Donehower, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|