Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003289
Status:
COMPLETED
Last Update Posted:
2010-08-09
First Post:
1999-11-01
Brief Title:
UCN-01 in Treating Patients With Advanced Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Phase I and Pharmacologic Study of UCN-01 NSC638850
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE Phase I trial to study the effectiveness of UCN-01 in treating patients with advanced cancer that has not responded to previous treatment
Detailed Description:
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 hours 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
OUTLINE This is dose escalation study Patients receive UCN-01 by intravenous infusions over 3 2 or 1 hours 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA070095 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| JHOC-98012305 | None | None | None |
| NCI-T97-0083 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |