Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045500
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2002-09-06
Brief Title:
UCN-01 and Prednisone in Treating Patients With Solid Tumors or Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial Of UCN-01 And Prednisone In Patients With Refractory Solid Tumors And Lymphomas
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE UCN-01 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining UCN-01 with prednisone may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of combining UCN-01 with prednisone in treating patients who have refractory solid tumors or lymphoma
PURPOSE Phase I trial to study the effectiveness of combining UCN-01 with prednisone in treating patients who have refractory solid tumors or lymphoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of UCN-01 in combination with prednisone in patients with refractory solid tumors or lymphomas
Determine the toxic effects of this regimen in these patients
Assess the pharmacokinetics of this regimen in these patients
Assess any tumor response in patients treated with this regimen
OUTLINE This is a dose-escalation study of UCN-01
Patients receive oral prednisone daily on days 1-5 and UCN-01 IV over 36-72 hours on days 3-5 Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of UCN-01 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 6 patients are treated at the recommended phase II dose
Patients are followed every 3-12 months for 5 years
PROJECTED ACCRUAL Approximately 24 patients will be accrued for this study within 18 months
Determine the maximum tolerated dose of UCN-01 in combination with prednisone in patients with refractory solid tumors or lymphomas
Determine the toxic effects of this regimen in these patients
Assess the pharmacokinetics of this regimen in these patients
Assess any tumor response in patients treated with this regimen
OUTLINE This is a dose-escalation study of UCN-01
Patients receive oral prednisone daily on days 1-5 and UCN-01 IV over 36-72 hours on days 3-5 Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of UCN-01 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 6 patients are treated at the recommended phase II dose
Patients are followed every 3-12 months for 5 years
PROJECTED ACCRUAL Approximately 24 patients will be accrued for this study within 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 |
|---|---|---|---|
| NCI-02-C-0241 | None | None | None |
| NCI-5694 | None | None | None |