Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019318
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Brief Title:
Depsipeptide in Treating Patients With Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of a Four Hour Infusion of Depsipeptide NSC630176 Given on Days 1 and 5 of a 21 Day Cycle in Patients With Refractory Neoplasms
Status:
COMPLETED
Status Verified Date:
2001-10
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 depsipeptide in treating patients who have solid tumors for which no standard therapy exists
PURPOSE Phase I trial to study the effectiveness of depsipeptide in treating patients who have solid tumors for which no standard therapy exists
Detailed Description:
OBJECTIVES I Determine the toxic effects and the maximum tolerated dose MTD of depsipeptide in patients with incurable solid tumors per 32900 notification only patients with cutaneous T-cell lymphoma are being accrued II Determine antineoplastic activity of depsipeptide in these patients
OUTLINE This is a dose escalation multicenter study Patients receive depsipeptide IV over 4 hours on days 1 and 5 Treatment continues every 21 days in the absences of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of depsipeptide If 2 of 6 patients experience dose-limiting toxicity at a given dose level escalation ceases and the maximum tolerated dose is defined as the previous dose level
PROJECTED ACCRUAL A maximum of 48 patients will be accrued for this study within 18-24 months
OUTLINE This is a dose escalation multicenter study Patients receive depsipeptide IV over 4 hours on days 1 and 5 Treatment continues every 21 days in the absences of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of depsipeptide If 2 of 6 patients experience dose-limiting toxicity at a given dose level escalation ceases and the maximum tolerated dose is defined as the previous dose level
PROJECTED ACCRUAL A maximum of 48 patients will be accrued for this study within 18-24 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-T95-0077 | None | None | None |
| NCI-97-C-0135G | None | None | None |