Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053963
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2003-02-05
Brief Title:
FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE I STUDY OF DEPSIPEPTIDE NSC630176 IND 51810 IN PEDIATRIC PATIENTS WITH REFRACTORY SOLID TUMORS AND LEUKEMIAS
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This phase I trial is studying the side effects and best dose of FR901228 in treating children with refractory or recurrent solid tumors or leukemia Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose MTD of FR901228 depsipeptide in pediatric patients with refractory or recurrent solid tumors
II Determine the dose-limiting toxic effects of this drug in these patients III Determine the pharmacokinetics of this drug in these patients IV Assess tolerability of this drug at the solid tumor MTD in patients with refractory or recurrent leukemia
V Determine preliminarily the antitumor activity of this drug in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive FR901228 depsipeptide IV over 4 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients with solid tumors receive escalating doses of FR901228 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Cohorts of 3 patients 6 patients total with leukemia receive FR901228 as above at the MTD
Patients are followed for survival
I Determine the maximum tolerated dose MTD of FR901228 depsipeptide in pediatric patients with refractory or recurrent solid tumors
II Determine the dose-limiting toxic effects of this drug in these patients III Determine the pharmacokinetics of this drug in these patients IV Assess tolerability of this drug at the solid tumor MTD in patients with refractory or recurrent leukemia
V Determine preliminarily the antitumor activity of this drug in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive FR901228 depsipeptide IV over 4 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients with solid tumors receive escalating doses of FR901228 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Cohorts of 3 patients 6 patients total with leukemia receive FR901228 as above at the MTD
Patients are followed for survival
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 |
|---|---|---|---|
| ADVL0212 | None | None | None |
| U01CA097452 | NIH | None | None |
| CDR0000269671 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA097452 |