Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021216
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2001-07-11
Brief Title:
Bortezomib in Treating Children With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of PS-341 In Pediatric Patients With Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-12
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:
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Phase I trial to study the effectiveness of bortezomib in treating children who have advanced solid tumors that have not responded to previous treatment
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of bortezomib in pediatric patients with refractory solid tumors
II Determine the dose-limiting toxicity and other toxic effects of this regimen in these patients
III Preliminarily determine the antitumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive bortezomib IV on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib 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 If dose-limiting toxicity in the form of myelosuppression occurs in stratum I dose escalation continues with patients meeting the qualifications for stratum II
PROJECTED ACCRUAL Approximately 24-36 patients will be accrued for this study
I Determine the maximum tolerated dose of bortezomib in pediatric patients with refractory solid tumors
II Determine the dose-limiting toxicity and other toxic effects of this regimen in these patients
III Preliminarily determine the antitumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive bortezomib IV on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib 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 If dose-limiting toxicity in the form of myelosuppression occurs in stratum I dose escalation continues with patients meeting the qualifications for stratum II
PROJECTED ACCRUAL Approximately 24-36 patients will be accrued for this study
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-2012-01860 | REGISTRY | None | None |
| COG-ADVL0015 | None | None | None |
| CDR0000068760 | None | None | None |
| ADVL0015 | OTHER | None | None |
| U01CA097452 | NIH | CTEP | httpsreporternihgovquickSearchU01CA097452 |
| ADVL0015 | OTHER | None | None |