Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077467
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2004-02-10
Brief Title:
Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of PS-341 Velcade Bortezomib in Pediatric Patients With RefractoryRecurrent Leukemias
Status:
COMPLETED
Status Verified Date:
2013-06
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 bortezomib in treating young patients with refractory or recurrent leukemia Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth
Detailed Description:
OBJECTIVES Primary I Determine the maximum tolerated dose and recommended phase II dose of bortezomib in children with refractory or recurrent leukemia
II Determine the toxic effects of this drug in these patients III Determine the pharmacokinetics of this drug in these patients
Secondary I Determine preliminarily the antitumor activity of this drug in these patients
II Determine preliminarily the biologic activity of this drug in these patients
OUTLINE This is a dose-escalation open-label multicenter study
Patients receive bortezomib IV over 3-5 seconds 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
PROJECTED ACCRUAL A total of 3-36 patients will be accrued for this study within 15-36 months
II Determine the toxic effects of this drug in these patients III Determine the pharmacokinetics of this drug in these patients
Secondary I Determine preliminarily the antitumor activity of this drug in these patients
II Determine preliminarily the biologic activity of this drug in these patients
OUTLINE This is a dose-escalation open-label multicenter study
Patients receive bortezomib IV over 3-5 seconds 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
PROJECTED ACCRUAL A total of 3-36 patients will be accrued for this study within 15-36 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 |
|---|---|---|---|
| ADVL0317 | None | None | None |
| CDR0000350340 | None | None | None |
| COG-ADVL0317 | None | None | None |
| U01CA097452 | NIH | None | httpsreporternihgovquickSearchU01CA097452 |