Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329589
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2006-05-24
Brief Title:
A Trial Using Velcade Plus Chemoradiation for Central Nervous System Head and Neck and Cervical Cancer Patients
Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
A Phase I Open-labeled Dose-escalation Safety Study of the Combination of Velcade and Chemoradiation for the Treatment of Cancer Patients
Status:
COMPLETED
Status Verified Date:
2017-05
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:
The purpose of this study is to determine the safety of Velcade when used with chemoradiation in cancer patients
Detailed Description:
To determine the maximum tolerated dose MTD and a recommended phase II dose RP2D of Velcade when administered as a twice weekly 3-5 second IV bolus every 3 weeks to patients with malignancies of the brain head and neck and cervix who receive 2-8 weeks of chemoradiation
To evaluate the safety and toxicity profile of Velcade when administered on a twice weekly days 1 4 8 and 11 every 3 weeks maximum 8 weeks concurrent with chemoradiation
To evaluate tumor response
To evaluate the safety and toxicity profile of Velcade when administered on a twice weekly days 1 4 8 and 11 every 3 weeks maximum 8 weeks concurrent with chemoradiation
To evaluate tumor response
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-2009-01797 | REGISTRY | NCI CTRP | None |
| 2005-28 | OTHER | None | None |