Status:
COMPLETED
A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Brain Cancer
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 o...
Eligibility Criteria
Inclusion
- Histologically confirmed malignancy
- Requiring at least grade 2 weeks of radiation therapy
- Solid tumors of the central nervous system, head and neck area, and cervix
- World Health Organization (WHO) performance status equal to or less than 2
Exclusion
- Equal to or greater than grade 2 peripheral neuropathy
- Myocardial infarction within 6 months
- Hypersensitivity to bortezomib, boron, or mannitol
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00329589
Start Date
September 1 2005
End Date
June 1 2010
Last Update
May 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107