NCT00329589

A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients

A Phase I Open-labeled, Dose-escalation, Safety Study of the Combination of Velcade and Chemoradiation for the Treatment of Cancer Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Brain Cancer
• Head and Neck Cancer
• Cervix Cancer
• Central Nervous System Neoplasms

Interventions

Type	Name	Description
DRUG	Velcade (bortezomib)

Timeline

• Start date: 2005-09-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2006-05-25
• Last updated: 2025-05-02

Locations

1 site across 1 country: United States