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

Phase 1

Completed

• Conditions: Head and Neck Cancer; Cervix Cancer; Central Nervous System Neoplasms; Brain Cancer
• Interventions: Drug: Velcade (bortezomib)

• Registration Number: NCT00329589
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

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

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-05-24
• Study First Submitted QC: 2006-05-24
• Study First Posted: 2006-05-25
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• 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 Criteria

• Equal to or greater than grade 2 peripheral neuropathy
• Myocardial infarction within 6 months
• Hypersensitivity to bortezomib, boron, or mannitol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Head and Neck	Velcade (bortezomib)	Velcade (bortezomib)
Cervix	Velcade (bortezomib)	Velcade (bortezomib)
CNS	Velcade (bortezomib)	Velcade (bortezomib)

Primary Outcome Measures

Name	Time	Method
To determine the safe and maximum tolerated dose of Velcade® when administered as a twice weekly 3-5 second intravenous (IV) bolus every 3 weeks to patients with malignancies of the brain, head and neck, and cervix who receive 2-8 weeks of radiotherapy	2-8 weeks

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States