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

The purpose of this study is to determine the safety of Velcade when used with chemoradiation in cancer patients.

• 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

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