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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase: Completed; Phase 1

Conditions: Head and Neck Cancer; Brain Cancer; Central Nervous System Neoplasms; Cervix Cancer

Treatments: Drug: Velcade (bortezomib)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00329589

2005-28 (Other Identifier)

JT 1133 (Other Identifier)

NCI-2009-01797 (Registry Identifier)

05C.255

Details and patient eligibility

About

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

Full 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

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 3 patient groups

CNS

Experimental group

Description:

Velcade (bortezomib)

Treatment:

Drug: Velcade (bortezomib)

Head and Neck

Experimental group

Description:

Velcade (bortezomib)

Treatment:

Drug: Velcade (bortezomib)

Cervix

Experimental group

Description:

Velcade (bortezomib)

Treatment:

Drug: Velcade (bortezomib)