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

Sidney Kimmel Cancer Center at Thomas Jefferson University54 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Velcade (bortezomib)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: 2-8 weeks

Data from ClinicalTrials.gov

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