Brain Cancer, Central Nervous System Neoplasms, Cervix Cancer, Head and Neck Cancer
Conditions
Keywords
Malignancies of the central nervous system, head and neck area, and cervix
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
Interventions
Sponsors
Millennium Pharmaceuticals, Inc.
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed