Head and Neck Cancer Clinical Trial
Official title:
A Phase I Open-labeled, Dose-escalation, Safety Study of the Combination of Velcade and Chemoradiation for the Treatment of Cancer Patients
Verified date | May 2017 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the safety of Velcade when used with chemoradiation in cancer patients.
Status | Completed |
Enrollment | 54 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Cancer Center at Thomas Jefferson University | Millennium Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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