A Trial of Concurrent Radiation Therapy, Cisplatin, & BMX-001 in Locally Advanced Head & Neck Cancer
Purpose
The purpose of this Phase 1 / Phase 2 study is to examine newly diagnosed patients with biopsy-proven head and neck cancer (squamous cell carcinoma) who are undergoing standard radiation therapy and treatment with cisplatin. BMX-001 added to radiation therapy and cisplatin is expected to reduce radiation-induced mucositis and xerostomia and also has the potential to benefit the survival of head and neck cancer patients.
Eligibility
- Ages: 18 years and older
- Sexes: All
- Accepts healthy volunteers?: No
For additional eligibility criteria. please contact the study team.
Procedures
In Phase 1, safety and tolerability of BMX-001 will be assessed using a Continual Reassessment Method (CRM) and a maximum tolerated dose (MTD) will be determined. BMX-001 will be given subcutaneously first with a loading dose zero to four days prior to the start of chemoradiation and followed by twice a week doses at one-half of the loading dose for the duration of radiation therapy plus two weeks. In Phase 2 both safety and efficacy of BMX-001 will be evaluated. Impact on mucositis and xerostomia will also be assessed.
Contact the study team
Additional eligibility criteria and study procedure details can be explained by the study team. Please call or email:
- Phone: 352.273.8675
- Email: trials@cancer.ufl.edu
Age
Gender
Keywords
Cancer, Head and neck cancers, radiation therapyPrincipal Investigator
Department
Contact Information
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