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

18 to 65

Gender

Male
Female

Keywords

Cancer, Head and neck cancers, radiation therapy

Principal Investigator

Department

Oncology

Contact Information

trials@cancer.ufl.edu

352.273.8675


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