MRX, Radiation, and Chemotherapy for Patients With Resected Squamous Cell Carcinoma of the Head and Neck
Status:
Terminated
Trial end date:
2007-07-01
Target enrollment:
Participant gender:
Summary
Rationale for Study
Oral mucositis is a major complication arising from contemporary chemoradiation treatment of
patients with head and neck cancer.
No effective therapy exists to prevent this complication in this population. MRX-1024 is an
investigational agent that has demonstrated in in vitro and in vivo experiments to have the
potential to exert a protective effect in normal mucosa cells, without interfering with the
intended antitumor effect of radiation.
A pilot Phase 1 study of MRX-1024 was conducted in India in patients with head and neck
cancer receiving radiation alone or radiation in combination with cisplatin or carboplatin.
MRX 1024 doses of 100 mgkg given orally twice a day, five days a week during radiation
treatment cycles, were well tolerated and appeared to exert a protective effect against the
development of severe mucositis.
Twice daily doses of MRX 1024 impose a certain level of inconvenience to the patient, to
their clinic companion, and to the general work flow within radiation oncology clinics.
This study is designed to study the safety and pharmacokinetics of both single daily dose and
twice daily dose regimens of oral MRX 1024 given in conjunction with daily radiation
fractions and intermittent high-dose cisplatin to patients with high-risk for recurrence head
and neck cancer following surgical resection. The study will also document the incidence and
severity of oral mucositis that occurs following such therapy. The results will be
instrumental in determining the regimen of MRX 1024 to use in subsequent definitive clinical
trials.
Phase:
Phase 1
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins