Study of Intralesional Injection of M4N in Patients With Refractory Malignant Tumors of the Head and Neck
Status:
Completed
Trial end date:
2003-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study will be to determine the safety and tolerability of intratumoral
M4N. Patients suffering from cancer of the head and neck that is recurrent after primary
treatment with surgery, radiation therapy, and/or chemotherapy may be eligible. The design is
a Phase 1 dose escalation study of M4N administered intratumorally once weekly, initially for
three weeks. Dose will be escalated on the starting schedule to a target of 20 mg/cm3 tumor
volume and then, new patient cohorts will have their schedule extended to weekly M4N for 4
weeks. Dose escalation will continue, assuming tolerability, so that cohorts will be treated
for 6 weeks, and finally, 8 weeks.
Phase:
Phase 1
Details
Lead Sponsor:
Erimos Pharmaceuticals
Collaborators:
Duke University Medical University of South Carolina