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Study of Intralesional Injection of M4N in Patients With Refractory Malignant Tumors of the Head and Neck

Head and Neck Neoplasms Clinical Trial

Official title:
Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients With Refractory Malignant Tumors of the Head and Neck

Clinical Trial 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.

Clinical Trial Description

Study data collected will include pre-study demographics and measurements, treatment compliance, efficacy determined by tumor measurements, M4N levels in blood for pharmacokinetics, serum and biochemical determinations, hematology determinations, and patient vital signs. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00057512
Study type Interventional
Source Erimos Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date January 2003
Completion date December 2003
View Details
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