NCT00057512

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Erimos Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
DRUG	M4N	Dose escalation study of M4N administered intratumorally on days 1, 8 and 15. Dose escalated in cohorts on three weeks schedule to a target of 20 mg/cm3 tumor volume.

Timeline

• Start date: 2003-01-01
• Primary completion: 2003-12-01
• Completion: 2003-12-01
• First posted: 2003-04-04
• Last updated: 2016-02-23

Locations

1 site across 1 country: United States