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

NCT00057512 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-02-23

No results posted yet for this study

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.

Conditions

  • Head and Neck Neoplasms

Interventions

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.

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • Erimos Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2003-12-31
Completion
2003-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00057512 on ClinicalTrials.gov