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

Tracking Information
First Received Date ^ICMJE	April 3, 2003
Last Updated Date	January 31, 2006
Start Date ^ICMJE	January 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00057512 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Intralesional Injection of M4N in Patients With Refractory Malignant Tumors of the Head and Neck
Official Title ^ICMJE	Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients With Refractory Malignant Tumors of the Head and Neck
Brief 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 Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Head and Neck Neoplasms
Intervention ^ICMJE	Drug: Tetra-O-Methyl Nordihydroguaiaretic Acid (M4N or EM-1421)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	28
Completion Date	October 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	Major Inclusion Criteria: Male or female patients >18 years of age. Patients with documented histologic evidence of head and neck cancer with clinically measurable disease. Head and neck cancer can be recurrent after primary treatment with surgery, radiation therapy and/or chemotherapy. ECOG Performance Status of 0, 1, or 2. Absolute neutrophil 1500/uL, hemoglobin 8 gm %, platelets 50,000/uL, ALT/AST < 3 x ULN (upper limit of the normal range), bilirubin < 1.5 x ULN and creatinine < 1.5 x ULN, PT and PTT within normal limits.
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00057512
Responsible Party
Study ID Numbers ^ICMJE	M4N001
Study Sponsor ^ICMJE	Erimos Pharmaceuticals
Collaborators ^ICMJE	Duke University Medical University of South Carolina
Investigators ^ICMJE
Information Provided By	Erimos Pharmaceuticals
Verification Date	January 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP