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

This study has been completed.

First Received: April 3, 2003 Last Updated: January 31, 2006 History of Changes

Sponsors and Collaborators:	Erimos Pharmaceuticals Duke University Medical University of South Carolina
Information provided by:	Erimos Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00057512

Purpose

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.

Condition	Intervention	Phase
Head and Neck Neoplasms	Drug: Tetra-O-Methyl Nordihydroguaiaretic Acid (M4N or EM-1421)	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Masoprocol Tetramethoxynordihydroguaiaretic acid

U.S. FDA Resources

Further study details as provided by Erimos Pharmaceuticals:

Estimated Enrollment:	28
Study Start Date:	January 2003
Estimated Study Completion Date:	October 2003

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057512

Locations

United States, South Carolina
MUSC
Charleston, South Carolina, United States, 29475

Sponsors and Collaborators

Erimos Pharmaceuticals

Duke University

Medical University of South Carolina

More Information

No publications provided

Study ID Numbers:	M4N001
Study First Received:	April 3, 2003
Last Updated:	January 31, 2006
ClinicalTrials.gov Identifier:	NCT00057512 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Nordihydroguaiaretic Acid
Antioxidants
Analgesics, Non-Narcotic
Head and Neck Neoplasms
Cyclooxygenase Inhibitors

Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Lipoxygenase Inhibitors

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Protective Agents
Lipoxygenase Inhibitors
Pharmacologic Actions
Nordihydroguaiaretic Acid
Neoplasms

Neoplasms by Site
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Head and Neck Neoplasms
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009