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

This study has been completed.

Sponsor:

Collaborators:

Duke University

Medical University of South Carolina

Information provided by:

Erimos Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00057512

First received: April 3, 2003

Last updated: January 31, 2006

Last verified: January 2006

History of Changes

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 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

Additional relevant MeSH terms:


Head and Neck Neoplasms Neoplasms Neoplasms by Site Masoprocol Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antioxidants Antirheumatic Agents Central Nervous System Agents	Cyclooxygenase Inhibitors Enzyme Inhibitors Lipoxygenase Inhibitors Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Protective Agents Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 02, 2015

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