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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:

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

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

ClinicalTrials.gov processed this record on May 21, 2013