Study of Intralesional Injection of M4N in Patients With Refractory Malignant Tumors of the Head and Neck
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ClinicalTrials.gov Identifier: NCT00057512 |
Recruitment Status :
Completed
First Posted : April 4, 2003
Last Update Posted : February 23, 2016
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Condition or disease | Intervention/treatment | Phase |
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Head and Neck Neoplasms | Drug: M4N | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | January 2003 |
Actual Primary Completion Date : | December 2003 |
Actual Study Completion Date : | December 2003 |

Arm | Intervention/treatment |
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Experimental: Intratumoral M4N
The initial dose was 5 mg/cm3 of tumor volume on Days 1, 8, and 15. Dose escalation in cohorts on this schedule took place up to 20 mg/cm3 tumor volume. The dose per lesion was based upon the volume of tumor, and the total dose did not exceed 1197 mg M4N/m2 body surface area.
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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.
Other Name: Tetra-O-Methyl Nordihydroguaiaretic Acid or EM-1421 |

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female patients ≥ 18 years of age.
- Patients with documented histologic evidence of head and neck cancer with clinically measurable disease. Head and neck cancer could have been recurrent after primary treatment with surgery, radiation therapy and/or chemotherapy.
- Measurable tumor by direct inspection, photography, or by imaging (CT scan or MRI).
- Life expectancy of at least 3 months in the Investigators' opinion.
- Negative pregnancy test if in women of childbearing potential within 1 week of starting therapy.
- Patients had provided written informed consent to participate in study.
- 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.
Exclusion Criteria:
- Women who were pregnant or nursing.
- Women of child bearing potential who were unwilling to use an adequate method of contraception during the course of the study.
- Treatment with prior investigational agent within 30 days of entering the study.
- Patients who are unable to comply with the study requirements.
- Patients with known sensitivity to any of the study medication components.
- Patients not consenting to photography.
- Patients with tumors that have enveloped the carotid artery or whose anatomy had been distorted such that in the Investigator's opinion present high-risk of perforation or compromise during injection.
- Prior chemotherapy, radiation therapy, or surgery for the primary carcinoma within 30 days of dosing and/or had not recovered from prior therapy toxicities.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057512
United States, South Carolina | |
MUSC | |
Charleston, South Carolina, United States, 29475 |
Responsible Party: | Erimos Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00057512 |
Other Study ID Numbers: |
M4N001 |
First Posted: | April 4, 2003 Key Record Dates |
Last Update Posted: | February 23, 2016 |
Last Verified: | January 2006 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Neoplasms Head and Neck Neoplasms Neoplasms by Site Masoprocol Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Lipoxygenase Inhibitors |
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