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
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasms||Drug: M4N||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
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|
|Charleston, South Carolina, United States, 29475|