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

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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.

James Oliver, PharmD      919-833-7196    joliver@biocuretech.us

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

Study ID Numbers:  M4N001
Record last reviewed:  April 2003
Record first received:  April 3, 2003
ClinicalTrials.gov Identifier:  NCT00057512
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10