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Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients With Refractory Malignant Tumors of the Head and Neck


Phase 1
18 Years
80 Years
Not Enrolling
Both
Head and Neck Neoplasms

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Trial Information

Open-Label Phase 1 Dose Escalation Study of Intralesional Injection of M4N in Patients With Refractory Malignant Tumors of the Head and Neck


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.

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

M4N001

NCT ID:

NCT00057512

Start Date:

January 2003

Completion Date:

October 2003

Related Keywords:

  • Head and Neck Neoplasms
  • Neoplasms
  • Head and Neck Neoplasms

Name

Location

MUSCCharleston, South Carolina  29475