A Randomized Trial Comparing Preservation of Function Status After Either Medpulser Electroporation With Intratumoral Bleomycin Therapy or Surgery in Patients With Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Anterior Oral Cavity, Soft Palate, or Tonsil That Have Failed Primary Curative Therapy
Recurrent tumors in head and neck squamous cell carcinoma usually have a poor prognosis. In
patients suitable for salvage surgery of their recurrent disease, the success rate for local
control has been reported to be 40-50%. The surgical treatment of H&N SCC frequently
results in significant loss of organ function (e.g., inability to swallow, speak, etc.)
and/or permanent disfigurement. There is a compelling and unmet medical need for a local
therapy that destroys tumors while preserving function status and appearance in patients
with primary, recurrent, or metastatic H&N SCC.
Comparison: To compare function status at 4 months after treatment with bleomycin-EPT or
surgery in patients with locally recurrent or second primary SCC of the anterior oral
cavity, soft palate, or tonsil that have failed primary curative therapy and in whom
surgical resection is seen as an option for disease control.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Function status at 4 months using the performance status scale for head and neck cancer (PSSHN) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck (EORTC-QLC-H&N35)
4 Months
No
Paul Goldfarb, MD
Study Chair
Inovio Pharmaceuticals
United States: Food and Drug Administration
HNBE-03-01
NCT00198315
June 2004
June 2007
Name | Location |
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Inovio Biomedical Corporation | San Diego, California 92121 |