NCT00198315

Medpulser Electroporation With Bleomycin Study to Treat Anterior Head and Neck Squamous Cell Carcinoma

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Inovio Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate Medpulser electroporation (EPT) with bleomycin with regard to local tumor recurrence, disease-free survival, and overall survival rates versus surgery in recurrent or secondary primary squamous cell carcinoma (SCC) of the anterior oral cavity, soft palate, or tonsil.

Detailed description

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Medpulser electroporation with Bleomycin	Patients receive electroporation with injection of bleomycin sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area.
PROCEDURE	Tumor surgical excision	Patients have their tumor surgically removed.

Timeline

• Start date: 2004-06-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2005-09-20
• Last updated: 2022-03-04

Locations

1 site across 1 country: United States