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

NCT00198315 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2022-03-04

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Paul Goldfarb, MD · Inovio Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2007-06-30
Completion
2007-06-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00198315 on ClinicalTrials.gov