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Sponsored by: |
Inovio Biomedical Corporation |
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Information provided by: | Inovio Biomedical Corporation |
ClinicalTrials.gov Identifier: | NCT00198328 |
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 base of the tongue, posterior lateral pharyngeal wall, hypopharynx or larynx.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Device: Medpulser Electroporation with Bleomycin Procedure: Surgical Excision |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 Base of the Tongue, Posterior Lateral Pharyngeal Wall, Hypopharynx, or Larynx That Have Failed Primary Curative Therapy |
Estimated Enrollment: | 200 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | May 2009 |
Arms | Assigned Interventions |
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Surgery Control: Active Comparator
Patients receive surgical excision of their tumor.
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Procedure: Surgical Excision
Patients have their tumor surgically removed.
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MedPulser EPT: Experimental
Patients receive electroporation with injection of Bleomycin Sulfate.
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Device: Medpulser Electroporation with Bleomycin
Patients receive injections of Bleomycin Sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area followed by electroporation.
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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 base of the tongue, posterior lateral pharyngeal wall, hypopharynx or larynx that have failed primary curative therapy and in whom surgical resection is seen as an option for disease control.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hematopoietic status:
Blood chemistry status:
Exclusion Criteria:
United States, California | |
Inovio Biomedical Corporation | |
San Diego, California, United States, 92121 |
Study Chair: | Paul Goldfarb, MD | Inovio Biomedical Corporation |
Responsible Party: | Inovio Biomedical Corporation ( Larry Young, Executive Director of Clinical Affairs ) |
Study ID Numbers: | HNBE-03-02 |
Study First Received: | September 12, 2005 |
Last Updated: | December 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00198328 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ireland: Irish Medicines Board; Belgium: Pharmaceutical Inspectorate; Latvia: Ministry of Health; Lithuania: Ministry of Health; Ukraine: Ministry of Health |
Squamous Cell Carcinoma carcinoma head and neck cancer larynx electroporation |
medpulser bleomycin cancer Locally recurrent or second primary squamous cell carcinoma of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx, or larynx |
Epidermoid carcinoma Squamous cell carcinoma Head and Neck Neoplasms Carcinoma, squamous cell Neoplasms, Squamous Cell |
Carcinoma, Squamous Cell Bleomycin Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents |
Therapeutic Uses Antibiotics, Antineoplastic Pharmacologic Actions |