Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198328
Status:
TERMINATED
Last Update Posted:
2022-03-04
First Post:
2005-09-12
Brief Title:
Medpulser Electroporation With Bleomycin Study to Treat Posterior Head and Neck Squamous Cell Carcinoma
Sponsor:
Inovio Pharmaceuticals
Organization:
Inovio Pharmaceuticals
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment was stopped based on the Data Monitoring Committees recommendation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 base of the tongue posterior lateral pharyngeal wall hypopharynx or larynx
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 HN SCC frequently results in significant loss of organ function eg inability to swallow speak etc andor 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 HN 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None