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

Primary Purpose

Head and Neck Cancer

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Medpulser electroporation with Bleomycin
Tumor surgical excision
Sponsored by
Inovio Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Squamous Cell Carcinoma, Carcinoma, Head and Neck Cancer, Oral, Soft Palate, Cancer, Medpulser, Electroporation, Local recurrent or second primary squamous cell carcinoma of anterior oral cavity, soft palate, or tonsil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The presence of SCC of the anterior oral cavity, soft palate or tonsil must be confirmed by histological examination of a tissue sample (e.g., biopsy) obtained within 1 month of the patient receiving the study treatment. Recurrent or second primary disease in patients where surgical resection is seen as an option for disease control. The length of the longest diameter of the study lesion must be < 5 cm and the calculated treatment volume must be < 60.0 cm3 (tumor volume plus a 0.5 cm margin around the tumor) for the study lesion [where treatment volume = 0.5 (A+1) (B+1)2 and where A = length of the longest diameter (cm), B = the next longest diameter perpendicular to "A" (cm)]. Tumor burden must be completely encompassed by surgery or bleomycin-EPT. Age: 18 years or older. Men and women of childbearing potential must use physician approved contraceptive methods for 7 days following bleomycin-EPT. Hematopoietic status: Absolute neutrophil count (ANC) > 1000/uL Platelets > 75,000/mm3 Prothrombin time:international normalized ratio (PT:INR) ? 1.5 (correctable with vitamin K injection) Blood chemistry status: Transaminases < 3 times upper limit of normal Total bilirubin < 2.5 mg/dL Creatinine < 2.5 mg/dL A written Informed Consent form must be signed prior to the patient receiving any study procedures or treatments. Exclusion Criteria: Patients with tumors suspected of involving a 50% or greater encasement of a blood vessel as measured by magnetic resonance imaging (MRI) or computed tomography (CT) scan. Patients with tumors having bone invasion. Patients with any metallic implants in the treatment field. Patients with hypersensitivity to bleomycin. Patients who have received or will exceed a total lifetime dose of bleomycin greater than 400 units. Patients deemed unsuitable for general anesthesia. Patients with a significant history of emphysema or pulmonary fibrosis. Patients with indwelling cardiac pacemakers who cannot tolerate a period with pacemaker turned off. Patients with a history of uncontrolled cardiac arrhythmia. Women who are pregnant, or are nursing. Women of childbearing potential must have a negative beta-human chorionic gonadotropin (beta-HCG) test within 7 days of study treatment. Radiation therapy to the treatment area within 8 weeks of study treatment. Chemotherapy or other cancer therapy (e.g., surgery, cryotherapy, etc.) to the treatment area within 4 weeks of study treatment. Patients participating in a clinical study for an investigational drug or device within 4 weeks prior to the study treatment. Patients previously randomized to this study.

Sites / Locations

  • Inovio Biomedical Corporation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Surgery Control

MedPulser EPT with Bleomycin

Arm Description

Patients will receive standard of care surgical removal of their tumor.

Patients who are eligible for surgical excision will receive MedPulser electroporation with injection of bleomycin sulfate into the tumor treatment area.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Local tumor recurrence, disease free survival and overall survival rates through 2 years after bleomycin-EPT or surgery treatment
Safety through 6 months after the study treatment
Durability of function status outcomes at 8 months after bleomycin-EPT or surgery treatment
Pharmacoeconomic parameters through 8 months after bleomycin-EPT or surgery treatment
Bleomycin systemic absorption and plasma pharmacokinetics following intratracheal (IT) bleomycin-EPT administration

Full Information

First Posted
September 12, 2005
Last Updated
March 2, 2022
Sponsor
Inovio Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00198315
Brief Title
Medpulser Electroporation With Bleomycin Study to Treat Anterior Head and Neck Squamous Cell Carcinoma
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 Anterior Oral Cavity, Soft Palate, or Tonsil That Have Failed Primary Curative Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Enrollment was stopped based on the Data Monitoring Committee's recommendation.
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 1, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inovio Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Squamous Cell Carcinoma, Carcinoma, Head and Neck Cancer, Oral, Soft Palate, Cancer, Medpulser, Electroporation, Local recurrent or second primary squamous cell carcinoma of anterior oral cavity, soft palate, or tonsil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery Control
Arm Type
Active Comparator
Arm Description
Patients will receive standard of care surgical removal of their tumor.
Arm Title
MedPulser EPT with Bleomycin
Arm Type
Experimental
Arm Description
Patients who are eligible for surgical excision will receive MedPulser electroporation with injection of bleomycin sulfate into the tumor treatment area.
Intervention Type
Combination Product
Intervention Name(s)
Medpulser electroporation with Bleomycin
Intervention Description
Patients receive electroporation with injection of bleomycin sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area.
Intervention Type
Procedure
Intervention Name(s)
Tumor surgical excision
Intervention Description
Patients have their tumor surgically removed.
Primary Outcome Measure Information:
Title
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)
Time Frame
4 Months
Secondary Outcome Measure Information:
Title
Local tumor recurrence, disease free survival and overall survival rates through 2 years after bleomycin-EPT or surgery treatment
Time Frame
4 Months
Title
Safety through 6 months after the study treatment
Time Frame
6 Months
Title
Durability of function status outcomes at 8 months after bleomycin-EPT or surgery treatment
Time Frame
8 Months
Title
Pharmacoeconomic parameters through 8 months after bleomycin-EPT or surgery treatment
Time Frame
8 Months
Title
Bleomycin systemic absorption and plasma pharmacokinetics following intratracheal (IT) bleomycin-EPT administration
Time Frame
96 Hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The presence of SCC of the anterior oral cavity, soft palate or tonsil must be confirmed by histological examination of a tissue sample (e.g., biopsy) obtained within 1 month of the patient receiving the study treatment. Recurrent or second primary disease in patients where surgical resection is seen as an option for disease control. The length of the longest diameter of the study lesion must be < 5 cm and the calculated treatment volume must be < 60.0 cm3 (tumor volume plus a 0.5 cm margin around the tumor) for the study lesion [where treatment volume = 0.5 (A+1) (B+1)2 and where A = length of the longest diameter (cm), B = the next longest diameter perpendicular to "A" (cm)]. Tumor burden must be completely encompassed by surgery or bleomycin-EPT. Age: 18 years or older. Men and women of childbearing potential must use physician approved contraceptive methods for 7 days following bleomycin-EPT. Hematopoietic status: Absolute neutrophil count (ANC) > 1000/uL Platelets > 75,000/mm3 Prothrombin time:international normalized ratio (PT:INR) ? 1.5 (correctable with vitamin K injection) Blood chemistry status: Transaminases < 3 times upper limit of normal Total bilirubin < 2.5 mg/dL Creatinine < 2.5 mg/dL A written Informed Consent form must be signed prior to the patient receiving any study procedures or treatments. Exclusion Criteria: Patients with tumors suspected of involving a 50% or greater encasement of a blood vessel as measured by magnetic resonance imaging (MRI) or computed tomography (CT) scan. Patients with tumors having bone invasion. Patients with any metallic implants in the treatment field. Patients with hypersensitivity to bleomycin. Patients who have received or will exceed a total lifetime dose of bleomycin greater than 400 units. Patients deemed unsuitable for general anesthesia. Patients with a significant history of emphysema or pulmonary fibrosis. Patients with indwelling cardiac pacemakers who cannot tolerate a period with pacemaker turned off. Patients with a history of uncontrolled cardiac arrhythmia. Women who are pregnant, or are nursing. Women of childbearing potential must have a negative beta-human chorionic gonadotropin (beta-HCG) test within 7 days of study treatment. Radiation therapy to the treatment area within 8 weeks of study treatment. Chemotherapy or other cancer therapy (e.g., surgery, cryotherapy, etc.) to the treatment area within 4 weeks of study treatment. Patients participating in a clinical study for an investigational drug or device within 4 weeks prior to the study treatment. Patients previously randomized to this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Goldfarb, MD
Organizational Affiliation
Inovio Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Inovio Biomedical Corporation
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States

12. IPD Sharing Statement

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

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