Medpulser Electroporation With Bleomycin Study to Treat Posterior 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 Base of the Tongue, Posterior Lateral Pharyngeal Wall, Hypopharynx, or Larynx That Have Failed Primary Curative Therapy

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.

Study Overview

• Status: Terminated
• Conditions: Head Neck Cancer
• Intervention / Treatment: Procedure: Surgical Excision; Combination product: Medpulser Electroporation with Bleomycin

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 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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Inovio Biomedical Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The presence of SCC of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx, or larynx must be confirmed by histological examination of a tissue sample (e.g., biopsy) obtained within 1 month of the patient receiving the study treatment.
2. Recurrent or second primary disease in patients where surgical resection is seen as an option for disease control.
3. 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)].
4. Tumor burden must be completely encompassed by surgery or bleomycin-EPT.
5. Age: 18 years or older.
6. Men and women of childbearing potential must use physician approved contraceptive methods for 7 days following bleomycin-EPT.

7. 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)

8. Blood chemistry status:

   • Transaminases < 3 times upper limit of normal
   • Total bilirubin < 2.5 mg/dL
   • Creatinine < 2.5mg/dL
9. A written Informed Consent form must be signed prior to the patient receiving any study procedures or treatments.

Exclusion Criteria:

1. 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.
2. Patients with tumors having bone invasion.
3. Patients with any metallic implants in the treatment field.
4. Patients with hypersensitivity to bleomycin.
5. Patients who have received or will exceed a total lifetime dose of bleomycin greater than 400 units.
6. Patients deemed unsuitable for general anesthesia.
7. Patients with a significant history of emphysema or pulmonary fibrosis.
8. Patients with indwelling cardiac pacemakers who cannot tolerate a period with pacemaker turned off.
9. Patients with a history of uncontrolled cardiac arrhythmia.
10. 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.
11. Radiation therapy to the treatment area within 8 weeks of study treatment.
12. Chemotherapy or other cancer therapy (e.g., surgery, cryotherapy, etc.) to the treatment area within 4 weeks of study treatment.
13. Patients participating in a clinical study for an investigational drug or device within 4 weeks prior to the study treatment.
14. Patients previously randomized to this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgery Control; Patients receive surgical excision of their tumor.	Procedure: Surgical Excision; Patients have their tumor surgically removed.
Experimental: MedPulser EPT; Patients receive electroporation with injection of Bleomycin Sulfate.	Combination product: 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.; Other Names: MedPulser EPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	4 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Local tumor recurrence, disease free survival and overall survival rates through 2 years after bleomycin-EPT or surgery treatment	4 Months
Safety through 6 months after the study treatment	6 Months
Durability of function status outcomes at 8 months after bleomycin-EPT or surgery treatment	8 Months
Pharmacoeconomic parameters through 8 months after bleomycin-EPT or surgery treatment	8 Months
Bleomycin systemic absorption and plasma pharmacokinetics following intratumoral (IT) bleomycin-EPT administration	96 Hours

Collaborators and Investigators

• Sponsor: Inovio Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2004
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: carcinoma; cancer; head and neck cancer; Squamous Cell Carcinoma; electroporation; larynx; bleomycin; medpulser; Locally recurrent or second primary squamous cell carcinoma of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx, or larynx
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Antineoplastic Agents; Antibiotics, Antineoplastic; Bleomycin
• Other Study ID Numbers: HNBE-03-02