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

NCT00198315 | Terminated Phase 3 DMC

• 1 other identifier: HNBE-03-01
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 intratracheal (IT) bleomycin-EPT administration

  96 Hours

Study Arms (2)

Surgery Control

ACTIVE COMPARATOR

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

Procedure: Tumor surgical excision

MedPulser EPT with Bleomycin

EXPERIMENTAL

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

Combination Product: Medpulser electroporation with Bleomycin

Interventions

Medpulser electroporation with Bleomycin COMBINATION_PRODUCT

Patients receive electroporation with injection of bleomycin sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area.

MedPulser EPT with Bleomycin

Tumor surgical excision PROCEDURE

Patients have their tumor surgically removed.

Surgery Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inovio Pharmaceuticals: lead

Study Sites (1)

Inovio Biomedical Corporation

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms

Interventions

Bleomycin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Paul Goldfarb, MD

  Inovio Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2004
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: March 4, 2022

Record last verified: 2022-03

Locations

US (1)