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

Stopped early · Phase 3

Conditions studied: Head Neck Cancer

In brief

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.

Key facts

Study ID

NCT00198328

Run by

Inovio Pharmaceuticals

People needed

84

Starts

2004-11-01

Expected to finish

2007-06-01

Last updated by the study team

2022-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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 < 2.5mg/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.

Where it is running

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

Full record on ClinicalTrials.gov

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