Status:
TERMINATED
Medpulser Electroporation With Bleomycin Study to Treat Posterior Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Inovio Pharmaceuticals
Conditions:
Head Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 recurr...
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 bee...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00198328
Start Date
November 1 2004
End Date
June 1 2007
Last Update
March 4 2022
Active Locations (1)
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1
Inovio Biomedical Corporation
San Diego, California, United States, 92121