A Randomized Trial Comparing Preservation of Function Status After Either MedPulser Electroporation With Intratumoral Bleomycin Therapy of Surgery in Patients With Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Base of Tongue, Posterior Lateral Pharyngeal Wall, Hypophyranx and Larynx That Have Failed Primary Curative Therapy.

• Conditions: Patients with locally recurrent or second primary SCC of the base tongue, posterior lateral pharyngeal wall, hypopharynx and larynx.

• Registration Number: EUCTR2004-003977-10-LV
• Lead Sponsor: Genetronics Biomedical Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11-17
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

•Biopsy confirmed SCC of the base of tongue, posterior lateral pharyngeal wall, hypopharynx and larynx (larynx without invasion through cartilage (i.e. T4a) but including stomal recurrence following laryngectomy).
•Recurrent or second primary disease inpatients where surgical resection is seen as an option for disease control.
•Lesion must be <= 4 cm in diameter.
•Tumor burden must be completely encompassed by surgery or bleomycin-EPT.
•Men and women of childbearing potential must use physician prescribed contraceptive methods for 7 days following bleomycin-EPT.
•Hematopoietic status:
ANC > 1000/uL
Platelets > 75,000/qmm
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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Subjects with tumours that involve a 50% or greater encasement of a blood vessel as measured by MRI or CT scan.
•Subjects with tumours having bone invasion or invasion through the laryngeal wall (T4a).
•Patients with any metallic implants in the treatment field.
•Subjects with hypersensitivity to Bleomycin.
•Subjects who have received or will exceed a total lifetime dose of Bleomycin greater than 400 International Units.
•Subjects deemed unsuitable for general anaesthesia.
•Subjects with significant history of emphysema or pulmonary fibrosis.
•Subjects with indwelling cardiac pacemakers who cannot tolerate a period with pacemaker turned off
•Subjects with a history of uncontrolled cardiac arrhythmia.
•Women who are pregnant, or are nursing. Woman must have a negative ßHCG 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified