A Randomized Trial Comparing Preservation of Function Status After Either MedPulser® Electroporation with Intraumoral Bleomycin Therapy or Surgery in Patients with Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Anterior Oral Cavity, Soft Plate, and Tonsil that have Failed Primary Curative Therapy

• Conditions: Patients with locally recurrent or second primary SCC of the anterior oral cavity, soft palate, and tonsil that have failed primary curative therapy in whom surgical resection is seen as an option for desease control.

• Registration Number: EUCTR2004-004107-37-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 anterior oral cavity, soft palate, and tonsil.
•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.
•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

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 anterior oral cavity, soft palate, or tonsil that have failed primary curative therapy and in whom surgical resection is seen as an option for disease control.;Secondary Objective: •To evaluate local tumor recurrence, disease free survival and overall survival rates through 2 years after bleomycin-EPT or surgery treatment.<br>•To evaluate the durability of function status outcomes at 8 months after bleomycin-EPT or surgery treatment.<br>•To evaluate pharmacoeconomic parameters through 8 months after bleomycin-EPT or surgery treatment.<br>•To characterize bleomycin systemic absorption and plasma pharmacokinetics following IT bleomycin-EPT administration.<br>;Primary end point(s): Function status, evaluated at 4 months after initiation of treatment by the validated, clinician-rated disease specific, head and neck Performance Status Scale (PSSHN).