A randomized trial comparing preservation of function status after either MedPulser Electroporation with intratumoral bleomycin therapy or surgery in patients with locally recurrent or second primary squamous cell carcinoma of the anterior oral cavity, soft palate, or tonsil that have failed primary curative therapy

Phase 1

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

• Registration Number: EUCTR2004-004107-37-GB
• Lead Sponsor: Genetronics / inovio Biomedical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-21
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

1. 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.
2. Recurrent or second primary disease in patients where surgical resection is seen as
an option for disease control.
3. 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)].
4. Tumor burden must be completely encompassed by surgery or bleomycin-EPT.
5. Age: 18 years or older.
6. Men and women of childbearing potential must use physician approved
contraceptive methods for 7 days following bleomycin-EPT.
7. Hematopoietic status:
ANC > 1000/uL
Platelets > 75,000/mm3
PT: INR = 1.5 (correctable with Vitamin K injection)
8. Blood Chemistry status:
Transaminases < 3 times upper limit of normal
Total Bilirubin < 2.5 mg/dL
Creatinine < 2.5mg/dL
9. A written Informed Consent Form must be signed prior to the patient receiving
any study procedures or treatments.

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

1. Patients with tumors suspected of involving a 50% or greater encasement of a
blood vessel as measured by MRI or CT scan.
2. Patients with tumors having bone invasion.
3. Patients with any metallic implants in the treatment field.
4. Patients with hypersensitivity to bleomycin.
5. Patients who have received or will exceed a total lifetime dose of bleomycin
greater than 400 Units.
6. Patients deemed unsuitable for general anesthesia.
7. Patients with a significant history of emphysema or pulmonary fibrosis.
8. Patients with indwelling cardiac pacemakers who cannot tolerate a period with
pacemaker turned off.
9. Patients with a history of uncontrolled cardiac arrhythmia.
10. Women who are pregnant, or are nursing. Women of childbearing potential must
have a negative ßHCG test within 7 days of study treatment.
11. Radiation therapy to the treatment area within 8 weeks of study treatment.
12. Chemotherapy or other cancer therapy (e.g., surgery, cryotherapy, etc.) to the
treatment area within 4 weeks of study treatment.
13. Patients participating in a clinical study for an investigational drug or device
within 4 weeks prior to the study treatment.
14. Patients previously randomized to this study.

Study & Design

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