Histologically confirmed primary oral cavity, primary pharyngeal, primary laryngeal, salivary gland, limited recurrent and second primary tumors.
Conditions
Interventions
Trade Name: Bleo-Kyowa
Product Name: Bleomycin Sulphate
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: Bleomycin Sulphate
Concentration unit: IU/ml international unit(s)/millilitre
Co
Sponsors
Genetronics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The presence of primary oral cavity, primary pharyngeal, primary laryngeal laryngary gland, limited recurrent and second primary tumors must be confirmed by histological examination of a tissue sample (e.g., biopsy) obtained within 2 months of the patient receiving the treatment. • The length of the longest diameter of lesion must be ==65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Subjects with tumors suspected of involving a 50% or greater encasement of a blood vessel as measured by MRI or CT scan • Subjects with tumors 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 anesthesia • Subjects with a significant history of emphysema or pulmonary fibrosis • Subjects with indwelling cardiac pacemakers who cannot tolerate aperiod with pacemaker turned off • Subjects with a history of uncontrolled cardiac arrhythmia • Women who are pregnant, or are nursing. Women must have a negative pregnancy tet (urine pregnancy tests are acceptable) within 7 days of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize local tumor recurrence through 8 months post-EPT/Bleomycin treatment;Secondary Objective: Secondary objectives : • To measure pharmacoeconomic factors (hospital costs, extent of medical interventions, medication use) in subjects treated by EPT/Bleomycin • To evaluate organ function and appearance using the performance Status Scale (PSS) (Appendix II) and the EORTC QLQ – H&N 35 (Appendix IV) at 4 and 8 months following treatment • To document the performance of the MedPulser® System during EPT/Bleomycin treatment • To monitor local and systemic adverse events through the 4 Month follow-up study visit.;Primary end point(s): Local tumor control through 8 months. | — |
Countries
United Kingdom
Outcome results
None listed