Patients with locally recurrent or second primary SCC of the base tongue, posterior lateral pharyngeal wall, hypopharynx and larynx.
Conditions
Interventions
Product Name: Bleomycin Sulphate
Product Code: Bleomycin-EPT
Pharmaceutical Form: Powder for injection*
Sponsors
Genetronics Biomedical Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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 1000/uL Platelets > 75,000/qmm PT:INR=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 base of tongue, posterior lateral pharyngeal wall, hypopharynx and larynx that have failed primary curative therapy and in whom surgical resection is seen as an option for the 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. • To evaluate the durability of function status outcomes at 8 months after bleomycin-EPT or surgery treatment. • To evaluate pharmacoeconomic parameters through 8 months after bleomycin-EPT or surgery treatment. • To characterize bleomycin systemic absorption and plasma pharmacokinetics following IT bleomycin-EPT administration. ;Primary end point(s): Primary end point: Function status, evaluated at 4 months after initiation of treatment by the validated, clinician-rated disease specific, head and neck Performance Status Scale (PSSHN). Secondary end points: • Durability of the PSSHN function status will be evaluated at 8 months after bleomycin-EPT or surgery treament. • Local tumor recurrence, disease free survival and overall survival rates will be evaluated through two years after bleomycin-EPT or surgery treatment. • Quality of life by the EORTC-QLQ-H&N 35 will be evaluated at 4 and 8 months after bleomycin-EPT or surgery treatment to globally confirm PSSHN function status results and to identify potential quality of life changes not included in the three PSSHN function staus scales. | — |
Countries
Latvia, United Kingdom
Outcome results
None listed