A Single Arm, Prospective, Open Label, Multi Center, Phase Ib Study to Evaluate the Safety, Tolerability and Initial Efficacy of a Single Intra-tumoral Injection of IntraGel's Polymer-based Cisplatin-loaded Gel (TumoCure) in Subjects With Progressive or Radio-resistant Primary Head and Neck Tumor

Exclusion Criteria9

• Subjects with life expectancy of less than 3 months.
• Pregnant or breastfeeding women.
• Known COPD or other chronic pulmonary or respiratory disease, with PFT's indicating a FEV\<50% predicted for age.
• Known reduced renal function, defined S-Creatinine ≥ 1.5xULN or Creatinine clearance \< 40 ml/min, calculated by using the Cockroft and Gault formula.
• Reduced hepatic function, defined as ASAT, ALAT, bilirubin \> 1.5xULN and PK-INR \> 1.5, or a known medical history of liver cirrhosis or portal hypertension.
• Blood leukocytes count \<1.5 \*103/microl or platelets \<75 \*103/microl.
• Subject who was treated with systemic chemotherapy during the 4 weeks preceding screening.
• Participation in any other clinical trial that included an investigational device or medicinal product.
• Any other condition that according to the discretion of the primary investigator precludes the subject from participating in the study.