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

Inclusion criteria

• Male and female aged 18-80 years.
• Subjects who are willing to comply with study procedures.
• Subjects who are mentally and cognitively capable and who are capable of understanding and signing the informed consent.
• Subjects with a known diagnosis of primary head and neck cancer, with or without metastases.
• Subjects with a progressing or radio-resistant disease, who are unable, unwilling or do not tolerate currently available treatments.
• Subjects with a measurable tumor by either ultrasound, MRI or CT.
• Subjects with ECOG performance status of 0 -2.

Exclusion criteria

• 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.