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
Trial Parameters
Brief Summary
IntraGel's polymer-based Cisplatin loaded Gel (TumoCure) is a single injectable compound, aimed at localized chemotherapy treatment. The treatment is offered to patients who currently have no other available treatment options, either due to inefficacy, intolerability or inapplicability of standard treatment
Eligibility Criteria
Inclusion Criteria: 1. Male and female aged 18-80 years. 2. Subjects who are willing to comply with study procedures. 3. Subjects who are mentally and cognitively capable and who are capable of understanding and signing the informed consent. 4. Subjects with a known diagnosis of primary head and neck cancer, with or without metastases. 5. Subjects with a progressing or radio-resistant disease, who are unable, unwilling or do not tolerate currently available treatments. 6. Subjects with a measurable tumor by either ultrasound, MRI or CT. 7. Subjects with ECOG performance status of 0 -2. Exclusion Criteria: 1. Subjects with life expectancy of less than 3 months. 2. Pregnant or breastfeeding women. 3. Known COPD or other chronic pulmonary or respiratory disease, with PFT's indicating a FEV\<50% predicted for age. 4. Known reduced renal function, defined S-Creatinine ≥ 1.5xULN or Creatinine clearance \< 40 ml/min, calculated by using the Cockroft and Gault formula. 5. Reduced hepatic funct