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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Combination Product: TumoCure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TumoCure Treatment<br>Subjects will be treated with a single intra-tumor injection of TumoCure, containing the polymeric delivery system and the Cisplatin hemotherapy agent at a dose of 100mg. | Combination Product: TumoCure<br>* TumoCure is a polymer-based gel, loaded with Cisplatin in a dose of 100mg (10% w/w), injected to head and neck tumors locally in a single injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Serious Adverse Events | Cumulative rate of treatment - related serious adverse events (SAEs) throughout the follow up period (90 days) | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tumor Size (Efficacy) | change in tumor size from baseline to the end of the follow up period (90 days) according to the RECIST methodology, as determined by MRI/CT imaging | 90 days |