Head and Neck Cancer
Conditions
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
Interventions
COMBINATION_PRODUCTTumoCure
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.
Sponsors
IntraGel Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 function, defined as ASAT, ALAT, bilirubin \> 1.5xULN and PK-INR \> 1.5, or a known medical history of liver cirrhosis or portal hypertension. 6. Blood leukocytes count \<1.5 \*103/microl or platelets \<75 \*103/microl. 7. Subject who was treated with systemic chemotherapy during the 4 weeks preceding screening. 8. Participation in any other clinical trial that included an investigational device or medicinal product. 9. Any other condition that according to the discretion of the primary investigator precludes the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Serious Adverse Events | 90 days | Cumulative rate of treatment - related serious adverse events (SAEs) throughout the follow up period (90 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tumor Size (Efficacy) | 90 days | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 90 days | Overall survival (OS) throughout the follow up period (90 days) |
| Subject Quality of Life | 90 days | Subject Quality of Life (QoL), as determined by the change in EORTC-QLQ30 (European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - 30) total score (ranging from 30-120, the lower the result, the better quality of life the subject reports) from baseline to end of follow up period. |
Countries
Israel
Contacts
Primary ContactMaya Shick
Outcome results
None listed