Actively Recruiting
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
Led by IntraGel Therapeutics · Updated on 2024-10-08
20
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female aged 18-80 years.
- Willing to comply with study procedures.
- Mentally and cognitively able to understand and sign informed consent.
- Diagnosed with primary head and neck cancer, with or without metastases.
- Disease is progressing or radio-resistant, and unable, unwilling, or intolerant to current treatments.
- Measurable tumor by ultrasound, MRI, or CT.
- ECOG performance status between 0 and 2.
You will not qualify if you...
- Life expectancy less than 3 months.
- Pregnant or breastfeeding women.
- Known COPD or chronic respiratory disease with FEV < 50% predicted.
- Reduced kidney function with S-Creatinine ≥ 1.5xULN or Creatinine clearance < 40 ml/min.
- Reduced liver function with ASAT, ALAT, bilirubin > 1.5xULN or PK-INR > 1.5, or history of liver cirrhosis or portal hypertension.
- Blood leukocytes count <1.5 *10^3/microl or platelets <75 *10^3/microl.
- Treated with systemic chemotherapy within 4 weeks before screening.
- Participation in other clinical trials involving investigational devices or drugs.
- Any other condition that the primary investigator judges excludes participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hadassah Medical Center
Jerusalem, Israel
Actively Recruiting
Research Team
M
Maya Shick
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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