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
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new treatment called TumoCure, a polymer-based gel loaded with Cisplatin, designed for patients with progressive or radio-resistant primary head and neck cancer who have no other treatment options due to ineffectiveness, intolerance, or inapplicability of standard therapies. This phase Ib, open-label, multi-center study evaluates the safety, tolerability, and initial effectiveness of a single intra-tumoral injection of TumoCure in these patients. Participants will receive one injection of TumoCure directly into their tumor, containing 100 mg of Cisplatin within the polymer gel. This single treatment aims to deliver localized chemotherapy to the tumor site. The study is conducted across multiple centers and involves close monitoring of patients following the injection. During the study, participants will be monitored for serious adverse events over 90 days to assess safety. Researchers will also measure changes in tumor size using ultrasound, MRI, or CT scans to evaluate treatment effect. Subjects must comply with study procedures and provide informed consent. The study includes patients aged 18 to 80 years and lasts at least 90 days from treatment to primary outcome assessment.
CONDITIONS
Brief 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
- Have progressing or radio-resistant disease and unable, unwilling, or intolerant to current treatments
- Have a measurable tumor by ultrasound, MRI, or CT
- ECOG performance status of 0 to 2
You will not qualify if you...
- Life expectancy less than 3 months
- Pregnant or breastfeeding women
- Known chronic pulmonary or respiratory disease with FEV<50% predicted for age
- Reduced kidney function (S-Creatinine ≥ 1.5xULN or Creatinine clearance < 40 ml/min)
- Reduced liver function (ASAT, ALAT, bilirubin > 1.5xULN or PK-INR > 1.5) or history of liver cirrhosis or portal hypertension
- Low blood leukocytes count (<1.5 *10^3/microl) or platelets (<75 *10^3/microl)
- Received systemic chemotherapy within 4 weeks before screening
- Participating in another clinical trial involving an investigational device or drug
- Any condition that the primary investigator believes precludes participation in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single administration
Participants receive a single intra-tumoral injection of TumoCure, a polymer-based gel loaded with Cisplatin, to treat progressive or radio-resistant primary head and neck tumors.
1 treatment visit (in-person)
Duration - 90 days
Participants are monitored for safety and efficacy, including tumor size changes and serious adverse events, for up to 90 days after treatment.
Multiple follow-up visits during 90 days
Trial Site Locations
Total: 1 location
1
Hadassah Medical Center
Jerusalem, Israel
Actively Recruiting
Research Team
M
Maya Shick
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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