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Tests treatment safety and results for Head and Neck Cancer
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
ClinicalTrials.gov ID: NCT05200650
What this study is testing
What is TumoCure?
TumoCure is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for head and neck cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Male and female aged 18-80 years.
- people who are willing to comply with study procedures.
- people who are mentally and cognitively capable and who are capable of understanding and signing the informed consent.
- people with a known diagnosis of primary head and neck cancer, with or without metastases.
- people with a progressing or radio-resistant disease, who are unable, unwilling or do not tolerate currently available treatments.
You likely can't join if
- people 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...
- Blood leukocytes count \<1.5 \ 103/microl or platelets \<75 \ 103/microl.
See the full eligibility criteria
- Male and female aged 18-80 years.
- people who are willing to comply with study procedures.
- people who are mentally and cognitively capable and who are capable of understanding and signing the informed consent.
- people with a known diagnosis of primary head and neck cancer, with or without metastases.
- people with a progressing or radio-resistant disease, who are unable, unwilling or do not tolerate currently available treatments.
- people with a measurable tumor by either ultrasound, MRI or CT.
- people with ECOG performance status of 0 -2.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jerusalem, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jerusalem, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.