Recruiting NCT05200650
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TumoCure.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 product TumoCure
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.
Primary outcome measures
- Rate of Serious Adverse Events [Time frame: 90 days]
Secondary outcome measures (1)
- Change in Tumor Size (Efficacy) [Time frame: 90 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Hadassah Medical Center — Jerusalem
Identifiers
NCT: NCT05200650 · CLPR-001