Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Head and Neck Cancer
Lead sponsor: IntraGel Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-01-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Serious Adverse Events
timeFrame: 90 days
Secondary outcomes:
measure: Change in Tumor Size (Efficacy)
timeFrame: 90 days
Other outcomes:
measure: Overall Survival
timeFrame: 90 days
measure: Subject Quality of Life
timeFrame: 90 days
measure: Subject Quality of Life
timeFrame: 90 days
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Head of Head and Neck Surgery Department
name: Aharon Popovizer, MD
role: PRINCIPAL_INVESTIGATOR
References: