Clinical trial NCT05898451: Effect of Refnot on Immunity in Cancer Patients
Official title: Effect of Refnot on Immunity in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solid Tumor
Keywords: solid tumors
Refnot
Lead sponsor: Refnot-Pharm Ltd
Sponsor class: INDUSTRY
First posted: 2023-06-12
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was planned to include disseminated patients with various solid tumors (melanoma, soft tissue sarcoma, breast cancer, colon cancer, etc.). The study drug was administered subcutaneously at a dose of 400,000 IU once a day, 3 times a week (every other day), for 4 weeks. In the absence of disease progression - an additional 4 weeks.

Detailed description: The study was planned to include 50 disseminated patients with various solid tumors. The patients were divided into 2 groups: 1 - Refnot, monotherapy, 2 - Refnot together with chemotherapy.

Refnot is administered at a dose of 400,000 IU subcutaneously 3 times a week for 4 weeks. 4 weeks constitute 1 course of treatment with Refnot. Immediately before use, 1 ml of water for injection is added to 4 vials (100,000 IU each) or to a vial containing 400,000 IU. After dilution, the drug is injected subcutaneously into the outer surface of the shoulder or thigh. Injection sites should alternate. In the absence of progression of the disease - an additional 4 weeks. Chemotherapy may be used after 4-8 weeks of Refnot use.

Eligibility criteria: Inclusion Criteria:

* Patients who have exhausted standard methods of treatment.
* Morphological (histological or cytological) confirmation of the diagnosis.
* Age no more than 75 years.
* General condition 0-2 (WHO).
* Estimated life expectancy of at least 3 months.
* Consent to treatment under this protocol.
* The number of granulocytes is more than 2000/mm, platelets are more than 150000/mm.
* The level of creatinine should not exceed 1.5 norms, liver enzymes (ALT, AST and alkaline phosphatase) should not exceed 3 norms.
* For common disease, patients should receive standard treatment earlier.

Exclusion Criteria:

* Severe manifestations of cardiovascular diseases in the past and at present (myocardial infarction, hypertension, stroke, phlebothrombosis, coronary insufficiency requiring drug control, etc.).
* Peptic ulcer of the stomach, duodenal ulcer (in the acute phase), uncorrected diabetes mellitus.
* Mental illness preventing understanding of the treatment plan.
* Pregnancy.
* Metastases of a malignant tumor in the brain (according to clinical data).
* Chronic use of corticosteroids or immunosuppressants.
* Various neurological diseases that prevent this treatment.
* Known allergic reactions and/or other significant allergic conditions.
* Any immunotherapy within the last 6 weeks prior to enrollment in the study.

Primary outcomes:
measure: Change in the level of CD3+-cells
timeFrame: 4 weeks
measure: Change in the level of CD4+-cells
timeFrame: 2 weeks
measure: Change in the level of CD4+-cells
timeFrame: 4 weeks
measure: Change in the level of CD8+-cells
timeFrame: 2 weeks
measure: Change in the level of CD8+-cells
timeFrame: 2 weeks
measure: Change in the ratio of CD4+/CD8+
timeFrame: 2 weeks
measure: Change in the ratio of CD4+/CD8+
timeFrame: 4 weeks
measure: Change in NK-cell activity
timeFrame: 4 weeks
measure: Change in NK-cell activity
timeFrame: 2 weeks
measure: Change in NK-cell activity
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Refnot-Pharm Ltd
name: Anatolij D Namgaladze, Master
role: STUDY_DIRECTOR
References: