Effect of Refnot on Immunity in Cancer Patients (R-2)

Refnot-Pharm

Status and phase: Completed; Phase 2

Conditions: Solid Tumor

Treatments: Drug: Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T); Drug: Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT05898451

R-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Independent use of Refnot

Experimental group

Description:

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. In the absence of progression of the disease - an additional 4 weeks.

Treatment:

Drug: Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T)

The use of Refnot in combination with chemotherapy

Experimental group

Description:

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. In the absence of progression of the disease - an additional 4 weeks. Chemotherapy may be used after 4-8 weeks of Refnot use.

Treatment:

Drug: Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and chemotherapy