Effect of Refnot on Immunity in Cancer Patients

NCT ID: NCT05898451

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-04
• Study Completion Date: 2011-11-30

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.

Conditions

Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Independent use of Refnot

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

has a direct antitumor effect in vitro and in vivo on various tumor cell lines

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Refnot has a direct antitumor effect in vitro and in vivo on various tumor cell lines, chemotherapy has a cytostatic and cytotoxic effect.

Interventions

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

has a direct antitumor effect in vitro and in vivo on various tumor cell lines

Intervention Type: DRUG

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

Refnot has a direct antitumor effect in vitro and in vivo on various tumor cell lines, chemotherapy has a cytostatic and cytotoxic effect.

Intervention Type: DRUG

Other Intervention Names

Refnot; Tumor necrosis factor-thymosin alfa 1 recombinant; and Dacarbazine, Lomustine, Cisplatin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Refnot-Pharm Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anatolij D Namgaladze, Master

Role: STUDY_DIRECTOR

Refnot-Pharm Ltd

Other Identifiers

R-2

Identifier Type: -

Identifier Source: org_study_id