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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T); Drug: Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and chemotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T); has a direct antitumor effect in vitro and in vivo on various tumor cell lines; Other Names: Refnot; Tumor necrosis factor-thymosin alfa 1 recombinant
Experimental: 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.	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.; Other Names: and Dacarbazine, Lomustine, Cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the level of CD3+-cells	An increase in the level of CD3+-cells relative to the initial	4 weeks
Change in the level of CD4+-cells	An increase in the level of CD4+-cells relative to the initial	2 weeks
Change in the level of CD4+-cells	An increase in the level of CD4+-cells relative to the initial	4 weeks
Change in the level of CD8+-cells	An increase in the level of T-lymphocytes relative to the initial one in those patients in whom it was reduced	2 weeks
Change in the level of CD8+-cells	A decrease in the level of T-lymphocytes relative to the initial one in those patients in whom it was elevated	2 weeks
Change in the ratio of CD4+/CD8+	Increase in the ratio of lymphocytes / lymphocytes relative to the initial	2 weeks
Change in the ratio of CD4+/CD8+	Increase in the ratio of lymphocytes / lymphocytes relative to the initial	4 weeks
Change in NK-cell activity	Increased activity of NK cells in patients with an initially reduced rate	4 weeks
Change in NK-cell activity	Percentage increase in NK cell activity in patients with initially normal values	2 weeks
Change in NK-cell activity	Percentage increase in NK cell activity in patients with initially normal values	4 weeks

Collaborators and Investigators

• Sponsor: Refnot-Pharm Ltd
• Investigators: Study Director: Anatolij D Namgaladze, Master, Refnot-Pharm Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2009
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: solid tumors; Refnot
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Adjuvants, Immunologic; Cisplatin; Dacarbazine; Thymalfasin; Lomustine
• Other Study ID Numbers: R-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No