Effect of Refnot on Immunity in Cancer Patients

NCT05898451 | Completed Phase 2

• 1 other identifier: R-2
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Solid Tumor

Keywords

solid tumors; Refnot

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

Independent use of Refnot

EXPERIMENTAL

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)

The use of Refnot in combination with chemotherapy

EXPERIMENTAL

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

Interventions

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

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

Also known as: Refnot, Tumor necrosis factor-thymosin alfa 1 recombinant

Independent use of Refnot

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

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

Also known as: and Dacarbazine, Lomustine, Cisplatin

The use of Refnot in combination with chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Refnot-Pharm Ltd: lead

MeSH Terms

Interventions

Drug Therapy; Dacarbazine; Lomustine; Cisplatin

Intervention Hierarchy (Ancestors)

Therapeutics; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Anatolij D Namgaladze, Master

  Refnot-Pharm Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 12, 2023
• Study Start: June 4, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 12, 2023

Record last verified: 2023-05