Skip to main content
OpenTrials
Completed

NCT Number: NCT05898451

Effect of Refnot on Immunity in Cancer Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Solid Tumor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Refnot, Tumor necrosis factor-thymosin alfa 1 recombinant

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.

Other names: and Dacarbazine, Lomustine, Cisplatin

Primary outcomes

  1. Change in the level of CD3+-cells

    Time frame: 4 weeks

    An increase in the level of CD3+-cells relative to the initial

  2. Change in the level of CD4+-cells

    Time frame: 2 weeks

    An increase in the level of CD4+-cells relative to the initial

  3. Change in the level of CD4+-cells

    Time frame: 4 weeks

    An increase in the level of CD4+-cells relative to the initial

  4. Change in the level of CD8+-cells

    Time frame: 2 weeks

    An increase in the level of T-lymphocytes relative to the initial one in those patients in whom it was reduced

  5. Change in the level of CD8+-cells

    Time frame: 2 weeks

    A decrease in the level of T-lymphocytes relative to the initial one in those patients in whom it was elevated

  6. Change in the ratio of CD4+/CD8+

    Time frame: 2 weeks

    Increase in the ratio of lymphocytes / lymphocytes relative to the initial

  7. Change in the ratio of CD4+/CD8+

    Time frame: 4 weeks

    Increase in the ratio of lymphocytes / lymphocytes relative to the initial

  8. Change in NK-cell activity

    Time frame: 4 weeks

    Increased activity of NK cells in patients with an initially reduced rate

  9. Change in NK-cell activity

    Time frame: 2 weeks

    Percentage increase in NK cell activity in patients with initially normal values

  10. Change in NK-cell activity

    Time frame: 4 weeks

    Percentage increase in NK cell activity in patients with initially normal values

Sponsors and collaborators

Lead sponsor

Refnot-Pharm Ltd

Industry

Registry information

Acronym: R-2

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 12, 2023
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.