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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anatolij D Namgaladze, Master | Refnot-Pharm Ltd | Study Director |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 15, 2023 | |
| Reset | Apr 26, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 15, 2023 | Apr 26, 2024 |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D003606 | Dacarbazine |
| D008130 | Lomustine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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|
| 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. |
|
|
| 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 |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |