Solid TumorPhase 2R-2NCT05898451
Effect of Refnot on Immunity in Cancer Patients
A Phase 2 study testing Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and chemotherapy in people with Solid Tumor, run by Refnot-Pharm Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 4 Jun 2009to Nov 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
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.
Read the 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
- Being tested
- Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T), Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and chemotherapy
- Keywords
- solid tumors, Refnot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T)Drug
Also called Refnot, Tumor necrosis factor-thymosin alfa 1 recombinant
has a direct antitumor effect in vitro and in vivo on various tumor cell lines
Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and chemotherapyDrug
Also called and Dacarbazine, Lomustine, Cisplatin
Refnot has a direct antitumor effect in vitro and in vivo on various tumor cell lines, chemotherapy has a cytostatic and cytotoxic effect.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the level of CD3+-cells
An increase in the level of CD3+-cells relative to the initial
Measured: 4 weeks
Change in the level of CD4+-cells
An increase in the level of CD4+-cells relative to the initial
Measured: 2 weeks
Change in the level of CD4+-cells
An increase in the level of CD4+-cells relative to the initial
Measured: 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
Measured: 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
Measured: 2 weeks
Change in the ratio of CD4+/CD8+
Increase in the ratio of lymphocytes / lymphocytes relative to the initial
Measured: 2 weeks
Change in the ratio of CD4+/CD8+
Increase in the ratio of lymphocytes / lymphocytes relative to the initial
Measured: 4 weeks
Change in NK-cell activity
Increased activity of NK cells in patients with an initially reduced rate
Measured: 4 weeks
Change in NK-cell activity
Percentage increase in NK cell activity in patients with initially normal values
Measured: 2 weeks
Change in NK-cell activity
Percentage increase in NK cell activity in patients with initially normal values
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start4 Jun 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Refnot-Pharm Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anatolij D Namgaladze, Master, Study director, Refnot-Pharm Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898451
- Sponsor's protocol ID
- R-2
- Acronym
- R-2
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Refnot on Immunity in Cancer Patients
- ClinicalTrials.gov ID
- NCT05898451
- Acronym / sponsor ID
- R-2 / R-2
- Conditions
- Solid Tumor
- Keywords
- solid tumors, Refnot
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Refnot-Pharm LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2009 (actual)
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Independent use of Refnot | Experimental | Drug: Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T)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 | Drug: Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and chemotherapyRefnot 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T)Also: Refnot, Tumor necrosis factor-thymosin alfa 1 recombinanthas a direct antitumor effect in vitro and in vivo on various tumor cell lines | Drug | Independent use of Refnot |
| Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and chemotherapyAlso: and Dacarbazine, Lomustine, CisplatinRefnot has a direct antitumor effect in vitro and in vivo on various tumor cell lines, chemotherapy has a cytostatic and cytotoxic effect. | Drug | The use of Refnot in combination with chemotherapy |
Primary outcome
Change in the level of CD3+-cells
Time frame: 4 weeks
An increase in the level of CD3+-cells relative to the initial
Change in the level of CD4+-cells
Time frame: 2 weeks
An increase in the level of CD4+-cells relative to the initial
Change in the level of CD4+-cells
Time frame: 4 weeks
An increase in the level of CD4+-cells relative to the initial
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
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
Change in the ratio of CD4+/CD8+
Time frame: 2 weeks
Increase in the ratio of lymphocytes / lymphocytes relative to the initial
Change in the ratio of CD4+/CD8+
Time frame: 4 weeks
Increase in the ratio of lymphocytes / lymphocytes relative to the initial
Change in NK-cell activity
Time frame: 4 weeks
Increased activity of NK cells in patients with an initially reduced rate
Change in NK-cell activity
Time frame: 2 weeks
Percentage increase in NK cell activity in patients with initially normal values
Change in NK-cell activity
Time frame: 4 weeks
Percentage increase in NK cell activity in patients with initially normal values
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anatolij D Namgaladze, Master study director
Refnot-Pharm Ltd
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and chemotherapy in people with Solid Tumor, run by Refnot-Pharm Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the level of CD3+-cells (time frame: 4 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.