R-2: Effect of Refnot on Immunity in Cancer Patients

Sponsor

Refnot-Pharm Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT05898451

Collaborator

(none)

Enrollment

Arms

28.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) Drug: Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and chemotherapy	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Refnot on Immunity in Cancer Patients

Actual Study Start Date :

Jun 4, 2009

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

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

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

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

Outcome Measures

Primary Outcome Measures

Change in the level of CD3+-cells [4 weeks]
An increase in the level of CD3+-cells relative to the initial
Change in the level of CD4+-cells [2 weeks]
An increase in the level of CD4+-cells relative to the initial
Change in the level of CD4+-cells [4 weeks]
An increase in the level of CD4+-cells relative to the initial
Change in the level of CD8+-cells [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 [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+ [2 weeks]
Increase in the ratio of lymphocytes / lymphocytes relative to the initial
Change in the ratio of CD4+/CD8+ [4 weeks]
Increase in the ratio of lymphocytes / lymphocytes relative to the initial
Change in NK-cell activity [4 weeks]
Increased activity of NK cells in patients with an initially reduced rate
Change in NK-cell activity [2 weeks]
Percentage increase in NK cell activity in patients with initially normal values
Change in NK-cell activity [4 weeks]
Percentage increase in NK cell activity in patients with initially normal values

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.