Clinical trial

Effect of Refnot on Immunity in Cancer Patients

Name

R-2

Description

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.

Trial arms

Trial start

2009-06-04

Estimated PCD

2011-11-01

Trial end

2011-11-01

Status

Completed

Phase

Early phase I

Treatment

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

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

Arms:

Independent use of Refnot

Other names:

Refnot, Tumor necrosis factor-thymosin alfa 1 recombinant

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.

Arms:

The use of Refnot in combination with chemotherapy

Other names:

and Dacarbazine, Lomustine, Cisplatin

Size

Primary endpoint

Change in the level of CD3+-cells

4 weeks

Change in the level of CD4+-cells

2 weeks

Change in the level of CD4+-cells

4 weeks

Change in the level of CD8+-cells

2 weeks

Change in the level of CD8+-cells

2 weeks

Change in the ratio of CD4+/CD8+

2 weeks

Change in the ratio of CD4+/CD8+

4 weeks

Change in NK-cell activity

4 weeks

Change in NK-cell activity

2 weeks

Change in NK-cell activity

4 weeks

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 55, 'type': 'ACTUAL'}}

Updated at

2023-06-12

2 organizations

2 products

4 indications

Organization

Rise Therapeutics

Product

R-2487

Indication

Sjögren

Indication