Effect of Refnot on Immunity in Cancer Patients

Solid Tumor Clinical Trial

— R-2  

Official title:

Effect of Refnot on Immunity in Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05898451
• Other study ID #: R-2
• Status: Completed
• Phase: Phase 2
• Start date: June 4, 2009
• Est. completion date: November 2011

Study information

• Verified date: May 2023
• Source: Refnot-Pharm Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. In the absence of disease progression - an additional 4 weeks.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumor

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Refnot-Pharm Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the level of CD3+-cells	An increase in the level of CD3+-cells relative to the initial	4 weeks
Primary	Change in the level of CD4+-cells	An increase in the level of CD4+-cells relative to the initial	2 weeks
Primary	Change in the level of CD4+-cells	An increase in the level of CD4+-cells relative to the initial	4 weeks
Primary	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
Primary	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
Primary	Change in the ratio of CD4+/CD8+	Increase in the ratio of lymphocytes / lymphocytes relative to the initial	2 weeks
Primary	Change in the ratio of CD4+/CD8+	Increase in the ratio of lymphocytes / lymphocytes relative to the initial	4 weeks
Primary	Change in NK-cell activity	Increased activity of NK cells in patients with an initially reduced rate	4 weeks
Primary	Change in NK-cell activity	Percentage increase in NK cell activity in patients with initially normal values	2 weeks
Primary	Change in NK-cell activity	Percentage increase in NK cell activity in patients with initially normal values	4 weeks