metastatic renal carcinoma Adjuvants, Immunologic Immunomodulating Agents Vaccines Injections, Subcutaneous
Conditions
Interventions
5 dose levels of VSSP will be administered in 5 groups of subjects: 200 µg, 400 µg, 800 µg, 1000 and 1200 µg doses. The frequency of treatment will initially be once a week for 3 weeks and then biweek
Immunomodulating Agents
Vaccines
Injections, Subcutaneous
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria of CRM or relapse, operated or not, who have received the standard 1st line treatment (recombinant IFN a2), and have completed it at least 3 months before inclusion 2. Patients who have not received the standard 1st line treatment (recombinant IFN a2), due to non-tolerance or contraindication. 3. Patients who give their informed consent for participation in writing. 4. Patients of any sex over 18 years of age. 5. Patients with general condition = 2 (according to ECOG). 6. Patients with a life expectancy of at least 6 months. 7. Patients who meet the following laboratory parameters: • Hb = 8.5 g / dL • Total leukocyte count = 3 x 109 / L • Platelet count = 100 x 109 / L • Total bilirubin = 2 times the normal value for each institution. • LDH = 2 times the normal value for each institution. • Creatinine = 2 times the normal value for each institution.
Exclusion criteria
Exclusion criteria: 1. Patients of childbearing age who are not using an adequate method of contraception prior to their inclusion in the study (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). 2. Pregnant or lactating patients. 3. Patients with acute allergic states or history of severe allergic reactions. 4. Patients with decompensated acute or chronic lung diseases that may interfere with the follow-up of the underlying disease. 5. Patients with a previous history of demyelinating or inflammatory diseases of the Central Nervous System (CNS) or Peripheral (SNP). 6. Patients with uncontrolled intercurrent diseases that include, but are not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes mellitus and psychiatric diseases that imply the incompetence of the subject. 7. Patients receiving another investigational product. 8. Patients with known hypersensitivity to any component of the formulation. 9. Patients with known positive serology for HIV, hepatitis B or C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage 1: - Proportion of patients with serious adverse events with a causal relationship (definite, very probable or probable) with the immunomodulator VSSPs. An adverse event will be evaluated as serious with an intensity greater than 4 (AE that threatens or incapacitates and AE that causes death) following the criteria of intensity, seriousness and causality, according to the CTCAE v5 classification. Measurement time: iteratively and in each administration of the product, for 2 years. Stage 2: - Overall survival at 2 years. The time elapsed from the inclusion of the patient in the study until the patient's death will be measured, regardless of the cause or until the date of the latest news by clinical history. Measurement time: at 12 and 24 months, for 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Type of AE. The presented EA will be described. Measurement time: iteratively and in each administration of the product, for 2 years. - Duration of the EA. It will be evaluated by the start and end dates of the adverse event. Measurement time: iteratively and in each administration of the product, for 2 years. - AE severity. It will be classified as Serious/Serious or Not Applicable (NP) when the AE is Not Serious/Not Serious. Measurement time: iteratively and in each administration of the product, for 2 years. - Intensity of the AE. It will be classified according to the Common Toxicity Criteria (CTCAE) version 5.0 of the US National Cancer Institute. It includes the following categories: Mild, Moderate, Severe, AE that threatens or incapacitates and AE that causes death. Measurement time: iteratively and in each administration of the product, for 2 years. - Causal relationship. It will be classified as: Definitive, Very Likely, Probable, Possible, Unrelated, Unknown. Measurement time: iteratively and in each administration of the product, for 2 years. - Attitude followed before the appearance of the AE. It includes the following categories: no change, dose modification, temporary or permanent interruption of study treatment. Measurement time: iteratively and in each administration of the product, for 2 years. - Results of the EA. It includes the following categories: recovered, improved, persists, sequelae. Measurement time: iteratively and in each administration of the product, for 2 years. - Evaluation of the percentage and absolute number in the population of peripheral blood mononuclear cells (PBMC) of MDSC, Lymphocytes, dendritic cells, regulatory T cells, monocytes by flow cytometry. Measurement of Arginase I, S100A8/A9 and HMGB1 levels in the serum (ELISA). Evaluation of the proliferation of T lymphocytes within the PBMC. Measurement time: days 0, 21, 28, 1 week before and 1 week after month 6, and months 12, 18 and 24. - Objective answer. Response to tre | — |
Countries
Cuba
Contacts
Public ContactLisania Reyes Espinosa
Center of Molecular Immunology (CIM)
Outcome results
None listed