Metastatic renal cell carcinoma
Conditions
Interventions
Stage I: Three levels of dose
Group A (Experimental): Dose of 200 µg of VSSP
Group B (Experimental): Dose of 400 µg of VSSP
Group C (Experimental): Dose of 600 µg of VSSP
The VSSP product will be admi
Vaccines
Injections, Subcutaneous
VSSP,
proteoliposomes
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients that meet the diagnostic criteria (CRM or relapse, operated or not). 2. Patients who give their informed consent to participate in writing. 3. Patients of any sex with age over 18 years. 4. Patients with general condition = 2 (according to ECOG). 5. Patients with life expectancy of at least 6 months. 6. Patients who have adequate functioning of organs and bone marrow.
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). In case of male sex (vasectomy, use of condoms). 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 illnesses that include, but are not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes mellitus and psychiatric illnesses that imply the incompetence of the subject. 7. Patients with cerebral metastasis. 8. Patients who are receiving another product under investigation. 9. Patients with known hypersensitivity to any component of the formulation. 10. Patients with positive serology known to HIV, hepatitis B or C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious adverse events with definite, very probable or probable causal relationship (Adverse events classified as “serious” and it has a causal relationship classified as “definite, very probable or probable”). Measurement time: in every evaluation visit and, in every product administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Variables related to the effect: 1. Overall survival (Time from randomization until death from any cause). Measurement time: 12 and 24 months. 2. Objective response (According to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) it will classify in “Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progression Disease (PD)). Measurement time: 4 weeks after last dose of second cycle and, 6, 9, 12 and 24 months. 3. Progression-Free Survival (Time from randomization until objective tumor progression or death). Measurement time: 24 months. 4. Response duration (Time from objective response (CR/PR) until objective tumor progression or death). Measurement time: 24 months 5. Evaluation of the percentage and absolute number in the population of peripheral blood mononuclear cells (PBMC). Measurement time: Day 0, 21, 28, 1 week before and 1 week after month 5, month 12, 18 and 24. 6. Percentage of lymphocytes in PBMC. Measurement time: 0, 21 and 28 days. Month 5, 12, 18 and 24. 7. Percentage of DC Myeloids and Plasmacytoids in PBMC. Measurement time: 0, 21 and 28 days. Month 5, 12, 18 and 24. 8. Percentage of regulatory T cells in the PBMC. Measurement time: 0, 21 and 28 days. Month 5, 12, 18 and 24. 9. Percentage of Monocytes in the PBMC. 0, 21 and 28 days. Month 5, 12, 18 and 24. 10. Arginase I, S100A8 / A9 and HMGB1 in the serum. Measurement time: 0, 21 and 28 days. Month 5, 12, 18 and 24. 11. Proliferation of T lymphocytes within PBMC. Measurement time: Day 0, 21, 28, 1 week after month 5, months 12, 18 and 24. 12. Quality of Life (EORTC QLQ-C30). Measurement time: At baseline and, 6, 12, 18 and, 24 months. Variables related to safety: 13. Adverse events-AE (Occurrence of AE (Yes, No); Description of AE (Name of the AE); Duration of the AE (Difference between the start and end date of the event); Intensity of the AE (Mild, Moderate, Severe, Life-threatening consequences, Death related to AE, according to the Common Criteria of Adverse Eve | — |
Countries
Cuba
Contacts
Public ContactLeslie Perez
Center of Molecular Immunology (CIM)
Outcome results
None listed