VSSPs in renal carcinoma.

Phase 1

• Conditions: metastatic renal carcinoma; Adjuvants, Immunologic; Immunomodulating Agents; Vaccines; Injections, Subcutaneous; Carcinoma, Renal Cell; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms

• Registration Number: RPCEC00000425
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-21
• Last Update Posted: 19 August 2024
• Study Completion: 2026-11-05
• Results First Posted: 2027-01-05

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 70

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stage 1:<br>- 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.<br>Stage 2:<br>- 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.