VSSP in metastasic renal cell carcinoma

Phase 1

• Conditions: Metastatic renal cell carcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Urologic Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Kidney Diseases

• Registration Number: RPCEC00000287
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

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

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.