VSSP in renal cell carcinoma

VSSP as immunopotentiator for the treatment of renal cell carcinoma: first approach to the clinic - VSSP-MDSC

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000365

Enrollment

Registered

2021-04-08

Start date

2011-11-29

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal cell carcinoma

Interventions

VSSP 400 µg by subcutaneous route. The first 4 doses every 7 days, and the remaining 4 doses every 30 days. Total doses (8). The treatment will be for five months.

Adjuvants, Immunologic

Vaccines

Injections, Subcutaneous

VSSP

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with histologically confirmed metastatic renal cell carcinoma. 2. Patients aged equal/over 18 years. 3. Patients who consent to participate in the study by signing the informed consent model. 4. Patients with performance status = 3 according to ECOG scale.

Exclusion criteria

Exclusion criteria: 1. Patients receiving other IND. 2. Patients with decompensated chronic diseases. 3. Patients with criteria to be included in any clinical trial. 4. Patients who are pregnant or breastfeeding 5. Patients who have received (3 months prior) or are receiving treatment with corticosteroids and / or immunomodulators. 6. Patients with congenital or acquired immune deficiency at the time of inclusion.

Design outcomes

Primary

Measure	Time frame
Decrease in suppression induced by MDSCs (inhibition of proliferation Test. It is determined by a suppressive effect of 30% compared to day 0 in 60% of patients. Determination of: CD11b + / cd14-/cd66b +, CD11b + / + and cd14-/cd15 and serum concentration of ARG). Measurement time: days 0, 21, 58 and 148	—

Secondary

Measure	Time frame
Adverse Events-AE (Occurrence of any AE in the subject (Yes, No); Description of AE (Name of AE); Duration of AE (Difference between start date and end date of the event; Intensity of AE (Mild, Moderate, Severe); Severity of AE (Severe/serious, Not severe/ not serious); Attitude respect to the treatment (unchanged dose, dose modification, temporal/definitive)). Measurement time: 7 days every 30 days until the end of the study.	—

Measure

Time frame

Adverse Events-AE (Occurrence of any AE in the subject (Yes, No); Description of AE (Name of AE); Duration of AE (Difference between start date and end date of the event; Intensity of AE (Mild, Moderate, Severe); Severity of AE (Severe/serious, Not severe/ not serious); Attitude respect to the treatment (unchanged dose, dose modification, temporal/definitive)). Measurement time: 7 days every 30 days until the end of the study.

—

Countries

Cuba

Contacts

Public ContactLeslie Perez Ruiz

Center of Molecular Immunology

leslie@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026