VSSP in renal cell carcinoma

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

VSSP-MDSC

Scientific title:

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

Acronym of Scientific Title:

VSSP-MDSC

Secondary indentifying numbers:

PL-009

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM), Cuban Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Eva

Last name:

Salomon Zaldivar

Medical Specialty :

First grade specialist in Oncology

Affiliation:

Joaquin Albarran Surgical Clinical Teaching Hospital

Postal address:

Ave. 26 final, Nuevo Vedado, Plaza de la Revolucion

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78555590

Email address:

kaineva@infomed.sld.cu. [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

29/11/2011

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Renal cell carcinoma

Health condition(s) code:

Carcinoma, Renal Cell

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Kidney Diseases

Urologic Diseases

Intervention(s):

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.

Intervention code:

Adjuvants, Immunologic

Vaccines

Injections, Subcutaneous

Intervention keyword:

VSSP

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

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:

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Leslie

Last Name:

Perez Ruiz

Specialty:

MSc, Pharmacy

Affiliation:

Center of Molecular Immunology

Postal Address:

Calle 216 esquina a 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

16040

Telephone:

+53-72717933

Email :

leslie@cim.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Circe

Last Name:

Mesa Pardillo

Specialty:

BSc Biochemist, PhD for Biological Sciences

Affiliation:

Center of Molecular Immunology

Postal Address:

Calle 216 esquina a 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

16040

Telephone:

+53-52169061

Email :

circe@cimab.cu [3]

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Joaquin Albarran Surgical Clinical Teaching Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

05/09/2011

Postal address of Ethic Committee :

Jovellar No.18 e/. Marina y Aramburo. ZC. 10300. Havana. Cuba

Telephone:

+53-78734355

Correo electrónico:

fmorejon@albarran.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

Study completion date:

07/12/2014

Date of available results:

01/08/2015

Date of first publication:

10/09/2017

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000365

Date of Registration in Primary Registry:

08/04/2021

Record Verification Date:

2021/04/08

Next update date:

2022/04/08

Link to the spanish version:

Click here [4]