Revisiones para VSSPs in renal carcinoma. | Registro Público Cubano de Ensayos Clínicos

Comparando dos revisiones:

3 Julio 2023 - 10:01am por CIM	3 Julio 2023 - 10:01am por CIM
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Cambios a Date of first enrollment
-	2023-06-30 00:00:00	+	2023-06-20 00:00:00

Revisión actual:

VSSPs in renal 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:

VSSPs in renal carcinoma

Scientific title:

Phase I-II study of dose escalation and cohort expansion with synthetic VSSP in patients with metastatic renal carcinoma

Secondary indentifying numbers:

Not Applicable

Issuing authority of the secondary identifying numbers:

Not Applicable

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM)

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:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

07/02/2023

Reference number:

49/05.0152BA

Principal investigator

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

First name:

Iraida

Last name:

Caballero Aguirrechu

Medical Specialty :

Second Degree Specialist in Oncology

Affiliation:

"Hermanos Ameijeiras" Hospital

Postal address:

San Lazaro street, 701, Belascoain corner, Centro Habana

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

+53-78761436

Email address:

iraida.caballero@infomed.sld.cu

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:

Havana, Calixto García Hospital, PhD Mercedes I Fundora Ramos, First Degree Specialist in Oncology

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

20/06/2023

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:

metastatic renal carcinoma

Health condition(s) code:

Carcinoma, Renal Cell

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Health condition keyword:

Adjuvants, Immunologic Immunomodulating Agents Vaccines Injections, Subcutaneous

Intervention(s):

5 dose levels of VSSP will be administered in 5 groups of subjects: 200 µg, 400 µg, 800 µg, 1000 and 1200 µg doses. The frequency of treatment will initially be once a week for 3 weeks and then biweekly or monthly until 24 months, depending on the response of myeloid suppressor cells (MDSC) on days 21 and 28. If the frequency of MDSC is high, the patient will continue biweekly treatment, if the frequency is low, the patient will continue monthly treatment. Subcutaneous route of administration

Intervention code:

Adjuvants, Immunologic

Immunomodulating Agents

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):

Stage 1: - 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. Stage 2: - 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.

Key secondary outcomes:

- Type of AE. The presented EA will be described. Measurement time: iteratively and in each administration of the product, for 2 years. - Duration of the EA. It will be evaluated by the start and end dates of the adverse event. Measurement time: iteratively and in each administration of the product, for 2 years. - AE severity. It will be classified as Serious/Serious or Not Applicable (NP) when the AE is Not Serious/Not Serious. Measurement time: iteratively and in each administration of the product, for 2 years. - Intensity of the AE. It will be classified according to the Common Toxicity Criteria (CTCAE) version 5.0 of the US National Cancer Institute. It includes the following categories: Mild, Moderate, Severe, AE that threatens or incapacitates and AE that causes death. Measurement time: iteratively and in each administration of the product, for 2 years. - Causal relationship. It will be classified as: Definitive, Very Likely, Probable, Possible, Unrelated, Unknown. Measurement time: iteratively and in each administration of the product, for 2 years. - Attitude followed before the appearance of the AE. It includes the following categories: no change, dose modification, temporary or permanent interruption of study treatment. Measurement time: iteratively and in each administration of the product, for 2 years. - Results of the EA. It includes the following categories: recovered, improved, persists, sequelae. Measurement time: iteratively and in each administration of the product, for 2 years. - Evaluation of the percentage and absolute number in the population of peripheral blood mononuclear cells (PBMC) of MDSC, Lymphocytes, dendritic cells, regulatory T cells, monocytes by flow cytometry. Measurement of Arginase I, S100A8/A9 and HMGB1 levels in the serum (ELISA). Evaluation of the proliferation of T lymphocytes within the PBMC. Measurement time: days 0, 21, 28, 1 week before and 1 week after month 6, and months 12, 18 and 24. - Objective answer. Response to treatment will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) and classified as Complete Response (CR), Partial Response (PR), Stable Disease (EE) or Progressive Disease (PD). Measurement time: 4 weeks after the last dose on day 28 (month 2 of treatment) and at months 6, 9, 12 and 24. - Duration of response. (Defined in days, as the time from the date the patient achieves a response to study treatment (CR/PR) to objective disease progression or death.) measurement time: up to 24 months progression-free survival. (Time that elapses from the start of treatment to the date that is considered, by the results of the imaging tests, the progression of the disease or death from any cause). Measuring time: up to 24 months - Quality of life. (It will be measured by the QLQ-C30 survey). measurement time: before treatment, at month 6, 12 and 24.

Selection criterias

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

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

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 α2), and have completed it at least 3 months before inclusion 2. Patients who have not received the standard 1st line treatment (recombinant IFN α2), 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.

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:

Other

Other design:

adaptative

Phase:

1-2

Target sample size:

70

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:

Lisania

Last Name:

Reyes Espinosa

Specialty:

First Degree Specialist in Immunology

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 street, 15 corner, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-72717933 ext 3489

Email :

lisania@cim.sld.cu

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:

Lisania

Last Name:

Reyes Espinosa

Specialty:

First Degree Specialist in Immunology

Affiliation:

Center of Molecular Immunology (CIM).

Postal Address:

216 Street, 15 corner, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-72717933 ext 3489

Email :

lisania@cim.sld.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

"Hermanos Ameijeiras" Hospital

"General Calixto Garcia" Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

19/01/2021

23/03/2021

Postal address of Ethic Committee :

San Lazaro street 701 corner Belascoain, Centro Habana, Havana, ZC 10300, Cuba

Avenue Universidad and J. Vedado, Havana. ZC 10400, Cuba

Telephone:

+53-78761000

+53-78382197

Correo electrónico:

hha@infomed.sld.cu

bcg@bcg.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

05/05/2026

Date of available results:

05/11/2026

Date of first publication:

05/01/2027

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:

RPCEC00000425

Date of Registration in Primary Registry:

21/06/2023

Record Verification Date:

2023/07/03

Next update date:

2024/07/03

Link to the spanish version:

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Ensayos Registrados

Proceso de Registro

VSSPs in renal carcinoma.

Acerca del RPCEC

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