VSSP in metastasic renal cell carcinoma

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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.

Scientific title:

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

Acronym of Scientific Title:

VSSPMRCC

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) 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:

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

Reference number:

In process

Principal investigator

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

First name:

Iraida

Last name:

Caballero

Medical Specialty :

Second degree specialist in Oncology

Affiliation:

Hermanos Ameijeiras Hospital

Postal address:

San Lazaro No. 701, Belascoain

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

+53-78761000

+53-78761019

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:

Not applicable

Research ethics committees:

Hermanos Ameijeiras Hospital, in review

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

15/01/2019

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 cell carcinoma

Health condition(s) code:

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urologic Diseases

Male Urogenital Diseases

Female Urogenital Diseases

Kidney Diseases

Intervention(s):

Stage I: Three levels of dose Group A (Experimental): Dose of 200 µg of VSSP Group B (Experimental): Dose of 400 µg of VSSP Group C (Experimental): Dose of 600 µg of VSSP The VSSP product will be administered by subcutaneous route once a week for 3 weeks. According to the response of Myeloid-Derived Suppressor Cells (MDSC) on days 21 and 28, the patient will continue with a maintenance period with a biweekly or monthly administration frequency for 5 months. At this time evaluation of CD11b+/CD33 +/CD14-/CD66b +, 1 week before and another after month 5, will be made. Then, according to the response obtained, the patient will continue with the scheme he had, will change to a biweekly administration frequency in the same dose level or the higher dose or better selected dose will be offered until month 24. If the probability of satisfying the criterion of evidence of effect on day 21 is small in the 3 dose levels (200 μg, 400 μg, 600 μg), two new dose levels will be opened (1000 and 1200 μg). Stage II A level of dose according to selected dose of stage I.

Intervention code:

Adjuvants, Immunologic

Vaccines

Injections, Subcutaneous

Intervention keyword:

VSSP, proteoliposomes

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):

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.

Key secondary outcomes:

Variables related to the effect: 1. Overall survival (Time from randomization until death from any cause). Measurement time: 12 and 24 months. 2. Objective response (According to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) it will classify in “Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progression Disease (PD)). Measurement time: 4 weeks after last dose of second cycle and, 6, 9, 12 and 24 months. 3. Progression-Free Survival (Time from randomization until objective tumor progression or death). Measurement time: 24 months. 4. Response duration (Time from objective response (CR/PR) until objective tumor progression or death). Measurement time: 24 months 5. Evaluation of the percentage and absolute number in the population of peripheral blood mononuclear cells (PBMC). Measurement time: Day 0, 21, 28, 1 week before and 1 week after month 5, month 12, 18 and 24. 6. Percentage of lymphocytes in PBMC. Measurement time: 0, 21 and 28 days. Month 5, 12, 18 and 24. 7. Percentage of DC Myeloids and Plasmacytoids in PBMC. Measurement time: 0, 21 and 28 days. Month 5, 12, 18 and 24. 8. Percentage of regulatory T cells in the PBMC. Measurement time: 0, 21 and 28 days. Month 5, 12, 18 and 24. 9. Percentage of Monocytes in the PBMC. 0, 21 and 28 days. Month 5, 12, 18 and 24. 10. Arginase I, S100A8 / A9 and HMGB1 in the serum. Measurement time: 0, 21 and 28 days. Month 5, 12, 18 and 24. 11. Proliferation of T lymphocytes within PBMC. Measurement time: Day 0, 21, 28, 1 week after month 5, months 12, 18 and 24. 12. Quality of Life (EORTC QLQ-C30). Measurement time: At baseline and, 6, 12, 18 and, 24 months. Variables related to safety: 13. Adverse events-AE (Occurrence of AE (Yes, No); Description of AE (Name of the AE); Duration of the AE (Difference between the start and end date of the event); Intensity of the AE (Mild, Moderate, Severe, Life-threatening consequences, Death related to AE, according to the Common Criteria of Adverse Event Terminology (CTCAE) version 4.0); Causality relationship (Very probable, Probable, Possible, Improbable, Not related, Not evaluable); Seriousness of the AE (Serious, Not serious); Attitude towards treatment (No change, Modification of doses, Temporary interruption, Definitive interruption); Result of AE (Recovered, Improved, Persist, Squeals)). Measurement time: in each evaluation, in each administration of the product

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 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.

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:

Randomized trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Parallel

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:

Leslie

Last Name:

Perez

Specialty:

Bachelor degree in Pharmaceutical Sciences.

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Street 216, corner 15. Atabey. Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+53-72143202

Email :

leslie@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:

Iraida

Last Name:

Caballero

Specialty:

Second degree specialist in Oncology

Affiliation:

Hermanos Ameijeiras hospital

Postal Address:

San Lazaro No. 701, corner to Belascoain.

City:

Havana

País:

Cuba

Zip Code:

10 300

Telephone:

+53-78761000; +53-78761019

Email :

iraida.caballero@infomed.sld.cu

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:

RPCEC00000287

Date of Registration in Primary Registry:

08/08/2018

Record Verification Date:

2018/08/08

Next update date:

2019/08/08

Link to the spanish version:

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VSSP in metastasic renal cell carcinoma

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