Racotumomab vaccine- Lung Cancer- Adults-predictors of response - Exploratory | Registro Público Cubano de Ensayos Clínicos

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Racotumomab vaccine- Lung Cancer- Adults-predictors of response - Exploratory

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:

Identification of potential predictors and surrogates for the selection of patients who may benefit from the use of Racotumomab, as switch maintenance therapy, in patients with non-small cell lung cancer, stages IIIA, IIIB and IV.

Secondary indentifying numbers:

FL-EC-019

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:

Sailyn

Last name:

Alfonso Aleman

Medical Specialty :

First degree specialist in Oncology

Affiliation:

“Celestino Hernandez Robau” Hospital

Postal address:

Calle Cuba No. 569 entre Hospital y Alejandro Oms

City:

Santa Clara

País:

Cuba

Zip Code:

50100

Telephone:

+53-042279442

+53-042271202

Email address:

sailyn@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:

“Celestino Hernandez Robau” Hospital Ethic Commite, March 16, 2017.

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

09/07/2018

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:

Advanced non small cell lung cancer

Health condition(s) code:

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intervention(s):

Racotumomab group (experimental): Racotumomab therapeutic vaccine, 1 mg by intradermic route. The first 5 administration will be every 14 days (induction stage) and, the rest of vaccines will be administered every 28 days (maintenance stage) until the patient's clinical conditions allow.

Intervention code:

Antibodies, Monoclonal, Murine-Derived

Antibodies, Anti-Idiotypic

Antibodies, Monoclonal

G(M3) Ganglioside

Antineoplastic Agents, Immunological

Cancer Vaccines

Injections, Intradermal

Intervention keyword:

Racotumomab

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):

-Immunocompetence of patients (Frequency and phenotype of B lymphocytes, T and NK cells). Measurement time: At baseline, at the end of the induction stage (day 84) and, every three months until the 15 doses are met. -Immune response (Title and functionality of antibodies induced by the vaccine). Measurement time: At baseline, at the end of the induction stage (day 84) and, every three months until the 15 doses are met. -Inhibition of tumor angiogenesis (Concentration of biomarkers related to angiogenesis and tumor inflammation: IL 8, VEGF, FGF, EGF, IL 6) Measurement time: At baseline, at the end of the induction stage ( day 84) and then every three months until the 15 doses -Overall Survival: (Time from recruitment until to death, from any cause). Measurement time: 24 months

Key secondary outcomes:

Laboratory tests (numerical values of the Hemogram with differential, GPT, GOT, GGT, Alkaline Phosphatase, LDH, Creatinine, Glycemia). Measurement time: At baseline and, very three months until 24 months.

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 who meet the diagnostic criteria. 2-Patients older than or equal to 18 years old. 3-Patients who have signed the informed consent for the investigation. 4-Patients with clinical status according to ECOG from 0 to 2. 5-Patients who have received first-line treatment and reached at least stable disease in response. 6-Patients in which the time between the end of the onco-specific treatment and the inclusion in the study is 4 to 6 weeks. 7-Patients with life expectancy of six months or more. 8-Patients with normal hepatic, renal and hematological functions defined by: • Hemoglobin greater or equal to 90 g / L (patients with lower Hb levels should be transfused prior to inclusion) • Total Leukocyte Count greater or equal to 3.0 x 109 / L • Absolute Neutrophil Count greater or equal to 1.5 x 109 / L • Platelet Count greater or equal to 100 x 109 / L • Bilirubin up to the normal upper limit. • TGP and TGO: greater or equal to 1.5 times the upper limit for the normal value of the institution, or <5 times the upper limit for the normal value of the institution, if the existence of liver metastasis is known. • Alkaline phosphatase greater or equal to 2.5 times the normal upper limit. • Creatinine: Within normal limits for each institution or creatinine clearance> 50 mL / min / 1.73 m2 for patients with creatinine levels above the normal value of the institution.

Exclusion criteria:

1-Patients who have previously received treatment with the anti-idiotypic vaccine Racotumomab. 2- Patients with acute, chronic, or inflammatory decompensated infectious diseases. 3- Patients of childbearing age who do not accept adequate contraceptive methods (intrauterine devices, barrier or tubal ligation methods, hormonal methods). 4- Pregnant or lactating patients. 5- Patients with acute allergic states or history of severe allergic reactions. 6- Patients who are receiving any other product under investigation. 7- Patients with brain metastasis. 8- Patient with other malignant diseases.

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:

0

Target sample size:

Patients to recruit in 18 months

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:

Geidy

Last Name:

Lorenzo Monteagudo

Specialty:

BSc. in Pharmaceutical Sciences

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa,

City:

Havana

País:

Cuba

Zip Code:

16040, Box 11600

Telephone:

+537-2717933

Email :

geydi@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:

Sailyn

Last Name:

Alfonso Aleman

Specialty:

First degree specialist in Oncology

Affiliation:

“Celestino Hernandez Robau” Hospital

Postal Address:

Calle Cuba No. 569 entre Hospital y Alejandro Oms

City:

Santa Clara

País:

Cuba

Zip Code:

50100

Telephone:

+53-042279442, +53-042271202

Email :

sailyn@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:

RPCEC00000279

Date of Registration in Primary Registry:

09/07/2018

Record Verification Date:

2018/07/09

Next update date:

2019/07/09

Link to the spanish version:

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