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Racotumomab vaccine- Lung Cancer- Adults-predictors of response - Exploratory
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9 Julio 2018 - 9:52am
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21 Diciembre 2020 - 11:32am
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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)
Primary sponsor:
Center of Molecular Immunology (CIM)
Secondary sponsor:
Not applicable
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:
2020/12/21
Next update date:
2021/12/21
Link to the spanish version:
Click here
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