CIGB-247 vaccine in patients with solid malignant tumors, phase I, randomized. (CENTAURO-2 study)

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:

Safety and immunogenicity of the CIGB-247 vaccine candidate combining different antigen doses with different amounts of VSSP adjuvant or with a fixed dose of aluminum phosphate in cancer patients.

Secondary indentifying numbers:

IG/CIGB-247I/TS/1302

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB) Ministry of Public Health, CUBA

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 the Quality of Drugs(CECMED)

Reference number:

05-006-13-BA (Procedure code), March 27, 2013. (In process)

Principal investigator

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

First name:

Ana V. de la Torre Santos, 2nd Degree Specialist in Oncology.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

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

Research ethics committees:

Villa Clara, Universitary Hospital “Celestino Hernández Robau”, March 11, 2013. Havana, Center of Medical and Surgical Research (CIMEQ), March 21, 2013. Matanzas, José R. López Tabranes Hospital, February 27, 2013.

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

15/07/2013

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:

Solid malignant tumors.

Intervention(s):

- Group I (CIGB-247V): antigen p64K-hVEGFKDR-(400 µg) + adjuvant NAcGM3/VSSP (200 µg) subcutaneously in the deltoid region. Scheme of 9 immunizations: 1 time / week (1st 8 weeks) + a booster at week 12. - Group II (CIGB-247V): antigen p64K-hVEGFKDR-(400 µg) + adjuvant NAcGM3/VSSP (400 µg) subcutaneously in the deltoid region. Scheme of 9 immunizations: 1 time / week (1st 8 weeks) + a booster at week 12. - Group III (CIGB-247V): antigen p64K-hVEGFKDR-(800 µg) + adjuvant NAcGM3/VSSP (200 µg) subcutaneously in the deltoid region. Scheme of 9 immunizations: 1 time / week (1st 8 weeks) + a booster at week 12. - Group IV (CIGB-247A): antigen p64K-hVEGFKDR-(200 µg) + aluminum phosphate adjuvant (0.7 mg AL3+) subcutaneously in the deltoid region. Scheme of 5 immunizations: 1 once every 14 days (1st 8 weeks) + booster at week 12. - Group V (IGBC-247A): antigen p64K-hVEGFKDR-(400 µg) + aluminum phosphate adjuvant (0.7 mg AL3+) subcutaneously in the deltoid region. Scheme of 5 immunizations: 1 every 14 days (1st 8 weeks) + booster at week 12.

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):

Clinical Adverse Events (AE). Measuring time: in each immunization and at weeks 12,13 and 16. -Apearence of EA (Yes, No) -Description of EA (name of the event) -Intensity of EA (mild, moderate, severe). Laboratory tests (numerical values of hematology, biochemistry and urine). Measuring time: at weeks 1, 5, 9, 13 and 16.

Key secondary outcomes:

Immune response(determination of serum titers of anti-VEGF; percent of inhibition - binding VEGF and its receptor; ELISPOT for interferon gamma: average number of points). Measuring time: in weeks 1, 5, 9, 13 and 16. Quality of life (questionnaire EORTC QLQ-C30: worse, unchanged, slightly improved, moderately improved, much improved). Measuring time: in weeks 16. Tumor Response Assessment (tumor diameter). Measuring time: at week 16.

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:

65 years

Inclusion criteria:

1) Fulfillment of diagnostic criteria (patients with histologically confirmed solid malignancy of selected locations, which are not eligible for other therapeutic regimens). 2) Age between 18 - 65 years inclusive. 3) Patient with a life expectancy = 6 months. 4) According to ECOG performance status = 2. 5) Primary tumor in any of the following locations: breast, lung, uterus (body), ovary, kidney, small intestine (duodenum, jejunum and ileum) or large (cecum, colon, rectum and anal canal), soft tissue and bone. 6) Patient with at least one measurable lesion according to RECIST. 7) Patients with stable or progressive disease at the time of study entry. 8) Voluntariness of the patient by signing the informed consent.

Exclusion criteria:

1) Unknown primary tumor. 2) Patients who have received any anti-angiogenic treatment in the past 3 months. 3) Have received chemoradiotherapy in the last 4 weeks. 4) Major surgery in the last 28 days. 5) Referred immunosuppressive disease, current drug intake immunosuppressive / immunomodulatory. 6) Patients with brain metastases. 7) Decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy). 8) History of autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, type 1 diabetes mellitus, etc.) and severe allergic history (urticaria, dermatitis, bronchitis and bronchial asthma persistent). 9) Moderate or severe systemic infections that interfere with patient evaluation. 10) History of allergy to any ingredient of the vaccine under study. 11) Patient pregnant or breastfeeding. 12) Mental incapacity to give consent obvious and act accordingly to the study.

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 controlled trial

Masking:

Open

Control group:

Dose comparison

Study design:

Parallel

Phase:

1

Target sample size:

50

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:

Francisco

Last Name:

Hernández-Bernal

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

hernandez.bernal@cigb.edu.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:

Francisco

Last Name:

Hernández Bernal

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

hernandez.bernal@cigb.edu.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:

RPCEC00000155

Date of Registration in Primary Registry:

2013-06-06

Record Verification Date:

2013-06-05

Next update date:

2014-06-05

Link to the spanish version:

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CIGB-247 vaccine in patients with solid malignant tumors, phase I, randomized. (CENTAURO-2 study)

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