CENTAURO 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:

"Administration of CIGB-247 in solid malignant tumors. Phase I study on scaling up dosages".

Secondary indentifying numbers:

IG/CIGB-247L/TS/1101

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:

05-003-11-B (Procedure code), March 21, 2011.

Principal investigator

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

First name:

Jorge Luis Soriano García, MD.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

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, Center of Medical and Surgical Research (CIMEQ), Josué de la Torre Pupo MD. Villa Clara, Universitary Hospital “Celestino Hernández Robau”, Ana Victoria de la Torre Santos MD.

Research ethics committees:

Havana, Clinical - Surgical Hospital "Hermanos Ameijeiras", March 7, 2011. Havana, Center of Medical and Surgical Research (CIMEQ), March 9, 2011. Villa Clara, Universitary Hospital “Celestino Hernández Robau”, April 5, 2011.

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

15/07/2011

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):

The product is administered repeated doses subcutaneously in the deltoid region of arm less skillful, in three antigen dose levels: 50, 100 and 400 µg antigen p64K-hVEGFKDR-. The amount of adjuvant (VSSP) will be kept constant at 200 µg protein. Each patient will receive 8 immunizations (1 time per week) with a re-immunization (booster) at week 12 (month after the eighth immunization). Once the patient's participation in the clinical trial (16 weeks), it may continue to receive the study vaccine, if the benefit outweighs the risks of administration of the CIGB-247. In that case, the patient consents and the candidate vaccine will be administered outside protocol (compassionate use) on a monthly basis, adjusting the dose according to the results of the investigation.

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):

Safety and tolerability of the vaccine candidate CIGB-247, for which the record the following parameters: a) Clinical adverse events (Event Number, Type and Frequency: Yes, No, intensity: mild, moderate, severe). Measuring time: a week after each of the first 8 immunizations and at weeks 12 (re-immunization), 13 and 16 (one week and one month after vaccination booster), but also at other times it is presented some adverse event. b) Laboratory tests (valores numéricos de pruebas hematology and biochemistry). Measuring time: at weeks 1, 7, 12, 13 and 16.

Key secondary outcomes:

Immune response to the vaccine (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, 7, 9, 12, 13 and 16. Quality of life of patients by applying the questionnaire EORTC QLQ-C30 (worse, unchanged, slightly improved, moderately improved, much improved). Measuring time: in weeks 9 and 16. Tumor Response Assessment, if applicable (tumor diameter). Measuring time: at week 16. Ophthalmologic evaluation, if applicable (visual acuity, contrast sensitivity, fundus, retinal sensitivity, optical coherence tomography). Measuring time: at week 13.

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 malignant tumor, from any location, advanced clinical stage, have received the best treatment available oncospecific, and have not responded to it). 2) Age between 18 - 65 years inclusive. 3) Patient with a life expectancy = 6 months. 4) According to ECOG performance status = 2. 5) Voluntariness of the patient by signing the informed consent.

Exclusion criteria:

1) Uncompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy). 2) Referred immunosuppressive disease, current drug intake immunosuppressive / immunomodulatory properties. 3) History of autoimmune disease (lupus erythematosus, rheumatoid arthritis, multiple sclerosis, type 1 diabetes mellitus, etc.) and previous severe allergic (hives, dermatitis, bronchitis and bronchial asthma persistent). 4) Moderate or severe systemic infections that interfere with patient evaluation. 5) Patients who have received any investigational biologic therapy (a cancer vaccine), including active or passive immunotherapy. 6. Chemoradiotherapy have received in the last 4 weeks. 7. History of allergy to any component of the vaccine under study. 8. Pregnancy or breastfeeding at the time of inclusion in the study. 9. Obvious mental incapacity to give consent 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:

Other

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Other

Other design:

Dose escalation.

Phase:

Target sample size:

21-30

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:

Dr. 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

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

hernandez.bernal@cigb.edu.cu [2]

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:

Dr. Jorge

Middle Name:

Victor

Last Name:

Gavilondo Cowley

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 e/ 158 y 190, Cubanacán, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2716022

Email :

jorge.gavilondo@cigb.edu.cu [3]

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:

RPCEC00000102

Date of Registration in Primary Registry:

2011-04-29

Record Verification Date:

2011-04-28 20:00

Link to the spanish version:

Click here [4]