NGcGM3/VSSP/Montanide ISA 51 vaccine for breast cancer IIa, IIb and IIIa surgically treated with positive ganglia and disease-free, Phase IIb/III.

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:

Clinical trial with the NGcGM3/VSSP/Montanide ISA 51 vaccine to treat patients with breast cancer IIa, IIb and IIIa surgically treated with positive ganglia and disease-free, Phase IIb/III.

Secondary indentifying numbers:

IIC RD-EC083

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Government funds

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)

Authorization date :

17/07/2006

Reference number:

1290/05.022.05B

Principal investigator

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

First name:

Noyde

Last name:

Batista Albuerne

Medical Specialty :

1st degree specialist in oncology

Affiliation:

"Hermanos Ameijeiras" Hospital

Postal address:

San Lázaro 701 esq. Belascoain

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

+53-78761000

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

Clinical sites:

Villa Clara, Celestino Hernandez Robau Hospital, Dra. Ana de la Torre Santos. 2nd degree specialist in oncology

Holguin, Vladimir Ilich Lenin Hospital , Dr. Rene Diaz Santos, Specialist of 1st degree specialist in oncology

Santiago de Cuba, Conrado Benitez Hospital , Dr. Miguel O'Farril. 1st degree specialist in oncology

Research ethics committees:

Hermanos Ameijeiras hospital (HHA), May 8th, 2006.

Celestino Hernandez Robau hospital, November 22, 2005.

Vladimir Ilich Lenin hospital, November 1st, 2006.

Conrado Benitez hospital, April 26, 2006.

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

17/04/2007

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:

Breast cancer IIa, IIb and IIIa surgically treated with positive ganglia

Health condition(s) code:

Breast Neoplasms

Breast Diseases

Intervention(s):

Group I (study): It receives intramuscular immunizations of 0.2 mg of the NGcGM3/VSSP Montanide ISA 51 vaccine preparation. Immunizations will be performed every 14 days until the 5th immunization. After the sixth immunization, the frequency will be set every 28 days until reaching one year treatment. Additional re-immunizations are suggested every 28 days until 18 months after inclusion. Group II (control): Placebo. Idem duration, frequency and route administration of study group. Immunizations can be concurrent with standard hormonal therapy.

Intervention code:

G(M3) Ganglioside

Gangliosides

Proteolipids

N-Acetylneuraminic Acid

Adjuvants, Immunologic

Vaccines

Injections, Intramuscular

Placebos

Intervention keyword:

NGcGM3/VSSP/Montanide ISA

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):

Episode-free survival. Measuring time: 24 months

Key secondary outcomes:

Global survival time, quality of life, safety and immunogenicity, measuring time: 24 months

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1.Female patients with breast cancer IIa, IIb y IIIa surgically treated with positive ganglia and clinical disease-free following onco-specific treatment. 2.Patients who underwent first-line onco-specific therapy (surgery, chemotherapy, hormonal therapy and radiotherapy) according to treatment guides established in the country, and those who completed the different protocols in a time period between 4 and 8 weeks before inclusion. 3.Informed consent of the patient to participate in the research. 4.Performance Status according to WHO from 0 to 2. 5.Age >= 18 years. 6.Reproductive-age patients with confirmed negative pregnancy tests using adequate contraceptive methods (intrauterine devices, hormonal contraceptives, barrier methods, or tubal ligation). 7.Determination of hormonal receptor (estrogens and progesterones), HER-1, HER-2/neu and 14F7 primary tumor expressions. This determination must be made using the surgical piece biopsy for diagnosis. 8.Patients with axillary dissection will only be eligible if 10 or more ganglia were ablated and examined.

Exclusion criteria:

1.Patients who underwent onco-specific therapy and completed the different protocols within 4 weeks or more than 8 weeks before trial inclusion. 2.Patients with history of demyelinating or inflammatory disease of the peripheral or central nervous system. 3.Pregnancy or breastfeeding. 4.Patients with acute or chronic infectious diseases. 5.Patients with acute allergic conditions or history of severe allergic reactions. 6.Patients with psychiatric diseases, unable to understand and sign the informed consent document. 7.Patients with autoimmune diseases or decompensated chronic 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:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2-3

Target sample size:

744

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:

Kirenia

Last Name:

Perez Ramirez

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 214-3146

Email :

kireniap@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:

Kirenia

Last Name:

Perez Ramirez

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 214-3146

Email :

kireniap@cim.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:

RPCEC00000070

Date of Registration in Primary Registry:

2010-12-17

Record Verification Date:

2010-12-09 19:00

Link to the spanish version:

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Proceso de Registro

NGcGM3/VSSP/Montanide ISA 51 vaccine for breast cancer IIa, IIb and IIIa surgically treated with positive ganglia and disease-free, Phase IIb/III.

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