NGcGM3/VSSP/Montanide ISA 51 vaccine in metastatic breast cancer. Phase II

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:

Active specific immunotherapy with NGcGM3/VSSP/Montanide ISA 51 vaccine in metastatic breast cancer patient treatment. Phase II.

Secondary indentifying numbers:

IIC RD-EC058

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 :

04/02/2002

Reference number:

877/06.006.04B

Principal investigator

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

First name:

Ana

Last name:

de la Torre Santos

Medical Specialty :

2nd degree specialist in oncology

Affiliation:

Celestino Hernandez Robau (CHR) Hospital

Postal address:

Cuba No. 564 entre Barcelona y Hospital

City:

Villa Clara

País:

Cuba

Zip Code:

50100

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, National Institute of Oncology and Radiobiology (INOR), Ronald Rodríguez Diaz, MD. 2nd degree Specialist in General Surgery.

Havana, Hermanos Ameijeiras Hospital, Joaquin Gonzalez, MD. 1st degree Specialist in Oncology.

Camaguey, Marie Curie Hospital, Jorge Cardoso, MD. 1st degree Specialist in Surgery.

Holguin, Vladimir Ilich Lenin Hospital, Peter Fernandez, MD. 1st degree Specialist in Oncology.

Santiago de Cuba, Conrado Benitez Cancer Hospital, Miguel O'farrill Mateu, MD. 1st degree Specialist in Oncology.

Research ethics committees:

Celestino Hernandez Robau Hospital, May, 27, 2002

National Institute of Oncology and Radiobiology (INOR), April, 30, 2003.

Hermanos Ameijeiras Hospital, March, 19, 2004.

Marie Curie Hospital, February, 23, 2004

Vladimir Ilich Lenin Hospital, June 18, 2004.

Conrado Benitez Cancer Hospital, March 2nd, 2004.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

27/08/2002

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:

Metastatic Breast Cancer

Health condition(s) code:

Breast Neoplasms

Breast Diseases

Intervention(s):

Study group (NGcGM3/VSSP/Montanide ISA 51 vaccine): The patients will receive a total of 15 administrations of the vaccine (0.2 mg/im) by intramuscular route. At the induction phase, patients will receive a total of 5 immunizations every 14 days. After that, the treatment will continue every 28 days for one year until the completion of a total of 15 immunizations with the vaccine. Patients could receive concomitant treatment with Tamoxifen during vaccination if they are suitable for it. Control group: The patients will receive the best supportive care for their disease.

Intervention code:

G(M3) Ganglioside

Tamoxifen

Gangliosides

Proteolipids

N-Acetylneuraminic Acid

Adjuvants, Immunologic

Vaccines

Injections, Intramuscular

Intervention keyword:

NAcGM3/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):

Overall Survival, Time to Progression. Measuring time: Until patient death/ until disease progression

Key secondary outcomes:

Immune response. Measuring time: 1 year Safety. Measuring time: Until patient death Clinical Response. Measuring time: until progression

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:

80 years

Inclusion criteria:

1.Patients with metastatic breast cancer (Stage IV or evolutive) with cito-histologic confirmation with the exception of bone lesions as the only site of metastases. 2.Patients who had finished their oncospecific treatment at least 4 weeks before entering the study. 3.Patients with signed informed consent. 4.Patients between 18 and 80 years old. 5.At least 6 months of life expectancy. 6.Patients with Performance Status between 0 and 2, according to WHO criteria (ECOG 0-2). 7.Laboratory parameters: a.-) Hb>=90g/L - Neutrophils .000/mm3 - Platelets >= 100 x 109 cells/Lb.-) Hepatics = 3 times upper normal limit - Bilirubin: 17 mol/L (LSN) - ALT: 40 U/L (LSN) - AST: 40 U/L (LSN) - Alkaline Phosphatase: 279 U/Lc.-) Creatinine ? 132 ?mol/L 8.Female patients.

Exclusion criteria:

1.Patients with metastatic breast cancer (Stage IV or evolutive) suitable for oncospecific treatments not available in Cuba. 2.Patients who had received their oncospecific treatments within the 4 weeks before entering the study. 3.Patients who had finished their oncospecific treatment 6 months or longer before entering the study. 4.Pregnancy or breast feeding. 5.Brain metastases or history of inflamatory CNS diseases. 6.Previous malignant disease, except for cervix carcinoma in situ or non melanoma skin lesions. 7.Acute or cronic infectious diseases. 8.Patients with acute alergic states or history of severe alergic reactions. 9.Autoimmune diseases or uncontrolled cronic diseases. 10.Patients with as unique site of metastasis the contralateral breast.

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:

Active

Study design:

Parallel

Phase:

Target sample size:

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:

Patricia

Last Name:

Marinello Erigolla.

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) 271-79-33 ext 223

Email :

marinello@cim.sld.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:

Patricia

Last Name:

Marinello Erigolla

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) 271-79-33 ext 224

Email :

marinello@cim.sld.cu [2]

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:

RPCEC00000068

Date of Registration in Primary Registry:

2010-12-17

Record Verification Date:

2008-07-07 20:00

Link to the spanish version:

Click here [3]