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

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000068
• Date of registration: 17/12/2010
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: NGcGM3/VSSP/Montanide ISA 51 vaccine in metastatic breast cancer. Phase II
• Scientific title: Active specific immunotherapy with NGcGM3/VSSP/Montanide ISA 51 vaccine in metastatic breast cancer patient treatment. Phase II.
• Date of first enrolment: 27/08/2002
• Target sample size: 80 patients
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000068-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Open. Placebo: Active Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Patricia Marinello Erigolla
• Affiliation: Center of Molecular Immunology (CIM)

• Name: Patricia Marinello Erigolla.
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: 80 years
Gender: Female

Health Condition(s) or Problem(s) studied

Metastatic Breast Cancer

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

IIC RD-EC058

Source(s) of Monetary Support

Government Funds

Secondary Sponsor(s)

Not applicable