Racotumomab-alum for recurrent platimun-sensitive epithelial ovarian cancer

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000199
• Date of registration: 08/07/2015
• Prospective Registration: Yes
• Primary sponsor: Center of Molecular Immunology
• Public title: Racotumomab-alum for recurrent platimun-sensitive epithelial ovarian cancer
• Scientific title: Efficacy and safety of acotumomab-alum vaccine (Vaxira®) as maintenance treatment of recurrent platinum-sensitive epithelial ovarian cancer (EOC)
• Date of first enrolment: 20/08/2015
• Target sample size: 88
• Recruitment status: Pending
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000199-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment
• Phase: 2-3

Countries of recruitment

Cuba

Contacts

• Name: Maurenis Hernandez Perez
• Affiliation: Center of Molecular Immunology

• Name: Maurenis Hernandez Perez
• Affiliation: Center of Molecular Immunology

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients with recurrent platinum-sensitive epithelial ovarian cancer
2. Patients with 18 years and older.
3. Patients who have signed informed consent .
4. Patients with performance status according to ECOG of 0-2.
5. Patients who have received only two platinum-based ChT schemes (the first-line treatment and treatment for relapsed platinum-sensitive), and achieve a complete or partial response within that treatment.
6. Patients in the time between the end of oncospecific treatment and inclusion in the study does not exceed two months.
7. Patients with hepatic, renal and haematological normal functions defined by:
• Hemoglobin 90 g / L (patients with lower levels of Hb should be transfused prior to inclusion)
• Leukocyte Count Total 3.0 x 109 / L
• Absolute Neutrophil Count 1.5 x 109 / L
• Platelet count 100 x 109 / L
• Bilirubin to the upper limit of normal.
• TGP and TGO: up 1.5 times the upper limit of normal value of the institution, or <5 times the upper limit of normal value of the institution, if known the existence of liver metastases.
• Alkaline phosphatase 2.5 times the ULN.
• Creatinine: Within normal limits for each institution or creatinine clearance> 50 mL / min / 1.73 m2 for patients with creatinine levels above the normal value of the institution.















Exclusion criteria: 1. Patients who have previously received treatment with the anti-idiotype alumina Racotumomab-vaccine or any other product on research.
2. Pregnant or lactating patients.
3. Patients with acute allergic conditions or history of severe allergic reactions.
4. patients with brain metastases.
5. Patients with stable disease or progression at the end of oncospecific treatment for platinum-sensitive relapse.
6. Patients with other cancer diagnosed in the last five years (excluding non-melanoma skin cancer, thyroid cancer and cervical cancer, successfully treated).










Age minimum: 18 years
Age maximum: None
Gender: Female

Health Condition(s) or Problem(s) studied

Recurrent platinum-sensitive ovarian cancer

Intervention(s)

Group I ( experimental) : Racotumomab-alum (1mg / ml) intradermally every two weeks (induction phase), and after that monthly re-immunizations until worsening of performance status or toxicity (serious adverse events related to the vaccine) .
Group II (control): Best supportive care (BSC).

Primary Outcome(s)

Progression Free Survival (PFS-Time from randomization to the first documented evidence of disease progression, or death by any cause). Measuring time: every 3 months for 2 years.

Secondary Outcome(s)

Overall Survival (OS-Time from randomization to death by any cause). Measuring time: every 3 months for 2 years.
Adverse events (CTCAE version 4). Measuring time: every 3 months for 2 years.
Quality of Life (EORTC QLQC3 and EORTC QLQ-OV28 questionnaires). Measuring time: every 3 months for 2 years.
Immunological Response (Antibody titers against NGcGM3, lysis and recognition of NGcGM3-expressing cell line, and frequency of regulatory T cells). Measuring time: at baseline and every 3 months for 2 years.
NeuGcGM3 expression and TIL immunophenotype. Measuring time: at baseline.

Secondary ID(s)

Not applicable

Source(s) of Monetary Support

Center of Molecular Immunology (CIM) Cuban Ministry of Public Health (MINSAP)

Secondary Sponsor(s)

Not applicable