Racotumomab-alum for recurrent platimun-sensitive epithelial ovarian cancer

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:

Efficacy and safety of acotumomab-alum vaccine (Vaxira®) as maintenance treatment of recurrent platinum-sensitive epithelial ovarian cancer (EOC)

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

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

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 Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

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

First name:

Sailyn

Last name:

Alfonso Aleman

Medical Specialty :

First degree specialist in Oncology

Affiliation:

Celestino Hernandez Robau Hospital

Postal address:

564 CUBA street

City:

Santa Clara

País:

Cuba

Zip Code:

50100

Telephone:

+53-42279442

Email address:

saily@hchr.vcl.sld.cu [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:

Not applicable

Research ethics committees:

Celestino Hernandez Robau hospital, October 8, 2014

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

20/08/2015

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:

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).

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):

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.

Key secondary outcomes:

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.

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. 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).

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:

2-3

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:

Maurenis

Last Name:

Hernandez Perez

Specialty:

First degree specialist in Oncology

Affiliation:

Center of Molecular Immunology

Postal Address:

216 Street & 15 Ave, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+537-2717933 ext 3489

Email :

maurenis@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:

Maurenis

Last Name:

Hernandez Perez

Specialty:

First degree specialist in Oncology

Affiliation:

Center of Molecular Immunology

Postal Address:

216 Street & 15 Ave, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+537 2717933 ext 3489

Email :

maurenis@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:

RPCEC00000199

Date of Registration in Primary Registry:

08/07/2015

Record Verification Date:

2015/07/08

Next update date:

2016/07/08

Link to the spanish version:

Click here [3]