1E10 anti-idiotype vaccine, metastatic breast cancer, phase II

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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 1E10 anti-idiotype vaccine to treat patients with metastatic breast cancer, phase II.

Secondary indentifying numbers:

IIC RD-059

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 :

12/03/2003

Reference number:

180/06.00.03B

Principal investigator

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

First name:

Dr. Jorge Cardoso. st Degree Specialist in surgery

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

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:

Holguin, "Vladimir Ilich Lenin" Hospital, Dr. Pedro Fernandez. 1st Degree Specialist in Oncology Santiago de Cuba, "Conrado Benitez" Oncology Hospital, Dr. Miguel O'farrill Mateu. 1st Degree Specialist in Oncology Havana City, "Calixto Garcia" Hospital, Dr. Victor Gonzalez Grillo. 1st Degree Specialist in Oncology. Havana City, "10 de Octubre" Hospital, Dr. Alfonso Guillermo Ramos Sosa. 1st Degree Specialist in Oncology, Havana City, "Salvador Allende" Hospital, Dra. Doris Gil Valdés. 1st Degree Specialist in Oncology. Matanzas, "Jose R. Lopez Tabrane" Hospital, Dr. Eduardo Santiesteban. 1st Degree Specialist in Oncology

Research ethics committees:

Maria Curie Hospital, April 29th, 2003. Vladimir Ilich Lenin Hospital, June, 18th, 2003. Conrado Benitez Oncology Hospital, June, 19th, 2003. Calixto Garcia Hospital, June 19th, 2003. 10 de Octubre Hospital, June, 20th, 2003. Salvador Allende Hospital, June 4th, 2004. Jose R. Lopez Tabrane Hospital, October, 18th, 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:

15/09/2003

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 carcinoma in stage IV or progressive metastatic disease

Intervention(s):

Study group. Anti-idiotype vaccine 1E10. The patients will receive 15 immunizations (1 ml per immunization, at a concentration of 1 mg/ml of antiserum 1E10) intradermally at intervals of fourteen days the first 5 immunizations and monthly thereafter until all 10 doses remaining. Control group: Placebo. Scheme identical to the study group. In addition to the vaccine preparation or placebo, patients may receive concurrent therapy with Tamoxifen.

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):

Survival time and time to progression. Measuring Time: 18 and 24 months.

Key secondary outcomes:

Humoral Immune Response, toxicity and clinical response. Measuring time: 18 and 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:

80 years

Inclusion criteria:

1)Female patients with cyto- ’histological confirmed diagnostic of recurrent or Stage IV metastatic breast cancer 2)Patients that have received the oncospecific therapy according to the treatment guidelines established in the country and that have ended the different protocols in a time period of 4 weeks prior to entry in the trial. 3)Patient’s informed consent to participate in the investigation obtained. 4)Age = 18 years. 5)Patients with life expectancy = 6 months. 6)Performance Status according to WHO from 0 to 2. 7)Clinical laboratory parameters: a.-) Hematopoietic parameters: - Hb>100g/l, - Leucocytes>4 x 109cells/l - Granulocytes>2x109 cells/l, - Platelets> 100 x 109cells/ l. b.-) Liver (not exceeding the normal upper limit by three times), bilirubin: 17mol/l (LSN), ALAT: 40U/l (LSN), ASAT: 40U/l (LSN), alkaline phosphatase: 279U/l c.-) Kidney: serum creatinine: 132 mmol/l.

Exclusion criteria:

1.Patients with breast cancer in stage Iv or recurrent diseases that have received oncospecific therapy and have concluded the different protocols in a time period inferior to 4 weeks or greater than 4 weeks prior to entry in the trial. 2.Pregnant or breastfeeding patients. 3.Patients with prior history of demielinizing disease or inflammatory disease of the CNS or the peripheral nervous system. 4.Patients with previous malignancies except carcinoma in situ of cervix or skin cancer (not melanoma), treated properly. 5.Patients with acute or chronic infectious diseases. 6.Patients with acute allergic status or history of severe allergic reactions. 7.Patients with autoimmune diseases or chronic non-compensated diseases. 8.Patients who present the contralateral breast as the only site of metastatic disease.

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:

Active

Study design:

Parallel

Phase:

2

Target sample size:

80

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:

Amparo

Middle Name:

Emilia

Last Name:

Macias Abraham

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana City

País:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

537-271-79-33

Email :

amparo@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:

Amparo

Middle Name:

Emilia

Last Name:

Macias Abraham

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana City

País:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933 Ext 224

Email :

amparo@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:

RPCEC00000008

Date of Registration in Primary Registry:

2010-12-27

Record Verification Date:

2010-02-27 19:00

Link to the spanish version:

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Ensayos Registrados

Proceso de Registro

1E10 anti-idiotype vaccine, metastatic breast cancer, phase II

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