EGF-based vaccine with VChTV Schedule in hormone-refractory prostate tumors

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:

Clinical evaluation of the VChTV Schedule with the EGF-based vaccine the treatment of patients suffering hormone-refractory prostate tumors

Secondary indentifying numbers:

IIC RD-EC077

Issuing authority of the secondary identifying numbers:

Centre of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Ministry of Public Health (MINSAP) Centre of Molecular Immunology (CIM)

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 :

31/10/2005

Reference number:

05.027.05.B

Principal investigator

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

First name:

Jorge Gonzalez Hernandez MD., First Grade Specialist in Urology.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

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

Research ethics committees:

National Institute for Oncology and Radiobiology, June 27th, 2005. Salvador Allende Hospital, November 20th, 2007. III Congreso Hospital, February 28th, 2005. Celestino Hernandez Hospital, May 30th, 2005. Jose Ramon Lopez Tabranes Hospital, May 30th, 2005.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

19/04/2006

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:

Hormone-refractory prostate tumors

Intervention(s):

Study Group (Vaccine EGF): Vaccine in schedule Vaccine-Chemotherapy-Vaccine (VChTV) Day 1 Cyclophosphamide 200 mg/m2 by intravenous route. Day 4 EGF vaccine 2.4 mg by intramuscular route quarterly up to 4 doses and thereafter every 28 days in VChTV schedule with Mitoxantrone, 12 mg/m2 by intravenous route, every 3 weeks for 10 cycles and Prednisone 10 mg daily by oral route while continue the 10 cycles of ChT. Control Group (Chemotherapy): Mitoxantrone, 12 mg/m2 by intravenous route, every 3 weeks for 10 cycles and Prednisone 10 mg daily by oral route while continue the 10 cycles of ChT.

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 (Alive, Dead). Measuring time: 24 months Immunogenicity (Anti-EGF antibodies titers and EGF sera concentration). Measuring time: in each immunization

Key secondary outcomes:

Adverse events (Name, Intensity, SAE, Vaccine related Death). Measuring time: in every immunization and in every cycle of chemotherapy Quality of Life (EORTC QLQ-C30). Measuring time: Every 6 months

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male

Minimum age:

18 years

Maximum age:

80 years

Inclusion criteria:

1. Patients who accomplished the diagnosis criteria. 2. Patients Oldest than 18 years. 3. Patients who sign the Informed Consent 4. Patients with measured lesions or valuable. 5. Patients with serum levels of testosterone equal = 30 ng/ml. 5. Patients with general performance status according ECOG <2. 6. Patients with life expectancy over 6 months. 7. Patients with an adequate function of organs and bone marrow.. 8. Patients who finalized the hormone therapeutic maneuvers 6 to 8 weeks before the recruitment.

Exclusion criteria:

1. Patients who are receiving another onco-specific product on research. 2. Patients with personal history of allergy related with compounds of similar chemical composition as the studied EGF. 3. Patients with personal history of hyper- sensibility to antracyclines and/or mitroxantrone. 4. Patients suffering of concomitant non controlled diseases including: active infections, symptomatic congestive heart failure, instable cardiac angina, cardiac arrhythmias, liver diseases and psychiatric disorders that limits the adherence to the clinical trial requirements. 5. Patients with brain metastases 6. Patients positive to HIV

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:

212

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:

Pedro

Middle Name:

Camilo

Last Name:

Rodriguez Rodriguez

Affiliation:

Centre of Molecular Immunology

Postal Address:

216 St & 15 Ave, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

(537) 271-7933 Ext 3146.

Email :

camilo@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:

Pedro

Middle Name:

Camilo

Last Name:

Rodriguez Rodriguez

Affiliation:

Centre of Molecular Immunology

Postal Address:

216 St & 15 Ave, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

(537) 271-79-33 ext 3146

Email :

camilo@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:

RPCEC00000159

Date of Registration in Primary Registry:

2013-06-19

Record Verification Date:

2013-05-22

Next update date:

2014-05-22

Link to the spanish version:

Click here [3]