EGF vaccine- Advanced Lung 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:

Survival of advanced Non Small Cells Lung Cancer patients treated with EGF therapeutic vaccine compared with conventional treatment.

Secondary indentifying numbers:

IIC RD-EC081

Issuing authority of the secondary identifying numbers:

Centre of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Centre 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 the Quality of Drugs(CECMED)

Authorization date :

10/06/2006

Reference number:

05.010.06.B

Principal investigator

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

First name:

Elia Neninger Vinageras, MD. Second Degree Specialist in Oncology

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:

“Hermanos Ameijeiras”, Hospital. February 25th, 2006. Center for Medical and Surgical Research, March 21th, 2006. “Benéfico Jurídico” Pneumologic Hospital, April 1st, 2006 “Celestino Hernández Robau” Hospital, April 4th, 2006 “Maria Curie” Hospital, Camagüey, April 11th, 2006 “Saturnino Lora” Hospital, April 29th, 2006 “Vladimir I. Lenin” Hospital, May 2nd, 2006 “José Luis López Tabranes” Hospital, May 23th, 2006.

Recruitment status

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

Recruitment status:

Suspended

Date of first enrollment:

05/07/2006

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:

Non Small Cells Lung Cancer

Intervention(s):

Study Group (Vaccine): Day 1 Cyclophosphamide 200 mg/m2. Day 4 EGF vaccine 2.4 mg quarterly up to 4 doses and thereafter every 28 days until . Treatment of the pain and supportive care if required. Control Group: Treatment of the pain and supportive care if required.

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

Key secondary outcomes:

Adverse events (name of event, intensity, SAE and death related to the product). Measuring time: every immunization Quality of Life (EORTC QLQ-30, EORTC QLQ-CC13). Measuring time: every 3 months until 24 months.

Selection criterias

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

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

80 years

Inclusion criteria:

1.Have histologically and/or cytologically confirmed diagnosis of NSCLC, corresponding to locally and regionally advanced, inoperable disease (Stage IIIb or Stage IV) 2.Aged >18 years 3.Have adequate bone marrow, liver and renal function, as assessed by the Investigator. A sample taken at Screening should confirm that: - Hemoglobin = 9 g/L - White blood cell (WBC) count = 3000/ µL - Neutrophils = 1500/µL - Platelet count = 100,000 per µL - Total bilirrubin in normal labs values - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x upper limit of normal (ULN) Serum creatinine = 1.5 x ULN 4.Life expectancy at least 3 years 5. Agree to use double-barrier contraception (males and females alike [if applicable]). A negative pregnancy test must be documented at Screening for females of childbearing potential. 6.Females of childbearing potential are defined as those women with less than 2 years after last menstruation and not surgically sterile, while post-menopausal refers to those women with at least 2 years from last menstruation. 7.Have signed a voluntary written informed consent form (ICF). Patients should be cooperative, willing and able to participate and adhere to the Protocol requirements, including their availability for the follow-up. 8.Are eligible to receive first-line chemotherapy (without concurrent thoracic radiotherapy or consolidation radiotherapy). 9.Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 10.Achieve tumor Objective Response of at least stable disease by RECIST.

Exclusion criteria:

1.Patient is currently enrolled in other investigational drug trial. 2.Patient has a history of any severe or life-threatening hypersensitivity reaction. 3.Patient has an unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal and metabolic disease). 4.Pregnant woman 5.Another active concurrent malignant disease except non- melanoma skin lesions or cervix cancer. 6.Brain metastases (Only if detectable by radiological image scan previous sign or symptoms).

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:

579

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:

Calle 216 Esquina 15, Atabey, Playa,

City:

Havana

Country:

Cuba

Zip Code:

CP 16040, Box 11600

Telephone:

53 7 2143146

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:

Rodríguez Rodríguez

Affiliation:

Centre of Molecular Immunology

Postal Address:

216 St & 15 Ave, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

537-2143146

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:

RPCEC00000161

Date of Registration in Primary Registry:

2013-06-20

Record Verification Date:

2013-06-14

Next update date:

2014-06-14

Link to the spanish version:

Click here [3]