Anti-idiotype 1E10 vaccine in advanced non- small cell lung (NSCLC) patients

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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:

Phase II study: Active specific immunotherapy with the 1e10 anti idiotype vaccine in the treatment of patients with advanced non small cell lung Cancer

Secondary indentifying numbers:

IIC RD-EC080

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 :

16/12/2006

Reference number:

1019/05.017.06B

Principal investigator

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

First name:

Sahily Alonso Aleman, MD. 1st 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

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:

Matanzas, Jose Ramon Lopez Tabrane Hospital, Eduardo Santiesteban Alvarez, MD. 1st Degree Specialist in Oncology.

Research ethics committees:

Celestino Hernandez Robau University Hospital, November 22 2006. Jose Ramon Lopez Tabrane Hospital, May 10, 2006.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

27/09/2006

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:

Advanced Lung Cancer Non-small Cell Lung Cancer

Intervention(s):

For each group, the treatment will begin between 28 and 56 days after oncospecific treatment. Stage I Study group (Vaccine): Patients will be administered a total of 15 vaccines. The first 5 vaccines will be administered at 14 day intervals, and the other 10 every month until reaching one year immunization. Each vaccine will contain 1 ml of the vaccine preparation, at a 2 mg/ ml concentration of the 1E10 MAb. The total dose will be subdivided into 4 equal subdoses, administering (0.25 ml) at each inoculation site. The 1E10 anti-idiotype vaccine will be intradermally injected. The potential immunization sites are: the deltoid region, anterior to the forearms and anterior thighs and back of legs. Control group: Placebo. Scheme identical to the study group.

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. Measuring time: 12 months.

Key secondary outcomes:

Progression free survival (PFS), Anti-tumoral response, Humoral and Cellular response and toxicity. Measuring time: 12 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:

75 years

Inclusion criteria:

1. Patients that have signed the informed consent. 2. Patients with complete response or with measurable lesions* of the disease with partial response or stable when finishing the standard first line of Chemotherapy/Radiotherapy. 3. Patients whose time interval between finishing the oncospecific treatment and starting the vaccination is between 28 and 56 days. 4. Patient age between 18 and 75 years old, both inclusive. 5. General status according to ECOG < 2 (Karnofsky > 60 %). 6. Patients that have normal functioning of organs defined by the following parameters: Hemoglobin>¬ 90 g/L, Total leukocytes count> 3.0 x 109/L, Absolute neutrophils count>1.5 x 109/L, Platelet count>¬100 x 109/L, Total Bilirubin: Within normal limits. TGP and TGO: ¬2.5 times the normal highest institutional limit. Creatinine: Within normal limits for each institution. Blood glucose: Within normal limits for each institution. Total and fractioned proteins: Within normal limits for each institution. 7. Life expectancy of 4 months or more.

Exclusion criteria:

1. Pregnant or breastfeeding patients. 2. Patients that have received any type of immunotherapy for NSCLC. 3. Patients with known hypersensitivity to any component of the formulation. 4. Patients of both sexes in fertile age that are not using an adequate contraceptive method (intrauterine device, hormone contraceptive, barrier methods or tubal ligation). In case of the male sex (vasectomy, use of condom) while treatment duration. 5. Patients that are receiving another research drug. 6. Patients with autoimmune diseases or decompensated chronic diseases. 7. Patients with acute allergic status or history of severe allergic reactions. 8. Patients with brain metastases or other primary neoplastic lesion. 9. Patients with prior history of demyelinizing or inflammatory diseases of the CNS or peripheral nervous system. 10. Patients with intercurrent non controlled diseases including active infections, symptomatic congestive cardiac insufficiency, unstable chest angina, cardiac arrhythmia and psychiatric diseases that imply the incompetence of the individual. 11. Patients with malignant diseases in the previous 5 years, except skin cancer (not melanoma). 12. Patients that are receiving systemic corticosteroids. 13. Patients with known HIV, B and C hepatitis.

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:

Placebo

Study design:

Parallel

Phase:

2

Target sample size:

176

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:

MD,PHD 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

Country:

Cuba

Zip Code:

16040

Telephone:

(537) 271-7933 Ext 224

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

Country:

Cuba

Zip Code:

CP 16040, Box 11600

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:

RPCEC00000009

Date of Registration in Primary Registry:

2010-12-28

Record Verification Date:

2010-11-01 20:00

Link to the spanish version:

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Anti-idiotype 1E10 vaccine in advanced non- small cell lung (NSCLC) patients

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