Anti-idiotype 1E10 vaccine in the treatment of patients with small cell lung (SCLC) 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:

Active specific immunotherapy with the 1E10 anti-idiotype vaccine in the treatment of patients with small-cell lung cancer.

Secondary indentifying numbers:

IIC RD-EC071

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 :

27/10/2004

Reference number:

2148/05.023.04B

Principal investigator

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

First name:

Sofia Alsina Sarmientos, MD, 2nd 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:

Havana City, Hermanos Ameijeiras Hospital, Elia Neninger Vinageras, MD. 2nd degree Specialist in Oncology. Villa Clara, Celestino Hernandez Robau University Hospital, Ana V. de la Torre Santos, MD. 2nd degree Specialist in Oncology. Havana City, Benefico Juridico Hospital, Rolando Rives Rodríguez, MD. 1st degree Specialist in Pulmonology. Santiago de Cuba, Saturnino Lora Hospital, Juan Castellanos Pierra, MD. 1st degree Specialist in Internal Medicine.

Research ethics committees:

National institute of Oncology and Radiobiology (INOR), March 23, 2004. Hermanos Ameijeiras Hospital, July 5, 2004. Celestino Hernandez Robau' University hospital, June 23, 2004. Benefico Juridico Hospital, November 4, 2004. Saturnino Lora Hospital, October 4, 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:

03/03/2005

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 Small Cell Lung Cancer

Intervention(s):

Group I. Vaccine preparation Patients will be administered 15 intradermal vaccines. The first 5 vaccines at a 14 day interval and theother 10 every 28 days until completing 1 year treatment. In each immunization, 1ml (1mg) of the vaccine divided into 4 sub-doses (0.25 ml) will be administered at each inoculation site. Potential immunization sites include deltoid region, anterior surface of forearm, and posterior surface of leg. After the 15 immunizations, the patient will continue to be vaccinated every three months for life, provided that the patient’s general health condition so permits. Group II. Placebo Patients will be administered the placebo using the same scheme, frequency and administration route as Group I.

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. Measuring time: 12 months.

Key secondary outcomes:

Progression time, clinical response, immune humoral and cell response, 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:

No limit

Inclusion criteria:

1) Patients who have signed informed consent in writing. 2) Patients with measurable lesions and partial or stable responses upon QTP completion. 3 )Patients whose period of time between onco-specific treatment completion and initial vaccine ranges from 4 to 6 weeks. 4) Age >= 18 years. 5) General condition according to ECOG < 2 (Karnofsky > 60%). 6) Patients with organs and bone marrow working normally, according to the following parameters: Hemoglobin>=9g/L, Leucocytes>=3,000/ml, Absolute neutrophil counting>=1,500/ml, Platelet counting>=100,000/mL, Total bilirubin: within normal limits. TGP and TGO<=2.5 times the institutional normal upper limit. LDH: Within normal limits for each institution. Creatinine: within normal limits for each institution. Urea and glycemia: within normal limits for each institution. Total and fractionary proteins: within normal limits for each institution. 7) Life expectancy over 3 months.

Exclusion criteria:

1) Pregnancy or breastfeeding. 2) Reproductive-age patients of both sexes not using appropriate contraceptive methods (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). Males should also use contraceptive methods (vasectomy, use of condoms) during the treatment. 3) Patients on other drugs under research. 4) Patients with autoimmune diseases or decompensated chronic diseases. 5) Patients with acute allergic conditions or history of severe allergic reactions. 6) Patients with brain metastasis or previous history of demyelinating or inflammatory diseases of the peripheral or central nervous system. 7) Patients with uncontrolled intercurrent diseases including active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and psychiatric diseases leading to subject incompetence. 8) Patients with previous malignant diseases, except in situ cervix carcinoma or skin cancer (other than melanoma), adequately 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:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2

Target sample size:

88

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

Country:

Cuba

Zip Code:

CP 16040, Box11600

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, 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:

RPCEC00000010

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 the treatment of patients with small cell lung (SCLC) patients

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