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

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000010
• Date of registration: 28/12/2010
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: Anti-idiotype 1E10 vaccine in the treatment of patients with small cell lung (SCLC) patients
• Scientific title: Active specific immunotherapy with the 1E10 anti-idiotype vaccine in the treatment of patients with small-cell lung cancer.
• Date of first enrolment: 03/03/2005
• Target sample size: 88
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000010-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Amparo Macias Abraham
• Affiliation: Center of Molecular Immunology (CIM)

• Name: Amparo Macias Abraham
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: No limit
Gender: Both

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.

Primary Outcome(s)

Survival time. Measuring time: 12 months.

Secondary Outcome(s)

Progression time, clinical response, immune humoral and cell response, toxicity. Measuring time: 12 months.

Secondary ID(s)

IIC RD-EC071

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable