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

Phase 2

• Conditions: Advanced Lung Cancer Small Cell Lung Cancer; Small Cell Lung Carcinoma; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

• Registration Number: RPCEC00000010
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival time. Measuring time: 12 months.

Secondary Outcome Measures

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