Advanced Lung Cancer Small Cell Lung Cancer
Conditions
Interventions
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 i
Vaccines
Immunotherapy, Active
Placebos
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival time. Measuring time: 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression time, clinical response, immune humoral and cell response, toxicity. Measuring time: 12 months. | — |
Countries
Cuba
Contacts
Public ContactAmparo Macias Abraham
Center of Molecular Immunology (CIM)
Outcome results
None listed