Immunotherapy With Racotumomab in Advanced Lung Cancer

Launched by RECOMBIO SL · Oct 24, 2011

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Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily signed informed consent.
• • 2. Cytologic or histologically diagnosed NSCLC in stages IIIA (non-resectable) or IIIB or IV (TNM).
• • 3. In continuous complete or partial remission or stable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) after standard first-line treatment.
• • 4. Imaging studies documenting the response to first-line therapy must be available for evaluation by the investigator.
• • 5. Time lapse of 21 to 56 days between the end of onco-specific treatment and start of vaccination. Patients must have recovered from any acute toxicity produced by previous therapy.
• • 6. Age greater than or equal to 18 years, either sex.
• • 7. Eastern Cooperative Oncology Group performance status less than 2.
• 8. Adequate organ function, defined as follows:
• • 8.1. Electrocardiogram (ECG) without significant anomalies, performed in the 7 days preceding entry
• • 8.2. Haemoglobin greater than or equal to 90 g/L
• • 8.3. Total white blood cell count (WBC) greater than or equal to 3.0 x 10\^9/L
• • 8.4. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9/L
• • 8.5. Platelet count greater than 100 x 10\^9/L
• • 8.6. Total bilirubin less than or equal to 1.5 fold the maximum normal value at the place of evaluation or 2.5 fold the maximum normal value in case of liver metastases
• • 8.7. Glutamic-oxaloacetic transaminase/aspartate aminotransferase (GOT/AST), and glutamic-pyruvic transaminase/alanine aminotransferase (GPT/ALT), less than or equal to 2.5 fold the maximum normal value at the place of evaluation (in case of liver metastasis, less than 5 fold the maximum normal value)
• • 8.8. Creatinine less than or equal to 2 mg/dL (less than or equal to 176 µmol/L)
• • 9. Known hepatitis B virus carriers who have liver function tests within the accepted limits are eligible
• Exclusion Criteria:
• • 1. Pregnant or breastfeeding patients
• • 2. Known hypersensitivity to any component of the formulation
• • 3. Fertile patients of either sex who do not use adequate contraceptive methods while on treatment
• • 4. Disease progression prior to randomization
• • 5. Recurrent NSCLC, who relapse less than one year after completing curative intent therapy
• • 6. Patients receiving other investigational medication (including investigational immunotherapy for NSCLC) or having received such medication within 30 days before entering the protocol
• • 7. Autoimmune diseases or chronic decompensated diseases
• • 8. Acute allergic disorders or a history of severe allergic reactions
• • 9. Known brain metastases
• • 10. History of demyelinating disease or inflammatory disease of the central nervous system or the peripheral nervous system
• • 11. Non-controlled intercurrent diseases, including active infections, symptomatic congestive heart failure, unstable chest angina or heart arrhythmia, as well as mentally incapable patients
• • 12. Other malignant diseases except non- melanoma skin cancer, in situ carcinoma of the cervix, incidental prostate cancer (T1a, Gleason less than or equal to 6, prostate specific antigen (PSA) less than 0.5 ng/ml) or any other tumour having received adequate treatment and evidencing a disease-free period greater than or equal to 5 years
• • 13. Receiving chronic therapy for more than 10 days at doses of prednisone greater than 10 mg/day (or equivalent) at the moment of the inclusion. Inhaled and topical corticosteroids are allowed.
• • 14. Active hepatitis C or positive tests for human immunodeficiency virus (HIV)