Status:
UNKNOWN
Immunotherapy With Racotumomab in Advanced Lung Cancer
Lead Sponsor:
Recombio SL
Collaborating Sponsors:
CIMAB (Cuba)
Laboratorio Elea Phoenix S.A.
Conditions:
NSCLC
Lung Cancer, Non-small Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a prospective, randomized, open label, parallel-group, multicenter phase III study to evaluate the efficacy and safety of active specific immunotherapy with racotumomab plus best supportive ca...
Eligibility Criteria
Inclusion
- Voluntarily signed informed consent.
- Cytologic or histologically diagnosed NSCLC in stages IIIA (non-resectable) or IIIB or IV (TNM).
- In continuous complete or partial remission or stable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) after standard first-line treatment.
- Imaging studies documenting the response to first-line therapy must be available for evaluation by the investigator.
- 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.
- Age greater than or equal to 18 years, either sex.
- Eastern Cooperative Oncology Group performance status less than 2.
- Adequate organ function, defined as follows:
- 1. Electrocardiogram (ECG) without significant anomalies, performed in the 7 days preceding entry
- 2. Haemoglobin greater than or equal to 90 g/L
- 3. Total white blood cell count (WBC) greater than or equal to 3.0 x 10\^9/L
- 4. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9/L
- 5. Platelet count greater than 100 x 10\^9/L
- 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
- 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. Creatinine less than or equal to 2 mg/dL (less than or equal to 176 µmol/L)
- Known hepatitis B virus carriers who have liver function tests within the accepted limits are eligible
Exclusion
- Pregnant or breastfeeding patients
- Known hypersensitivity to any component of the formulation
- Fertile patients of either sex who do not use adequate contraceptive methods while on treatment
- Disease progression prior to randomization
- Recurrent NSCLC, who relapse less than one year after completing curative intent therapy
- Patients receiving other investigational medication (including investigational immunotherapy for NSCLC) or having received such medication within 30 days before entering the protocol
- Autoimmune diseases or chronic decompensated diseases
- Acute allergic disorders or a history of severe allergic reactions
- Known brain metastases
- History of demyelinating disease or inflammatory disease of the central nervous system or the peripheral nervous system
- Non-controlled intercurrent diseases, including active infections, symptomatic congestive heart failure, unstable chest angina or heart arrhythmia, as well as mentally incapable patients
- 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
- 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.
- Active hepatitis C or positive tests for human immunodeficiency virus (HIV)
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2016
Estimated Enrollment :
1082 Patients enrolled
Trial Details
Trial ID
NCT01460472
Start Date
September 1 2010
End Date
September 1 2016
Last Update
July 29 2016
Active Locations (46)
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1
Instituto Médico CER
Quilmes, Buenos Aires, Argentina
2
Hospital Privado de Córdoba
Córdoba, Córdoba Province, Argentina
3
Instituto Oncológico de Córdoba
Córdoba, Córdoba Province, Argentina
4
Fundación COIR
Mendoza, Mendoza Province, Argentina