Non-Small Cell advanced Lung Cancer
Conditions
Interventions
Study group: CIMAvax -EGF therapeutic vaccine. Doses 2.4 mg by intramuscular route following the scheme: The first four vaccines will be administered every 14 days. The rest of vaccines will be admini
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosis NSCLC IIIb / IV in secondary care 2. Either sex, and age equal or greater than 18 years. 3. Eligible No chemotherapy or radiation therapy or who have received the treatment oncospecific available and have no other therapeutic option. 4. Which have signed informed consent for research. 5. Criteria of clinical status ECOG 0-3.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received treatment with EGF therapeutic vaccine CIMAvax and / or Nimotuzumab (therapeutic monoclonal antibody hR3). 2. Patients with chronic or acute infectious diseases, inflammatory or unbalanced 3. Patients with decompensated diabetes. 4. Patients of childbearing potential not using adequate contraception accept (intrauterine devices, barrier methods, or tubal ligation, hormonal methods). 5. Pregnant patients or nursing. 6. Patients with acute allergic conditions or history of severe allergic reactions. 7. Patients who can not attend or receive the proposed I have difficulties in accessing the APS treatment center.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of severe adverse reactions or deaths. Measuring time: at baseline, monthly during 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events (AE). Measuring time: at baseline, monthly during 2 years. Measurable by: -Occurrence of any AE (Yes, No) -Description of the AE (Name of the adverse events) -Duration of the AE (difference between the beginning and the end of the AE) -Intensity of the AE (Mild, Moderate, Severe, Extremely Severe, Death) -Severity (Serious, No serious) -Result (Recovered, Enhanced, Persists or squeals) -Attitude towards treatment (Unchanged, Dose modification, Temporary interruption, Definitive interruption) -Causality relationship (Very Likely, Probable, Possible, Unlikely, not related, Unknown) -Batch of CIMAvaxEGF Vaccine (number of the batch of vaccine) Overall survival time (Time in months from the inclusion date until death or last date you have news). Measuring time: at baseline, monthly during 2 years. Evolution of nutritional status (Body mass index: weight / height ² and percentage (%) weight loss). Measuring time: at baseline, monthly during 2 years. Quality of life (EORTC QLQ-C30 y EORTC QLQ-CC 13). Measuring time: at baseline, monthly during 2 years. Changes staggering pain therapy (Absence of Pain: The patient does not require treatment, First step: Nonsteroidal anti-inflammatory drugs (NSAIDs) (aspirin, diclofenac, dipyrone, ibuprofen, indomethacin, naproxen, Paracetamol, Piroxicam) and / or adjuvants, Second step: is added to NSAIDs and adjuvants, a weak opioid (Amicodex, Dextropropoxyphene, Codeine, Tramadol, Demerol) Third step: strong opioids are introduced into the treatment (Morphine, Methadone, Oxycodone, Fentanyl) Fourth step: Blocking peripheral nerves, intraspinal administration, neurosurgery and / or anesthesia). Measuring time: at baseline, monthly during 2 years. | — |
Countries
Cuba
Contacts
Public ContactPedro Guerra Chaviano
National Coordinating Center for Clinical Trials (CENCEC)
Outcome results
None listed