Non-small cells lung cancer with brain metastasis
Conditions
Interventions
2 treatment groups, A and B. Group A. Radiant+HR3 MaB palliative therapy Palliative therapy. Palliative radiant treatment (30 Gy) for 2 weeks. hR3 MAb. The group will receive six 200mg HR3 MAb adminis
Antibodies, Monoclonal, Humanized
Radiotherapy
Antibodies, Monoclonal
Palliative Care
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1- Patients with non small cell lung cancer (NSCLC) confirmed by Pathological Anatomy techniques. 2-Patients with one or more measurable brain metastatic lesions who, at the time of inclusion, are not eligible for surgical treatment (total exeresis), defined as those than can be accurately measured in, at least, one dimension (meaning the greater diameter) using imaging techniques (CAT and/or NMR). 3- The study includes metastasis detected during diagnosis and evolving metastasis. 4- Patients could have received any previous onco-specific treatment (surgery, chemotherapy, radiotherapy or any other) for primary lung tumor, provided that such treatment had ended, at least, 4 weeks before being included in the study and who, at the time of inclusion, are only receiving palliative radiotherapy to treat brain metastatic disease. The trial can also include phase IV patients who are only on radiotherapy to treat lung primary tumor and those who are concurrently under radiotherapy for brain metastasis. 5- Patients with brain metastasis diagnosed up to 6 weeks earlier. 6- Reproductive-age patients should have a negative pregnancy test and all patients included in the trial should use effective contraceptive methods. 7- Age >= 18 years. 8- Life expectancy >= 12 weeks. 9- General health condition according to the Karnosfsky Index >= 60. 10- Laboratory parameters within the normal limits, defined as: hematopoietic parameters: haemoglobin>= 9 g/l, total leukocytes >= 4 x 109 cells/l, platelets >= 100 x 109/l, Liver: liver functioning within normal limits and without liver conditions confirmed by TGP, TGO or alkaline phosphatase. Kidney function: serum creatinine<132 mmol/l, creatinine clearing within normal limits. 11- Patients who sign the informed consent document.
Exclusion criteria
Exclusion criteria: 1- Patients on any monoclonal antibody. 2- Pregnancy or breastfeeding. 3- Patients who, at the time of inclusion, have any decompensated related chronic disease (for example: cardiopathy, diabetes, high blood pressure). 4- Patients with history of hypersensitivity to this or any other similar biological product. 5- Fever, severe septic processes, or acute or serious allergic conditions. 6- Presence of a second primary tumor. 7- Patients who, at the time of inclusion, are participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival time, measuring time: 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Global objective response, duration of disease control and quality of life, measuring time: 12 months. | — |
Countries
Cuba
Contacts
Public ContactAmparo Macias Abraham
Center of Molecular Immunology (CIM)
Outcome results
None listed