Patients with non small cells lung cancer (NSCLC) and brain metastasis.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000016
• Date of registration: 29/12/2010
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: Patients with non small cells lung cancer (NSCLC) and brain metastasis.
• Scientific title: Use of hR3 MAb and radiotherapy to treat patients with non small cells lung cancer (NSCLC) and brain metastasis.
• Date of first enrolment: 08/09/2006
• Target sample size: 30
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000016-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Open. Placebo: Active Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Amparo Macias Abraham
• Affiliation: Center of Molecular Immunology (CIM)

• Name: Amparo Macias Abraham
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion 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: 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.

Age minimum: 18 years
Age maximum: No limit
Gender: Both

Health Condition(s) or Problem(s) studied

Non-small cells lung cancer with brain metastasis

Intervention(s)

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 administrations every week, for 6 consecutive weeks, along with radiotherapy. Group B. Radiant palliative therapy The group will receive the palliative therapy indicated for metastatic disease, just as Group A.

Primary Outcome(s)

Survival time, measuring time: 12 months.

Secondary Outcome(s)

Global objective response, duration of disease control and quality of life, measuring time: 12 months.

Secondary ID(s)

IIC RD-EC079

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable