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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Use of hR3 MAb and radiotherapy to treat patients with non small cells lung cancer (NSCLC) and brain metastasis.

Secondary indentifying numbers:

IIC RD-EC079

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Government funds

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

15/02/2006

Reference number:

281/05.023.05B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Javier

Last name:

Figueredo

Medical Specialty :

MD. 1st degree Specialist in Neurosurgery.

Affiliation:

Center of Researches Surgical-Medical (CIMEQ)

Postal address:

216 street, corner 11-B, Siboney

City:

Havana

País:

Cuba

Zip Code:

12100

Telephone:

+53-78581000

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana City, Hermanos Ameijeiras Hospital, Elia Neninger, MD. 2nd degree Specialist in Oncology.

Matanzas, José Ramón López Tabrane Hospital, Eduardo Santiesteban Alvarez, MD. 1st degree Specialist in Oncology.

Research ethics committees:

Center of Researches Surgical-Medical (CIMEQ), November 1th, 2005.

Hermanos Ameijeiras Hospital, December 20, 2006.

Jose Ramon Lopez Tabrane Hospital, September 19, 2007.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

08/09/2006

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Non-small cells lung cancer with brain metastasis

Health condition(s) code:

Carcinoma, Non-Small-Cell Lung

Brain Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Diseases

Respiratory Tract Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Nervous System Diseases

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.

Intervention code:

Antibodies, Monoclonal, Humanized

Radiotherapy

Antibodies, Monoclonal

Palliative Care

Intervention keyword:

AcMh-R3

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Survival time, measuring time: 12 months.

Key secondary outcomes:

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

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Amparo

Middle Name:

Emilia

Last Name:

Macias Abraham

Specialty:

Second Degree Specialist in Clinical Biochemistry

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 street, corner 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933, Ext 224

Email :

amparo@cim.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Amparo

Middle Name:

Emilia

Last Name:

Macias Abraham

Specialty:

Second Degree Specialist in Clinical Biochemistry

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 street, corner 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933, Ext 224

Email :

amparo@cim.sld.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000016

Date of Registration in Primary Registry:

2010-12-29

Record Verification Date:

2017/01/20

Next update date:

2018/01/20

Link to the spanish version:

Click here [3]