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Clinical Trials/RPCEC00000290
RPCEC00000290
Not yet recruiting
Phase 1

Efficacy and safety of cold kit of monoclonal antibody nimotuzumab labeled with 99mTc for the immunodiagnosis of head and neck tumors, lung and gliomas - Nimo cold kit

Center of Molecular Immunology (CIM)0 sitesOctober 5, 2018
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ConditionsLung DiseasesTumors of head and neck, lung and gliomasHead and Neck NeoplasmsLung NeoplasmsGliomaRespiratory Tract NeoplasmsThoracic NeoplasmsRespiratory Tract DiseasesNeoplasms, NeuroepitheliaNeoplasms, Glandular and EpithelialNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNeuroectodermal Tumors

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Lung Diseases
Sponsor
Center of Molecular Immunology (CIM)
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 5, 2018
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Center of Molecular Immunology (CIM)

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients who have signed the informed consent.
  • •2\. Patients that meet the diagnostic criteria.
  • •3\. Patients with biopsy samples that allow IHC study of overexpression of EGFR, imaging study and clinical documentation to corroborate the existence of the lesions.
  • •4\. Patients of both sexes older than 18 years.
  • •5\. Patients with life expectancy of 3 months or more.
  • •6\. Patients with functional status according to the ECOG scale \= 2, (Eastern Cooperative Oncology Group) ECOG.
  • •7\. Patients with functioning of organs and bone marrow defined by the following parameters:
  • •Hemoglobin greater than or equal to 90 g / L.
  • •Total leukocyte count greater than or equal to 3\.0 x 109 / L
  • •Platelet count greater than or equal to 100 x 109 / L.

Exclusion Criteria

  • •1\. Patients with acute allergic states, history of severe allergic reactions or autoimmune diseases.
  • •2\. Patients who are receiving another product under investigation.
  • •3\. Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the monoclonal antibody.
  • •4\. Patients with uncontrolled intercurrent diseases, including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and psychiatric illnesses that could limit adherence to trial requirements.
  • •5\. Female patients who are pregnant, nursing.

Outcomes

Primary Outcomes

Not specified

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