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Clinical Trials/NCT02616211
NCT02616211
Completed
Not Applicable

An Integrated Approach to Treating Recurrent Thoracic Carcinomas Resistant to Tyrosine Kinase Inhibitors

Mayo Clinic1 site in 1 country15 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adenocarcinoma of Lung
Sponsor
Mayo Clinic
Enrollment
15
Locations
1
Primary Endpoint
Identify the number of molecular changes in the recurrent tumor through molecular analysis with gene panels.
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Patients are asked to participate in this study if they have been diagnosed with a thoracic carcinoma which includes lung cancer and have a gene mutation (alteration in the body's genetic instructions) and after undergoing treatment the cancer has come back, progressed, or shown a partial response on standard treatment.

Detailed Description

In order to improve the treatment outcome for thoracic carcinomas after they become resistant to targeted therapy, the investigator is using tumor biopsies at the time of recurrence for genomic analysis to identify novel somatic changes in critical genes and gene pathways that can potentially be targeted with therapy. The study team is also creating patient-derived xenografts to test drug efficacy and optimize personalized therapy for each patient.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
December 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jin Jen, M.D., Ph.D.

PI

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • 18 years or older
  • Thoracic carcinoma tumors are positive for any targetable genetic alterations
  • Have shown partial or no response, progression or recurrence while on or after gene targeted therapy by CT/PET scan
  • Tumor is accessible for biopsy or surgery
  • Expected life is 6 months or longer.

Exclusion Criteria

  • \< 18 years
  • Not able to communicate in English

Outcomes

Primary Outcomes

Identify the number of molecular changes in the recurrent tumor through molecular analysis with gene panels.

Time Frame: 1 Year

To determine molecular changes in the recurrent tumor, identify the most significant genes and pathways and clinical phenotypes in lung adenocarcinomas resistant to tyrosine kinase inhibitor treatment.

Number of tumorgrafts from biopsies of the recurrent tumor grown and used for drug treatment selection based on genomic signatures.

Time Frame: 1 Year

Mice will be used to grow tumor xenografts. For subsequent passages, tumors will be implanted through passage mice. The patient-derived xenograft-baring mice will then be used for anti-tumor efficacy studies according to the patient prior therapeutic history and molecular signature of the tumor biopsy.

Secondary Outcomes

  • Recording turn-around-time(1 year)

Study Sites (1)

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