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OpenTrials
Completed

NCT Number: NCT02616211

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

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.

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Key information

Conditions

Adenocarcinoma of Lung ALK Genes Adenocarcinoma Cancer of Lung Carcinoma EGFR Genes Lung Cancer Lung Diseases Lung Neoplasm Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pulmonary Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  1. Recording turn-around-time

    Time frame: 1 year

    Time metrics from biopsy to completion of molecular genetic tests; the time and the success rate of tumorgraft growth in mice as well as the optimal time lapse between initiation treatment to observation of response will be examined. This will aid in the determination of feasibility and opportunities of using patient specific treatment for tumor recurrence.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Foundation for Cancer Research

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Nov 26, 2015
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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