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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02616211
Collaborator
National Foundation for Cancer Research (Other)
15
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62
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Study Details

Study Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
15 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
An Integrated Approach to Treating Recurrent Thoracic Carcinomas Resistant to Tyrosine Kinase Inhibitors
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Dec 1, 2019

Outcome Measures

Primary Outcome Measures

  1. Identify the number of molecular changes in the recurrent tumor through molecular analysis with gene panels. [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. [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 Outcome Measures

  1. Recording turn-around-time [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic
  • National Foundation for Cancer Research

Investigators

  • Principal Investigator: Jin Jen, MD, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Jin Jen, M.D., Ph.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02616211
Other Study ID Numbers:
  • 14-002084
First Posted:
Nov 26, 2015
Last Update Posted:
Oct 19, 2020
Last Verified:
Oct 1, 2020
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2020