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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616211
• Other study ID #: 14-002084
• Status: Completed
• Start date: October 2014
• Est. completion date: December 2019

Study information

• Verified date: October 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma of Lung
• ALK Genes
• Cancer of Lung
• EGFR Genes
• Lung Cancer
• Lung Neoplasm
• Lung Neoplasms
• Pulmonary Cancer

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Foundation for Cancer Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify the number of molecular changes in the recurrent tumor through molecular analysis with gene panels.	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.	1 Year
Primary	Number of tumorgrafts from biopsies of the recurrent tumor grown and used for drug treatment selection based on genomic signatures.	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.	1 Year
Secondary	Recording turn-around-time	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.	1 year

External Links

•   Mayo Clinic Clinical Trials