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

Completed

• Conditions: Lung Cancer; Cancer of Lung; Adenocarcinoma of Lung; Pulmonary Cancer; EGFR Genes; Lung Neoplasm; ALK Genes

• Registration Number: NCT02616211
• Lead Sponsor: Mayo Clinic

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-26
• Primary Completion: 2018-10
• Study Completion: 2019-12
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States