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

NCT02616211 | Completed

• 1 other identifier: 14-002084
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of Lung; Lung Neoplasm; Cancer of Lung; Lung Cancer; Pulmonary Cancer; EGFR Genes; ALK Genes

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Recording turn-around-time

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen at the Mayo Clinic Rochester

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Foundation for Cancer Research: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

At the time of recurrence, a minimum of two (2) and a maximum of four (4) tissue cores will be taken through interventional biopsy, ultra sound guided biopsy, surgical resection, or bronchoscopy. Investigators may also collect waste pleural fluid in patients who have a pleurx catheter in place. These biopsies will be collected and individually processed for pathology, gene mutation screening, transcriptome profiling and tumor xenografts.

MeSH Terms

Conditions

Adenocarcinoma of Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jin Jen, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 26, 2015
• Study Start: October 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2019
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

US (1)