Molecular Determinants of Acquired Clinical Resistance to Crizotinib in Non-small Cell Lung Cancer Harboring a Translocation or Inversion Event Involving the ALK Gene Locus
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to try to learn more about how small molecule kinase inhibitor medications work in treating lung cancer. Crizotinib (PF-02341066) is a drug that has been shown to shrink tumors in some patients with lung cancer. While the investigators know how this drug works to stop the growth of tumors that depend on change in the gene named ALK (also called EML4-ALK), the investigators do not know why the drug stops working. The investigators would like to examine the tumor to help us better understand why crizotinib has stopped working as well as it once did. The tumor will be examined with multiple tests to look for the reason that crizotinib stopped working.
| Condition | Intervention |
|---|---|
|
Lung Cancer |
Genetic: obtain tissue specimens |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Molecular Determinants of Acquired Clinical Resistance to Crizotinib in Non-small Cell Lung Cancer Harboring a Translocation or Inversion Event Involving the ALK Gene Locus |
Tissue
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
patients with Non Small Cell Lung cancer
This is a protocol to obtain and/or analyze tissue specimens of patients with NSCLC harboring an activating ALK inversion or translocation that have had a previous clinical response to tyrosine kinase inhibitor therapy and subsequently experience progressive disease. The tissue will be used to identify changes in the ALK gene that are acquired during treatment with an ALK TKI and may account for acquired resistance.
|
Genetic: obtain tissue specimens
One core biopsy specimen will be placed in formalin and processed for cytogenetic and FISH analyses as well as DNA for ALK sequencing. The second core biopsy specimen will be immediately frozen in liquid nitrogen and stored in a -80 degree freezer for research specimen. Collection will be performed on-site at the time of the procedure.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All patients seen by the Thoracic Oncology Service who have been diagnosed with an ALK mutant NSCLC and treated with an ALK kinase inhibitor who have experienced objective regression by RECIST, WHO, or clinical criteria and who then progress will be screened for this protocol.
Inclusion Criteria:
- ≥18 years of age
- Histologically proven diagnosis of NSCLC at MSKCC Tumor positive for a translocation or inversion event involving the ALK gene locus
- Clinical response to treatment with crizotinib as defined by either:
Radiographic partial or complete response defined by RECIST or WHO
OR:
Radiographic stable disease for at least 8 weeks
- Radiographic progression of disease amenable to biopsy while on treatment with crizotinib as defined by RECIST or WHO
- Signed informed consent
Exclusion Criteria:
- Deemed by their treating physician to be medically unfit for biopsy
- Women who are pregnant or breast-feeding
Contacts and Locations| Contact: Gregory Riely, MD, PhD | 646-888-4199 | |
| Contact: Marc Ladanyi, MD | 212-639-6369 |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Gregory Riely, PhD, MD 646-888-4199 | |
| Contact: Marc Ladanyi, MD 212-639-6369 | |
| Principal Investigator: Gregory Riely, MD, PhD | |
| Principal Investigator: | Gregory Riely, MD, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01300429 History of Changes |
| Other Study ID Numbers: | 11-014 |
| Study First Received: | February 17, 2011 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
core biopsy Resistance to Crizotinib Non-small Cell Lung Cancer 11-014 |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013