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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03497624
Other study ID # ALCMI-006
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 23, 2018
Est. completion date March 2022

Study information

Verified date July 2018
Source Addario Lung Cancer Medical Institute
Contact Alicia Sable-Hunt, RN,MBA,CCRA
Phone 866-988-7671
Email asable-hunt@alcmi.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patient Derived Xenografts (PDXs) are models to study tumor growth, response to anti-cancer therapies, and resistance to anti-cancer therapies. The purpose of this study is to develop up to 24 PDX models for ROS1-fusion driven cancers to be used for research purposes only. That is, these patient derived PDX models will have no immediate benefit to the patient from whom the tumor specimen was obtained. Rather, these PDX models will be used to inform the study of ROS1-fusion driven cancers at large.


Description:

ROS1-fusions occur in several cancer types such as non-small cell lung cancer, gastric cancer, ovarian cancer, glioblastoma, cholangiocarcinoma and melanoma. In each of these cancers, ROS1-fusions account for a small sliver of the pie, accounting for 1-2% of all diagnoses, forming a relatively rare molecular subset of cancer. The Addario Lung Cancer Medical Institute (ALCMI) would like to focus on this under-studied rare molecular subset of cancer to understand how cancer begins and spreads in these tumors, how these tumors respond to treatment and what happens when tumors stop responding to treatment. Therefore, in collaboration with cancer patients whose tumors have ROS1-fusions (known as the "ROS1ders"), we are studying ROS1-fusions across all cancer types.

Patient Derived Xenografts (PDXs) are models to study cancer. These models are developed by injecting a fresh piece of tumor specimen from a patient into a special type of mouse, which then acts as 'host' to allow the tumor to grow. Peer-reviewed and published experimental studies have shown that PDX models can maintain features similar to the original tumor from the patient. PDX models can be used to study tumor growth, response to anti-cancer therapies, and resistance to anti-cancer therapies.

The purpose of this study is to develop up to 24 PDX models for ROS1-fusion driven cancers to be used for research purposes only. That is, these patient derived PDX models will have no immediate benefit to the patient from whom the tumor specimen was obtained. Rather, these PDX models will be used to inform the study of ROS1-fusion driven cancers at large.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 2022
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Male or female greater than 18 years of age at the time of consent.

2. Confirmed diagnosis of ROS1-fusion positive tumor via IHC, FISH and/or NGS.

3. A clinically-indicated procedure (required by the patient's treating physician) scheduled no more than 30 calendar days from date of consent.

4. A minimum of 21 calendar days between the last dose of systemic therapy and the clinically-indicated procedure.

5. A minimum of 42 hours between the last dose of a tyrosine kinase inhibitor (TKI) and the time of the clinically-indicated procedure.

6. Willingness to undergo all study collection procedures and follow up.

7. Provision of written informed consent by the patient.

8. Able to communicate (read, write and speak) in English.

9. Clinically-indicated procedure to be performed within the US (including Alaska, Hawaii and Puerto Rico), Canada, England, or Israel.

Exclusion Criteria:

1. Less than 18 years of age at time of consent.

2. No confirmed diagnosis of ROS1-fusion positive tumor via IHC, FISH and/or NGS.

3. A biopsy or surgical procedure not scheduled for clinical/diagnostic purposes.

4. A clinically-indicated procedure scheduled more than 30 calendar days from the date of consent.

5. Receipt of systemic therapy less than 21 days from the time of the clinically-indicated procedure.

6. Receipt of tyrosine kinase inhibitor less than 42 hours from the time of the clinically-indicated procedure.

7. Unwilling to undergo all study collection procedures and follow up.

8. Unable or unwilling to provide consent.

9. Unable to communicate in English.

10. Clinically-indicated procedure not scheduled within the US, Canada, England, or Israel.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Biospecimens collection
Collection of tumor tissue when a participant is having a clinically-indicated biopsy or surgery for their ROS1-fusion cancer.

Locations

Country Name City State
United States ALCMI San Carlos California

Sponsors (1)

Lead Sponsor Collaborator
Addario Lung Cancer Medical Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary objective is to develop a unique cohort of PDX models for ROS1-fusion driven cancers as a resource to the research community. Successful generation of at least ten (10), but no more than twenty-four (24), ROS1-fusion PDX models with full characterization including whole exome sequencing (WES) and RNA sequencing. Models can be used as a resource for clinical and translational research to understand mechanisms of resistance and develop new therapies. 1 year
Secondary The secondary/exploratory objectives are to enhance scientific knowledge of how to diagnose and treat ROS1-fusion driven cancers. These models will be made available to researchers to enhance scientific knowledge of how to diagnose and treat ROS1-fusion driven cancers. 24 months