Clinical trial NCT03497624: ALCMI-006: A Prospective Biospecimen Collection Study From Patients With ROS1-Fusion Positive Tumors
Official title: ALCMI-006: A Prospective Biospecimen Collection Study From Patients With ROS1-Fusion Positive Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ROS1-fusion Positive Tumor
Lead sponsor: Addario Lung Cancer Medical Institute
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults diagnosed with a ROS1-fusion positive cancer.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary objective is to develop a unique cohort of PDX models for ROS1-fusion driven cancers as a resource to the research community.
timeFrame: 1 year
Secondary outcomes:
measure: The secondary/exploratory objectives are to enhance scientific knowledge of how to diagnose and treat ROS1-fusion driven cancers.
timeFrame: 24 months
Other outcomes:
Locations:
city: San Carlos
country: United States
facility: ALCMI
state: California
Study officials:
affiliation: Vanderbilt University Medical Center
name: Christine Lovly, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: