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Next-generation Sequencing of Small Cell Lung Cancer to Identify Actionable Targets for Treatment

Primary Purpose

Small Cell Lung Cancer

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard of care based on target(s) identified via GWS.

About this trial

This is an interventional diagnostic trial for Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must understand the rigors of the study and provide written informed consent and HIPAA authorization prior to initiation of any study procedures
Life expectancy > 3 months
Karnofsky Performance Status ≥ 70
Diagnosis of histological or cytologically confirmed advanced, incurable SCLC, which has progressed on one or more prior chemotherapeutic, hormonal, or biological regimens for advanced SCLC
Age ≥ 18 years
Adequate organ and bone marrow function, defined as: Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 x 109/L; hemoglobin > 9 g/dL; platelets > 100 x 109/L Renal: creatinine clearance ≥ 50 mL/min (calculated according to Cockroft and Gault) or creatinine ≤ 1.5 mg/dL Hepatic: bilirubin ≤ 1.5 x the upper limit of normal (ULN); aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases); internation normalized value for prothrombin time (INR) ≤ 1.5 x ULN (except in the case of anticoagulation therapy), albumin ≥ 2.0
Good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy.

Exclusion Criteria:

Symptomatic CNS metastasis. Patients with a history of CNS metastases, who have been treated, must be stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for ≥ 2 weeks prior to enrollment
Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
Known HIV, HBV, or HCV infection requiring antiviral therapy.
Pregnant or breastfeeding patients or any patient of childbearing potential not using adequate contraception.
Tumor inaccessible for biopsy

Sites / Locations

Cancer Treatment Center of America @ Western Regional Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pilot

Arm Description

Obtain the necessary tumor biopsies to yield sufficient DNA and RNA for Genome-Wide Sequencing (GWS).

Outcomes

Primary Outcome Measures

amount of DNA and RNA obtained from tumor biopsies and if can perform Genome-Wide Sequencing (GWS).

Secondary Outcome Measures

Full Information

NCT ID

NCT02297087

First Posted

November 14, 2014

Last Updated

November 7, 2017

Sponsor

Western Regional Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02297087

Brief Title

Next-generation Sequencing of Small Cell Lung Cancer to Identify Actionable Targets for Treatment

Official Title

Next-generation Sequencing of Small Cell Lung Cancer to Identify Actionable Targets for Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Terminated

Why Stopped

PI no longer at site and he does

Study Start Date

October 2014 (Actual)

Primary Completion Date

October 2017 (Actual)

Study Completion Date

October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Western Regional Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Aim 1 - Launch Pilot Study. In this aim, the investigators seek to launch a pilot study and enroll 12 eligible patients with advanced small cell lung cancer (SCLC) and to obtain the necessary tumor biopsies to yield sufficient DNA and RNA for Genome-Wide Sequencing (GWS). Aim 2 - Treatment Selection. Completion of this study aim will provide a new clinical paradigm in the treatment of SCLC such that each individual patient would be treated with a single-agent or combination therapy of commercially available agents that relates to particular target(s) that have been identified via GWS.

Detailed Description

Participants will be consented into the study after they are found to meet the study inclusion criteria. The clinical staff will schedule a tissue biopsy and a blood draw for the participant. Blood will be sent to Ashion for DNA extraction. Tumor specimens will be shipped to Ashion for DNA and RNA extraction. Ashion will process the samples for DNA and RNA Sequencing in their CLIA certified laboratory. A portion of the nucleic acid will be stored in Ashion and used to confirm actionable targets. Results will be submitted to the physician for possible inclusion in the treatment regimen. After sequencing analysis has been performed, a report will be provided to the treating oncologist. The PI and the treating oncologist may review the results to identify potential treatment. The treating oncologist may use this information at their discretion, and is not required to treat the patient based on the targets identified by the GWS analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

This study is testing the specimens for genomic results. There are no other interventions.

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pilot

Arm Type

Other

Arm Description

Obtain the necessary tumor biopsies to yield sufficient DNA and RNA for Genome-Wide Sequencing (GWS).

Intervention Type

Genetic

Intervention Name(s)

Standard of care based on target(s) identified via GWS.

Primary Outcome Measure Information:

Title

amount of DNA and RNA obtained from tumor biopsies and if can perform Genome-Wide Sequencing (GWS).

Time Frame

28 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must understand the rigors of the study and provide written informed consent and HIPAA authorization prior to initiation of any study procedures Life expectancy > 3 months Karnofsky Performance Status ≥ 70 Diagnosis of histological or cytologically confirmed advanced, incurable SCLC, which has progressed on one or more prior chemotherapeutic, hormonal, or biological regimens for advanced SCLC Age ≥ 18 years Adequate organ and bone marrow function, defined as: Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 x 109/L; hemoglobin > 9 g/dL; platelets > 100 x 109/L Renal: creatinine clearance ≥ 50 mL/min (calculated according to Cockroft and Gault) or creatinine ≤ 1.5 mg/dL Hepatic: bilirubin ≤ 1.5 x the upper limit of normal (ULN); aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases); internation normalized value for prothrombin time (INR) ≤ 1.5 x ULN (except in the case of anticoagulation therapy), albumin ≥ 2.0 Good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy. Exclusion Criteria: Symptomatic CNS metastasis. Patients with a history of CNS metastases, who have been treated, must be stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for ≥ 2 weeks prior to enrollment Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent Known HIV, HBV, or HCV infection requiring antiviral therapy. Pregnant or breastfeeding patients or any patient of childbearing potential not using adequate contraception. Tumor inaccessible for biopsy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Glen Weiss, MD

Organizational Affiliation

Western Regional Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Treatment Center of America @ Western Regional Medical Center

City

Goodyear

State/Province

Arizona

ZIP/Postal Code

85338

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Next-generation Sequencing of Small Cell Lung Cancer to Identify Actionable Targets for Treatment

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