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

Stopped early · Not applicable

Conditions studied: Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT02297087

Run by

Western Regional Medical Center

People needed

12

Starts

2014-10-01

Expected to finish

2017-10-01

Last updated by the study team

2017-11-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Cancer Treatment Center of America @ Western Regional Medical Center — Goodyear, Arizona, United States

Full record on ClinicalTrials.gov

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