TerminatedNot applicableNCT02297087

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

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.

Checked against the public recordLast updated Nov 9, 2017 · Source: ClinicalTrials.gov

StatusTerminated
PhaseNot applicable
U.S. locations1
SponsorWestern Regional Medical Center
01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Not applicable
Sponsor
Western Regional Medical Center
Interventions being studied
Genetic: Standard of care based on target(s) identified via GWS.
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Cancer Treatment Center of America @ Western Regional Medical CenterGoodyear, Arizona

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 9, 2017. Always confirm current availability with the study team.

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