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

NCT02297087 | Terminated

• 1 other identifier: gweiss 13-007
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

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

  28 Days

Study Arms (1)

Pilot

OTHER

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

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

Interventions

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

Pilot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Western Regional Medical Center: lead

Study Sites (1)

Cancer Treatment Center of America @ Western Regional Medical Center

Goodyear, Arizona, 85338, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Glen Weiss, MD

  Western Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 21, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11

Locations

US (1)