Clinical Trials /

Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network

NCT01574300

Description:

The purpose of this study is to facilitate application of the known biomarkers to patients presenting today, and to establish a collection of biospecimens that will be useful for discovering and validating new biomarkers for future use.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
  • Small Cell Lung Carcinoma
Recruiting Status:

Terminated

Trial Eligibility

Document

Title

  • Brief Title: Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network
  • Official Title: Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network

Clinical Trial IDs

  • ORG STUDY ID: VICC THO 09110
  • SECONDARY ID: CASTLE Study
  • NCT ID: NCT01574300

Conditions

  • Non-small Cell Lung Cancer Metastatic
  • Small Cell Lung Carcinoma

Purpose

The purpose of this study is to facilitate application of the known biomarkers to patients presenting today, and to establish a collection of biospecimens that will be useful for discovering and validating new biomarkers for future use.

Detailed Description

      Because of the historically poor outcomes of lung cancer patients, suboptimal therapeutic
      efficacy, and significant side effects of chemotherapy, and the need to choose more
      efficacious treatment regimens, and patients most likely to benefit from them, there is a
      need to predict a priori whether an individual patient's tumor will respond to a particular
      therapeutic agent. However, virtually all lung cancer tumor samples available today are from
      resection specimens so direct, intra-patient molecular-clinical therapy correlations are
      impossible.

      Without the critical mass of tissue and data necessary to identify optimal molecular targets
      for lung cancer and drugs active against these targets, new discoveries that offer the only
      hope of long-term survival for many lung cancer patients remain elusive.

      This study facilitates the collection of biospecimens from advanced lung cancer patients and
      routine determination of a panel of documented clinically significant biomarkers. In
      addition, it will centrally integrate and standardize research tissue samples with
      corresponding proteomic, genomic, molecular and clinical data across a multitude of
      institutions and oncology networks
    

Trial Arms

NameTypeDescriptionInterventions
Biospecimens and biofluidsThis is a multi-cohort parallel study in which tumor, plasma and serum samples will be collected prior to the start of any therapeutic intervention for stage IV lung cancer. These biospecimens will be correlated with treatment and clinical data and distributed for peer reviewed research purposes to academic and community centers in the U.S. and Europe. The biospecimens collected in CASTLE will be analyzed for a panel of biomarkers, currently including: tumor: epidermal growth factor receptor (EGFR), KRAS (Kirsten RAt Sarcoma) gene and EML4-ALK (echinoderm microtubule-associated protein-like 4 - anaplastic lymphoma kinase) translocations, and EGFR, TS (thymidylate synthase), ERCC1 (excision repair cross-complementing 1) and RRM1 (Ribonucleotide Reductase, M1 Subunit) gene expressions serum: proteomics predictive for EGFR-TKI (tyrosine kinase inhibotors)response

    Eligibility Criteria

            Inclusion Criteria:
    
              -  M1A or B NSCLC with any number of prior therapies or any stage Small cell Lung Cancer
                 (SCLC) with any number of prior therapies
    
              -  Planned systemic therapy (i.e. intent to treat)
    
              -  Provision of written informed consent for biospecimen storage, broad genetic and
                 proteomic analysis of tumor and normal tissues, without restrictions, AND correlation
                 with outcome data
    
              -  Aged 18 years and over.
    
              -  Measurable or evaluable disease.
    
              -  ECOG performance status of 0-2 with expected survival of at least 3 months.
    
              -  Tumor specimens:
    
              -  Tumor specimens:
    
              -  4.7.1 First Priority: availability of a minimum of a 1 X 10 mm core fresh frozen
                 tumor, or ≥3 mm diameter spherical pellet from a pleural effusion (≥50% tumor cells),
                 or ≥3 mm diameter spherical pellet from a fine needle aspirate (≥50% tumor cells) from
                 clinically indicated interventional procedures, with no systemic anti-cancer therapy
                 or radiation to all sites of evaluable disease between collection of the biopsy and
                 entry into the study (e.g. if a brain metastasis was radiated but the lung tumor was
                 not, then the latter could still be biopsied and the subject enrolled after radiation
                 therapy of the brain metastasis (and vice versa)).
    
            or
    
              -  Second Priority: availability of paraffin-embedded tumor (via biopsies or pleural
                 effusions) at least 5 X 5 mm (3 X 3 mm for pleural effusions) cross-sectional tumor
                 area, with no systemic anti-cancer therapy or radiation to all sites of evaluable
                 disease between collection of the biopsy and entry into the study; the collection of
                 the paraffin-embedded tissues may have taken place up to 12 months prior to enrollment
                 in CASTLE.
    
              -  Willingness to undergo all study collection procedures and sample analyses including
                 prerequisite baseline molecular testing via ResponseDX: Lung (Response Genetics Inc.)
                 and VeriStrat (Biodesix) - see 6.3 below for details.
    
              -  Exclusion criteria
    
              -  Other co-existing malignancies except for basal cell carcinoma or cervical cancer in
                 situ.
    
              -  Compromise of patient diagnosis or staging if tissue is harvested for research
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Collect, process, store, and distribute for peer-reviewed research studies tumor-related and normal biospecimens from advanced stage lung cancer patients
    Time Frame:7 years
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Maintain a centralized, computerized database of all specimens
    Time Frame:7 years
    Safety Issue:
    Description:Database would contain uniform and complete demographic, pathologic, and clinical information
    Measure:Facilitate integration of molecular assays and other laboratory studies with clinical patient outcomes
    Time Frame:7 years
    Safety Issue:
    Description:
    Measure:Enable the discovery of novel genes and proteins related to cancer and its therapies
    Time Frame:7 years
    Safety Issue:
    Description:Obtain funding from National Institutes of Health based on use of the biorepository

    Details

    Phase:
    Primary Purpose:Observational
    Overall Status:Recruiting
    Lead Sponsor:Addario Lung Cancer Medical Institute

    Trial Keywords

    • Small Cell Lung Cancer (SCLC)
    • Non-Small Cell Lung Cancer (NSCLC)
    • M1A or B NSCLC

    Last Updated