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Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network (CASTLE)

This study has suspended participant recruitment.
(interim assessment by sponsor)
Sponsor:
Collaborator:
Addario Lung Cancer Medical Institute
Information provided by (Responsible Party):
Leora Horn, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01574300
First received: March 28, 2012
Last updated: October 25, 2016
Last verified: October 2016
  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.

Condition Intervention
Non-small Cell Lung Cancer Metastatic
Small Cell Lung Carcinoma
Other: therapeutic interventions

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maintain a centralized, computerized database of all specimens [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    Database would contain uniform and complete demographic, pathologic, and clinical information

  • Facilitate integration of molecular assays and other laboratory studies with clinical patient outcomes [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Enable the discovery of novel genes and proteins related to cancer and its therapies [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    Obtain funding from National Institutes of Health based on use of the biorepository


Estimated Enrollment: 250
Study Start Date: November 2010
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Biospecimens and biofluids

This 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
Other: therapeutic interventions
All therapeutic interventions are allowed, and their details recorded and correlated with data from the collected biospecimens. Examples would include single or multiple agent chemotherapy or targeted therapeutics

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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Advanced stage lung cancer patients
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574300

Locations
United States, California
Alta Bates Summit Medical Center, The Jordan Research and Educational Institute
Berkley, California, United States, 94705
University of California, Los Angeles
Los Angeles, California, United States, 90033
University of California, Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
University of California, Davis Cancer Center
Sacramento, California, United States, 95817
University of California, Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Massachusetts
Lahey Clinic Hospital
Burlington, Massachusetts, United States, 01805
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Addario Lung Cancer Medical Institute
Investigators
Principal Investigator: Leora Horn, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Responsible Party: Leora Horn, MD, Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01574300     History of Changes
Other Study ID Numbers: THO 09110  CASTLE Study 
Study First Received: March 28, 2012
Last Updated: October 25, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt-Ingram Cancer Center:
Small Cell Lung Cancer (SCLC)
Non-Small Cell Lung Cancer (NSCLC)
M1A or B NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on December 02, 2016