Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01574300
Other study ID # VICC THO 09110
Secondary ID CASTLE Study
Status Terminated
Phase
First received
Last updated
Start date November 2010
Est. completion date March 1, 2019

Study information

Verified date January 2020
Source Addario Lung Cancer Medical Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Terminated
Enrollment 136
Est. completion date March 1, 2019
Est. primary completion date March 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Addario Lung Cancer Medical Institute

Outcome

Type Measure Description Time frame Safety issue
Primary Collect, process, store, and distribute for peer-reviewed research studies tumor-related and normal biospecimens from advanced stage lung cancer patients 7 years
Secondary Maintain a centralized, computerized database of all specimens Database would contain uniform and complete demographic, pathologic, and clinical information 7 years
Secondary Facilitate integration of molecular assays and other laboratory studies with clinical patient outcomes 7 years
Secondary Enable the discovery of novel genes and proteins related to cancer and its therapies Obtain funding from National Institutes of Health based on use of the biorepository 7 years
See also
  Status Clinical Trial Phase
Recruiting NCT05882058 - DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers Phase 2
Terminated NCT03963414 - A Study of Durvalumab Plus Tremelimumab With Chemotherapy in Untreated ES-SCLC Phase 1
Active, not recruiting NCT04358237 - Lurbinectedin (PM01183) Combined With Pembrolizumab in Small Cell Lung Cancer. Phase 1/Phase 2
Not yet recruiting NCT06419179 - Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in HRD Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC) Phase 2
Completed NCT02874664 - A Study of Rovalpituzumab Tesirine to Study Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer Phase 1
Completed NCT02397733 - Memory Preservation of Prophylactic Cranial Irradiation With Hippocampal Avoidance (PREMER-TRIAL) N/A
Recruiting NCT01977235 - Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer Phase 2
Completed NCT00759824 - A Phase II Study of Doxorubicin, Cyclophosphamide and Vindesine With Valproic Acid in Patients With Refractory or Relapsing Small Cell Lung Cancer After Platinum Derivatives and Etoposide Phase 2
Active, not recruiting NCT03568097 - Immunotherapy in Combination With Chemotherapy in Small-cell Lung Cancer Phase 2
Withdrawn NCT02876081 - Phase II Study of Afatinib as Third- or Further-line Treatment for Patients With Stage IV Bronchial Adenocarcinoma, Harboring Wild-type EGFR, Expressing the Neurotensin - Neurotensin Receptor Complex Phase 2
Recruiting NCT06247605 - A Phase IIII Study of AL8326 in Small Cell Lung Cancer Phase 3
Recruiting NCT04996771 - Surufatinib Combined With Chemotherapy Plus Toripalimab or Not in the Treatment of Small Cell Lung Cancer Phase 1/Phase 2
Terminated NCT03662074 - Subsequent Line Gemcitabine and Nivolumab in Treating Participants With Metastatic Small Cell Lung Cancer Phase 2
Completed NCT03232593 - A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s)
Completed NCT01941316 - Study of Carfilzomib With Irinotecan in Irinotecan-Sensitive Malignancies and Small Cell Lung Cancer Patients Phase 1/Phase 2
Recruiting NCT06131840 - A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors Phase 1
Recruiting NCT05683977 - A French Real-life Study: EvaluatioN of durvALumab Utilization and Effectiveness for First Line Extensive Stage Small Cell Lung Cancer.
Recruiting NCT04620837 - Tislelizumab in Combination With Anlotinib With ES-SCLC as Maintenance Therapy After First Line Chemotherapy Phase 2
Recruiting NCT05329623 - A Phase 1 Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Hepatic Impairment Compared to Matched Healthy Control Participants. Phase 1
Active, not recruiting NCT04902872 - Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors Phase 1/Phase 2