Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Study of Patients With Non-Small Cell Lung Cancer, Esophageal Cancer, Malignant Pleural Mesothelioma, Mediastinal or Chest Wall Neoplasms, or Lung Metastases from Cancers of Non-Thoracic Origin

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Biomarker/Laboratory analysis, Diagnostic, Tissue collection/Repository	Active	Any age	NCI	NCI-06-C-0014 NCI-P6650, NCT00447447

Special Category: NIH Clinical Center trial

Objectives

1. Evaluate patients referred to the Thoracic Oncology Section of the Surgery Branch, NCI in order to identify patients who are suitable candidates for clinical research protocols.
2. Obtain biopsies during staging studies of tumor and adjacent normal tissues as well as serum and urine samples from patients with primary aerodigestive tract malignancies to support preclinical research endeavors in the Thoracic Oncology Section.
3. Permit standard treatment for patients who are not eligible for investigational therapy on a current Thoracic Oncology protocol, but who present a novel and unique clinical training opportunity, or who manifest a clinical condition that requires immediate intervention to prevent compromise to the patient's well-being.
4. Permit long-term follow up of patients with thoracic malignancies, including the collection of tissue and fluids to support preclinical research, particularly to ascertain if gene expression and DNA methylation profiles coincide with response to therapy.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed or radiographic evidence of primary non-small cell lung cancer, esophageal cancer, malignant pleural mesothelioma, mediastinal or chest wall neoplasms, or pulmonary metastases from cancers of non-thoracic origin
• Intracranial metastases potentially treatable with surgery and/or radiotherapy allowed

Prior/Concurrent Therapy:

• Not specified

Patient Characteristics:

• ECOG performance status 0-2
• ANC ≥ 1,000/mm³
• Platelet count ≥ 75,000/mm³
• PT ≤ 16 OR INR ≤ 2
• Creatinine < 2.5 g/dL
• Bilirubin ≤ 2 times upper limit of normal

Expected Enrollment

A total of 375 patients will be accrued for this study.

Outcomes

Identification of patients who are suitable candidates for clinical research protocols
Biopsies

Outline

This is a prospective study.

Patients undergo bronchoscopy. Tumor tissue and normal tissue are collected via endoscopy, fine-needle aspiration, core-needle techniques, or single-port site thoracoscopic methods. Biopsies are examined for gene expression and DNA methylation analysis. Blood and urine are also collected.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

David Schrump, MD, Protocol chair		Ph: 301-496-2127 Email: david_schrump@nih.gov

U.S.A.
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937

Related Information

Web site for additional information

Registry Information
Official Title		Prospective Evaluation of Epigenetic Alterations in Patients with Lung and Esophageal Cancers and Malignant Pleural Mesotheliomas
Trial Start Date		2005-11-16
Registered in ClinicalTrials.gov		NCT00447447
Date Submitted to PDQ		2005-10-20
Information Last Verified		2008-11-03

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