Protocol Number: 06-C-0014

Title:

Prospective Evaluation of Epigenetic Alterations in Patients with Thoracic Malignancies

Number:

06-C-0014

Summary:

Background:

-Chromatin is is the structural building block of a chromosome. It is found inside the nucleus of the cell and consists of a complex of DNA and protein.

-Cancers of the lung, pleura (lung lining) and esophagus show profound changes in chromatin structure that may affect the course of disease in patients.

-A better understanding of these diseases and the genetic changes associated with them may be helpful in developing new treatments for them.

Objectives:

-To evaluate people with cancer of the lung, pleura or esophagus for participation in NCI clinical trials.

-To obtain biopsies (small pieces of tissue) from tumor, normal tissue and blood samples to learn more about the cellular changes in blood and tissue in tumors of the lung, esophagus and pleura and surrounding structures in the chest.

Eligibility: Patients 18 years of age and older with cancer of the lung, esophagus, pleura, mediastinum or chest wall, or cancers of other origin that have invaded the lung.

Design:

-Up to 375 patients may be included in this study.

-Patients undergo standard tests for evaluating the stage of their disease and for determining eligibility for an NCI investigational treatment study.

-All patients undergo bronchoscopy and bronchoalveolar lavage ("washing" with salt water) to assess their tumor and collect a sample of normal tissue. Patients whose tumor is located on the outside portion of the lung may also undergo thoracoscopy to obtain a tumor sample. For bronchoscopy and bronchoalveolar lavage a tube with a light is passed through the nose or mouth into the lungs to examine the airways. Salt water is injected through the tube and then withdrawn to obtain cells for laboratory studies. For the thoracoscopy a small tube with a light is put through a small hole in the chest to obtain the tumor sample. Both procedures are usually done under general anesthesia. The tissue is examined to identify cell characteristics of people who respond to certain therapies and to identify markers on the surface of the tissue that may be useful in future research and treatment.

-Blood and urine samples are collected from patients.

-Patients who are eligible for a treatment study at NCI are offered participation in the study.

-Patients for whom standard surgery, radiation or chemotherapy is more appropriate may receive treatment at NCI or with their own physician.

-Patients who receive treatment at NCI return for follow-up examinations 4 weeks after discharge and then every 2 to 4 months depending on the nature of their cancer.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

Patients with radiographic evidence of, or histologically/cytologically proven, lung cancers or esophageal cancers, malignant pleural mesotheliomas, mediastinal or chest wall neoplasms, or pulmonary metastases from cancers of non-thoracic origin, are eligible for evaluation.

Patients with concomitant intracranial metastases, which are potentially treatable by surgery and/or radiation therapy are eligible for study.

Patients must have an ECOG performance score of 0-2.

Patients must be 18 years of age or older. Patients under 18 years of age may participate if the tissue acquisition is performed during a clinically indicated surgical procedure, and the sampling of tissue, blood and urine does not add risk to the clinically indicated procedures.

Patients must have coagulation parameters within acceptable limits by standard of practice guidelines prior to biopsy.

Patients must be aware of the neoplastic nature of his/her illness. The patient or parent must be willing to sign an Informed Consent, and undergo endoscopic biopsies of tumor and adjacent normal tissues, and provide blood (30cc) and urine(100cc) samples to support ongoing laboratory research endeavors pertaining to the thoracic malignancies.

EXCLUSION CRITERIA:

Candidates who do not meet the inclusion criteria

Special Instructions:

Currently Not Provided

Keywords:

Lung Cancers

Esophageal Cancer

Malignant Pleural Mesothelioma

Biopsy

Staging Studies

Recruitment Keyword(s):

Lung Cancer

Esophageal Cancer

Malignant Pleural Mesothelioma

Condition(s):

Thoracic Malignancy

Lung Cancer

Esophageal Cancer

Malignant Pleural Mesothelioma

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Schrump DS, Waheed I. Strategies to circumvent SV40 oncoprotein expression in malignant pleural mesotheliomas. Semin Cancer Biol. 2001 Feb;11(1):73-80. Review.

Schrump DS, Nguyen DM. Targeting the epigenome for the treatment and prevention of lung cancer. Semin Oncol. 2005 Oct;32(5):488-502.

Hong JA, Kang Y, Abdullaev Z, Flanagan PT, Pack SD, Fischette MR, Adnani MT, Loukinov DI, Vatolin S, Risinger JI, Custer M, Chen GA, Zhao M, Nguyen DM, Barrett JC, Lobanenkov VV, Schrump DS. Reciprocal binding of CTCF and BORIS to the NY-ESO-1 promoter coincides with derepression of this cancer-testis gene in lung cancer cells. Cancer Res. 2005 Sep1;65(17):7763-74.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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