Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Neoplasm Metastasis

Brain Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

This study will examine patients with non-small cell lung cancer metastasis, that is, the distant spreading of tumors to the brain, and compare them with patients without brain metastasis. The molecular and genetic events that permit tumor metastasis are not well understood. There is intense investigation going on into the process in which tumor cells escape the primary local tumor, spread to distant places in the body, and find and create conditions that promote growth in those tissues. Metastasis of tumors such as lung cancer to the brain is a common problem. Tumor cells will be analyzed with the use of microarrays. A microarray is a tool for analyzing gene expression, consisting of a small membrane or glass slide containing samples of many genes arranged in a regular pattern. The goal is to identify a potential molecular signature. It is hoped that there will be discovery of why some patients are more likely than others to develop a brain metastasis, which can have a major negative effect on the quality of life and survival.

Patients 18 years of age with known or evidence by radiology of a non-small cell lung cancer metastatic to the brain, either squamous cells or adenocarcinoma tumors, or those who have had a removal of a brain tumor for diagnosis or treatment may be eligible for this study.

Participants will undergo the following procedures and tests:

* Craniotomy, that is, surgical opening of the skull, and removal of the brain tumor.
* Blood specimens taken from a central vein or artery before the operation, throughout as needed, and for several days afterward, to measure blood chemistries, blood count, and so forth.
* Physical examination and imaging of the central nervous system before and after surgery.
* Urine or serum, or both, pregnancy test of women of childbearing potential.

Patients will also undergo blood tests at 3-month intervals after surgery for up to 5 years. The purpose is to determine if there are tumor cells in the blood, which may explain how they reached the brain.

Introduction: The molecular and genetic events that permit tumor metastasis are not well understood. The process whereby tumor cells escape the primary, local tumor, spread to distant sites in the body and find and create conditions conducive to growth in these disparate tissues remains an area of intense investigation. Metastasis of epithelial tumors, such as lung cancer, to the brain is a common problem, with significant consequences with respect to neurological dysfunction and shortening of survival.

Objective: To study two subset of patients with non small cell lung cancer (NSCLC) metastatic to the brain, to identify genes and proteins that facilitate metastasis.

Study Population: 78 patients with NSCLC (n=39 squamous cell (SQ), and n=39 adenocarcinoma (AC) tumors) metastatic to the brain to compare with published microarray studies of non-metastatic NSCLC patients with these tumor types as well as with one another to help explain the differential trend toward metastasis in some patients with NSCLC and not others, as well as the differential trend to brain metastasis in the AC subtype.

Anticipated Risks and Benefits: Less than minimal risk to the patients to sample tissue already removed from the brain as part of medically-necessary surgery and to sample blood. No direct benefit to the patient is expected.

Outcome Estimate and Potential Meaning for the Field: That this very detailed investigation of the genes and proteins expressed differentially between the non-metastatic and metastatic NSCLCs, as well as between SQ and AC subtypes will identify new or previously-unsuspected targets for new therapies to either prevent the development of brain metastasis or to treat brain metastases more effectively.

Analysis of Brain Metastasis in Patients With Lung Cancer

National Institute of Neurological Disorders and Stroke (NINDS)

Skin and Connective Tissue Diseases

Breast Neoplasms

Hyperplasia

Breast Diseases

Skin Diseases

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Anti-Infective Agents

Celecoxib

Formaldehyde

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Enzyme Inhibitors

celecoxib 400 mg BID

Carol J Fabian, MD

To assess the quantitative real time PCR results results of oligonucleotide probes for a number of gene transcription products that may be useful as predictors of indicators of response to celecoxib.

To assess the quantitative real time PCR results of oligonucleotide probes for a number of gene transcription products that may be useful as predictors or indicators of response to celecoxib, the feasibility of performing six different molecular assays by qRTPCR on formalin fixed paraffin embedded tissue obtained from breast cancer core biopsies and breast cancer reexcision patients, to assess change in Ki-67, PCNA, and several other markers by qRTPCR, correlate change in expression of Ki-67, PCNA, CAX-2, and bcl-2, measured by immunohistochemistry to change measured by qRTPCR, and to determine the reliability of the qRTPCR and immunohistochemical assays by performed selected assays on the same tissue in two different institutions

An Examination of Predictors of Indicators of Response to Celecoxib in Women Who Have a Diagnosis of Early Breast Cancer

Quantitative Real Time PCR in Formalin Fixed Breast Tissue From Biopsy and Re-Excision Specimens: An Ancillary Protocol to a Chemoprevention Trial of Celecoxib

University of Kansas

Letrozole

Aromatase Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

letrozole 2.5 mg

To assess the quantitative real time PCR results of oligonucleotide probes for a number of gene transcription products that may be useful as predictors or indicators of response to letrozole

To assess the quantitative real time PCR results of oligonucleotide probes for a number of gene transcription products (PCNA, cyclin-D1, ER alpha, PR, pS2, 450 aromatase, bcl-2, bax, caspase-3, and VEGFR) that may be useful as predictors or indicators of response to letrozole

An Examination of Predictors of Indicators of Response to Letrozole 2.5 mg

Quantitative Real Time PCR in Cytolytic Formalin Fixed Breast Cells Obtained by Periareolar Fine Needle Aspiration. An Ancillary Protocol to a Chemoprevention Trial of Letrozole

This study will examine two subsets of patients with breast cancer metastasis, that is, spreading, to the brain. It will identify genes and proteins that promote metastasis, particularly in women who are found to over-express (have more than other people do) the human epidermal growth factor receptor, ErbB2, also known as HER-2. The molecular and genetic events that permit tumor metastasis are not well understood. There is intense investigation going on into the process in which tumor cells escape the primary local tumor, spread to distant places in the body, and find and create conditions that promote growth in those tissues. Metastasis of tumors such as breast cancer to the brain is a common problem. Tumor cells will be analyzed with the use of microarrays. A microarray is a tool for analyzing gene expression, consisting of a small membrane or glass slide containing samples of many genes arranged in a regular pattern. The goal is to identify a potential molecular signature. It is hoped that there will be discovery of why some patients are more likely than others to develop a brain metastasis, which can have a major negative effect on the quality of life and survival.

Female patients 18 years of age with known or evidence by radiology of a breast tumor metastatic to the brain or those who have had a removal of a brain tumor for diagnosis or treatment may be eligible for this study.

Participants will undergo the following procedures and tests:

* Craniotomy, that is, surgical opening of the skull, and removal of the brain tumor.
* Blood specimens taken from a central vein or artery before the operation, throughout as needed, and for several days afterward, to measure blood chemistries, blood count, and so forth.
* Physical examination and imaging of the central nervous system before and after surgery.
* Urine or serum, or both, pregnancy test of women of childbearing potential.

Patients will also undergo blood tests at 3-month intervals after surgery for up to 5 years. The purpose is to determine if there are tumor cells in the blood, which may explain how they reached the brain.

Introduction: The molecular and genetic events that permit tumor metastasis are not well understood. The process whereby tumor cells escape the primary, local tumor, spread to distant sites in the body and find and create conditions conducive to growth in these disparate tissues remains an area of intense investigation. Metastasis of epithelial tumors, such as breast cancer, to the brain is a common problem, with significant consequences with respect to neurological dysfunction and shortening of survival.

Objective: To study two subset of patients with breast cancer metastatic to the brain, to identify genes and proteins that facilitate metastasis, particularly in women who over-express the growth factor receptor HER2, in which an increased risk of brain metastasis has recently been identified.

Study Population: 78 patients with breast cancer metastatic to the brain (39 women whose tumors are HER2-(-) and 39 women whose tumors are HER2-(+)) to compare with published microarray studies of non-metastatic breast cancer patients with these tumor types as well as with one another to help explain the differential trend toward metastasis in patients treated with Herceptin, a new therapy directed at HER-2 over-expressing tumors.

Anticipated Risks and Benefits: Less than minimal risk to the patients to sample tissue already removed from the brain as part of medically-necessary surgery and to sample blood. No direct benefit to the patient is expected.

Outcome Estimate and Potential Meaning for the Field: That this very detailed investigation of the genes and proteins expressed differentially between the non-metastatic and metastatic breast cancers, as well as between HER2-(-) and HER2-(+) subtypes will identify new or previously-unsuspected targets for new therapies to either prevent the development of brain metastasis or to treat these brain metastases more effectively.

Analysis of Brain Metastasis in Patients With Breast Cancer, With and Without Over-Expression of HER-2

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

This study will examine prostate tumor tissue cultures to try to identify genetic abnormalities that contribute to the cause or progression of the disease.

Patients with prostate cancer enrolled in the National Cancer Institute protocol 97-C-0147 (Collection of Serum and Tissue Samples from Patients with Biopsy-Proved or Suspected Malignant Disease) may be eligible for this study.

Specimens for tissue culture for this study will be obtained from tumors surgically removed from patients participating in NCI protocol 97-C-0146.

The findings of this study may lead to better methods of predicting the course of disease in individual patients.

Prostate cancer is the most common solid tumor in American males and the most common malignancy among men in Western industrialized countries. Widespread testing for early detection of prostate cancer utilizing digital rectal examination and prostate specific antigen (PSA) has led to a significant clinical conundrum. Differentiating organ confined indolent disease from aggressive cancer has been imperfect. Nonetheless, increased detection has led to increased radical prostatectomies. A prevailing goal of the contemporary, ardent research seeks to discover a molecular biomarker for prognostication.

Given the limitations of the current knowledge of the molecular pathology of prostate cancer, there are several viewpoints regarding the process of tumorigenesis. However, a generally accepted hypothetical model describes normal prostatic epithelium progressing to a pre-malignant or low-grade prostatic intraepithelial neoplasia (PIN). Then, after further genetic alterations, a succession of histologically apparent adenocarcinoma--first confined, then metastatic, and finally refractory to hormone treatment ensues. Current molecular research has shown already complex genetics alterations at the high-grade prostatic intraepithelial neoplasia stage. Thus, invasive disease represents amplification or further aberration of precursor events. The seminal event or events have not been recognized and the undiscovered tumor suppressor gene or proto-oncogene may be a principal tumor marker.

The purpose of this study is to identify specific, shared, consistent, chromosomal rearrangements found in metaphase preparations for short-term cultures of pathologically identified and scored primary prostate tumors. These, tumor specimens will be obtained from patients enrolled in protocol (97-C-0147) by the NCI. Fresh tumor, taken from bi-valved specimens with one half undergoing tissue pathology, will be immediately placed in growth media and transferred as a coded specimen as a sample from patients selected and enrolled in protocol (97-C-0147). Informed consent will be obtained by participating investigators in the NCI protocol. The outcome measurement will be the characterization, or failure of characterization, of specific, shared consistent, chromosomal rearrangements. Current molecular cytogenetics technologies, primarily utilizing chromosomal microdissection, will be employed toward this goal. Ultimately, this research may help to focus further molecular studies towards the ultimate goal of finding a unique, cancer specific alteration.

Analysis of Prostate Cancer Short-Term Cultures Using Molecular Cytogenetic Methods

Analysis of Prostate Cancer Short-Term Cultures Utilizing Molecular Cytogenetic Methods

National Human Genome Research Institute (NHGRI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Analysis of Brain Metastasis in Patients With Lung Cancer	NCT00071344	Carcinoma, Non-...		-	National Institutes of Health Clinical Center (CC)
An Examination of Predictors of Indicators of Response to Celecoxib in Women Who Have a Diagnosis of Early Breast Cancer	NCT00291122	Breast Cancer	celecoxib 400 m...	18 Years -	University of Kansas Medical Center
An Examination of Predictors of Indicators of Response to Celecoxib in Women Who Have a Diagnosis of Early Breast Cancer	NCT00291122	Breast Cancer	celecoxib 400 m...	18 Years -	University of Kansas Medical Center
An Examination of Predictors of Indicators of Response to Letrozole 2.5 mg	NCT00291109	Breast Cancer	letrozole 2.5 m...	18 Years -	University of Kansas Medical Center
Analysis of Brain Metastasis in Patients With Lung Cancer	NCT00071344	Carcinoma, Non-...		-	National Institutes of Health Clinical Center (CC)
Analysis of Brain Metastasis in Patients With Breast Cancer, With and Without Over-Expression of HER-2	NCT00071383	Breast Neoplasm...		-	National Institutes of Health Clinical Center (CC)
Analysis of Brain Metastasis in Patients With Breast Cancer, With and Without Over-Expression of HER-2	NCT00071383	Breast Neoplasm...		-	National Institutes of Health Clinical Center (CC)
Analysis of Prostate Cancer Short-Term Cultures Using Molecular Cytogenetic Methods	NCT00022919	Prostate Cancer		-	National Institutes of Health Clinical Center (CC)
Analysis of Prostate Cancer Short-Term Cultures Using Molecular Cytogenetic Methods	NCT00022919	Prostate Cancer		-	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for microdissection