Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Carcinoma in Situ

Carcinoma, Lobular

Breast Carcinoma In Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Breast Diseases

Skin Diseases

gene expression analysis

molecular diagnostic method

polymorphism analysis

protein expression analysis

medical chart review

questionnaire administration

Contact Person

Elinor Sawyer, MD

Rebecca Roylance, MD

RATIONALE: Gathering information about genetic changes in patients with lobular carcinoma in situ of the breast may help doctors learn more about the disease and find better methods of treatment.

PURPOSE: This clinical trial is studying the genetics of women with lobular carcinoma in situ of the breast.

OBJECTIVES:

Primary

* Identify inherited variation that predisposes women to develop lobular carcinoma in situ (LCIS) of the breast.
* Identify the frequency of these variants and determine the effect they have on tumor risk.
* Determine how worthwhile it would be to test for these variants in the clinical setting so that those at higher risk could be identified, counseled, and screened.

Secondary

* Analysis of genetic changes within LCIS with the aim of identifying cases of LCIS which may progress to invasive cancer.

OUTLINE: Patients and control participants undergo blood collection. DNA is extracted from blood samples and used to genotype at selected polymorphisms, compare allele frequencies (used to associate alleles with disease) using a genome-wide single nucleotide polymorphism (SNP) screen. Archival tumor samples (if available) from patients are used for DNA-, RNA-, or protein-based analyses.

All participants complete a questionnaire about family history, a brief medical history, and provide epidemiological data to a genetic counselor. Participants identified to be at risk for known hereditary predisposition to cancer will be referred to a clinical genetics service. Individual results of this study are not disclosed to participants.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

PROJECTED ACCRUAL: A total of 2,000 participants (1,000 patients and 1,000 matched controls) will be accrued for this study.

Genetics of Women With Lobular Carcinoma in Situ of the Breast

GLACIER: A Study to Investigate the Genetics of LobulAr Carcinoma In Situ in EuRope

National Cancer Research Network

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Prostatic Neoplasms

Neoplasm Metastasis

Syndrome

Anemia

Preleukemia

Myelodysplastic Syndromes

Monoclonal Gammopathy of Undetermined Significance

Precancerous Conditions

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Hematologic Diseases

Bone Marrow Diseases

fluorescence in situ hybridization

microarray analysis

immunohistochemistry staining method

laboratory biomarker analysis

biopsy

immunoscintigraphy

Michael L. Cher, MD

RATIONALE: Collecting and storing samples of bone marrow and tissue from patients to test in the laboratory may help the study of cancer.

PURPOSE: This laboratory study is comparing proteases (enzymes that break down protein) in patients with prostate cancer that has spread to the bone with patients who do not have cancer that has spread to the bone.

OBJECTIVES:

* Examine the roles of proteases and protease-associated molecules in bone metastases in patients with metastatic prostate cancer.

OUTLINE: Patients undergo bone marrow aspiration and core bone biopsies. Tissues are analyzed by immunohistochemistry methods, in situ hybridization assays, gelatin zymography and/or Western blot analysis, and gene profiling analysis in order to visualize and quantitate protease or protease-related levels.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Proteases in Patients With Prostate Cancer That Has Spread to the Bone

Proteases in Prostate Cancer Bone Metastasis

National Cancer Institute (NCI)

Barbara Ann Karmanos Cancer Institute

Respiratory Tract (Lung and Bronchial) Diseases

Recurrence

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Mitogens

mutation analysis

Alex Y. Chang, MD

RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations in the blood of patients with advanced non-small cell lung cancer.

OBJECTIVES:

* Determine if epidermal growth factor receptor (EGFR) mutation exists in the peripheral blood of patients with advanced non-small cell lung cancer (NSCLC).
* Estimate the frequency of EGFR mutation in these patients.
* Correlate the presence of EGFR mutation in blood with EGFR mutation in primary or metastatic NSCLC tumor block.

OUTLINE: Patients undergo blood collection for analysis of epidermal growth factor receptor mutation by DNA sequencing.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Epidermal Growth Factor Receptor Mutations in the Blood of Patients With Advanced Non-Small Cell Lung Cancer

Study of Mutations of Epidermal Growth Factor Receptor in the Blood of Patients With Advanced Non Small Cell Lung Cancer

Number of participants with EGFR mutation in tissue and plasma.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Antineoplastic Agents

Cetuximab

Antineoplastic Agents, Immunological

Dose level 0: cetuximab 400 mg/m2 week 1, 250 mg/m2 weekly; Dose level 1: cetuximab 400 mg/m2 week 1, 300 mg/m2 weekly; Dose level 2: cetuximab 400 mg/m2 week 1, 350 mg/m2 weekly; Dose level 3: cetuximab 400 mg/m2 week 1, 400 mg/m2 weekly

cetuximab

Tissue and Blood Specimens; IHC Methodology; IHC Scoring; K-RAS Mutation Analysis

Peripheral Blood Mononuclear Cells (PBMC)

immunologic technique

Angela Davies, MD

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase I trial is studying the side effects and best dose of cetuximab in treating patients with advanced solid tumors.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose of cetuximab in patients with advanced solid tumors.

Secondary

* Evaluate the safety and tolerability of this drug in these patients.
* Develop a detailed scale for assessment of rash in these patients.
* Investigate potential predictors of response using correlative studies on patient tissue, buccal mucosa, and blood samples.
* Obtain preliminary efficacy data and evaluate the relationship of efficacy to grade of rash.
* Correlate downstream markers (e.g., pMAPK, pAKT, and Ki-67) and the presence of epidermal growth factor receptor (EGFR) polymorphisms with clinical response and/or survival.
* Examine the levels of downstream marker proteins in buccal cells obtained pre- and post-treatment.
* Correlate basal p27 expression levels with response and/or survival.
* Determine if the presence of a K-RAS mutation influences response or survival outcome.
* Correlate the presence or absence of mutant K-RAS tumor DNA shed into patient plasma with response and/or outcome.
* Correlate levels of cytokines and chemokines with rash and clinical response.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive cetuximab IV over 90 minutes once weekly for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of cetuximab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

Patients undergo blood and buccal mucosa collection at baseline and prior to courses 2 and 3 of treatment for molecular correlative studies. Archival tumor tissue specimens are also used for molecular correlative studies. Immunologic correlative studies are performed using patient blood samples.

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Cetuximab in Treating Patients With Advanced Solid Tumors

A Phase I Study of the Safety and Tolerability of Four Doses of Cetuximab (C225) in Patients With Advanced Solid Tumors

University of California, Davis

Nervous System Diseases

Sarcoma

Liposarcoma

Histiocytoma, Malignant Fibrous

Chondrosarcoma

Fibrosarcoma

Histiocytoma

Histiocytoma, Benign Fibrous

Hemangiosarcoma

Leiomyosarcoma

Sarcoma, Synovial

Neurofibrosarcoma

Solitary Fibrous Tumors

Hemangiopericytoma

Mesenchymoma

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Undifferentiated Pleomorphic Sarcoma

Synovial Sarcoma

Malignant Peripheral Nerve Sheath Tumor

Epithelioid Sarcoma

Malignant Mesenchymoma

biologic sample preservation procedure

Catherine West

RATIONALE: Collecting and storing samples of tumor tissue from patients with soft tissue sarcoma to test in the laboratory may help the study of cancer in the future.

PURPOSE: This laboratory is collecting tissue samples from patients with soft tissue sarcoma of the arms, hands, legs, or feet treated on clinical trial CRUK-VORTEX.

OBJECTIVES:

* Determine early in the course of treatment which patients treated on clinical trial CRUK-VORTEX have an increased likelihood of distant metastases so as to highlight individuals who might benefit from early adjuvant systemic therapy.

OUTLINE: This is a multicenter study.

Tumour and normal tissue samples will be taken at the time of surgery during treatment on clinical trial CRUK-VORTEXand preserved for future microarray analyses. Tissue microarrays will be produced from both tumor and normal tissues. Blood samples will be collected for future DNA analysis.

Tissue Sample Collection From Patients With Soft Tissue Sarcoma of the Arms, Hands, Legs, or Feet Treated on Clinial Trial CRUK-VORTEX

VORTEX-BIOBANK: Prospective Sample Collection for the VORTEX Randomised Radiotherapy Trial in Patients With Extremity Soft Tissue Sarcoma [VORTEX BIOBANK]

The Christie NHS Foundation Trust

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Genetics of Women With Lobular Carcinoma in Situ of the Breast	NCT00536718	Breast Cancer	gene expression... molecular diagn... polymorphism an... protein express... medical chart r... questionnaire a...	- 60 Years	National Cancer Institute (NCI)
Proteases in Patients With Prostate Cancer That Has Spread to the Bone	NCT00899665	Anemia Metastatic Canc... Myelodysplastic... Precancerous Co... Prostate Cancer	fluorescence in... microarray anal... molecular diagn... immunohistochem... laboratory biom... biopsy immunoscintigra...	40 Years -	Barbara Ann Karmanos Cancer Institute
Epidermal Growth Factor Receptor Mutations in the Blood of Patients With Advanced Non-Small Cell Lung Cancer	NCT00899756	Lung Cancer	molecular diagn... mutation analys...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Cetuximab in Treating Patients With Advanced Solid Tumors	NCT00376727	Unspecified Adu...	cetuximab molecular diagn... immunologic tec... laboratory biom...	18 Years -	University of California, Davis
Tissue Sample Collection From Patients With Soft Tissue Sarcoma of the Arms, Hands, Legs, or Feet Treated on Clinial Trial CRUK-VORTEX	NCT00900211	Sarcoma	microarray anal... molecular diagn... biologic sample...	16 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for molecular diagnostic method