Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

flow cytometry

fluorescence activated cell sorting

immunohistochemistry staining method

immunologic technique

biomarker analysis

Vered Stearns, MD

RATIONALE: Studying samples of blood and pleural or peritoneal fluid from patients with metastatic breast cancer in the laboratory may help doctors identify biomarkers related to breast cancer and learn more about how breast cancer begins and spreads in the body.

PURPOSE: This research study is looking at a new way of identifying circulating breast cancer cells in blood and in pleural or peritoneal fluid in women with metastatic breast cancer.

OBJECTIVES:

Primary

* To compare identification of circulating breast cancer cells (CBCCs) in blood or pleural or peritoneal fluid by a novel technique using stem cell marker retinaldehyde dehydrogenase (ALDH) and surface antigen expression (CD44+, CD24-) to the standard technique using the CellSearch® system in women with metastatic breast cancer.

Secondary

* To determine whether CBCCs have the potential to grow into metastatic lesions.

OUTLINE: Patients undergo sample collection to help develop a new technique using stem cell marker retinaldehyde dehydrogenase (ALDH) and surface antigen expression (CD44+, CD24-) in isolating circulating breast cancer cells (CBCCs) from blood and pleural or peritoneal fluid. Blood may also be drawn to measure the number of circulating tumor cells using the standard CellSearch® system.

Mononuclear cells are isolated by density centrifugation. Cells are stained against surface antigens that provide specific expression patterns for CBCCs (CD44, CD24). Cells are analyzed on a fluorescence activated cell sorting (FACS) Calibur flow cytometer and sequentially gated (ALDHhigh→CD44+ vs CD24-/low or CD44+ vs CD24-/low→ALDHhigh) for detection of CBCCs. For further confirmation of epithelial origin, ALDHhighCD44+CD24-/low cells are isolated using a FACSAria flow sorter, cytocentrifuged onto glass slides then stained for the expression of epithelial-specific cytokeratins 5, 8, 14, 18 and 19 by standard immunohistochemical techniques. Using the phenotype that is found to most highly enrich for epithelial cells, cells are isolated by FACS and assayed for clonogenic growth.

Identifying Circulating Breast Cancer Cells in Women With Metastatic Breast Cancer

A Feasibility Study of a Novel Technique to Identify Circulating Breast Cancer Cells in Patients With Metastatic Breast Cancer

National Cancer Institute (NCI)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

cytogenetic analysis

immunoenzyme technique

laboratory biomarker analysis

David Kaplan, MD, PhD

RATIONALE: Studying samples of cells in the laboratory from patients with cancer may help identify biomarkers related to cancer. It may also help doctors learn how patients respond to treatment.

PURPOSE: This laboratory study is analyzing samples of cells from patients with chronic lymphocytic leukemia who were treated on clinical trial ECOG-2997.

OBJECTIVES:

* To analyze the expression of a variety of informative molecules using a unique high-resolution flow cytometric immunophenotyping technology in samples from patients with chronic lymphocytic leukemia enrolled in clinical trial ECOG-2997.

OUTLINE: Cell samples are analyzed for the following prognostic biomarkers: ZAP-70, phospho-Syk, phospho-GSK-3β, phospho-Akt, phospho-ZAP-70, cyclin D1, cyclin D2, p21cip1, phospho-ReIA, IkappaBα, Bax, Mcl-1, PTEN, phospho-Erk1/2, and phospho-MEK1/2. Biomarker signals are amplified using enzymatic amplification staining to obtain high resolution detection of cell-surface markers on leukemic cells. Biomarker expression levels are measured using fluorescence activated cell sorting analysis. Relationships between clinical outcomes, standard flow cytometric analysis, cytogenetic studies, and high resolution immunophenotyping will also be assessed.

Biomarkers in Samples From Patients With Chronic Lymphocytic Leukemia Treated on Clinical Trial ECOG-2997

Proposed Study of CLL Samples

ECOG-ACRIN Cancer Research Group

Diseases and Abnormalities at or Before Birth

Congenital Abnormalities

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Myelomonocytic, Acute

Leukemia, Monocytic, Acute

Leukemia, Erythroblastic, Acute

Leukemia, Megakaryoblastic, Acute

Leukemia, Basophilic, Acute

Leukemia, Eosinophilic, Acute

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Acute Monoblastic Leukemia

Acute Myelomonocytic Leukemia

Acute Erythroid Leukemia

Di Guglielmo's Syndrome

Acute Megakaryoblastic Leukemia

Acute Myeloblastic Leukemia Without Maturation

Acute Myeloblastic Leukemia With Maturation

gene expression analysis

medical chart review

Roland Walter, MD, PhD

RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research trial studies bone marrow samples from women with acute myeloid leukemia.

OBJECTIVES:

* Estimate the proportion of acute myeloid leukemia (AMLs) that originate in CD33+ precursors or in which uncontrolled growth is limited to CD33+ precursors.
* Explore whether there is an association between the cellular origin of AML (i.e., origination in CD33+ precursors or not) and cytogenetic, molecular, and other patient characteristics.
* Explore whether overall survival (OS), event-free survival (EFS), disease-free survival (DFS), response rate (RR), or relapse rate is improved for patients with AMLs that originate in CD33+ precursors or in which uncontrolled growth is limited to CD33+ precursors compared to patients with clonally involved cells not detected.

OUTLINE: Archived bone marrow samples are analyzed for CD33+ progenitors, X-chromosome inactivation, and somatic mutations (t(8;21), inv(16), FLT3/ITD, NPM1, CEBPA, KIT) by fluorescence-activated cell sorting, long-term culture in hypoxic condition in cytokine-containing liquid media, and flow cytometry. Results are then compared with each patient clinical data.

S0106B Studying Bone Marrow Samples From Women With Acute Myeloid Leukemia

S0106B, Stem Cell Origin in AML: Prognostic and Therapeutic Implications

SWOG Cancer Research Network

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Papillomavirus Infections

Papilloma

Acquired Immunodeficiency Syndrome

HIV Infections

Virus Diseases

HIV Seropositivity

Precancerous Conditions

Disease Attributes

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Single group study. Blood, saliva, anal cytology, and penile cytology samples, and questionnaire responses will be collected from participants at a single study visit.

Anal pap smear, penile pap smear, blood collection, and saliva collection at a single study visit for HPV DNA analysis.

DNA analysis

Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.

polymerase chain reaction

Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.

questionnaire administration

study of socioeconomic and demographic variables

study of high risk factors

Joel Palefsky, MD

Dilip Mathai, MD

Ashok Row Kavi

RATIONALE: Gathering information about human papilloma virus (HPV) infection in HIV-positive men who have sex with men may help doctors learn more about the disease.

PURPOSE: This clinical trial is studying HPV infection in HIV-positive Indian men who have sex with men.

OBJECTIVES:

* Describe the prevalence of penile, anal, and oral human papilloma virus (HPV) infection in HIV-seropositive Indian men who have sex with men.
* Determine the spectrum of HPV types at these anatomic sites in these patients.
* Determine the distribution of strain variants of HPV 16, 18, and 31 at these anatomic sites in these patients.
* Describe risk factors for penile, anal, and oral HPV infection in these patients.

OUTLINE: This is a multicenter study.

Patients complete interviewer-administered questionnaires on demographics, native place, socioeconomic status, medical history, numbers of sexual partners and sexual practices, circumcision status, and risk factors for oral malignancies and human papilloma virus (HPV), including oral sex, smoking or chewing tobacco, drug use, oral hygiene, and tooth loss.

Patients undergo cell sample collection from the penis, scrotum, anus, and mouth, and saliva sample collection for HPV DNA testing by PCR. Patients also undergo blood sample collection to measure CD4+ count and HIV viral load by FACS and PCR.

Anal cytology Penile cytology Saliva Blood

Human Papilloma Virus Infection in HIV-Positive Indian Men Who Have Sex With Men

HPV Infection in Indian HIV-Seropositive Men Who Have Sex With Men (MSM)

The Emmes Company, LLC

AIDS Malignancy Consortium

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Head and Neck Neoplasms

Epstein-Barr Virus Infections

Nasopharyngeal Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Carboplatin

Antimetabolites

autologous Epstein-Barr virus-specific cytotoxic T lymphocytes

carboplatin

gemcitabine hydrochloride

Toh Han Chong, MD, MBBS, MRCP

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving an infusion of a person's T lymphocytes that have been treated in the laboratory may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with laboratory-treated T lymphocytes may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine and carboplatin together with laboratory-treated T lymphocytes works in treating patients with metastatic or locally recurrent Epstein-Barr virus-positive nasopharyngeal cancer.

OBJECTIVES:

Primary

* To determine progression-free survival (PFS 1) of patients with metastatic or locally recurrent Epstein-Barr virus (EBV)-positive nasopharyngeal carcinoma treated with gemcitabine hydrochloride and carboplatin followed EBV-specific cytotoxic T-lymphocytes (CTL).

Secondary

* To determine progression-free survival (PFS 2) of these patients during the immunotherapy portion of this study.
* To determine the clinical benefit rate of EBV-specific CTL in these patients.
* To determine the tolerability of EBV-specific CTL therapy in these patients.
* To demonstrate persistence of EBV-specific immune response in these patients.

OUTLINE: Patients undergo collection of peripheral blood mononuclear cells (PBMC) from which T cells are purified, co-cultured with irradiated autologous Epstein-Barr virus (EBV)-specific cytotoxic T-lymphocytes (CTLs), and expanded in vitro for the establishment of cytotoxic T-cell lines.

* Chemotherapy: Patients receive gemcitabine hydrochloride IV over 30 minutes and carboplatin IV over 60 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of course 2, patients undergo evaluation for response. Patients with progressive disease proceed directly to induction immunotherapy. Patients with stable disease (SD), partial response (PR), or complete response (CR) receive 2 additional courses of chemotherapy and then proceed to induction immunotherapy.
* Induction immunotherapy: Beginning 14-28 days after the completion of chemotherapy, patients receive EBV-specific CTLs IV over 1-10 minutes on days 1 and 14. Six weeks after the second infusion, patients undergo evaluation for response. Patients who demonstrate clinical benefit (i.e., CR, PR, SD) to induction immunotherapy proceed to maintenance immunotherapy.
* Maintenance immunotherapy: Patients receive EBV-specific CTLs IV over 1-10 minutes. Treatment repeats every 1-3 months for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection at baseline and prior to each course of induction immunotherapy and maintenance immunotherapy. Samples are analyzed for EBV CTL frequency by immune function assays (i.e., tetramer analysis, enzyme-linked immunospot, and cytotoxic T-lymphocyte precursor assays); for specificity of response by cytotoxicity assays (in patients for whom the appropriate reagents are available); and for evaluation of EBV DNA by polymerase chain reaction. In addition, T-cells are isolated from blood samples for fluorescence-activated cell sorter analysis and for extraction of RNA.

After completion of study therapy, patients are followed at least every 2 months until disease progression.

Gemcitabine and Carboplatin Followed By Laboratory-Treated T Lymphocytes in Treating Patients With Metastatic or Locally Recurrent Epstein-Barr Virus-Positive Nasopharyngeal Cancer

Phase II Trial Evaluating Efficacy of a Strategy Employing Combination Gemcitabine and Carboplatin Chemotherapy Followed by EBV-Specific Cytotoxic T-Lymphocytes in Patients With Metastatic or Locally Recurrent EBV-Positive Nasopharyngeal Carcinoma

National Cancer Centre, Singapore

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Identifying Circulating Breast Cancer Cells in Women With Metastatic Breast Cancer	NCT00897338	Breast Cancer	flow cytometry fluorescence ac... immunohistochem... immunologic tec... biomarker analy...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Biomarkers in Samples From Patients With Chronic Lymphocytic Leukemia Treated on Clinical Trial ECOG-2997	NCT00899873	Leukemia	cytogenetic ana... flow cytometry fluorescence ac... immunoenzyme te... laboratory biom...	18 Years - 120 Years	Eastern Cooperative Oncology Group
S0106B Studying Bone Marrow Samples From Women With Acute Myeloid Leukemia	NCT01575535	Leukemia	gene expression... flow cytometry fluorescence ac... laboratory biom... medical chart r...	18 Years -	SWOG Cancer Research Network
Identifying Circulating Breast Cancer Cells in Women With Metastatic Breast Cancer	NCT00897338	Breast Cancer	flow cytometry fluorescence ac... immunohistochem... immunologic tec... biomarker analy...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Human Papilloma Virus Infection in HIV-Positive Indian Men Who Have Sex With Men	NCT00919997	Nonneoplastic C... Precancerous Co...	DNA analysis polymerase chai... fluorescence ac... questionnaire a... study of socioe... study of high r...	18 Years -	AIDS Malignancy Consortium
Identifying Circulating Breast Cancer Cells in Women With Metastatic Breast Cancer	NCT00897338	Breast Cancer	flow cytometry fluorescence ac... immunohistochem... immunologic tec... biomarker analy...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Gemcitabine and Carboplatin Followed By Laboratory-Treated T Lymphocytes in Treating Patients With Metastatic or Locally Recurrent Epstein-Barr Virus-Positive Nasopharyngeal Cancer	NCT00690872	Head and Neck C...	autologous Epst... carboplatin gemcitabine hyd... polymerase chai... fluorescence ac... immunoenzyme te...	21 Years -	National Cancer Institute (NCI)

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