Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Pancreatic Neoplasms

Skin Neoplasms

Teratoma

Carcinogenesis

Testicular Neoplasms

Cell Transformation, Neoplastic

Neoplasms, Germ Cell and Embryonal

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neoplasms by Histologic Type

Skin Diseases

Intestinal Diseases

Pancreatic Cancer

Germ Cells Tumors

Testicular Germ Cell Tumor

Small Intestine Cancer

All Drugs and Chemicals

Antibodies

Immunoglobulins

Tumor tissue samples from paraffin-embedded tissue blocks are analyzed for TAB3 transcript and protein expression using in situ hybridization and immunostaining with TAB3 cRNA probe and antibody. Antibodies against the proteins involved in the NFkB signaling pathway (e.g., p65, TAK1, MyD88, and Akt) are used in the immunostaining assays.

in situ hybridization

protein expression analysis

immunologic technique

Ge Jin, PhD

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is evaluating a tumor marker for testicular cancer, skin cancer, small intestine cancer, and pancreatic cancer.

OBJECTIVES:

* To identify TAB3 transcript/protein as a molecular marker of cancer, specifically testicular, skin, small intestine, and pancreatic cancer.
* To characterize TAB3 and its signaling networks that are involved in tumorigenesis.

OUTLINE: Tumor tissue samples from paraffin-embedded tissue blocks are analyzed for TAB3 transcript and protein expression using in situ hybridization and immunostaining with TAB3 cRNA probe and antibody. Antibodies against the proteins involved in the NFkB signaling pathway (e.g., p65, TAK1, MyD88, and Akt) are used in the immunostaining assays.

Tumor tissue samples from paraffin-embedded tissue blocks.

Studying a Tumor Marker for Testicular Cancer, Skin Cancer, Small Intestine Cancer, and Pancreatic Cancer

The Role of TAB3 Protein in Tumorigenesis

National Cancer Institute (NCI)

Case Comprehensive Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Laryngeal Diseases

Laryngeal Cancer

Hypopharyngeal Cancer

Antineoplastic Agents

Amino Acids

Docetaxel

Carboplatin

Fluorouracil

Fluorodeoxyglucose F18

Cisplatin

Lapatinib

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Radiopharmaceuticals

Tyrosine

carboplatin

cisplatin

docetaxel

fluorouracil

lapatinib ditosylate

cytogenetic analysis

fluorescence in situ hybridization

polymerase chain reaction

reverse transcriptase-polymerase chain reaction

immunohistochemistry staining method

laboratory biomarker analysis

conventional surgery

neoadjuvant therapy

fludeoxyglucose F 18

radiation therapy

Ahmad Awada, MD, PhD

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with radiation therapy, with or without lapatinib, before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed or eliminate the need for surgery.

PURPOSE: This phase I/II trial is studying the side effects and best dose of combination chemotherapy given together with radiation therapy with or without lapatinib and to see how well it works in treating patients with locally advanced cancer of the larynx or hypopharynx.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose and recommended dose for phase II of lapatinib ditosylate in patients with locally advanced squamous cell carcinoma of the larynyx or hypopharynx who are concomitantly treated with neoadjuvant induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil, followed by chemoradiotherapy comprising carboplatin and radiotherapy. (Phase I)
* To document the feasibility, in the framework of an organ preservation program, of this regimen in these patients. (Phase II)

Secondary

* To look at the role of PET in patients with N1-3 disease, in terms of PET being used as a reliable method to spare patients from planned neck dissection. (Phase II)

OUTLINE: This is a multicenter, dose-escalation phase I study followed by a randomized phase II study. Patients are stratified by institution and EGFR status (negative vs positive).

* Phase I:

  * Neoadjuvant chemotherapy: Patients receive neoadjuvant chemotherapy comprising docetaxel IV and cisplatin IV on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete or partial response after 4 courses of neoadjuvant chemotherapy proceed to chemoradiotherapy. Patients with less than a partial response after course 2 or course 4 proceed to surgery, including total laryngectomy.
  * Chemoradiotherapy: Within 3 weeks after completion of neoadjuvant chemotherapy, patients undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 and receive carboplatin IV on days 1, 8, 15, 22, 29, 36, and 43.
  * Concurrent lapatinib ditosylate: Patients receive oral lapatinib ditosylate once daily during neoadjuvant chemotherapy, during the break between neoadjuvant chemotherapy and chemoradiotherapy, and during chemoradiotherapy.
* Phase II: Patients are randomized to 1 of 2 treatment arms.

  * Arm I: Patients receive neoadjuvant chemotherapy and undergo chemoradiotherapy as in phase I.
  * Arm II: Patients receive neoadjuvant chemotherapy and undergo chemoradiotherapy as in phase I. Patients also receive concurrent lapatinib ditosylate as in phase I at the recommended dose determined in phase I.

In both phases, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients with node-positive disease (initially) undergo tumor and blood sample collection for biological studies. Samples are analyzed for ErbB-related activation via immunohistochemistry, in situ hybridization, and PCR/sequencing of genes/proteins, to detect DNA amplification and polysomy (for AKT, ErbB2, EGFR) and genomic losses (for PTEN) via FISH, and the ratio between EGFR and EGFRvIII via QRT-PCR. Patients with node-positive disease undergo at least elective neck dissection to evaluate the negative predictive value of PET scanning.

Patients are followed every 3 months for one year and then every 6 months thereafter.

Combination Chemotherapy and Radiation Therapy With or Without Lapatinib in Treating Patients With Locally Advanced Cancer of the Larynx or Hypopharynx

Phase I/II Study on Induction Chemotherapy Followed by Chemoradiation With or Without Lapatinib, a Dual EGFR/ErbB2 Kinase Inhibitor, in Patients With Locally Advanced Larynx and Hypopharynx Squamous Cell Carcinoma

European Organisation for Research and Treatment of Cancer - EORTC

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Herbal and Botanical

Sage

The proposed research intends to construct a set of tissue microarrays containing different types of normal and lung cancer tissues for the study of genes associated with lung cancer. Thus far we have generated a lung cancer tissue arrayusing paraffin embedded archival tissues from 300 lung turmors tissues and 100 adjacent normal tissues. Four- micrometer thickness sections have been cut from the tissue array and were used to survey gene expression status in arrayed tumors using immunohistochemistry methody. We are currently performing IHC studies ot 1) determine protein expression and its correlation with gene expression patterms ovserved using cDNA arrays. 2) Analyze protein expression in the chromosome remodeling pathyway in non-small cell lung cancer. And 3) determine the association of gene expression with lung tumor stage and clinical outcome. The current protocol is needed to complete the above studies and for the production of neuroendocrine tumors.

The proposed research intends to construct a set of tissue microarrays containing different types of lung cancer tissues for the study of genes associated with lung cancer. In this study, lung tissue arrays will be generated using paraffin embedded archival tissues containing adjacent normal tissues and tumors from approximately 300 non-small cell lung cancers and 100 neuroendocrine tumors of the lung. Corded tissues of 0.6 um in diameter will be taken from each tumor and arrayed onto recipient paraffin blocks to generate a lung tumor specific microarray. Four-micrometer thickness sections will be cut from the tissue array and used to survey gene expression status in arrayed tumors using fluorescence in situ hybridization (FISH, in situ hybridization, and/or immunohistochemistry methods. Additionally, approximately 20 sections will be cut from each primary tumor block to isolate genomic DNA for the analysis of genetic changes in the arrayed tumor samples. The goals of this proposal are 1) to generate a single tissue block containing multiple tumors, 2) allow rapid and efficient analysis of gene expressions in a large number of samples using a single tissue section, and 3) to correlate the molecular changes in the tumors with the clinical and pathological features of the disease. Due to the experimental nature of the research and the fact that all tumors obtained are archival tissues at AFIP, the investigators will not report the result of gene expression back to the subject.

To date, all samples needed for the protocol have been reached and there will be no more patient accrual but survival status of the patients as well as molecular analysis using the constructed lung tissue microarrays will continue for the foreseeable future.

Construction and Use of Lung Tumor Microarray for the Analysis of Gene Expression in Lung Cancer

Infections

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Communicable Diseases

Epstein-Barr Virus Infections

Hodgkin Disease

Virus Diseases

Lymphohistiocytosis, Hemophagocytic

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

DNA analysis

RNA analysis

mutation analysis

western blotting

flow cytometry

medical chart review

Kim E. Nichols, MD, BA

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

PURPOSE: This research trial studies biomarkers in blood and tissue samples from patients with Epstein-Barr virus positive Hodgkin lymphoma.

OBJECTIVES:

* Evaluate germline DNA from patients with Epstein-Barr virus positive (EBV+) and Hodgkin lymphoma (HL) for inducible T-cell kinase (ITK) mutations.
* Examine the effects of ITK mutations on expression of the ITK protein.
* Determine whether ITK mutations correlate with specific clinical or histopathological features of HL.

OUTLINE: Archived blood and tumor tissue samples are analyzed for germline DNA expression and inducible T-cell kinase (ITK) mutations by PCR, IHC, flow cytometry, and western blotting, and EBV-encoded RNA (EBER) using in situ hybridization. Each patient's data, such as date, sex, age, tumor stage and histology at diagnosis, treatment received, response to treatment, development of recurrent disease, date of last follow-up, and outcomes are also collected.

Biomarkers in Blood and Tissue Samples From Patients With Epstein-Barr Virus-Positive Hodgkin Lymphoma

Role of the IL-2 Inducible Tcell Kinase in EBV-HLH and EBV+ Hodgkin's Lymphoma

Children's Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Studying a Tumor Marker for Testicular Cancer, Skin Cancer, Small Intestine Cancer, and Pancreatic Cancer	NCT00899132	Non-melanomatou... Pancreatic Canc... Small Intestine... Testicular Germ...	in situ hybridi... protein express... immunologic tec...	-	Case Comprehensive Cancer Center
Combination Chemotherapy and Radiation Therapy With or Without Lapatinib in Treating Patients With Locally Advanced Cancer of the Larynx or Hypopharynx	NCT00498953	Head and Neck C...	carboplatin cisplatin docetaxel fluorouracil lapatinib ditos... cytogenetic ana... fluorescence in... in situ hybridi... polymerase chai... reverse transcr... immunohistochem... laboratory biom... conventional su... neoadjuvant the... fludeoxyglucose... radiation thera...	18 Years - 120 Years	European Organisation for Research and Treatment of Cancer - EORTC
Construction and Use of Lung Tumor Microarray for the Analysis of Gene Expression in Lung Cancer	NCT00340847	Lung Cancer		-	National Institutes of Health Clinical Center (CC)
Biomarkers in Blood and Tissue Samples From Patients With Epstein-Barr Virus-Positive Hodgkin Lymphoma	NCT01490801	Lymphoma Nonneoplastic C...	DNA analysis RNA analysis cytogenetic ana... in situ hybridi... mutation analys... polymerase chai... western blottin... flow cytometry immunohistochem... medical chart r...	- 9 Years	Children's Oncology Group
Biomarkers in Blood and Tissue Samples From Patients With Epstein-Barr Virus-Positive Hodgkin Lymphoma	NCT01490801	Lymphoma Nonneoplastic C...	DNA analysis RNA analysis cytogenetic ana... in situ hybridi... mutation analys... polymerase chai... western blottin... flow cytometry immunohistochem... medical chart r...	- 9 Years	Children's Oncology Group

Spots Global Cancer Trial Database for in situ hybridization