Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Neuroendocrine Tumors

Carcinoma, Neuroendocrine

Carcinoma, Islet Cell

Carcinoma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neoplasms, Glandular and Epithelial

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Adenocarcinoma

Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Neuroepithelioma

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Everolimus

Liver Extracts

Sunitinib

A total of 30 patients with well differentiated pancreatic NETs who have known liver metastases and who are planned to initiate therapy with either targeted (everolimus or sunitinib) or traditional cytotoxic chemotherapy will be recruited for this study. We plan to recruit approximately 10 patients for each therapy (everolimus, sunitinib, cytotoxic chemotherapy). Evidence of metastatic disease will be determined at the discretion of the oncologist based on available imaging, surgical and pathologic evidence.

Patients will be treated with either sunitinib, everolimus, or traditional chemotherapy according to standard of care. Follow-up with imaging (either MRI or CT) will be performed approximately every 3 months. Unidimensional tumor measurement on standard CT and MRI sequences will be performed, according to guidelines from RECIST v1.1, which will be used to assess for progression of disease. Patients will be followed for up to 5 years. Upon evidence of disease progression, patients will be asked to undergo a post-treatment biopsy. If medically possible and safe, they will stay on the drug until the time of biopsy.

Nitya Raj, M.D

Sunitinib and everolimus are two new treatments approved in 2011 for patients with pancreatic neuroendocrine tumors (NETs). In addition, some traditional chemotherapies are often used to treat pancreatic NETs. Traditional chemotherapy is also known as "cytotoxic therapy" and works by killing cells that are actively dividing. There have been no studies to compare the different types of treatment. Since the patient is eligible for treatment with either sunitinib, everolimus or traditional chemotherapy it can help us identify factors that may help future patients benefit from these therapies.

Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors

A Pilot Study to Identify Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors

standard MRI sequences will be performed, according to guidelines from RECIST 1.1.

Memorial Sloan Kettering Cancer Center

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Melanoma

Prostatic Neoplasms

Sarcoma

Carcinoma, Renal Cell

Neoplastic Cells, Circulating

Kidney Neoplasms

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplasm Metastasis

Neoplastic Processes

Renal Cell Carcinoma

Soft Tissue Sarcoma

Patients with histologically confirmed melanoma

Patients with histologically confirmed prostate cancer

Patients with histologically confirmed solid tumor cancers other than melanoma and prostate

Patients diagnosed with non-cancerous hematologic conditions

Family members of patients undergoing treatment at Comprehensive Cancer Centers of Nevada, or other healthy volunteers

Approximately 40 cc of blood will be drawn from participants at a time when they are having blood drawn for routine or treatment-related purposes. Sequential samples may be obtained in the same manner from selected patients to allow exploration of potential correlation of CTC with response to treatment, progression-free survival and overall survival.

Blood Draw

Wolfram Samlowski, MD

The purpose of this study is to determine if circulating tumor cells (CTC) can be accurately detected and isolated from the blood of participants with melanoma using novel laboratory techniques. Blood samples will be collected from participants with melanoma, and also from participants with other solid tumor cancers and healthy volunteers for purposes of comparison.

Relevant information will be collected from participant's medical record and stored in a coded manner in a password-protected format. This information will be used to look for correlations of research results on blood samples to participant's medical condition. Test results will not be given to participants or their physicians. In some cases, CTC may be grown for long-term cell lines for further research.

A strong correlation has been established between CTC and the progression of breast, colon and prostate cancers. The number of CTC appears to act as a prognostic marker for relapse and survival in a number of epithelial cancers. Unfortunately, current CTC assays are not effective in reliably detecting circulating melanoma cells and the assay procedures damage cells prohibiting further study.

This study is designed to evaluate the sensitivity and specificity of the TrueCells assay, a novel approach to isolate and preserve cells for further research.

Primary Objectives:

* Evaluate feasibility and reproducibility of isolation of CTC using TrueCells technology.
* Optimize quantitative CTC recovery
* Provide preliminary data concerning correlation of these measurements with other methods of CTC recovery such as immunofluorescence, lipid-based staining.

Secondary Objectives:

* Explore correlation of immunofluorescent CTC assay and TrueCells CTC cultures with response to treatment by objective and immune response criteria, progression free survival, 1 and 2-year survival landmarks, and overall survival in cancer patients.
* Attempt to isolate long-term tumor cell lines for evaluation of somatic gene mutations, and gene and protein expression patterns related to individual tumors (not intended to identify familial or inherited mutations), and to test drug and biologic sensitivity.
* Isolate plasma RNA and DNA to assess expression tumor-specific markers (e.g., tyrosinase, B-FRAF, V600E, etc.) and metastasis-associated genes (e.g., MSH-1, thymidylate synthase, etc.).
* Perform ongoing developmental testing to continue to develop and optimize novel technical approaches to facilitate isolation of intact CTC.

Methods:

Blood samples will be collected from patients with melanoma (200), prostate cancer (200), other solid tumor cancers (up to 400), benign hematologic conditions (100), and healthy volunteers (up to 100). Sequential samples will be obtained from selected patients during disease progression or treatment response to allow exploration of potential correlation of CTC with response to treatment, progression-free survival and overall survival. Samples will be immediately de-identified and assigned a numerical code, dated and sent to TrueCells, LLC. Once donated, sample ownership passes to TrueCells, LLC.

Research studies include:

* CTC independently counted using immunofluorescent staining of thick smear prepared from entire buffy coat of two tubes of blood (tubes 1 \& 2), stained with appropriate primary pan-tumor monoclonal antibody or lipid markers with confirmatory secondary antibodies to exclude inadvertent inclusion of leukocyte and endothelial subsets and verify recognition of the patient's cancer.
* Leukocytes (containing CTC) isolated by density gradient centrifugation. The buffy coat is plated into TrueCells proprietary cell culture medium and tumor cells grown and propagated (tubes 3 \& 4). Cell colonies enumerated and compared to number of colonies identified by immunofluorescent staining.
* In some cases CTC may be able to be grown as long-term cell lines. These cells may be subject to further analysis such as evaluation of somatic gene mutations as well as gene and protein expression patterns to identify characteristics of individual tumors as well as drug and biologic agent sensitivity. There may be additional future in vitro experimental applications for these de-identified early-passage cell lines that have not yet been identified or anticipated in this application.
* Plasma (byproduct of leukocyte isolation process from tubes 3 \& 4) will be collected and temporarily frozen for DNA and RNA isolation for molecular assays of melanoma molecular markers and metastatic gene expression. These samples are consumed in the assay procedure.

Clinical information will be abstracted from medical records and de-identified and stored in a password-protected spreadsheet. Information to be collected includes age, gender, T, N, M status, other health conditions, serum LDH, any specific tumor markers (e.g. PSA), circulating tumor cells (if analyzed by commercial assay), somatic genetic mutations present in cancer (e.g. B-RAF V600E in melanoma patients) mitotic rate of tumor, date of tumor diagnosis, treatment history, date of regional and metastatic progression and date of death (if applicable).

Whole blood (up to 40 cc) collected in four 7.5 - 10 ml tubes. Serum samples may be stored frozen in a coded, de-identified format until DNA or RNA is extracted for assays to allow for batch processing. Samples will be consumed in the course of the research studies. Viable tumor cells may be grown as long-term cell lines.

Culture and Characterization of Circulating Tumor Cells (CTC) in Melanoma and Other Cancers

Culture and Characterization of Circulating Tumor Cells (CTC) From Patients With Malignant Melanoma and Other Cancers

TrueCells, LLC

Comprehensive Cancer Centers of Nevada

University of Pittsburgh

Wolfram Samlowski

Physician, Comprehensive Cancer Centers of Nevada; Member, Developmental Therapeutics and Genitourinary Committee, US Oncology Research Clinical; Professor, University of Nevada, Reno

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors	NCT01603004	Pancreatic Neur...	MRI	18 Years -	Memorial Sloan Kettering Cancer Center
Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors	NCT01603004	Pancreatic Neur...	MRI	18 Years -	Memorial Sloan Kettering Cancer Center
Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors	NCT01603004	Pancreatic Neur...	MRI	18 Years -	Memorial Sloan Kettering Cancer Center
Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors	NCT01603004	Pancreatic Neur...	MRI	18 Years -	Memorial Sloan Kettering Cancer Center
Culture and Characterization of Circulating Tumor Cells (CTC) in Melanoma and Other Cancers	NCT01528774	Melanoma	Blood Draw	18 Years -	Comprehensive Cancer Centers of Nevada
Culture and Characterization of Circulating Tumor Cells (CTC) in Melanoma and Other Cancers	NCT01528774	Melanoma	Blood Draw	18 Years -	Comprehensive Cancer Centers of Nevada

Spots Global Cancer Trial Database for pancreatic neuroendocrine cancer