Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Digestive System Diseases

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Neoplasm Metastasis

Lung Neoplasms

Melanoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Patients with a current diagnosis of cancer

Anti-CD19 CAR PBL

Steven A Rosenberg, M.D.

Background:

The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.

Objective:

This study will collect white blood cells from normal volunteers and white blood cells and/or tumor cells, from patients who have been screened for and are eligible for a NCI Surgery Branch treatment protocol. The cells collected from normal volunteers will be used as growth factors for the cells during the period of laboratory growth. The cells and/or tumor from patients will be used to make the cell treatment product.

Eligibility:

Patients must be eligible for a NCI Surgery Branch Treatment Protocol

Normal Volunteers must meet the criteria for blood donation

Design

Both patients and normal Volunteers will undergo apheresis. Patients will then undergo further testing as required by the treatment protocol.

There is no required follow up for normal volunteers.

Background:

There are numerous clinical trials underway in the National Cancer Institute Surgery Branch (NCI-SB) in which patients are administered autologous lymphocytes with anti-tumor activity generated from either peripheral blood mononuclear cells (PBMC) or tumor-infiltrating lymphocytes (TIL). All adoptive cell therapy protocols require that certain cell criteria be evaluated and met prior to enrollment.

This protocol is also designed to serve as a biorepository for samples and associated data collected on patients enrolled on NCI-SB protocols, current and historical. Patients who were enrolled prior to 2003 were not enrolled on this protocol. Their tissue and data will now be retained on this protocol for long-term storage. The protocol is concerned with the retention of serum, CSF, bone marrow, ascites fluid, PBMCs, tumor, healthy tissue samples, and CD34 purified HSCS samples collected from patients with cancer to support basic science and clinical research activities of the NCI-SB at the NIH Clinical Research Center and Center for Cancer Research.

Objectives:

To obtain autologous blood, stem cells, and/or tumor tissue from patients currently with cancer for laboratory analysis and ex vivo generation of autologous anti-tumor lymphocytes for potential future enrollment on an NCI-SB adoptive cell therapy clinical trial.

To obtain allogeneic PBMC via apheresis, whole blood, or other blood products from healthy volunteers, for use in generating anti-tumor patient lymphocytes ex vivo.

To conduct genomic, proteomic, and immunologic research studies on samples collected from patients with a current diagnosis of cancer.

Eligibility:

Patients with cancer must be \>= 18 years of age and meet the laboratory safety testing for infection included in all treatment trials.

Healthy volunteers for PBMC donation must meet the safety evaluation criteria established by the FDA for donation of blood products. They must also meet the strict behavioral and medical history requirements.

Healthy volunteers for whole blood donation must meet the safety evaluation criteria established by the NIH Clinical Center Department of Transfusion Medicine (DTM) Blood Bank for screening of allogeneic whole blood donors.

Design:

Once a cancer patient is determined to be a potential candidate for one of the NCI-SB clinical trials, they will undergo an apheresis and/or tumor resection for future treatment and/or research purposes. In addition, this protocol will allow for the apheresis of healthy volunteers for allogeneic PBMC or donation of whole blood for processing into serum for use in generating autologous anti-tumor lymphocytes in the laboratory, or for research purposes.

No treatments, investigational or standard therapy, will be administered on this protocol.

Harvesting Cells for Experimental Cancer Treatments

Cell Harvest and Preparation for Surgery Branch Treatment Protocols

.All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

Obtain allogeneic PBMC via apheresis, whole blood, or other blood products from healthy volunteers, for use in generating anti-tumor patient lymphocytes ex vivo.

Conduct genomic, proteomic, and immunologic research studies on samples collected from patients with a current diagnosis of cancer.

Obtain autologous blood, stem cells, and/or tumor tissue from patients currently with cancer for laboratory analysis and ex vivo generation of autologous anti-tumor lymphocytes for potential future enrollment on an NCI-SB adoptive cell therapy clinical trial.

Repository for specimens and associated data obtained on patients enrolled on NCI-SB protocols who were not consented on this protocol.

Long-term storage of data and biospecimens collected during prospective clinical trials in patients with various cancer phenotypes, to support the research activities of the NCI-SB.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Harvesting Cells for Experimental Cancer Treatments	NCT00068003	Melanoma Gastrointestina... Metastatic Canc... Breast Cancer Non-Small Cell ...	Anti-CD19 CAR P...	18 Years -	National Institutes of Health Clinical Center (CC)
Harvesting Cells for Experimental Cancer Treatments	NCT00068003	Melanoma Gastrointestina... Metastatic Canc... Breast Cancer Non-Small Cell ...	Anti-CD19 CAR P...	18 Years -	National Institutes of Health Clinical Center (CC)

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