Harvesting Cells for Experimental Cancer Treatments
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00068003|
Recruitment Status : Enrolling by invitation
First Posted : September 4, 2003
Last Update Posted : February 9, 2021
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.
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.
Patients must be eligible for a NCI Surgery Branch Treatment Protocol
Normal Volunteers must meet the criteria for blood donation
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.
|Condition or disease|
|Melanoma Gastrointestinal Cancer Metastatic Cancer Breast Cancer Non-Small-Cell Lung Cancer|
|Study Type :||Observational|
|Actual Enrollment :||2109 participants|
|Official Title:||Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols|
|Actual Study Start Date :||September 8, 2003|
Patients with a current diagnosis of cancer
- Bank of autologous blood, stem cells and/or tumor tissue frompatients currently with cancer [ Time Frame: approximately 20 years ]Obtain autologous blood, stem cells and/or tumor tissue from patientscurrently with cancer for laboratory analysis and ex vivo generation ofautologous anti-tumor lymphocytes for future enrollment on a Surgery Branch adoptive cell therapy clinical trial.
- Generation of anti-tumor patient lymphocytes ex vivo [ Time Frame: approximately 20 years ]Obtain allogeneic PBMC via apheresis, or blood samples from healthy volunteers for use in generating anti-tumor patient lymphocytes ex vivo.
- Development of genomic, proteomic and immunologic research studies [ Time Frame: approximately 20 years ]Conduct genomic, proteomic and immunologic research studies onsamples collected from patients with a current diagnosis of cancer.
- Long-term storage of data and biospecimens [ Time Frame: approximately 20 years ]Long-term storage of data and biospecimens collected duringprospective clinical trials in patients with various cancer phenotypes, to support the research activities of the NCI Surgery Branch.
- Repository of specimens and associated data [ Time Frame: approximately 20 years ]Repository for specimens and associated data obtained on patients enrolled on NCI-SB protocols who were not consented on this protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068003
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Steven A Rosenberg, M.D.||National Cancer Institute (NCI)|