Harvesting Cells for Experimental Cancer Treatments
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|ClinicalTrials.gov Identifier: NCT00068003|
Recruitment Status : Enrolling by invitation
First Posted : September 4, 2003
Last Update Posted : January 9, 2019
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|
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, which are now closed. 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.
- 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 future enrollment on a NCI-SB adoptive cell therapy clinical trial.
- To obtain allogeneic PBMC via apheresis, or blood samples from healthy volunteers for use in generating anti-tumor patient lymphocytes ex vivo.
- To conduct genomic, proteomic and immunologic research studies on samples collected.
Patients with cancer must be >15 years of age and meet the laboratory safety testing for infection included in all the cell therapy treatment trials.
Healthy volunteers must meet the safety evaluation criteria established by the FDA for donation of blood products including HBsAg, HBc, HCV, Trypanosoma cruzi, West Nile Virus, CMV, syphilis, and other requirements as updated on the FDA website.They must also meet the strict behavioral and medical history requirements.
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 pheresis of healthy volunteers for allogeneic PBMC used in generating autologous antitumor lymphocytes in the laboratory, or for research purposes.
No treatments, investigational or standard therapy, will be administered on this protocol.
|Study Type :||Observational|
|Actual Enrollment :||1998 participants|
|Official Title:||Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols|
|Actual Study Start Date :||September 16, 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
- 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 ]
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)|