Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068003
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-08
First Post:
2003-09-04
Brief Title:
Harvesting Cells for Experimental Cancer Treatments
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cell Harvest and Preparation for Surgery Branch Treatment Protocols
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor 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 andor 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
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 andor 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 andor 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
Detailed Description:
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 andor 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 andor tumor resection for future treatment andor 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
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 andor 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 andor tumor resection for future treatment andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-C-0277 | None | None | None |