Cell Harvest and Preparation for Surgery Branch Treatment Protocols
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- Generating anti-tumor patient lymphocytes ex vivo
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ELIGIBILITY CRITERIA FOR PATIENTS WITH A CURRENT DIAGNOSIS OF CANCER:
- •INCLUSION CRITERIA:
- •Patients must have a form of cancer currently being studied in the NCI-SB.
- •Patient is able to understand and willing to sign a written informed consent document.
- •Age greater than or equal to 18 years.
- •Clinical performance status of ECOG 0 or
- •Seronegative for HIV antibody. (The experimental treatments being evaluated depend upon an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities).
- •Seronegative for hepatitis B surface antigen and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
- •Lesions which will be harvested for the generation of TIL should be accessible via standard surgical or radiological techniques and be associated with acceptable morbidity.
排除标准
- •Active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular, respiratory, or immune system.
- •Patients who cannot give proper informed consent to the experimental therapy due to an active psychiatric disorder or inability to understand the nature of the proposed therapy and attendant risk.
- •Women of child-bearing potential who are pregnant because of the potentially dangerous effects of some of the procedures (e.g., tumor biopsy or surgery for tumor resection) on the fetus.
- •ELIGIBILITY CRITERIA FOR HEALTHY VOLUNTEERS:
- •INCLUSION CRITERIA for PBMC Donors:
- •Age greater than or equal to 18 years.
- •Non-reactive for HBsAg, anti-HBc, anti-HCV, anti-HIV-1/2, HBV/HCV/HIV-1 NAT, anti-HTLV-I/II, anti-T. cruzi, West Nile Virus NAT,syphilis, and babesia.
- •PBMC donors must meet the strict behavioral and medical history requirements as per applicable NCI-SB Apheresis Donor SOP(s).
- •INCLUSION CRITERIA FOR WHOLE BLOOD DONORS:
- •Age greater than or equal to 18 years.
- •Whole blood donors must meet the DTM inclusion criteria for allogeneic whole blood donation.
- •EXCLUSION CRITERIA for PBMC Donors:
- •Has had babesiosis.
- •Is at risk or has Creutzfeldt-Jakob Disease.
- •Is on steroid therapy or any other medication or has received vaccination that might interfere with cell preparation per Principal Investigator s (PI) discretion.
- •Has ongoing illness that would cause harm to the volunteer during the apheresis procedure as determined by the PI.
- •Has had yellow jaundice, liver disease, or hepatitis since the age of
- •Has uncontrolled diabetes.
- •Has a hematologic malignancy or any bleeding abnormalities.
- •Has received any type of organ transplant in the past 12 months.
- •Has undergone xenotransplantation at any time.
- •Has received a dura mater graft.
- •If female, is pregnant or has given birth within the last six weeks.
- •Has had an ear or body piercing or tattoos within the past 12 months.
- •Has had a blood transfusion within the past 12 months.
- •Has spent time outside the United States to a restricted country.
- •Has participated in any high-risk activities.
- •EXCLUSION CRITERIA for Whole Blood Donors:
- •- Whole blood donors who do not meet the DTM criteria for allogeneic whole blood donation.
研究组 & 干预措施
2/Healthy Volunteers
Healthy volunteers
1/Cancer Patients
Patients with a current diagnosis of cancer
干预措施: Anti-CD19 CAR PBL (Drug)
结局指标
主要结局
Generating anti-tumor patient lymphocytes ex vivo
时间窗: Approximately 20 years
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
时间窗: Approximately 20 years
Conduct genomic, proteomic, and immunologic research studies on samples collected from patients with a current diagnosis of cancer.
To obtain autologous blood, stem cells, and/or tumor tissue from patients currently with cancer
时间窗: Approximately 20 years
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.
次要结局
- Repository of specimens and associated data(Approximately 20 years)
- Long-term storage of data and biospecimens(Approximately 20 years)