Harvesting Cells for Experimental Cancer Treatments

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Enrolling by invitation

CT.gov ID

NCT00068003

Collaborator

(none)

7,000

Enrollment

Location

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma Gastrointestinal Cancer Metastatic Cancer Breast Cancer Non-Small Cell Lung Cancer

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, 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.

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 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 the cell therapy treatment trials.

Healthy volunteers for PBMC donation must meet the safety evaluation criteria established by the FDA for donation of blood products including HBsAg, HBc, HCV, HIV, HTLV, Trypanosoma cruzi, West Nile Virus, and syphilis. 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

7000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols

Actual Study Start Date :

Sep 8, 2003

Arms and Interventions

Arm	Intervention/Treatment
1/Cancer Patients Patients with a current diagnosis of cancer
2/Healthy Volunteers Healthy volunteers

Outcome Measures

Primary Outcome Measures

Generation of anti-tumor patient lymphocytes ex vivo [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.
Development of genomic, proteomic, and immunologic research studies [Approximately 20 years]
Conduct genomic, proteomic, and immunologic research studies on samples collected from patients with a current diagnosis of cancer.
Bank of autologous blood, stem cells, and/or tumor tissue from patients currently with cancer [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 future enrollment on an NCI-SB adoptive cell therapy clinical trial.

Secondary Outcome Measures

Repository of specimens and associated data [Approximately 20 years]
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 [Approximately 20 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

ELIGIBILITY CRITERIA FOR PATIENTS WITH A CURRENT DIAGNOSIS OF CANCER:

INCLUSION CRITERIA:

Patients must have a form of cancer currently being studied with adoptive cell therapies 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 1.
Serology
Seronegative for HIVantibody. (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

EXCLUSION CRITERIA:

Active systemic infections, coagulation disorders, or other major medial illnesses of the cardiovascular, respiratory, or immune system.
Patients who cannot give proper informed consent to the adoptive cell 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, and syphilis.
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 Creutzfeld-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 11.
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 xenotransplantaion 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 tatoos 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.