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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
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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
Melanoma Gastrointestinal Cancer Metastatic Cancer Breast Cancer Non-Small-Cell Lung Cancer

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Study Type : Observational
Actual Enrollment : 2109 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols
Actual Study Start Date : September 8, 2003

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Group/Cohort
1/Cancer Patients
Patients with a current diagnosis of cancer
2/Healthy Volunteers
Healthy volunteers



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
- Patients with a current diagnosis of cancer who are 18 years of age or older- Healthy volunteers who are 18 years of age or older and meet the safety evaluation criteria established by the FDA for donation of blood products, or, 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
Criteria
  • 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.
  • Seronegative 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 RPR.
  • 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.

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 Whole Blood Donors:

-Whole blood donors who do not meet the DTM criteria for allogeneic whole blood donation.


Information from the National Library of Medicine

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


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Steven A Rosenberg, M.D. National Cancer Institute (NCI)
Additional Information:
Publications:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00068003    
Obsolete Identifiers: NCT00897195
Other Study ID Numbers: 030277
03-C-0277
First Posted: September 4, 2003    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 4, 2021

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Adoptive Cell Therapy
Screening
Cell Harvest
Blood
Tumor Tissue
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases