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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 : July 16, 2018
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

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 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.

ELIGIBILITY:

Patients with cancer must be 16 years of age or older 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.

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 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 : 1914 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols
Study Start Date : August 22, 2003

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


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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
- Patients currently with cancer that are 16 years of age or older@@@- Healthy volunteers that meet the safety evaluation criteria established by the FDA for donation of blood products
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, or their parent(s)/legal guardian(s) (if the patient is less than 18 years of age), is able to understand and willing to sign a written Informed consent document.
  • Age greater than or equal to 16 years
  • All participants greater than 18 years of age must be willing to sign a durable power of attorney.
  • 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:

  • Healthy volunteers 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, anti-CMV, RPR, and other requirements as updated on the FDA website: https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/TissueSafety/ucm095440.htm#approved.
  • Healthy donors volunteers must meet the strict behavioral and medical history requirements

EXCLUSION CRITERIA:

  • 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 discretion.
  • Has ongoing illness that would cause harm to the volunteer during the apheresis procedure as determined by the Principal Investigator.
  • 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 body piercing or tatoos within the past year.
  • Has spent time outside the United States to a restricted country.
  • Has participated in any high-risk activities.

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
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
Principal Investigator: Steven A Rosenberg, M.D. National Cancer Institute (NCI)

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00068003     History of Changes
Obsolete Identifiers: NCT00897195
Other Study ID Numbers: 030277
03-C-0277
First Posted: September 4, 2003    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: June 19, 2018

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:
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Gastrointestinal Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases