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Harvesting Cells for Experimental Cancer Treatments

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) Identifier:
First received: September 4, 2003
Last updated: April 21, 2017
Last verified: February 28, 2017


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.


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.


Patients must be eligible for a NCI Surgery Branch Treatment Protocol

Normal Volunteers must meet the criteria for blood donation


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.

Metastatic Melanoma
Metastatic Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 Surgery Branch adoptive cell therapy cl... [ Time Frame: 15 years ]

Enrollment: 1839
Study Start Date: August 22, 2003
Detailed Description:


There are numerous clinical trials underway in the Surgery Branch, NCI 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.


  • 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 Surgery Branch adoptive cell therapy clinical trial, or for research purposes.
  • To obtain allogeneic PBMC via apheresis, or blood samples from healthy volunteers for use in generating anti-tumor patient lymphocytes ex vivo, or for research.
  • To obtain PBMC via apheresis, blood samples, and skin biopsies from subjects with spontaneous vitiligo for research purposes. (With amendment-X, no longer enrolling in this cohort)
  • To conduct genomic, proteomic and immunologic research studies on samples collected.


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 HIV, HCV, HTLV, CMV, HBsAg, HBc, Trypanosoma cruzi, syphilis, and West Nile Virus. They must also meet the strict behavioral and medical history requirements.


Once a cancer patient is determined to be a potential candidate for one of the Surgery Branch 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.


Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • Patients must have a form of cancer currently being studied with adoptive cell therapies in the Surgery Branch.
  • Ability of subject or Legally Authorized Representative to understand and sign the Informed Consent Document.
  • Patients must be greater than or equal to 16 years of age.
  • Clinical performance status of ECOG 0 or 1.
  • Seronegative for HIV (The experimental treatments being evaluated depend upon an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities).
  • Seronegative for hepatitis B surface antigen and seronegative for antibody to hepatitis C. If hepatitis C antibody test is positive, then patients must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
  • If Surgery is required to obtain TIL for cell acquisition, the expected procedure must be associated with minimal morbidity and minimal hospitalization.


  • 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.



  • Normal donors must be greater than or equal to 18 years of age.
  • Seronegative for HBsAg, Anti-HBc, Anti-HCV, Anti-HIV-1/2, HIV- 1/HCV/HBV NAT, anti-HTLV-1/2, RPR, T. cruzi, and West Nile Virus NAT
  • Normal donors must meet the strict behavioral and medical history requirements


  • 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, has been pregnant in 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00068003

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Steven A Rosenberg, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Responsible Party: National Cancer Institute (NCI) Identifier: NCT00068003     History of Changes
Obsolete Identifiers: NCT00897195
Other Study ID Numbers: 030277
Study First Received: September 4, 2003
Last Updated: April 21, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
Adoptive Cell Therapy
Cell Harvest
Tumor Tissue

Additional relevant MeSH terms:
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes processed this record on April 26, 2017