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Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols


N/A
16 Years
N/A
Open (Enrolling)
Both
Neoplasms

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Trial Information

Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols


BACKGROUND:

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.

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 Surgery Branch adoptive cell therapy clinical
trial, or for research purposes.

- To obtain autologous blood from patients with a history of cancer who currently have no
evidence of disease for research purposes.

- To obtain allogeneic PBMC via apheresis, or blood samples from normal 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.

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.

Normal 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. Patients with a history of cancer who currently have no evidence of disease
and subjects with spontaneous vitiligo must meet the laboratory safety testing for infection
and other criteria outlined in the protocol.

DESIGN:

Once a cancer patient is determined to have a cell product that meets the requirements of
one of the Surgery Branch clinical trials, the candidate will be screened according to the
eligibility evaluation of the prospective adoptive cell therapy trial, if eligible, the
patient 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 normal
volunteers for allogeneic PBMC used in generating autologous anti-tumor lymphocytes in the
laboratory, or for research purposes. This protocol will also allow for apheresis of
patients with a history of cancer, and apheresis and , blood samples and skin biopsies in
subjects with spontaneous vitiligo.

No treatments, investigational or standard therapy, will be administered on this protocol.

Inclusion 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 Surgery Branch.

- Patients must be greater than or equal to 16 years of age.

- Clinical performance status of ECOG 0 or 1.

- Life expectancy of greater than three months.

- 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 Surgery is required to obtain TIL for cell acquisition, the expected procedure
must be associated with minimal morbidity and minimal hospitalization.

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.

ELIGIBILITY CRITERIA FOR NORMAL DONORS:

INCLUSION CRITERIA:

- Normal donors must be greater than 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

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, 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

Eligibility Criteria for Subjects with Spontaneous Vitiligo and for Patients with a
history of cancer who currently have no evidence of disease.

INCLUSION CRITERIA:

- Greater than or equal to 18 years of age.

EXCLUSION CRITERIA:

- Has ongoing illness that would cause harm to the volunteer during the apheresis
procedure as determined by the Principal Investigator.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Steven A Rosenberg, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

030277

NCT ID:

NCT00068003

Start Date:

August 2003

Completion Date:

Related Keywords:

  • Neoplasms
  • Adoptive Cell Therapy
  • Screening
  • Cell Harvest
  • Blood
  • Tumor Tissue
  • Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892