Protocol Number: 03-C-0277

Title:

Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols

Number:

03-C-0277

Summary:

This study will collect white blood cells from normal volunteers and white blood cells or tumor cells, or both, from patients with melanoma, kidney cancer, and ovarian cancer. The cells will be processed and used in experimental treatment studies for the patients under another protocol. The cells collected from patients will be processed in the laboratory to give them special tumor-fighting ability. The cells collected from normal volunteers will be used as growth factors for the cells during the period of laboratory growth.

The experimental therapy for which these cells will be used is called adoptive cell therapy. Patients in this study who are eligible for this experimental treatment will be enrolled in a subsequent treatment protocol, in which their treated cells will be returned to them for evaluation as a cancer-fighting therapy. This protocol deals only with collection and treatment of the cells from patients and healthy volunteers.

Healthy normal volunteers and patients with melanoma, renal cell carcinoma (kidney cancer) or ovarian cancer 16 years of age and older may be eligible for this study. Candidates will be screened with a medical history, physical examination, and blood tests. Participants will undergo the following tests and procedures:

Normal Volunteers

Normal volunteers will undergo leukapheresis, a procedure for collecting large numbers of white blood cells, at the NIH Blood Bank. Before the procedure, donors will fill out a standard blood donor questionnaire and have a blood test. Their temperature, blood pressure, and pulse will be checked. Hemoglobin will be checked with a finger stick test. For the apheresis, a needle is placed in a vein in each arm. Whole blood is collected through one needle, similar to donating blood. The blood circulates through a machine that separates the white cells from the red cells and plasma by a spinning process. The white cells are then removed and the rest of the blood is returned to the body through a needle in the other arm.

Patients

Patients will have leukapheresis (described above) or a tumor biopsy, or both. A biopsy is the surgical removal of a piece of tissue or tumor. A biopsy may be performed with a large needle, called a needle biopsy, with a small sharp cookie-cutter instrument, called a punch biopsy, or with a small knife, called an excisional biopsy. The procedure is similar for each. After the skin is cleaned thoroughly, a small amount of numbing medicine is given as a shot into the skin around the biopsy site. Then, if a needle biopsy is being done, a needle is put through the skin into the tumor to pull out a small piece of tumor in the length of the needle. If a punch biopsy is being done, the cookie-cutter instrument is pushed into the numbed skin, and a small piece of tissue is removed. This may require a suture to close the skin. If an excisional biopsy is required, depending on the location to be biopsied, this may be done in the operating room, in the patient's room, or in the clinic. The tissue is removed by cutting a small piece of tumor with a sharp knife or scalpel. This may or may not require a suture to close the skin.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Patients Undergoing Cell Harvesting:

Patients must have a form of cancer currently being studied with adoptive cell therapies in the Surgery Branch, e.g. melanoma, renal cell carcinoma, or ovarian cancer.

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:

Patients Undergoing Cell Harvesting:

Active systemic infections, coagulation disorders, or other major medical 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:

Seronegative for HBsAg, Anti-HBc, Anti-HCV, Anti-HIV-1/2, HIV NAT, anti-HTLV-1, RPR, and West Nile Virus NAT.

EXCLUSION CRITERIA:

Has been deferred from donating blood in the past

Has had any problems with prior donations

Has chest pain, heart disease, irregular heartbeats

Has high blood pressure or kidney disease

Has yellow jaundice, liver disease, or hepatitis

Has been treated for Diabetes

Has any bleeding abnormalities

Has swollen glands, night sweats, purple skin lesions, white spots of mouth or a Positive AIDS test

If female, has been pregnant in the last six weeks

In the last eight weeks has participated in other protocols

Has donated whole blood or blood components in the last month

Has had body piercing or tattoos within the past year

Has spent time outside the United States in the past year to a restricted country

Has participated in any high-risk activities

Special Instructions:

This protocol is not recuriting patients.

Keywords:

Adoptive Cell Therapy

Screening

PBMC

TIL Cells

Recruitment Keyword(s):

None

Condition(s):

Neoplasms

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

Recruitment Center - SB
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Building 10, Room 2-1730, Bethesda, Maryland 20892, United States
Phone: (866) 820-4505
Fax: (301) 451-1927
Electronic Address: ncisbirc@mail.nih.gov

Citation(s):

Yannelli JR, Hyatt C, McConnell S, Hines K, Jacknin L, Parker L, Sanders M, Rosenberg SA. Growth of tumor-infiltrating lymphocytes from human solid cancers: summary of a 5-year experience. Int J Cancer. 1996 Feb 8;65(4):413-21.

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