Harvesting Cells for Experimental Cancer Treatments - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00068003

Purpose

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.

Condition
Neoplasms

Study Type:	Observational
Official Title:	Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

Estimated Enrollment:	2500
Study Start Date:	August 2003

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068003

Contacts

Contact: Recruitment Center - SB	(866) 820-4505	ncisbirc@mail.nih.gov
Contact: June Kryk, R.N.	(301) 451-1929	ncisbirc@mail.nih.gov

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892
Sub-Investigator: NCI/Surgery Branch Recruitment Center For more information at the NIH Clinical Center contact

Sponsors and Collaborators

National Cancer Institute (NCI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00068003 History of Changes
Obsolete Identifiers:	NCT00897195
Other Study ID Numbers:	030277, 03-C-0277
Study First Received:	September 4, 2003
Last Updated:	December 30, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Adoptive Cell Therapy
Screening
Cell Harvest
Blood
Tumor Tissue

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on February 12, 2012