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| Sponsored by: |
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 |
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Neoplasms |
| MedlinePlus related topics: | Cancer |
| Study Type: | Observational |
| Official Title: | Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols |
| Estimated Enrollment: | 1728 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | April 2006 |
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.
Objective:
The purpose of this protocol is to provide a mechanism for screening patients for these adoptive cell protocols, and obtaining and/or analyzing blood, stem cells and/or tumor tissue from potential candidates. It also allows for normal donor participation to obtain cells for product development.
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, HBsAg, HBc, and West Nile Virus. They must also meet the strict behavioral and medical history requirements.
Design:
Once a candidate 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. 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.
No treatments, investigational or standard therapy, will be administered on this protocol.
Eligibility
| Ages Eligible for Study: | 7 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Recruitment Center - SB | june_kryk@nih.gov | |
| Contact: Recruitment Center - SB | 8668204505 | june_kryk@nih.gov |
| United States, Maryland | |||||
| National Cancer Institute (NCI) | Recruiting | ||||
| Bethesda, Maryland, United States, 20892 | |||||
More Information
NIH Clinical Center Detailed Web Page
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| Study ID Numbers: | 030277, 03-C-0277 |
| First Received: | September 4, 2003 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00068003 |
| Health Authority: | United States: Federal Government |
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