Harvesting Cells for Experimental Cancer Treatments
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 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 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.
|Official Title:||Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols|
|Study Start Date:||August 2003|
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 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.
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.
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.
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Steven A Rosenberg, M.D.||National Cancer Institute (NCI)|