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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) National Institutes of Health (NIH) Rockefeller University |
Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00700167 |
Cancer cells make proteins called antigens that act as markers for the tumor cells. These antigens cannot cause the cancer itself. Special white blood cells, called T cells or T lymphocytes, recognize and respond to antigens. In many diseases, these and other cells in the immune system help your body get rid of the disease. However, T cells are normally resting, and they need other proteins on the diseased cell surface to begin working. Unfortunately, cancer cells do not usually make all the other proteins that T cells need to work. Therefore, T cells do not normally work against the cancer cells. We think this is one of the reasons that cancers grow and are not rejected by the body in the first place.
Another white blood cell, called a dendritic cell, does have most if not all of the special proteins needed to make T cells work to destroy cancer cells. However, dendritic cells do not normally have the cancer proteins on their surface. The challenge then is to combine the cancer markers (antigens) with these dendritic cells to make a vaccine. We think that the body's T cells might then react against the tumor and help destroy it. This study will see if putting tumor antigens made in a lab onto dendritic cells will make T cells work against tumor cells. We want to answer this question by injecting you with dendritic cells loaded with the antigens. Then we will check for a response based on lab studies and your own clinical course. We will compare your response against melanoma with your response against a common antigen, to which almost everyone has already been exposed. Flu, for example, is a common antigen to which most people have been exposed. We also need to test your response to an antigen that your body has not likely seen before. For example, we plan to use KLH (keyhole limpet hemocyanin), which is a pigment or color protein made from a sea creature known as a keyhole limpet. Each of these, the flu and KLH antigens, which should be harmless to you, will be used along with the dendritic cell-tumor vaccine. This will help us find out if the vaccine is working, based on the lab studies we will check before and after the vaccinations.
Condition | Intervention | Phase |
Melanoma |
Biological: dendritic cell vaccine |
Phase I |
MedlinePlus related topics: | Cancer Flu Melanoma |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Immune Responses To Antigen-Bearing Dendritic Cells in Patients With Malignancy - A Phase I Trial in Melanoma |
Enrollment: | 43 |
Study Start Date: | September 2001 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
The vaccine will be split between as many as 10 injections, more or less. Each shot will be about 1/25th to 1/50th of a teaspoon (100 to 200 microliters). Each vaccine will be injected with a tiny needle just under your skin. This will usually cause a very small area of swelling at the injection site that may last for a few minutes to an hour or so. You will receive two additional "booster" doses of the same vaccine every 4-6 weeks. This would mean that you receive a total of three vaccines over about 2-3 months. The vaccines will be given during an outpatient visit. If for some reason, you happen to be in the hospital, you can still receive the vaccines. These visits should take no longer than 15-30 minutes. |
Biological: dendritic cell vaccine
The vaccine will be split between as many as 10 injections, more or less. Each shot will be about 1/25th to 1/50th of a teaspoon (100 to 200 microliters). Each vaccine will be injected with a tiny needle just under your skin. This will usually cause a very small area of swelling at the injection site that may last for a few minutes to an hour or so. You will receive two additional "booster" doses of the same vaccine every 4-6 weeks. This would mean that you receive a total of three vaccines over about 2-3 months.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pregnancy tests are not required for post-menopausal women, and post-menopausal status by patient report should be documented accordingly.
United States, New York | |||||
Memorial Sloan Kettering Cancer Center | |||||
New York, New York, United States, 10065 |
Memorial Sloan-Kettering Cancer Center |
National Cancer Institute (NCI) |
National Institutes of Health (NIH) |
Rockefeller University |
Principal Investigator: | James Young, MD | Memorial Sloan-Kettering Cancer Center |
Memorial Sloan-Kettering Cancer Center 
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Responsible Party: | Memorial Sloan-Kettering Cancer Center ( James Young, M.D ) |
Study ID Numbers: | 98-098, NIH CA33049 |
First Received: | June 17, 2008 |
Last Updated: | June 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00700167 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
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