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Home > "C" Clinical Trials Conditions > Comparison of Two Kinds of Dendritic Cell Immunizations in Treating Melanoma  Comparison of Two Kinds of Dendritic Cell Immunizations in Treating Melanoma
Comparison of Two Kinds of Dendritic Cell Immunizations in Treating Melanoma
For Condition: Melanoma,Neoplasm Metastasis
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will look at the safety and effectiveness of immunizations derived from two different substances in fighting melanoma. Both immunizations will contain dendritic cells-a type of cell that boosts immune system activity-but the cells will be produced by two different methods and their effects on the immune response compared. The body normally produces small amounts of dendritic cells, but large numbers of these cells can be made in the laboratory. In this study, one group of patients will receive dendritic cells derived from a type of white blood cell called monocytes, and a second group will receive cells derived from what are called stem cells. Small amounts of protein substances called gp100 and MART-1 that are found in most melanoma cells will be added to both types of dendritic cells. These protein substances may provoke the immune system to attack the tumor cells in much the same way a vaccine works. Patients in both groups will receive four cycles of immunizations four weeks apart. In the first two cycles, the cells will be injected into lymph vessels, and in the next two, they will be injected under the skin. Patients will also undergo apheresis-a procedure in which whole blood is drawn much like donating blood, but the lymphocytes are separated out by a machine and the rest of the blood is then returned to the body. This procedure may be repeated from two to four times during the study, depending on which immunization group the patient is in. Some patients may be asked to have a lymph node biopsy (removal of a few lymph nodes) to examine the effects of the dendritic cells. Some patients may also receive injections of a drug to boost white cell production.
Details: HLA-A201 positive patients with high risk stage III melanoma or completely resected metastatic melanoma will receive dendritic cells pulsed with peptides representing HLA-A201 restricted T cell epitopes of the melanoma antigens, MART-1:26-35(27L) and gp100. Dendritic cells will be administered intralymphatically for 2 cycles, then subcutaneously for 2 cycles. Patients will be randomized to receive either CD34-derived or peripheral monocyte derived dendritic cells. This study is designed to compare the immunologic effects of CD34-derived and peripheral monocyte derived dendritic cells.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Any HLA-201 positive patient with high risk stage III melanoma (greater than 3 lymph nodes positive) or completely resected metastatic melanoma within 6 months of surgical resection will be considered. Patients must be disease free at the time of protocol entry, as documented by radiologic studies including full body CT scans within 4 weeks of patient entry. Serum creatinine of 2.0 mg/dl or less. Bilirubin 1.6 mg/dl or less. WBC 3000/mm(3) or greater. Platelet count 90,000 mm(3) or greater. Serum AST/ALT less than three times normal. ECOG performance status of 0 or 1. 16 years old or greater. Patients or legal guardian must be able to provide an informed consent. Patients must not be undergoing or have undergone in the past month any other form of therapy except surgery for their cancer. Patients must not have active systemic infections, coagulation disorders, history of autoimmune disorders or other major medical illnesses of the cardiovascular or respiratory systems. Patients must not require systemic steroid therapy. Females must not be pregnant and/or breast feeding. Patients must not be known to be positive for hepatitis B(S)Ag, or HIV antibody. Patients must not have previously been immunized with MART-1:26-35(27L) or gp100 peptide, G9-209-2M.
Total Enrollment: 28
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990132; 99-C-0132
Study Start Date: July 7, 1999
Record last reviewed: May 14, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001825
Other Melanoma Studies:
1. Comparison of Two Kinds of Dendritic Cell Immunizations in Treating Melanoma
2. CTLA-4 Antibody (MDX-010) Plus Interleukin-2 to Treat Advanced Melanoma
3. gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma
4. Immunotherapy with Autologous Dexosomes for Patients with Stage IV Melanoma
5. Tyrosinase-Related Protein (TRP-2) Vaccination for Metastatic Melanoma
Related Studies:
Other Melanoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Comparison of Two Kinds of Dendritic Cell Immunizations in Treating Melanoma
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