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gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma Clinical research trials and gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma. gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma clinical trial. Test subjects typically receive the most expert healthcare available for their gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma  gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma
gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma
For Condition: Melanoma,Neoplasm Metastasis
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will examine the effectiveness and side effects of an experimental vaccine against metastatic melanoma (melanoma that has spread beyond the original site). Melanoma tumors produce proteins called gp100 and MART-1. Vaccination with specific pieces of these proteins (peptides) may boost the immune system's fight against the cancer. Candidates for this study-patients with metastatic melanoma-will have a physical examination and blood tests, as well as X-rays and imaging scans if current ones are not available. Participants will have tests to determine the size and extent of their tumor and will then be given a series of four vaccinations-one every 3 weeks. The vaccine will be injected under the skin of the thighs; it may contain either one or three peptides, depending on the individual's specific tissue type, which will be determined by a blood test. If the tumor does not shrink by the end of the treatment, patients whose condition permits may receive a second series of vaccines, along with a substance called IL-2, which may boost the immune response to the peptides. IL-2 is given intravenously (through a small tube placed in a vein) every 8 hours for 5 days after each vaccination. Patients may receive up to 12 cycles of treatment (peptide injections), and will continue to be followed if the tumor responds to treatment. Blood will be drawn every 3 weeks during the study and daily for patients receiving IL-2. Patients will also undergo plasmapheresis just before treatment begins, and this procedure may be repeated before the third and after the last vaccination. In plasmaphereis, blood is drawn through a needle in the arm, similar to donating blood. The blood goes through a machine that separates out the white cells (immune system cells), and the rest of the blood is returned through a needle in the other arm. Patients may also have biopsies (removal of a small piece of tissue for microscopic examination) of normal skin and tumor or lymph nodes.
Details: Patients with metastatic melanoma who are HLA-DRB1*0401+, HLA-A0201+ will be immunized with class I restricted peptides from the gp100 and MART-1 molecules and a class II restricted peptide from the gp100 molecule. Patients who are HLA-DRB1*0401+, HLA-A0201- will be immunized only with the class II restricted peptide. Patients will be evaluated for clinical response, as well as undergo studies of the immunologic response to the peptide immunization.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA Any patient age greater than or equal to 16 with metastatic melanoma who is HLA-DRB1*0401+, has failed standard treatment and has an expected survival of greater than three months will be considered. Serum creatinine of 2.0 mg/dl or less. Total bilirubin 2.0 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 or 2. Patients of both genders must be willing to practice effective birth control during this trial. EXCLUSION CRITERIA Patients will be excluded: Who are undergoing or who have undergone in the past 3 weeks any other form of therapy except surgery for their cancer. Have active systemic infections, symptomatic cardiac disease, autoimmune disease or any known immunodeficiency disease. Who require steroid therapy. Who are pregnant or lactating. Who are known to be positive for hepatitis BsAG or HIV antibody. Who have any form of primary or secondary immunodeficiency. Who have previously been immunized to the entire gp100 molecule.
Total Enrollment: 75
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990159; 99-C-0159
Study Start Date: August 23, 1999
Record last reviewed: August 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001833
Other Melanoma Studies:
1. Immunization of Patients with Metastatic Melanoma Using the GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
2. Vaccine Treatment for Advanced Melanoma
3. Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma
4. A Phase I Study of Intralesional Administration of an Adenovirus Vector Expressing the HSV-1 Thymidine Kinase Gene (AdV.RSV-TK) in Combination with Escalating Doses of Ganciclovir in Patients with Cutaneous Metastatic Malignant Melanoma
5. Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox Virus Encoding a gp100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
Related Studies:
Other Melanoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma
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