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Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201 Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201 conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201 Clinical research trials and Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201 medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201. Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201 Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201 clinical trial. Subjects typically recieve the finest healthcare available for their Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201 condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201  Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201
Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201
For Condition: Melanoma,Neoplasm Metastasis
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Patients with metastatic melanoma who are HLA-A0201 positive will be immunized with peptides from the MART-1 and gp100 molecules that are modified to increase binding to HLA-A0201 positive. These peptides will be administered either alone or in combination with high dose IL-2. Patients will be evaluated for clinical response, as well as undergo studies of the immunologic response to the peptide immunization.
Details: Patients with metastatic melanoma who are HLA-A0201 positive will be immunized with peptides from the MART-1 and gp100 molecules that are modified to increase binding to HLA-A0201 positive. These peptides will be administered either alone or in combination with high dose IL-2. 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 16 with measurable metastatic melanoma who is HLA-A0201 positive, 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 of 2.0 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl. 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 have undergone in the past 3 weeks any other form of therapy except surgery for their cancer. Have active systemic infections, coagulation disorders, autoimmune disease or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease. Patients with cardiovascular disease will be eligible to receive peptide in Montanide ISA-51 alone. Who require steroid therapy. Who are pregnant. Who are known to be positive for hepatitis B(s)Ag or HIV antibody. Who have previously been immunized to the MART-1 antigen. Who have any form of primary or secondary immunodeficiency.
Total Enrollment: 103
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990092; 99-C-0092
Study Start Date: April 15, 1999
Record last reviewed: March 27, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001808
Other Neoplasm Metastasis Studies:
1. Immunization of Patients with Metastatic Melanoma Using the GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
2. Vaccine Plus Interleukin-2 Treatment of Metastatic Melanoma
3. Immunotherapy with Autologous Dexosomes for Patients with Stage IV Melanoma
4. gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma
5. A Phase I Study of gp100 Human Melanoma Peptide Vaccine with Incomplete Freund's Adjuvant
Related Studies:
Other Neoplasm Metastasis Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201
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