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Immunization of HLA-A201 Patients with Metastatic Melanoma Using a Combination of Immunodominant Peptides from Three Melanoma Antigens, MART-1, GP100 and Tyrosinase Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Immunization of HLA-A201 Patients with Metastatic Melanoma Using a Combination of Immunodominant Peptides from Three Melanoma Antigens, MART-1, GP100 and Tyrosinase conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Immunization of HLA-A201 Patients with Metastatic Melanoma Using a Combination of Immunodominant Peptides from Three Melanoma Antigens, MART-1, GP100 and Tyrosinase Clinical research trials and Immunization of HLA-A201 Patients with Metastatic Melanoma Using a Combination of Immunodominant Peptides from Three Melanoma Antigens, MART-1, GP100 and Tyrosinase healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Immunization of HLA-A201 Patients with Metastatic Melanoma Using a Combination of Immunodominant Peptides from Three Melanoma Antigens, MART-1, GP100 and Tyrosinase. Immunization of HLA-A201 Patients with Metastatic Melanoma Using a Combination of Immunodominant Peptides from Three Melanoma Antigens, MART-1, GP100 and Tyrosinase Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Immunization of HLA-A201 Patients with Metastatic Melanoma Using a Combination of Immunodominant Peptides from Three Melanoma Antigens, MART-1, GP100 and Tyrosinase clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Immunization of HLA-A201 Patients with Metastatic Melanoma Using a Combination of Immunodominant Peptides from Three Melanoma Antigens, MART-1, GP100 and Tyrosinase condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Immunization of HLA-A201 Patients with Metastatic Melanoma Using a Combination of Immunodominant Peptides from Three Melanoma Antigens, MART-1, GP100 and Tyrosinase  Immunization of HLA-A201 Patients with Metastatic Melanoma Using a Combination of Immunodominant Peptides from Three Melanoma Antigens, MART-1, GP100 and Tyrosinase
Immunization of HLA-A201 Patients with Metastatic Melanoma Using a Combination of Immunodominant Peptides from Three Melanoma Antigens, MART-1, GP100 and Tyrosinase
For Condition: Melanoma,Neoplasm Metastasis
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is a study of a melanoma tumor antigen peptide vaccine. Peptides representing HLA-A201 restricted T cell epitopes of the melanoma antigens, MART-1, gp100 and tyrosinase will be administered emulsified in Incomplete Freund's Adjuvant, (IFA) to HLA-A201 patients with melanoma. The study is designed to evaluate the potential therapeutic role, immunologic effects and toxicity of repeated doses of this peptide vaccine administered subcutaneously. Immune reactivity to the peptide epitope will be monitored in all patients by analysis of melanoma-specific T cell precursors prior to and after immunization.
Details: This is a study of a melanoma tumor antigen peptide vaccine. Peptides representing HLA-A201 restricted T cell epitopes of the melanoma antigens, MART-1, gp100 and tyrosinase will be administered emulsified in Incomplete Freund's Adjuvant, (IFA) to HLA-A201 patients with melanoma. The study is designed to evaluate the potential therapeutic role, immunologic effects and toxicity of repeated doses of this peptide vaccine administered subcutaneously. Immune reactivity to the peptide epitope will be monitored in all patients by analysis of melanoma-specific T cell precursors prior to and after immunization.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Any patient 16 years of age or older with measurable metastatic melanoma who has failed standard treatment and has an expected survival of greater than three months. Must be HLA-A0201. 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 then two times normal. ECOG performance status of 0 or 1. Patients of both genders must be willing to practice effective birth control during the trial. Must not be undergoing or have undergone in the past 3 weeks any other form of therapy except surgery for their cancer. Must not have active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease. Must not require steroid therapy. Must not be pregnant. Must not be positive for hepatitis B(s)AG or HIV antibody. Must not have had a known allergic reaction to Incomplete Freund's Adjuvant (IFA).
Total Enrollment: 114
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 980023; 98-C-0023
Study Start Date: November 3, 1997
Record last reviewed: October 1, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001685
Other Neoplasm Metastasis Studies:
1. CPG 7909 in Melanoma
2. A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion with Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients with Locally Advanced Extremity Melanoma
3. Treatment of Patients with Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide
4. gp100 and MDX-010 Vaccination for Stage IV Melanoma
5. Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
Related Studies:
Other Neoplasm Metastasis Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Immunization of HLA-A201 Patients with Metastatic Melanoma Using a Combination of Immunodominant Peptides from Three Melanoma Antigens, MART-1, GP100 and Tyrosinase
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