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Immunization of Patients with Metastatic Melanoma Using Immunodominant Peptides from the Tyrosinase Protein, Tyrosinase Related Protein-1 (TRP1), or GP100 Protein Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Immunization of Patients with Metastatic Melanoma Using Immunodominant Peptides from the Tyrosinase Protein, Tyrosinase Related Protein-1 (TRP1), or GP100 Protein conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Immunization of Patients with Metastatic Melanoma Using Immunodominant Peptides from the Tyrosinase Protein, Tyrosinase Related Protein-1 (TRP1), or GP100 Protein Clinical research trials and Immunization of Patients with Metastatic Melanoma Using Immunodominant Peptides from the Tyrosinase Protein, Tyrosinase Related Protein-1 (TRP1), or GP100 Protein healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Immunization of Patients with Metastatic Melanoma Using Immunodominant Peptides from the Tyrosinase Protein, Tyrosinase Related Protein-1 (TRP1), or GP100 Protein. Immunization of Patients with Metastatic Melanoma Using Immunodominant Peptides from the Tyrosinase Protein, Tyrosinase Related Protein-1 (TRP1), or GP100 Protein Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Immunization of Patients with Metastatic Melanoma Using Immunodominant Peptides from the Tyrosinase Protein, Tyrosinase Related Protein-1 (TRP1), or GP100 Protein clinical trial. Subjects frequently obtain the most expert healthcare possible for their Immunization of Patients with Metastatic Melanoma Using Immunodominant Peptides from the Tyrosinase Protein, Tyrosinase Related Protein-1 (TRP1), or GP100 Protein condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Immunization of Patients with Metastatic Melanoma Using Immunodominant Peptides from the Tyrosinase Protein, Tyrosinase Related Protein-1 (TRP1), or GP100 Protein  Immunization of Patients with Metastatic Melanoma Using Immunodominant Peptides from the Tyrosinase Protein, Tyrosinase Related Protein-1 (TRP1), or GP100 Protein
Immunization of Patients with Metastatic Melanoma Using Immunodominant Peptides from the Tyrosinase Protein, Tyrosinase Related Protein-1 (TRP1), or GP100 Protein
For Condition: Melanoma,Neoplasm Metastasis
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is a study of melanoma tumor antigen peptide vaccines. The peptides representing HLA-A1 or A24 restricted T cell epitopes of the melanoma antigen, tyrosinase or the A31 restricted peptide from the melanoma antigen, tyrosinase related protein-1 (TRP-1) will be administered emulsified in Incomplete Freund's Adjuvant, (IFA) to patients with melanoma who express the appropriate HLA antigen. The study is designed to evaluate the potential therapeutic role, immunologic effects and toxicity of repeated doses of peptide vaccines administered subcutaneously. Immune reactivity to the epitope peptides 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 melanoma tumor antigen peptide vaccines. The peptides representing HLA-A1 or A24 restricted T cell epitopes of the melanoma antigen, tyrosinase or the A31 restricted peptide from the melanoma antigen, tyrosinase related protein-1 (TRP-1) or the A3 restricted peptide from the gp100 protein will be administered emulsified in Incomplete Freund's Adjuvant, (IFA) to patients with melanoma who express the appropriate HLA antigen. The study is designed to evaluate the potential therapeutic role, immunologic effects and toxicity of repeated doses of peptide vaccines administered subcutaneously. Immune reactivity to the epitope peptides 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: INCLUSION CRITERIA Any patient age greater than or equal to 16 with measurable metastatic melanoma who has failed standard treatment and has an expected survival of greater than three months will be considered. Eligible patients must be HLA-A1, HLA-A3, HLA-A24 or HLA-A31. Eligibility requirements include a 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 two times normal and ECOG performance status of 0 or 1. Patients of both genders must be willing to practice effective birth control during this trial. EXCLUSION CRITERIA Patients will be excluded: a. who are undergoing or have undergone in the past 3 weeks any other form of therapy except surgery for their cancer. b. have active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease. c. who require steroid therapy. d. who are pregnant. e. who are known to be positive for hepatitis BsAG or HIV antibody. f. who have had a known allergic reaction to Incomplete Freund's Adjuvant (IFA).
Total Enrollment: 457
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 980022; 98-C-0022
Study Start Date: October 30, 1997
Record last reviewed: September 26, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001684
Other Neoplasm Metastasis Studies:
1. Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma
2. Flt3L and CD40L to Treat Metastatic Melanoma and Kidney Cancer
3. Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer
4. Immunization of Patients with Metastatic Melanoma Using DNA Encoding the GP100 Melanoma Antigen
5. EPO906 Therapy in Patients with Advanced Melanoma
Related Studies:
Other Neoplasm Metastasis Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Immunization of Patients with Metastatic Melanoma Using Immunodominant Peptides from the Tyrosinase Protein, Tyrosinase Related Protein-1 (TRP1), or GP100 Protein
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