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Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen Clinical research trials and Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen. Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen clinical trial. Participants frequently obtain the most expert healthcare available for their Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen  Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen
Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen
For Condition: Melanoma,Neoplasm Metastasis
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Patients with metastatic melanoma will be immunized with recombinant fowlpox and vaccinia viruses encoding the melanoma associated antigen, tyrosinase. Patients will be eligible for this protocol regardless of HLA type, since tyrosinase contains multiple immunogenic peptides recognized by CD4+ and CD8+ T cells in the context of a variety of HLA alleles. The viruses will be administered intramuscularly on an alternating schedule (heterologous boosting) designed to minimize immune reactions against viral proteins and maximize responses against the tyrosinase transgene. In this randomized phase II therapy trial, patients will be assigned to one of three treatment groups: vaccine alone, vaccine administered with low dose subcutaneous IL-2, or vaccine administered with high dose intravenous IL-2. Patients will be evaluated for clinical as well as immunological responses.
Details: Patients with metastatic melanoma will be immunized with recombinant fowlpox and vaccinia viruses encoding the melanoma associated antigen, tyrosinase. Patients will be eligible for this protocol regardless of HLA type, since tyrosinase contains multiple immunogenic peptides recognized by CD4+ and CD8+ T cells in the context of a variety of HLA alleles. The viruses will be administered intramuscularly on an alternating schedule (heterologous boosting) designed to minimize immune reactions against viral proteins and maximize responses against the tyrosinase transgene. In this randomized phase II therapy trial, patients will be assigned to one of three treatment groups: vaccine alone, vaccine administered with low dose subcutaneous IL-2, or vaccine administered with high dose intravenous IL-2. Patients will be evaluated for clinical as well as immunological responses.
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. Serum creatinine of 1.6 mg/dl or less. Total 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. Patients of both genders must be willing to practice effective birth control during this trial. Patients must be able to avoid close contact with children less than 5 years of age, pregnant women, individuals with active or a past history of eczema or other eczematoid skin disorders, and immuno-suppressed individuals for two weeks after each vaccinia vaccination. EXCLUSION CRITERIA: Patients will be excluded: Who are undergoing or have undergone in the past 3 weeks any form of systemic therapy for their cancer. Who have active systemic infections, coagulation disorders, autoimmune disease or other major medical illnesses of the cardiovascular or respiratory systems. Who require steroid therapy. Who are pregnant or nursing. Who are known to be positive for hepatitis BsAg or anti-HIV antibody. Who have any form of primary or secondary immunodeficiency. Who are allergic to eggs. Who have existing brain metastases. Who have active atopic dermatitis or active or a past history of eczema, because of the risk of eczema vaccinatum. Patients with active cases of extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns or other traumatic or pruritic skin conditions or open wounds should not be treated until the condition has resolved. Surgical scars must be healed. Patients with healed surgical stomas (e.g., colostomy) will be eligible. Who have been inoculated with recombinant vaccinia or fowlpox vaccines to treat melanoma, because of anticipated high serum titers of neutralizing anti-viral antibodies. Whose primary site of melanoma was ocular or mucosal.
Total Enrollment: 73
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990095; 99-C-0095
Study Start Date: April 22, 1999
Record last reviewed: March 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001811
Other Melanoma Studies:
1. Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma
2. A Phase I Study of gp100 Human Melanoma Peptide Vaccine with Incomplete Freund's Adjuvant
3. gp100 and MDX-010 Vaccination for Stage IV Melanoma
4. Immunization of Patients with Metastatic Melanoma Using DNA Encoding the GP100 Melanoma Antigen
5. Surgery vs. Chemotherapy in Patients with Stage IV Melanoma
Related Studies:
Other Melanoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen
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