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Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen conditions. Clinical Trials Search.org is a site devoted 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 healthcare trials take place in many of cities across 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 generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including 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 allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid 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 Neoplasm Metastasis Studies:
1. A Phase I Study of Weekly Gemcitabine Given in Combination with Infusional Fluorouracil and Oral and Intravenous Calcium Leucovorin in Adult Cancer Patients
2. Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects with Metastatic Malignant Melanoma
3. Phase I Study in Patients with Metastatic Melanoma of Immunization with Dendritic Cells Presenting Epitopes Derived from the Melanoma Associated Antigen MART-1 and gp100
4. Effect of Preoperative Chemotherapy on Axillary Lymph Node Metastases in Stage II Breast Cancer: A Prospective Randomized Trial
5. A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients with Primary and Metastatic Brain Tumors
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Other Neoplasm Metastasis Clinical Trials
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Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen
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