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Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox Virus Encoding a gp100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox Virus Encoding a gp100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox Virus Encoding a gp100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence Clinical research trials and Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox Virus Encoding a gp100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox Virus Encoding a gp100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence. Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox Virus Encoding a gp100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox Virus Encoding a gp100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence clinical trial. Participants oftentimes recieve the finest healthcare available for their Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox Virus Encoding a gp100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), 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 Virus Encoding a gp100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence  Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox Virus Encoding a gp100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox Virus Encoding a gp100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
For Condition: Melanoma,Neoplasm Metastasis
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Patients with metastatic melanoma who are HLA-A201+ will be immunized with recombinant fowlpox virus encoding a modified peptide from the gp100 molecule preceded by a signal sequence designed to improve peptide presentation by antigen presenting cells. This virus will be administered either intramuscularly or intravenously. Patients will be evaluated for clinical response, as well as undergo studies of the immunologic response to the virus immunization.
Details: Patients with metastatic melanoma who are HLA-A201+ will be immunized with recombinant rF-gp100P209 virus encoding a modified peptide from the gp100 molecule preceded by a signal sequence designed to improve peptide presentation by antigen presenting cells. This virus will be administered either intramuscularly or intravenously. Patients will be evaluated for clinical response, as well as undergo studies of the immunologic response to the virus immunization.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Any patients age greater than or equal to 16 with measurable metastatic melanoma who is HLA-A201+, 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 1.6 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 must be 90,000 mm(3) or greater, Serum AST/ALT less than two times normal, ECOG performance status of 0, 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. Who require steroid therapy. Who are pregnant. Who are known to be positive for hepatitis B(S)AG or HIV antibody. Who have any form of primary or secondary immunodeficiency. Who are allergic to eggs. Must be eligible to receive IL-2. To be eligible to receive IL-2, patients may not have active major medical illnesses such as cardiac ischemia as evidenced by a stress thalium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease. To be eligible to receive IL-2, patients must be willing to sign a durable power of attorney (DPA).
Total Enrollment: 84
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990044; 99-C-0044
Study Start Date: February 24, 1999
Record last reviewed: February 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001800
Other Neoplasm Metastasis Studies:
1. Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer
2. Study of ILX651 in Patients with Inoperable Locally Advanced or Metastatic Melanoma
3. 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
4. Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
5. gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma
Related Studies:
Other Neoplasm Metastasis Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox Virus Encoding a gp100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
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