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Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Fowlpox Virus Encoding the gp100 Melanoma Antigen Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Fowlpox Virus Encoding the gp100 Melanoma Antigen conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Fowlpox Virus Encoding the gp100 Melanoma Antigen Clinical research trials and Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Fowlpox Virus Encoding the gp100 Melanoma Antigen medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Fowlpox Virus Encoding the gp100 Melanoma Antigen. Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Fowlpox Virus Encoding the gp100 Melanoma Antigen Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Fowlpox Virus Encoding the gp100 Melanoma Antigen clinical trial. Subjects often receive the most expert healthcare possible for their Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Fowlpox Virus Encoding the gp100 Melanoma Antigen condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Fowlpox Virus Encoding the gp100 Melanoma Antigen  Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Fowlpox Virus Encoding the gp100 Melanoma Antigen
Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Fowlpox Virus Encoding the gp100 Melanoma Antigen
For Condition: Melanoma,Neoplasm Metastasis
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Vaccination with and without Biological Response Modifier Therapy. Vaccination with recombinant fowlpox virus encoding the gp100 melanoma antigen, FPV-gp100, NSC-673927; with and without Interleukin-2 (Chiron), IL-2, NSC-373364.
Details: Patients with metastatic melanoma who are hepatitis B negative and HIV negative will be immunized with a recombinant fowlpox virus encoding the gp100 melanoma antigen. This study will evaluate the toxicity, immunologic effects and potential therapeutic role of this immunization alone or in conjunction with the administration of interleukin-2.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients must have evidence of measurable or evaluable metastatic melanoma that has failed standard effective therapy. Age greater than or equal to 18 years. Patients must have undergone standard HLA typing of peripheral blood lymphocytes. Patients must have a histologic diagnosis of melanoma confirmed by pathologists at the NIH. Clinical performance status of ECOG 0, 1 or 2. White blood cell count greater than 3,000/mm(3). Platelet count greater than 100,000/mm(3). Hemoglobin greater than 8.0 g/dl. Serum ALT/AST less than four times the upper limit of normal. Serum creatinine less than or equal to 1.6 mg/dl. Bilirubin less than or equal to 2.0 mg/dl. More than 20 days must have elapsed since any prior therapy. Women of child-bearing potential must have a negative pregnancy test and be willing to use an effective method of contraception during the trial. Life expectancy of greater than three months. No steroid therapy required. Seronegative for HIV antibody. Seronegative for hepatitis B antigen. EXCLUSION CRITERIA: No active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system. Patients with eczema psoriasis or hypersensitivity to eggs will be excluded.
Total Enrollment: 91
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 960121; 96-C-0121
Study Start Date: August 1, 1996
Record last reviewed: May 20, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001510
Other Neoplasm Metastasis Studies:
1. gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma
2. gp100 and MDX-010 Vaccination for Stage IV Melanoma
3. Treating Inoperable Lung Tumors With Heated Chemotherapy Medicine Delivered Solely to the Lung
4. Immunization of Patients with Metastatic Melanoma Using DNA Encoding the GP100 Melanoma Antigen
5. Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects with Metastatic Malignant Melanoma
Related Studies:
Other Neoplasm Metastasis Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Fowlpox Virus Encoding the gp100 Melanoma Antigen
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