|
Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Fowlpox Virus Encoding the gp100 Melanoma 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 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 site 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 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 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 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 Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Fowlpox Virus Encoding the gp100 Melanoma Antigen clinical trial. Test subjects oftentimes recieve the best 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. 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.
|
|
|
|
|
|
|
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. Vaccine Therapy and/or Sargramostim in Treating Patients With Locally Advanced or Metastatic Melanoma
2. Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects with Metastatic Malignant Melanoma
3. A Phase III Multi-Institutional Randomized Study of Immunization with the gp100: 209-217 (210M) Peptide Followed by High Dose IL-2 vs. High Dose IL-2 Alone in Patients with Metastatic Melanoma
4. Vaccination to Treat Melanoma in the Adjuvant Setting
5. Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of 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
|
|
|
|
|
|
|
|
