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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 Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on 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 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials happen in a lot of of localities 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 measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as 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. 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 Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a 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 clinical trial. Human subjects often receive the most effective healthcare possible for their 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 condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: Melanoma,Neoplasm Metastasis
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Patients with metastatic cutaneous melanoma who are HLA-A0201(+) will be randomly assigned to receive immunization with a modified peptide from the gp100 molecule [gp100:209-217 (210M)] in Incomplete Freund's Adjuvant (IFA) followed by high dose IL-2 or to receive high dose IL-2 alone. Patients will be evaluated for clinical response, as well as undergo studies of the immunologic response to treatment. Since high dose IL-2 is currently approved by the U.S. Food and Drug Administration for use in treating patients with metastatic melanoma, the experimental nature of this protocol relates to the use of a vaccine in conjunction with IL-2.
Details: Patients with metastatic cutaneous melanoma who are HLA-A0201+ will be randomly assigned to receive immunization with a modified peptide from the gp100 molecule [gp100:209-217 (210M)] in Incomplete Freund's Adjuvant (IFA) followed by high dose IL-2 or to receive high dose IL-2 alone. Patients will be evaluated for clinical response, as well as undergo studies of the immunologic response to treatment. Since high dose IL-2 is currently approved by the U.S. Food and Drug Administration for use in treating patients with metastatic melanoma, the experimental nature of this protocol relates to the use of a vaccine in conjunction with IL-2.
Eligibility:
Study Type: Interventional, Treatment, Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Any patient age greater than or equal to 18 with measurable metastatic (Stage IV or locally advanced Stage III) cutaneous melanoma and 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. Pathologic confirmation of cutaneous melanoma. Patients may enter the study with a pathologic diagnosis of cutaneous melanoma from any institution. All slides will be reviewed at NIH (department of Anatomic Pathology) and if the diagnosis is not confirmed, the patient will be excluded from the study. Tissue type HLA A0201. EXCLUSION CRITERIA: Patients will be excluded: Who have types of melanoma other than cutaneous, i.e. ocular or mucosal. Who are undergoing or have undergone in the past 4 weeks any other form of therapy except surgery for their cancer, including radiation therapy to any site. who have active systemic infections, coagulation disorders, autoimmune disease or history of other major medical illnesses such as insulin dependent diabetes mellitus, cardiac ischemia, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary diseases and inflammatory bowel disorders. Who have significant psychiatric disease which in the opinion of the principal investigator would prevent adequate informed consent or render immunotherapy unsafe or contraindicated. Who require steroid therapy or steroid-containing compounds, or have used systemic steroids in the past 4 weeks, or have used topical or inhalational steroids in the past 2 weeks. Who are pregnant (because of possible side effects on the fetus). Who are known to be positive for viral hepatitis B or C (HBsAg or Anti HCV) or HIV. Who have any form of primary or secondary immunodeficiency. Who have received previous high dose IL-2 (greater than 600,000 IU/kg). Who have received previous gp100 vaccines. Who have an abnormal stress cardiac test (stress thallium, stress MUGA, dobutamine echocardiogram or other stress test that will rule out cardiac ischemia). Who have abnormal pulmonary function tests (FEV1 less than 65% or FVC less than 65% of predicted). Who have brain metastasis or history of brain metastasis.
Total Enrollment: 185
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990051; 99-C-0051
Study Start Date: February 26, 1999
Record last reviewed: January 29, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001801
Other Melanoma Studies:
1. Tyrosinase-Related Protein (TRP-2) Vaccination for Metastatic Melanoma
2. Study of Karenitecin (BNP1350) to treat Malignant Melanoma
3. A Phase I Study of Oral COL-3 (NSC-683551), a Matrix Metalloproteinase Inhibitor, in Patients with Refractory Metastatic Cancer
4. Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma
5. Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma
Related Studies:
Other Melanoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
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
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