|
Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201 Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201 Clinical research trials and Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201 health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201. Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201 Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance 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 MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201 clinical trial. Test subjects typically receive the most expert healthcare available for their Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201 condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "I" Clinical Trials Conditions > Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201  Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201
Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201
For Condition: Melanoma,Neoplasm Metastasis
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Patients with metastatic melanoma who are HLA-A0201 positive will be immunized with peptides from the MART-1 and gp100 molecules that are modified to increase binding to HLA-A0201 positive. These peptides will be administered either alone or in combination with high dose IL-2. Patients will be evaluated for clinical response, as well as undergo studies of the immunologic response to the peptide immunization.
Details: Patients with metastatic melanoma who are HLA-A0201 positive will be immunized with peptides from the MART-1 and gp100 molecules that are modified to increase binding to HLA-A0201 positive. These peptides will be administered either alone or in combination with high dose IL-2. Patients will be evaluated for clinical response, as well as undergo studies of the immunologic response to the peptide immunization.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Any patient age 16 with measurable metastatic melanoma who is HLA-A0201 positive, 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 2.0 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 90,000 mm(3) or greater, Serum AST/ALT less than three times normal, ECOG performance status of 0 or 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. Patients with cardiovascular disease will be eligible to receive peptide in Montanide ISA-51 alone. Who require steroid therapy. Who are pregnant. Who are known to be positive for hepatitis B(s)Ag or HIV antibody. Who have previously been immunized to the MART-1 antigen. Who have any form of primary or secondary immunodeficiency.
Total Enrollment: 103
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990092; 99-C-0092
Study Start Date: April 15, 1999
Record last reviewed: March 27, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001808
Other Melanoma Studies:
1. A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer
2. A Randomized Phase II Study of High Dose Ketoconazole Plus Alendronate Versus High Dose Ketoconazole in Patients with Androgen Independent Metastatic Prostate Cancer
3. Immunization of Patients with Metastatic Melanoma Using Immunodominant Peptides from the Tyrosinase Protein, Tyrosinase Related Protein-1 (TRP1), or GP100 Protein
4. Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer
5. Antimetabolite Induction, High-Dose Alkylating Agent Consolidation and Retroviral Transduction of the MDR1 Gene into Peripheral Blood Progenitor Cells Followed by Intensification Therapy with Sequential Paclitaxel and Doxorubicin for Stage 4 Breast Cancer
Related Studies:
Other Melanoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201
|
|
|
|
|
|
|
|
