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gp100 and MART-1 Peptide Vaccine for Metastatic Ocular Melanoma Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on gp100 and MART-1 Peptide Vaccine for Metastatic Ocular Melanoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. gp100 and MART-1 Peptide Vaccine for Metastatic Ocular Melanoma Clinical research trials and gp100 and MART-1 Peptide Vaccine for Metastatic Ocular Melanoma healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like gp100 and MART-1 Peptide Vaccine for Metastatic Ocular Melanoma. gp100 and MART-1 Peptide Vaccine for Metastatic Ocular Melanoma Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a gp100 and MART-1 Peptide Vaccine for Metastatic Ocular Melanoma clinical trial. Human subjects often obtain the finest healthcare possible for their gp100 and MART-1 Peptide Vaccine for Metastatic Ocular Melanoma condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > gp100 and MART-1 Peptide Vaccine for Metastatic Ocular Melanoma  gp100 and MART-1 Peptide Vaccine for Metastatic Ocular Melanoma
gp100 and MART-1 Peptide Vaccine for Metastatic Ocular Melanoma
For Condition: Melanoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will examine the effectiveness and side effects of an experimental vaccine to treat ocular metastatic melanoma. Melanoma tumors produce proteins called gp100 and MART-1. Vaccination with specific pieces of these proteins (peptides) may boost the immune system's fight against the cancer. The vaccine injections are mixed with an oil-based substance called Montanide ISA-51, which is intended to increase the immune response to the peptide. Patients 16 years of age and older with progressive metastatic ocular melanoma and for whom standard treatments no longer work may be eligible for this study. Candidates will be screened with a complete physical and examination, including an eye examination, blood and urine tests, chest X-ray, electrocardiogram, X-ray and nuclear medicine imaging scans to evaluate the size and extent of tumor, and, if needed, a cardiac stress test and lung function test. In addition, patients will be tested for their HLA tissue type; patients must be type HLA-A*0201, the type on which this vaccine is based. Participants will receive two injections of both peptide vaccines (a total of four shots) in the thigh each week for 4 weeks. Some patients may undergo a biopsy -surgical removal of a small piece of tissue under local anesthetic-of normal skin and tumor or lymph node tissue to examine the effects of the vaccines on the tumor immune cells. Patients will also undergo plasmapheresis-a procedure to collect white blood cells-before treatment begins, after the second vaccination and 3 weeks after the fourth vaccination. For this procedure, blood is drawn through a needle in the arm, similar to donating blood. The blood goes through a machine that separates out the white cells (immune system cells), and the rest of the blood is returned through a needle in the other arm. Patients return for follow-up 3 to 4 weeks after the fourth injection. Patients in whom disease has not progressed or whose tumor has shrunk may receive additional 4-week treatment courses for up to 6 courses (24 immunizations). Patients whose tumor has not responded to therapy and who are physically eligible to receive a substance called interleukin-2 (IL-2) may receive a second series of vaccines together with this agent. IL-2 may boost the immune response to the peptides. It is given intravenously (through a small tube placed in a vein) every 8 hours for 5 days after each vaccination. Patients who respond to the vaccine and IL-2 may be offered additional courses of this treatment regimen.
Details: Patients who are HLA-A0201 positive with metastatic ocular melanoma will be immunized with peptides from the MART-1 and gp100 molecules that are modified to increase binding to HLA-A*0201. Patients will be evaluated for clinical response as well as undergo studies of the immunologic response to the peptide immunization. Patients with progressive disease after vaccination with peptide only, who are eligible to receive high-dose interleukin-2, will be offered treatment with vaccination plus interleukin-2.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Any patient age greater than or equal to 16 with measurable progressive metastatic ocular melanoma who is HLA-A*0201 positive. Must have an expected survival of greater than three months. Serum creatinine of 2.0 mg/dl or less. Total bilirubin 2.0 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 or 2. Patients of both genders must be willing to practice effective birth control during this trial. Patients who are undergoing or have undergone in the past 3 weeks any other form of therapy except surgery for their cancer are not eligible. Patients must not 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 must not require steroid therapy. Patients must not be pregnant. Patients must not be positive for hepatitis BsAG or HIV antibody. Patients must not have any form of primary or secondary immunodeficiency as evidenced by abnormal lymphocyte counts or presence of opportunistic infections. Patients must not have active major medical illnesses such as cardiac ischemia, myocardial infarction, cardiac arrhythmias, and obstructive or restrictive pulmonary disease to receive IL-2. Patients must be willing to sign a durable power of attorney (DPA) to receive IL-2.
Total Enrollment: 25
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 010074; 01-C-0074
Study Start Date: January 24, 2001
Record last reviewed: May 14, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009516
Other Melanoma Studies:
1. Immunization of Patients with Metastatic Melanoma Using Immunodominant Peptides from the Tyrosinase Protein, Tyrosinase Related Protein-1 (TRP1), or GP100 Protein
2. Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma
3. Vaccine Treatment for Advanced Melanoma
4. A Phase I Study of Oral COL-3 (NSC-683551), a Matrix Metalloproteinase Inhibitor, in Patients with Refractory Metastatic Cancer
5. Thalidomide and Dacarbazine for Metastatic Melanoma
Related Studies:
Other Melanoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
gp100 and MART-1 Peptide Vaccine for Metastatic Ocular Melanoma
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