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Tyrosinase-Related Protein (TRP-2) Vaccination for Metastatic Melanoma 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 Tyrosinase-Related Protein (TRP-2) Vaccination for Metastatic Melanoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Tyrosinase-Related Protein (TRP-2) Vaccination for Metastatic Melanoma Clinical research trials and Tyrosinase-Related Protein (TRP-2) Vaccination for Metastatic Melanoma 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 Tyrosinase-Related Protein (TRP-2) Vaccination for Metastatic Melanoma. Tyrosinase-Related Protein (TRP-2) Vaccination for Metastatic Melanoma 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 Tyrosinase-Related Protein (TRP-2) Vaccination for Metastatic Melanoma clinical trial. Subjects often receive the most expert healthcare possible for their Tyrosinase-Related Protein (TRP-2) Vaccination for Metastatic Melanoma 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 > "T" Clinical Trials Conditions > Tyrosinase-Related Protein (TRP-2) Vaccination for Metastatic Melanoma  Tyrosinase-Related Protein (TRP-2) Vaccination for Metastatic Melanoma
Tyrosinase-Related Protein (TRP-2) Vaccination for Metastatic Melanoma
For Condition: Melanoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will test the safety and effectiveness of an experimental vaccine for fighting metastatic melanoma. The vaccine contains a peptide (piece of a protein) called tyrosinase-related protein-2 (TRP-2), which is made by some kinds of cancers. It also contains an oil-based liquid called Montanide ISA-51, another experimental substance, which is intended to boost the immune reaction to the peptide. Patients 16 years of age and older who have metastatic melanoma that does not respond to standard treatment may be eligible for this study. Candidates will be screened with a medical history and physical examination, chest X-ray, electrocardiogram, blood and urine tests, and X-rays and scans to the evaluate the extent and size of the tumor. Because the vaccine formulation is based on tissue type, only patients with tissue type HLA-A*0201 may participate. Tissue type is determined by a blood test. Depending on the size and extent of tumor, participants will receive either the vaccine alone or the vaccine plus interleukin-2 (IL-2), a drug that boosts the immune reaction to the tumor. Patients who do not immediately require IL-2 will be randomly assigned to receive the vaccine either 1) once a week for 4 weeks, followed by a 3-week break, and then again once a week for 4 weeks; or 2) once every 3 weeks for four times. The vaccine is given as an injection (shot) in the thigh. A physical examination and blood tests will be done at each treatment visit to monitor side effects and any reaction to the vaccine. For patients receiving IL-2, this drug will be infused through a vein over 15 minutes every 8 hours for 4 days after each vaccine injection. They will be required to stay in the hospital for about one week during each treatment cycle. About 40 cc (8 teaspoons) of blood will be drawn every 3 weeks to monitor body functions. Patients will undergo leukapheresis to evaluate how the vaccine affects the action of lymphocytes-white blood cells of the immune system. For this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The lymphocytes are then removed and the rest of the blood-red cells, platelets and plasma-is returned to the body through a second needle in the other arm. All patients will undergo leukapheresis just before beginning treatment. The procedure may be repeated after the fourth and eighth vaccines in patients receiving weekly injections, and after the second and fourth vaccine cycles in patients receiving injections every 3 weeks. Patients will return for follow-up studies after the fourth and eighth weekly injections, or after the second and fourth injections for those on the every-3-weeks injection schedule. If the tumor has responded to the vaccine, the treatment may be repeated on the same schedule for up to 12 months, with continuing follow-up visits. Some patients may have a needle biopsy of normal skin and tumor or lymph node to examine the effects of the vaccine on the immune cells in the tumor. For this procedure, a needle is put into the skin or tumor and a small amount of tissue is withdrawn. Patients whose cancer progresses during treatment with the peptide vaccine alone may then receive IL-2 if their condition permits. In other studies with melanoma patients, those who received a peptide vaccine plus IL-2 had more tumor shrinkage than those receiving just vaccine alone or just IL-2 alone.
Details: Patients with metastatic melanoma who are HLA-A0201 positive will be immunized with a peptide from the TRP-2 molecule. This peptide will be administered by one of two immunization schedules. Patients will undergo studies of the immunologic response to the peptide immunization and will be evaluated for clinical response.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Any patient age greater than or equal to16 with measurable metastatic melanoma who is HLA-A0201 positive, has disease refractory to standard treatment and has an expected survival of greater than three months will be considered. Patients with resectable local/regional disease would undergo standard treatment with surgical resection and not be eligible. Serum creatinine of 2.0 mg/dl or less, Total bilirubin 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/mm3 or greater, Platelet count 90,000 mm3 or greater, Serum AST/ALT less then three times normal, ECOG performance status of 0, 1 or 2. Patients of both genders must be willing to practice effective birth control during this trial. Must be willing to undergo leukapheresis Patients with resected brain metastases, brain metastases which are table after radiosurgery, or patients with brain metastases less than 1 cm without edema, will be eligible to participate. 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 systemic steroid therapy. Who are pregnant. Who are known to be positive for hepatitis B2AG or HIV antibody (because of possible immune effects of these conditions). Who have previously been immunized to the TRP-2 antigen. Who have any form of primary or secondary immunodeficiency or who have not recovered from immune compromise after chemotherapy or radiation therapy as evidenced by abnormal lymphocyte counts, abnormal WBC or presence of opportunistic infections. To be eligible to receive IL-2, patients may not have active major medical illnesses such as cardiac ischemia as evidenced by a stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restive pulmonary disease. To be eligible to receive IL-2 , patients must be willing to sign a durable power of attorney (DPA).
Total Enrollment: 83
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 010193; 01-C-0193
Study Start Date: June 13, 2001
Record last reviewed: June 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017849
Other Melanoma Studies:
1. A Phase I Study of Intralesional Administration of an Adenovirus Vector Expressing the HSV-1 Thymidine Kinase Gene (AdV.RSV-TK) in Combination with Escalating Doses of Ganciclovir in Patients with Cutaneous Metastatic Malignant Melanoma
2. Peptide Vaccination for Patients at High Risk for Recurrent Melanoma
3. Immunotherapy with Autologous Dexosomes for Patients with Stage IV Melanoma
4. gp100 and MDX-010 Vaccination for Stage IV Melanoma
5. Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma
Related Studies:
Other Melanoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Tyrosinase-Related Protein (TRP-2) Vaccination for Metastatic Melanoma
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