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gp100 and MDX-010 Vaccination for Stage IV Melanoma Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about gp100 and MDX-010 Vaccination for Stage IV Melanoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. gp100 and MDX-010 Vaccination for Stage IV Melanoma Clinical research trials and gp100 and MDX-010 Vaccination for Stage IV Melanoma healthcare trials happen in hundreds of localities throughout 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as gp100 and MDX-010 Vaccination for Stage IV Melanoma. gp100 and MDX-010 Vaccination for Stage IV Melanoma Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a gp100 and MDX-010 Vaccination for Stage IV Melanoma clinical trial. Subjects frequently obtain the most expert healthcare possible for their gp100 and MDX-010 Vaccination for Stage IV Melanoma condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > gp100 and MDX-010 Vaccination for Stage IV Melanoma  gp100 and MDX-010 Vaccination for Stage IV Melanoma
gp100 and MDX-010 Vaccination for Stage IV Melanoma
For Condition: Melanoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will examine the safety and effectiveness of an experimental vaccine given with an immune booster to treat advanced melanoma. The vaccine contains peptides (pieces of proteins) of two gp100 proteins, which are produced by melanoma tumors. The vaccine injections are mixed with an oil-based substance called Montanide ISA-51, which is intended to increase the immune response to the peptides. The vaccine will be given along with CTLA-4 antibody, an immune booster. Patients 16 years of age and older with melanoma that has spread from the primary site and does not respond to standard treatment may be eligible for this study. Candidates will be screened with a physical examination, eye examination, blood tests, electrocardiogram, and imaging studies (x-rays and scans) to check the size and extent of tumor, and lung function tests, if medically indicated. 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. Participants will receive CTLA-4 antibody, administered intravenously (IV) over 90 minutes through a catheter (plastic tube) placed in a vein. They will then be given four injections of the peptide vaccines in the thigh. The vaccination plus antibody treatments will be given four times-once every 3 weeks. Participants will have blood tests and physical examinations at each clinic visit to measure CTLA-4 antibody levels and look for changes in the blood that signal reactions to the vaccine or antibody, and to check for side effects. During the first injection of CTLA-4 antibody and for 6 hours after, six small blood samples will be taken to measure levels of the antibody. Once a day for 3 days after the first vaccine injection, and once a week for the next 3 weeks, a nurse will call the patient at home to check health status and drug side effects. Patients will also undergo plasmapheresis-a procedure to collect quantities of white blood cells-before treatment begins and possibly again 3 weeks after the second and fourth vaccinations. For this procedure, blood is drawn through a needle in the arm and circulated through a machine that spins it to separate the components. The white cells are removed and the plasma and red cells are returned to the patient through a needle in the other arm. Some patients may also have a biopsy of normal skin and tumor or lymph node tissue to examine the effects of the vaccine on the tumor immune cells. This involves drawing a small amount of tissue through a needle put in the skin. Patients will return to the clinic 3 weeks after the fourth vaccination for a follow-up examination and blood tests. Patients who experience severe side effects to the vaccine or develop an immune reaction against CTLA-4 antibody, or whose condition worsens with treatment, may be taken off the study. Patients whose disease has not progressed or whose tumor has shrunk may receive another course of four vaccinations, with continued follow-up if the disease improves.
Details: This is an open-label study of repeated doses of human monoclonal antibody (mAb) to CTLA-4 (MDX-CTLA4) in combination with gp100 -209-217- (210M) and gp100 -280-288- (288V) peptides emulsified with Montanide ISA 51 in the treatment of up to 55 patients with stage IV melanoma. This study will evaluate the toxicities, clinical response, safety, and immunologic response to the immunization of gp100 (210M) and gp100 (288V) in combination with MDX-CTLA4. Toxicity assessment and pharmacokinetic evaluation will also be performed.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Any patient greater than or equal to 16 years of age with a histologic diagnosis of stage IV melanoma (may include mucosal or ocular melanoma) that is clinically evaluable. Patients may not have received prior therapy with anti-tumor vaccination with gp100 peptides. Positive for HLA-A*0201 by genotyping. Greater than or equal to 3 weeks since treatment (chemo-, radiation, hormone, immuno-, etc., therapy) for melanoma and recovered from any serious toxicity experienced during treatment. Women should be either: post-menopausal for at least one (1) year; surgically incapable of bearing children; or utilizing a reliable form of contraception. Women of childbearing potential must have a negative urine pregnancy test conducted during screening. Because of the risk of a negative influence of this therapy on reproductive processes, men who may father a child must agree to the use of male contraception for the duration of their participation in the trial. Life expectancy greater than or equal to 6 months. Karnofsky performance status greater than or equal to 60%. Required values for initial laboratory test: WBC greater than or equal to 2500/ml; ANC greater than or equal to 1500/ml; Platelets greater than or equal to 100 x 10(3) /ml; Hemoglobin greater than or equal to 10 g/dl; Hematocrit greater than or equal to 30%; Creatinine less than 2.0 mg/dl; AST less than or equal to 3 x ULN; Bilirubin less than or equal to 1.0 x ULN (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dl); Thyroglobulin antibody within normal limits; Rheumatoid factor normal; ANA negative; HBsAg negative; HIV negative; Anti-HCV nonreactive EXCLUSION CRITERIA: Any other prior malignancy, except for the following: adequately treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or any other cancer from which the patient has been disease-free for five (5) years or more. Autoimmune disease (including uveitis and autoimmune inflammatory eye disease) prior to the study. Active infection, this includes positive results from HIV, HBsAg and anti-HCV. Pregnancy or nursing: due to the possibility that MDX-CTLA4 could have a detrimental effect on the developing immune system of the fetus or infant, exposure in utero or via breast milk will not be allowed. Hypersensitivity to Montanide ISA 51 (IFA). Any underlying medical condition which, in the opinion of the principal investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Any concurrent medical condition requiring the use of systemic or topical corticosteroids or the use of immunosuppressive agents (e.g. cyclosporin and its analog, or chemotherapy agents). All corticosteroids use must have been discontinued greater than or equal to four (4) weeks prior to trial entry. Prior treatment with MDX-CTLA4. Prior treatment with gp100.
Total Enrollment: 68
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 020106; 02-C-0106
Study Start Date: January 11, 2002
Record last reviewed: January 11, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029549
Other Melanoma Studies:
1. Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects with Metastatic Malignant Melanoma
2. Vaccine Treatment for Advanced Melanoma
3. Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
4. Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201
5. 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
Related Studies:
Other Melanoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
gp100 and MDX-010 Vaccination for Stage IV Melanoma
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