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Vaccine Therapy in Treating Patients With Melanoma of the Eye 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 Vaccine Therapy in Treating Patients With Melanoma of the Eye conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Melanoma of the Eye Clinical research trials and Vaccine Therapy in Treating Patients With Melanoma of the Eye 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 Vaccine Therapy in Treating Patients With Melanoma of the Eye. Vaccine Therapy in Treating Patients With Melanoma of the Eye 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 Vaccine Therapy in Treating Patients With Melanoma of the Eye clinical trial. Subjects often receive the most expert healthcare possible for their Vaccine Therapy in Treating Patients With Melanoma of the Eye 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 > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Melanoma of the Eye  Vaccine Therapy in Treating Patients With Melanoma of the Eye
Vaccine Therapy in Treating Patients With Melanoma of the Eye
For Condition: ciliary body and choroid melanoma, medium/large size
Status: No longer recruiting
Sponsor(s): EORTC Melanoma Cooperative Group , EORTC Ophthalmic Oncology Task Force
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells and decrease the recurrence of melanoma of the eye. PURPOSE: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who are at high risk for recurrent melanoma of the eye.
Details: OBJECTIVES: - Determine whether adjuvant NA17.A2 antigen and melanoma differentiation peptides are effective in decreasing the occurrence of liver metastasis in HLA-A2-positive patients with primary ocular melanoma at high risk of relapse. - Determine whether this regimen increases survival of these patients. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor size (medium vs large), prior treatment of primary tumor (surgery vs radiotherapy), and participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive vaccination with NA17.A2 antigen and melanoma differentiation peptides (e.g., tyrosinase, Melan-A, and gp100 antigens) subcutaneously and intradermally on days 1, 8, 15, and 22. Patients then receive a vaccination once every 14 days for 4 doses, once every 28 days for 4 doses, once every 56 days for 4 doses, and then once every 3 months for a total of 4 years. - Arm II: Patients undergo observation only every 3 months for 2 years and then every 6 months for 2 years. All patients are followed every 3 months for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of ocular melanoma - No melanoma of the iris - Disease adequately treated by prior surgery (enucleation or tumorectomy) and/or radiotherapy - No more than 5 weeks since the beginning of primary tumor treatment - Measurable disease - At least 12.0 mm in largest diameter OR - At least 6.0 mm in height - HLA-A2 positive - No distant metastases PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Hemoglobin at least 9 g/dL - Neutrophil count at least 2,000/mm^3 - Lymphocyte count at least 700/mm^3 - Platelet count at least 100,000/mm^3 - No bleeding disorder Hepatic: - Bilirubin no greater than 2.0 mg/dL - AST and ALT no greater than 2 times upper limit of normal (ULN) - Lactate dehydrogenase no greater than 2 times ULN - Alkaline phosphatase no greater than 2 times ULN - Gamma glutamyl transpeptidases no greater than 2 times ULN - Hepatitis C antibody negative - Hepatitis B antigen negative Renal: - Creatinine no greater than 2.0 mg/dL Immunologic: - No clinical immunodeficiency - No autoimmune diseases - No inflammatory bowel disease - No active infection requiring antibiotics - No multiple sclerosis Other: - HIV negative - No other malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin - No other uncontrolled illness - No psychological, familial, sociological, or geographical conditions that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - No other concurrent immunotherapy or biologic therapy Chemotherapy: - No concurrent chemotherapy Endocrine therapy: - At least 3 weeks since prior steroids - No concurrent chronic therapy with high doses of corticosteroids (e.g., methylprednisolone at least 12 mg/day) - Concurrent topical or inhalation steroids allowed - No concurrent hormonal therapy Radiotherapy: - See Disease Characteristics - Prior proton beam therapy allowed - Prior brachytherapy without tumor resection allowed - Recovered from prior radiotherapy - No prior radiotherapy to the spleen - No prior pre-enucleation radiotherapy - No prior ruthenium Ru 106 as primary therapy alone - No concurrent radiotherapy Surgery: - See Disease Characteristics - Prior transcleral tumor resection allowed - Recovered from prior surgery - No prior major organ allograft - No prior splenectomy Other: - No other concurrent investigational drugs - No concurrent systemic immunosuppressive drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JanPrause, Study Chair, University of Copenhagen
Cliniques Universitaires Saint-Luc
Brussels, , 1200
Belgium
University of Copenhagen
Copenhagen, , 2100
Denmark
Additional Information:
Study ID Numbers: CDR0000069325; EORTC-88001,EORTC-18001
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036816
Other Ciliary Body And Choroid Melanoma, Medium/large Size Studies:
1. Vaccine Therapy in Treating Patients With Melanoma of the Eye
2. Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
3. Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery
Related Studies:
Other ciliary body and choroid melanoma, medium/large size Clinical Trials
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Vaccine Therapy in Treating Patients With Melanoma of the Eye
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