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Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery Clinical research trials and Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery healthcare trials take place in many of cities across 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 generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery. Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery  Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery
Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery
For Condition: ciliary body and choroid melanoma, small size,extraocular extension melanoma,Stage 4 Melanoma,stage 3 melanoma,iris melanoma,ciliary body and choroid melanoma, medium/large size,recurrent intraocular melanoma,Recurrent Melanoma
Status: Suspended
Sponsor(s): University of Southern California , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining monoclonal antibody therapy and vaccine therapy in treating patients who have stage III or stage IV melanoma that has been removed during surgery.
Details: OBJECTIVES: - Determine the safety and adverse event profile of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody combined with tyrosinase:368-376, gp100:209-217, and MART-1:26-35 peptides emulsified in Montanide ISA-51 in patients with resected stage III or IV melanoma. - Determine if this regimen causes antigen-specific T-cell activation in these patients. - Determine the clearance profile of this regimen in these patients. - Assess the development of host immune response in patients treated with this regimen. OUTLINE: This is a dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4). Patients receive tyrosinase:368-376, gp100:209-217, and MART-1:26-35 peptides emulsified in Montanide ISA-51 subcutaneously followed by MDX-CTLA4 IV over 90 minutes at 0, 1, 2, 3, 4, 5, 8, and 11 months in the absence of disease progression or unacceptable toxicity. Cohorts of at least 6 patients receive escalating doses of MDX-CTLA4 until the maximum tolerated dose is determined. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter until disease progression. PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed completely resected stage III or IV melanoma - Mucosal or ocular subtypes allowed - HLA-A2 positive - Positive staining of tumor tissue with antibody HMB-45 for gp100, tyrosinase, and/or MART-1 - Failed (or ineligible for or refusal of) interferon alfa PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Karnofsky 60-100% Life expectancy: - At least 12 months Hematopoietic: - WBC at least 2,500/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL - Hematocrit at least 30% Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - AST no greater than 1.25 times ULN - Hepatitis B surface antigen negative - Hepatitis C antibody nonreactive Renal: - Creatinine less than 1.25 times ULN Immunologic: - Antinuclear antibody (ANA) negative OR - If ANA positive, must be: - Antithyroglobulin antibody negative - Rheumatoid factor negative - Anti-LKM antibody negative - Anti-phospholipid antibody negative - Anti-islet cell antibody negative - Anti-neutrophil cytoplasmic antibody negative - HIV negative - No autoimmune disease (e.g., uveitis or autoimmune inflammatory eye disease) - No active infection - No hypersensitivity to tyrosinase:368-376, gp100:209-217, MART-1:26-35, or Montanide ISA-51 Other: - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix - No underlying medical condition that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody - No prior tyrosinase, gp100, or MART-1 peptide - No prior antitumor vaccination - No prior interleukin-2 - At least 4 weeks since prior immunotherapy for melanoma Chemotherapy: - At least 4 weeks since prior chemotherapy for melanoma Endocrine therapy: - At least 4 weeks since prior hormonal therapy for melanoma - At least 4 weeks since prior corticosteroids - No concurrent systemic or topical corticosteroids Radiotherapy: - At least 4 weeks since prior radiotherapy for melanoma Surgery: - See Disease Characteristics Other: - No prior cytotoxic therapy - At least 4 weeks since any other prior therapy for melanoma - Concurrent analgesics allowed if on stable dose for at least 2 weeks before study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeffreyWeber, Study Chair, University of Southern California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089
United States
Additional Information:
Study ID Numbers: CDR0000068934; LAC-USC-10M004,MDX-MDXCTLA4-03,NCI-4210
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025181
Other Recurrent Melanoma Studies:
1. Vaccine Therapy in Treating Patients With Stage IV Melanoma
2. Radiation Therapy Followed by Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Malignant Melanoma
3. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma
4. Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma
5. Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery
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