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Phase I Study in Patients with Metastatic Melanoma of Immunization with Dendritic Cells Presenting Epitopes Derived from the Melanoma Associated Antigen MART-1 and gp100 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 Phase I Study in Patients with Metastatic Melanoma of Immunization with Dendritic Cells Presenting Epitopes Derived from the Melanoma Associated Antigen MART-1 and gp100 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase I Study in Patients with Metastatic Melanoma of Immunization with Dendritic Cells Presenting Epitopes Derived from the Melanoma Associated Antigen MART-1 and gp100 Clinical research trials and Phase I Study in Patients with Metastatic Melanoma of Immunization with Dendritic Cells Presenting Epitopes Derived from the Melanoma Associated Antigen MART-1 and gp100 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 Phase I Study in Patients with Metastatic Melanoma of Immunization with Dendritic Cells Presenting Epitopes Derived from the Melanoma Associated Antigen MART-1 and gp100. Phase I Study in Patients with Metastatic Melanoma of Immunization with Dendritic Cells Presenting Epitopes Derived from the Melanoma Associated Antigen MART-1 and gp100 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 Phase I Study in Patients with Metastatic Melanoma of Immunization with Dendritic Cells Presenting Epitopes Derived from the Melanoma Associated Antigen MART-1 and gp100 clinical trial. Human subjects often obtain the finest healthcare possible for their Phase I Study in Patients with Metastatic Melanoma of Immunization with Dendritic Cells Presenting Epitopes Derived from the Melanoma Associated Antigen MART-1 and gp100 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 > "P" Clinical Trials Conditions > Phase I Study in Patients with Metastatic Melanoma of Immunization with Dendritic Cells Presenting Epitopes Derived from the Melanoma Associated Antigen MART-1 and gp100  Phase I Study in Patients with Metastatic Melanoma of Immunization with Dendritic Cells Presenting Epitopes Derived from the Melanoma Associated Antigen MART-1 and gp100
Phase I Study in Patients with Metastatic Melanoma of Immunization with Dendritic Cells Presenting Epitopes Derived from the Melanoma Associated Antigen MART-1 and gp100
For Condition: Melanoma,Neoplasm Metastasis
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is a dose escalation study. Patients are given separate doses of dendritic cells (DC) pulsed with either the MART-1 or G9-209-2M peptides. Patients receive four successive immunizations of an equal number of DCs every 3 weeks. When the maximum tolerated dose (MTD) or the highest dose of DCs to be given is reached, interleukin-2 (IL-2) is administered according to one of three dosage schedules. IL-2 is begun within 24 hours after DC administration. If 2 or more patients out of 6 at any dose level exhibit dose limiting toxicity, the preceding dose level will be considered the MTD.
Details: Patients with metastatic melanoma who are HLA-A2 positive, hepatitis B negative and HIV negative will be immunized with repeated intravenous or intralymphatic administrations of autologous dendritic cells pulsed in vitro with immunogenic peptides derived from the MART-1 and gp100 melanoma antigens. Patients who do not respond to dendritic cell administration alone may be treated with 2 cycles of high dose interleukin-2 (IL-2). The study will evaluate the toxicity, immunologic effects and potential therapeutic role of this immunization alone or in conjunction with the administration of interleukin-2.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients must have evidence of measurable or evaluable metastatic melanoma. Patients with completely resected metastatic disease are also eligible. Age greater than or equal to 18 years. Patients must have undergone standard HLA typing of peripheral blood lymphocytes and be HLA-A2 positive. Patients must have a histologic diagnosis of melanoma confirmed by pathologists at the NIH. Clinical performance status of ECOG 0,1 or 2. White blood cell count must be greater than 3,000/mm(3). Platelet count greater than 100,000/mm(3). Hemoglobin greater than 8.0 g/dl. Serum ALT/AST less than four times the upper limit of normal. Serum creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than 75 ml/min. Bilirubin less than or equal to 2.0 mg/dl. More than four weeks must have elapsed since any prior therapy. Women of child-bearing potential must have a negative pregnancy test and be willing to use an effective method of contraception during the trial. Life expectancy greater than three months. No steroid therapy required during the last month. Seronegative for HIV antibody. Seronegative for hepatitis B antigen. No active systemic infection, coagulation disorder or other major medical illness of the cardiovascular, respiratory or immune system. Patients must be able to provide informed consent. Patients must have recovered from toxicities from previous therapies. EXCLUSION CRITERIA: All patients not eligible according to inclusion criteria. Allergy to Penicillin. ELIGIBILITY FOR ADMINISTRATION OF IL-2: Patients with EKG abnormalities, symptoms of cardiac ischemia or arrhythmias or age greater than 50 years will have a normal stress cardiac test (stress thallium, stress MUGA, dobutamine echocardiogram or other stress test). Patients with recent prolonged history of cigarette smoking or symptoms of respiratory dysfunction must have a normal pulmonary function test as evidenced by a FEV(1) greater than 60% predicted. Patients may not have active major medical illnesses such as cardiac ischemia, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease. Patients may not have received prior high dose IL-2 therapy (greater than or equal to 600,000 IU/kg). Patients must be willing to sign a Durable Power of Attorney.
Total Enrollment: 42
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: 970019; 97-C-0019
Study Start Date: October 30, 1996
Record last reviewed: September 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001558
Other Melanoma Studies:
1. Phase II Trial of Allovectin-7® for Metastatic Melanoma
2. gp100 and MART-1 Peptide Vaccine for Metastatic Ocular Melanoma
3. CTLA-4 Antibody (MDX-010) Plus Interleukin-2 to Treat Advanced Melanoma
4. Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen
5. Study of Talabostat in Advanced Melanoma
Related Studies:
Other Melanoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Phase I Study in Patients with Metastatic Melanoma of Immunization with Dendritic Cells Presenting Epitopes Derived from the Melanoma Associated Antigen MART-1 and gp100
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