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Treatment of Patients with Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide 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 Treatment of Patients with Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Treatment of Patients with Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide Clinical research trials and Treatment of Patients with Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide 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 Treatment of Patients with Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide. Treatment of Patients with Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide 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 Treatment of Patients with Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide clinical trial. Human subjects often obtain the finest healthcare possible for their Treatment of Patients with Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide 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 > "T" Clinical Trials Conditions > Treatment of Patients with Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide Treatment of Patients with Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide
Treatment of Patients with Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide
For Condition: Melanoma,Neoplasm Metastasis
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Patients with metastatic melanoma who are HLA-A201 positive and HIV and Hepatitis B negative and who have previously received the gp-209-2M peptide will be treated by the adoptive transfer of cloned peripheral blood lymphocytes sensitized, in vitro, to the gp-209-2M peptide. This study will evaluate the toxicity, immunologic effects and potential therapeutic role of this treatment.
Details: Patients with metastatic melanoma who are HLA-A201 positive and HIV and Hepatitis B negative and who have previously received the gp-209-2M peptide will be treated by the adoptive transfer of cloned peripheral blood lymphocytes or tumor infiltrating lymphocytes sensitized, in vitro, to the gp-209-2M peptide. This study will evaluate the toxicity, immunologic effects and potential therapeutic role of this treatment.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients must have measurable or evaluable metastatic melanoma that has failed therapy on protocols involving immunization against the gp100 molecule (which involves immunization with the gp209-9M peptide in IFA). Age greater than or equal to 18 years. Patients must be HLA-A201 positive by standard HLA typing. Patients of both genders must be willing to practice birth control. Clinical performance status of ECOG 0, 1, or 2. Absolute neutrophil count greater than 1000/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 1.6 mg/dl. 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. Life expectancy of greater than three months. No steroid therapy required. Seronegative for HIV antibody. Seronegative for hepatitis B antigen. Patients to be randomized to receive IL-2 must have no active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system.
Total Enrollment: 91
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 980095; 98-C-0095
Study Start Date: April 17, 1998
Record last reviewed: March 27, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001694
Other Neoplasm Metastasis Studies:
1. A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion with Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients with Locally Advanced Extremity Melanoma
2. Immunotherapy After Surgery in Treating Patients With Breast Cancer, Colon Cancer, or Melanoma
3. Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer
4. gp100 and MDX-010 Vaccination for Stage IV Melanoma
5. Treatment of Patients with Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide
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Treatment of Patients with Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide
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