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Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma Clinical research trials and Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma. Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma clinical trial. Participants oftentimes recieve the finest healthcare available for their Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma  Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma
Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma
For Condition: Melanoma,Neoplasm Metastasis
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This experiment will test the safety and effectiveness of a treatment for metastatic melanoma in which certain lymphocytes (a type of white blood cell) are taken from the patient, grown in the laboratory, and returned after the patient's immune system has been weakened with immune-suppressing drugs. Some patients will also receive interleukin-2, a drug that may enhance the activity of the re-infused lymphocytes. Patients with metastatic melanoma (melanoma whose tumor has spread) who have been treated unsuccessfully with gp100 vaccination may participate in this study. They will undergo apheresis or a tumor biopsy, or both, to collect lymphocytes. In apheresis, whole blood is drawn through a needle in the arm. A machine separates the blood components and removes the white cells. The rest of the blood is returned through a needle in the other arm. A biopsy is a surgical procedure to remove a small piece of tumor tissue. We will find the best cells to fight the melanoma from cells obtained from the pheresis or biopsy. We will take these and grow them in larger numbers in the laboratory. These are called "cloned cells" because we grow a lot of cells that are exactly like the best melanoma fighting cells we started with. Several weeks before we weaken the immune system and give the "cloned cells", additional lymphocytes are collected after patients receive injections of G-CSF every day for five days. This drug stimulates white cell production, permitting as many cells as possible to be obtained during collection. These white cells will be frozen in the laboratory and will only be given back to the patient if their immune system does not completely recover from the chemotherapy drugs used to suppress the immune system. Seven days before the "cloned cells" are re-infused, the patient is admitted to the hospital and a catheter (small tube) is placed in a large vein in the chest or neck. Two drugs, cyclophosphamide and fludarabine, are given through the tube. These drugs suppress the immune system so that it will not interfere with the work of the reinfused lymphocytes. The lymphocytes are then given through the catheter over a 30-minute period. After the infusion, patients who receive IL-2 will be given the drug over a 15-minute period every 8 hours for up to 5 days. Fourteen to 21 days after this, the patient will be given a second infusion of "cloned cells". Blood and tissue samples will be taken before and during the study to evaluate the size of the tumor and response to treatment. If, 3 to 5 weeks after therapy is completed, scans and x-rays of the patient's tumor show that is has stabilized or shrunk, the cell treatment, except for chemotherapy, may be repeated two more times.
Details: Patients with metastatic melanoma who are HIV and Hepatitis B negative and who have previously progressed after receiving standard therapy will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine and then will be treated by the adoptive transfer of lymphocytes reactive with shared antigens on their tumors. 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 evaluable metastatic melanoma that is refractory to standard therapy. Age greater than or equal to 16 years. Patients of both genders must be willing to practice birth control for four months after receiving the preparative regimen. Clinical performance status of ECOG 0, 1 at entry to the trial and at the time of chemotherapy induction. 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 two times the upper limit of normal. Serum creatinine less than or equal to 1.6 mg/dl. Total bilirubin less than or equal to 1.6 mg/dl, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl. More than four weeks must have elapsed since any prior therapy at the time the patient receives the preparative regimen. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus. Life expectancy of greater than three months. No steroid therapy required. Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.) Seronegative for hepatitis B antigen. Patients to receive high dose IL-2 must have no active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system. Patients who will receive high doseIL-2 as part of the phase I portion of this study or who will be randomized must be eligible to receive high dose IL-2. Any patient receiving IL-2 must sign a durable power of attorney.
Total Enrollment: 220
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: 990158; 99-C-0158
Study Start Date: August 26, 1999
Record last reviewed: August 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001832
Other Neoplasm Metastasis Studies:
1. A Phase II Study of Isolated Hepatic Perfusion (IHP) with Melphalan Followed by Postoperative Hepatic Arterial Chemotherapy Infusion for Metastatic Unresectable Colorectal Cancers of the Liver
2. 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
3. A Multimodality Treatment Approach to Patients with Inflammatory Cancer of the Breast and Locally Advanced Non-Inflammatory Stage III Breast Cancer and Stage IV Breast Cancer
4. ABX-EGF in Combination with Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
5. For Prevention of Diarrhea in Patients Diagnosed with Metastatic Colorectal Cancer Treated with Chemotherapy
Related Studies:
Other Neoplasm Metastasis Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma
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