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Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma conditions. Clinical Trials Search.org is a site 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 healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds 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 allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, 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 typically obtain the most effective healthcare available for their Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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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 Melanoma Studies:
1. Studies on Tumors of the Thyroid
2. For Prevention of Diarrhea in Patients Diagnosed with Metastatic Colorectal Cancer Treated with Chemotherapy
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. Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Fowlpox Virus Encoding the gp100 Melanoma Antigen
5. A Phase I Study of OncoLAR® (Registered Trademark) (NSC 685403) with/without Tamoxifen in Patients with Osteosarcoma
Related Studies:
Other Melanoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma
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