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Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma Clinical research trials and Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma medical trials take place in many of places throughout 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma. Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma clinical trial. Test subjects typically obtain the finest healthcare available for their Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma  Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma
Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: Completed
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells can reject the body's normal tissues. Donor lymphocytes that have been treated in the laboratory may prevent this. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, total-body irradiation, peripheral stem cell transplantation, and lymphocyte infusion in treating patients who have stage IV melanoma.
Details: OBJECTIVES: - Determine the objective response rate in patients with metastatic melanoma treated with nonmyeloablative allogeneic peripheral blood stem cell transplantation with fludarabine and total body irradiation, followed by cyclosporine and mycophenolate mofetil, followed by donor lymphocyte infusion. - Determine the disease-free and overall survival of patients treated with this regimen. - Determine the toxicity of this nonmyeloablative conditioning regimen in these patients. OUTLINE: Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and total body irradiation on day 0. Allogeneic peripheral blood stem cells are reinfused on day 0. Patients also receive cyclosporine IV every 12 hours on days -1 and 0 and orally twice a day on days 1-35 and then tapered until day 56. Mycophenolate mofetil is administered orally twice a day on days 0-27. Patients with mixed chimerism and no graft-versus-host disease on day 56 receive donor lymphocyte infusion (DLI) over 30 minutes on day 65 unless there is evidence of increasing donor chimerism. DLI may be repeated every 65 days for up to 4 doses. Patients are followed weekly for 3 months, monthly for 6 months, every 6 months through year 2, and then annually through year 5. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/64 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven stage IV melanoma with partial response, minor response, or stable disease after a maximum of 2 regimens of chemotherapy, immunotherapy, or chemoimmunotherapy - Bidimensionally measurable disease - HLA genotypically identical sibling donor available - Not an identical twin - Age 12 to 74 - No ocular melanoma - No brain metastases or transmural gastrointestinal metastases PATIENT CHARACTERISTICS: Age: - 18 to 64 Performance status: - Karnofsky 80-100% Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN) - SGOT and SGPT no greater than 2 times ULN Renal: - Creatinine clearance at least 40 mL/min Cardiovascular: - LVEF at least 40% if history of congestive heart failure - No uncontrolled hypertension Pulmonary: - DLCO at least 50% predicted - No supplementary continuous oxygen Other: - Not pregnant - Fertile patients must use effective contraception during and for 1 year after study - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No concurrent growth factors during mycophenolate mofetil administration Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnThompson, Study Chair, Seattle Cancer Care Alliance
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1023
United States
Additional Information:
Study ID Numbers: CDR0000068157; FHCRC-1462.00,NCI-G00-1841
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006233
Other Recurrent Melanoma Studies:
1. Biological Therapy in Treating Patients With Metastatic Melanoma
2. Vaccine Therapy in Treating Patients With Stage IV Melanoma
3. Flavopiridol in Treating Patients With Metastatic Malignant Melanoma
4. Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain
5. Melanoma Vaccine With or Without Sargramostim in Treating Patients With Stage IV Malignant Melanoma
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma
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