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Immunosuppression With Mycophenolate Mofetil and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies or Metastatic Renal Cell Carcinoma Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Immunosuppression With Mycophenolate Mofetil and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies or Metastatic Renal Cell Carcinoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Immunosuppression With Mycophenolate Mofetil and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies or Metastatic Renal Cell Carcinoma Clinical research trials and Immunosuppression With Mycophenolate Mofetil and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies or Metastatic Renal Cell Carcinoma health trials happen in many 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 measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Immunosuppression With Mycophenolate Mofetil and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies or Metastatic Renal Cell Carcinoma. Immunosuppression With Mycophenolate Mofetil and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies or Metastatic Renal Cell Carcinoma Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Immunosuppression With Mycophenolate Mofetil and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies or Metastatic Renal Cell Carcinoma clinical trial. Human subjects often get the best healthcare available for their Immunosuppression With Mycophenolate Mofetil and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies or Metastatic Renal Cell Carcinoma condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Immunosuppression With Mycophenolate Mofetil and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies or Metastatic Renal Cell Carcinoma  Immunosuppression With Mycophenolate Mofetil and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies or Metastatic Renal Cell Carcinoma
Immunosuppression With Mycophenolate Mofetil and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies or Metastatic Renal Cell Carcinoma
For Condition: childhood non-Hodgkin's lymphoma,childhood Hodgkin's lymphoma,Graft Versus Host Disease,kidney and urinary cancer,hematopoietic and lymphoid cancer
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Giving different schedules of mycophenolate mofetil and cyclosporine may be effective in reducing graft-versus-host disease in patients undergoing donor peripheral stem cell transplantation for hematologic malignancies (cancer) and metastaticrenal cell carcinoma. PURPOSE: Phase I/II trial to study the effectiveness of immunosuppression using a lengthened schedule of mycophenolate mofetil and a shortened schedule of cyclosporine in reducing graft-versus-host disease in patients who are undergoing donor peripheral stem cell transplantation for hematologic cancer or metastatic renal cell carcinoma.
Details: OBJECTIVES: Primary - Determine whether the incidence of life-threatening graft-versus-host disease (GVHD) can be reduced after unrelated donor peripheral blood mononuclear cell hematopoietic stem cell transplantation using nonmyeloablative conditioning with truncated cyclosporine and prolonged administration of mycophenolate mofetil in patients with hematologic malignancies or metastatic renal cell carcinoma. Secondary - Compare the incidence of acute and chronic GVHD in patients treated with this regimen vs patients treated on protocols FHCRC-1463.00 and FHCRC-1641.00. - Compare the utilization of corticosteroids in patients treated with this regimen vs patients treated on protocols FHCRC-1463.00 and FHCRC-1641.00. - Compare the survival of patients treated with this regimen vs patients treated on protocols FHCRC-1463.00 and FHCRC-1641.00. OUTLINE: This is a multicenter study. - Conditioning regimen: Patients receive fludarabine IV on days -4 to -2 and low-dose total body irradiation (TBI) on day 0. - Allogeneic hematopoietic stem cell transplantation (HSCT): After the completion of TBI, patients undergo allogeneic HSCT on day 0. - Immunosuppression: Patients receive oral cyclosporine twice daily on days -3 to 80 in the absence of acute graft-versus-host disease (GVHD). Patients also receive oral mycophenolate mofetil (MMF) 3 times daily on days 0-29 and then, in the absence of GVHD, twice daily on days 30-149. MMF is tapered beginning on day 150 and continuing until day 180. Patients are followed at 6 months, 12 months, 18 months, and 24 months and then annually for 5 years after HSCT. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 1.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of either of the following: - Hematologic malignancy - Meeting 1 of the following criteria: - Over 50 years of age with a hematologic malignancy treatable by unrelated hematopoietic stem cell transplantation (HSCT) - 50 years of age and under with a hematologic malignancy treatable by allogeneic HSCT and considered to be at high risk for regimen-related toxicity associated with a conventional transplantation (greater than 40% risk of transplant-related mortality) due to a pre-existing medical condition or prior therapy OR refused a conventional HSCT - Including, but not limited to the following: - Intermediate- or high-grade non-Hodgkin's lymphoma (NHL) - Not eligible for autologous HSCT or failed autologous HSCT - Low-grade NHL - Less than 6 months duration of complete remission (CR) between courses of conventional therapy - Chronic lymphocytic leukemia - Refractory to fludarabine - Hodgkin's lymphoma - Failed prior front-line therapy - Multiple myeloma - Received prior chemotherapy (consolidation of chemotherapy by autografting prior to nonmyeloablative HSCT is allowed) - Acute myeloid leukemia (AML) - Less than 5% marrow blasts at the time of transplantation - Acute lymphoblastic leukemia - Less than 5% marrow blasts at the time of transplantation - Chronic myelogenous leukemia (CML) - Chronic phase or accelerated phase - Prior autografts after high-dose therapy OR prior intensive chemotherapy with filgrastim (G-CSF)-mobilized peripheral blood mononuclear cell autologous or conventional HSCT for advanced CML allowed provided disease is in CR or chronic phase and there are less than 5% marrow blasts at the time of transplantation - Myelodysplastic syndromes (MDS) or myeloproliferative disorder - Refractory anemia (RA) - RA with ringed sideroblasts - Patients with greater than 5% marrow blasts (including those with transformation to AML) must receive cytotoxic chemotherapy and achieve less than 5% marrow blasts at the time of transplantation - Metastatic renal cell carcinoma (RCC) not amenable to surgical cure OR history of or active histologically or radiologically confirmed metastatic disease, including 1 of the following histological types: - Clear cell - Papillary - Medullary - No rapidly progressive intermediate- or high-grade NHL - No history of brain metastases (RCC patients) - No CNS involvement with disease refractory to intrathecal chemotherapy - No other non-hematological tumors except RCC - Available unrelated donor - Matched for HLA-A, B, C, DRB1, and DQB1 - Only a single allele disparity is allowed for HLA-A, B, or C - No positive anti-donor cytotoxic crossmatch - No patient and donor pairs homozygous at a mismatched allele in the graft rejection vector - No marrow donors NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age - See Disease Characteristics - Any age Performance status - Karnofsky 60-100% (70-100% for RCC patients) Life expectancy - At least 6 months (RCC patients) Hematopoietic - Not specified Hepatic - No fulminant liver failure - No cirrhosis of the liver with evidence of portal hypertension - No alcoholic hepatitis - No hepatic encephalopathy - No uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the PT - No ascites related to portal hypertension - No bacterial or fungal liver abscess - No biliary obstruction - No chronic viral hepatitis with bilirubin greater than 3 mg/dL - No symptomatic biliary disease - No esophageal varices - No history of bleeding esophageal varices Renal - Not specified Cardiovascular - Cardiac ejection fraction at least 35% - No hypertension greater than grade II Pulmonary - DLCO at least 40% - No concurrent continuous supplementary oxygen Other - Not pregnant - Fertile patients must use effective contraception during and for 1 year after study participation - HIV negative - No fungal infection with radiological progression after prior amphotericin B or active triazole therapy for more than 1 month - No vertebral instability (RCC patients) PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - Prior cytokine therapy allowed - No concurrent growth factors for 1 month after HSCT Chemotherapy - See Disease Characteristics - More than 2 weeks since prior intensive chemotherapy, excluding low-dose cytarabine and chlorambucil Endocrine therapy - Not specified Radiotherapy - Prior radiotherapy for advanced malignancy or to reduce tumor bulk allowed Surgery - Not specified Other - More than 2 weeks since prior cytotoxic agents for cytoreduction, excluding hydroxyurea and imatinib mesylate
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelMaris, Study Chair, Fred Hutchinson Cancer Research Center
Universitaet Leipzig *Recruiting*
Leipzig, , D-04103
Germany
Recruiting Dietger Niederwieser 49-341-971-3050
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting James Wade 414-805-4609
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Amelia Langston 404-778-1900
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting Michael Maris 206-667-2480
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5623
United States
Recruiting Karl Blume 650-723-0822
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting Richard Maziarz 503-494-6345
University of Torino *Recruiting*
Torino, , 10126
Italy
Recruiting Benedetto Bruno 39-11-633-4418
Universitaetsklinikum Tuebingen *Recruiting*
Tuebingen, , D-72076
Germany
Recruiting Wolfgang Bethge 49-4707-1298-2726
Baylor University Medical Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Edward Agura 214-370-1500
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112
United States
Recruiting Michael Pulsipher 801-585-0303
Additional Information:
Study ID Numbers: CDR0000346473; FHCRC-1668.00
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078858
Other Hematopoietic And Lymphoid Cancer Studies:
1. Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia
2. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
3. Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation
4. Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract
5. Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation
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Immunosuppression With Mycophenolate Mofetil and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies or Metastatic Renal Cell Carcinoma
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