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Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers Clinical research trials and Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers health trials occur in hundreds of cities 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 typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers. Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers clinical trial. Participants oftentimes recieve the most expert healthcare available for their Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers  Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
For Condition: Multiple Myeloma,Leukemia,Lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Johns Hopkins Oncology Center
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bone marrow transplantation may be able to replace immune cells that have been destroyed by radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Mycophenolate mofetil and tacrolimus may be an effective treatment for graft-versus-host disease caused by bone marrow transplantation. PURPOSE: Phase II trial to study the effectiveness of total-body irradiation, tacrolimus, and mycophenolate mofetil plus bone marrow transplantation in treating patients with hematologic cancers.
Details: OBJECTIVES: I. Determine whether sustained engraftment of HLA identical sibling marrow can be achieved in patients treated with total body irradiation before transplant and tacrolimus and mycophenolate mofetil after transplant. II. Document the nonhematologic toxicities of this regimen. III. Characterize immune reconstitution of patients during this treatment regimen. IV. Document the incidence of aplasia and graft-versus-host disease associated with donor leukocyte infusions when administered after this regimen. PROTOCOL OUTLINE: Patients receive total body irradiation in a single fraction on day -1. Tacrolimus is given orally twice per day on days -1 to 50. Mycophenolate mofetil is given orally on day 0 and twice per day on days 1 to 28. Patients receive donor bone marrow infusion on day 0. Patients are evaluated on days 56, 180, 292, and 365. If there is donor engraftment, donor chimerism is less than 80%, there is no active graft-versus-host disease, no disease progression, less than 50% decrease in donor cell chimerism from last measurement, and the patient is not taking immunosuppressive agents, then donor leukocyte infusions are administered on days 70, 194, and 306. Patients are followed annually for 5 years. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Must have a 6 antigen HLA identical related donor and one of the following diseases: Acute myelogenous leukemia in high risk first complete remission or second or greater complete remission; Acute lymphocytic leukemia in high risk first complete remission or second or greater remission; Chronic myelogenous leukemia in chronic phase; Indolent non-Hodgkin's lymphoma (NHL) or aggressive NHL in complete or partial remission, not eligible for autologous bone marrow transplant (ABMT); Multiple myeloma in complete or partial response; Myelodysplastic syndrome; Stage III or IV chronic lymphocytic leukemia; Hodgkin's disease after first complete remission - Patients must also have one of the following high risk features: Age 55-70; Age 18-54 must have one of the following conditions: LVEF 35-44%; FEV1 or FVC 40-49%; Bilirubin 2.1-3.0 mg/dL, AST 71-175, or ALT 81-200; Creatinine 2.1-3.0 mg/dL; Disease recurrence less than 1 year after ABMT; Between 18 to 24 months of prior chemotherapy (12 to 24 months for multiple myeloma) --Prior/Concurrent Therapy-- - See Disease Characteristics --Patient Characteristics-- - Age: 18 to 70 - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin less than 3.1 mg/dL - Renal: Creatinine less than 3.1 mg/dL - Cardiovascular: LVEF at least 35% - Pulmonary: FEV1 and FVC at least 40% of predicted (60% for patients who have received thoracic or mantle radiotherapy) - Other: Not pregnant; Fertile patients must use effective contraception; Not HIV positive
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EphraimFuchs, Study Chair, Johns Hopkins Oncology Center
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231-2410
United States
Additional Information:
Study ID Numbers: CDR0000066639; JHOC-98070603,NCI-H98-0023,JHOC-9845
Study Start Date: August 1998
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003572
Other Multiple Myeloma Studies:
1. CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation
2. Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation
3. Specialized Blood Cell Transplants for Cancers of the Blood and Bone Marrow
4. 506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment
5. A Trial of Skeletal Targeted Radiotherapy Using Holmium-166-DOTMP in Patients with Multiple Myeloma
Related Studies:
Other Multiple Myeloma Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
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