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Fludarabine, Total-body Irradiation, Donor Peripheral Stem Cell Transplantation, and Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer 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 Fludarabine, Total-body Irradiation, Donor Peripheral Stem Cell Transplantation, and Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Fludarabine, Total-body Irradiation, Donor Peripheral Stem Cell Transplantation, and Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer Clinical research trials and Fludarabine, Total-body Irradiation, Donor Peripheral Stem Cell Transplantation, and Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer 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 Fludarabine, Total-body Irradiation, Donor Peripheral Stem Cell Transplantation, and Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer. Fludarabine, Total-body Irradiation, Donor Peripheral Stem Cell Transplantation, and Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer 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 Fludarabine, Total-body Irradiation, Donor Peripheral Stem Cell Transplantation, and Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Fludarabine, Total-body Irradiation, Donor Peripheral Stem Cell Transplantation, and Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer 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 > "F" Clinical Trials Conditions > Fludarabine, Total-body Irradiation, Donor Peripheral Stem Cell Transplantation, and Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer  Fludarabine, Total-body Irradiation, Donor Peripheral Stem Cell Transplantation, and Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer
Fludarabine, Total-body Irradiation, Donor Peripheral Stem Cell Transplantation, and Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer
For Condition: Eye Cancer,Lymphoma,Kidney Cancer,Leukemia,Renal Cell Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fred Hutchinson Cancer Research Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with donor peripheral stem cells and donor white blood cells may kill more hematologic cancer cells. PURPOSE: Phase I trial to study the effectiveness of fludarabine, total-body irradiation, donor peripheral stem cell transplantation, and donor white blood cell infusions in treating patients who have hematologic cancer.
Details: OBJECTIVES: I. Determine whether stable allogeneic stem cell engraftment from unrelated donors can be safely established using a nonmyeloablative conditioning regimen comprising fludarabine and total body irradiation in patients with hematologic malignancies or renal cell carcinoma. II. Determine whether donor lymphocyte infusions can be safely used in patients with mixed or full donor chimerism to eliminate persistent or progressive disease. III. Determine the response rate, disease-free survival, disease relapse, and disease-related mortality in these patients treated with this regimen. PROTOCOL OUTLINE: This is a multicenter study. Cytoreduction: Patients with advanced malignancies may receive cytoreduction and/or radiotherapy at the discretion of the attending physician and protocol chairperson. Conditioning: Patients receive fludarabine IV on days -4 to -2. Patients undergo low-dose total body irradiation followed by infusion of allogeneic peripheral blood stem cells (PBSC) or bone marrow on day 0. Donor lymphocyte infusions: Donor lymphocytes are collected from the PBSC of the same unrelated donor prior to PBSC transplantation OR from the same unrelated bone marrow donor after bone marrow transplantation. Eligible patients receive the first donor lymphocyte infusion (DLI) over 30 minutes. Patients with disease progression and no graft versus host disease (GVHD) at greater than day 28 after the first DLI OR persistent/progressive disease, mixed chimerism, and no GVHD at day 65 after the first DLI receive a second DLI. Patients with disease progression and no GVHD at greater than day 28 after the second DLI OR persistent disease, mixed chimerism, and no GVHD at day 65 after the second DLI receive a third DLI. Patients are followed weekly until day 90, then at 4, 6, 12, 18, and 24 months, and then annually thereafter. PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven hematologic malignancy including, but not limited to, the following: Non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia, or Hodgkin's disease; Failed prior front-line therapy; No rapidly progressive intermediate or high grade NHL; Multiple myeloma Prior chemotherapy required; Consolidation of prior autografting allowed; Acute myeloid leukemia (AML) or acute lymphoblastic leukemia; Incomplete remission and prior cytotoxic chemotherapy at some point before transplantation required; Molecular or early relapse allowed if donor available; Persistent or refractory disease considered on a case-by-case basis; Chronic myelogenous leukemia (CML); Chronic or accelerated phase allowed; Patients who have received autografts after high-dose therapy or who have undergone intensive chemotherapy for either peripheral blood stem cell mobilization or treatment of advanced CML eligible if in complete remission, chronic phase, or accelerated phase Myelodysplastic syndrome (MDS); All patients with MDS eligible except those with frank AML (greater than 30% blasts in bone marrow aspirate) OR Diagnosis of renal cell carcinoma - Over age 50: Must have a hematologic disease that is treatable by allogeneic stem cell transplantation (alloSCT) - Age 50 and under: Patients who have hematologic malignancy that is treatable by alloSCT and who, through preexisting medical conditions or prior therapy, are considered at high risk for regimen-related toxicity associated with conventional transplantation - Availability of a 10 antigen (A, B, C, DR-B, and DR-Q loci) HLA-matched unrelated donor - Any active CNS disease [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.] --Prior/Concurrent Therapy-- - See Disease Characteristics --Patient Characteristics-- - Age: See Disease Characteristics - Performance status: Karnofsky 50-100% - Life expectancy: Not specified - Hematopoietic: See Disease Characteristics - Hepatic: Significant elevations in bilirubin, SGOT, and SGPT allowed on a case-by-case basis; No synthetic dysfunction or severe cirrhosis - Renal: Not specified - Cardiovascular: Cardiac ejection fraction at least 30%; No cardiac failure requiring therapy; No poorly controlled hypertension on multiple antihypertensives - Pulmonary: DLCO at least 35% predicted; No requirement for supplementary continuous oxygen - Other: Not pregnant or nursing; Fertile patients must use effective contraception during and for 1 year after study; HIV negative
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelMaris, Study Chair, Fred Hutchinson Cancer Research Center
Baylor University Medical Center
Dallas, Texas, 75246
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Cancer Center and Beckman Research Institute, City of Hope
Los Angeles, California, 91010-3000
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Stanford University
Stanford, California, 94305
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Universitaet Leipzig
Leipzig, , D-04103
Germany
Additional Information:
Study ID Numbers: CDR0000067770; NCI-G00-1762,FHCRC-1463.00
Study Start Date: November 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005799
Other Eye Cancer Studies:
1. High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
2. Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
3. BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
4. Combination Chemotherapy in Treating Patients With Advanced Cancer
5. Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma
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Fludarabine, Total-body Irradiation, Donor Peripheral Stem Cell Transplantation, and Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer
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