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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005799 |
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.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Kidney Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Small Intestine Cancer |
Drug: fludarabine phosphate Drug: therapeutic allogeneic lymphocytes Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Low-Dose TBI and Fludarabine Followed by Unrelated Donor Stem Cell Transplantation for Older Patients With Hematologic Malignancies |
Study Start Date: | November 1999 |
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.
OUTLINE: This is a multicenter study. Cytoreduction therapy: Patients with advanced malignancies may receive cytoreduction and/or radiotherapy at the discretion of the attending physician and protocol chairperson. Conditioning therapy: Patients receive fludarabine IV on days -4 to -2. Patients undergo low-dose total body irradiation followed by infusion of filgrastim (G-CSF)-mobilized 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. Patients with mixed chimerism, persistent or progressive disease, and no evidence of graft-versus-host disease and who have been off immunosuppression for at least 2 weeks receive donor lymphocyte infusion (DLI) over 30 minutes. DLI may be repeated every 65 days for up to 3 doses. 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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 In complete remission (CR) and received prior cytotoxic chemotherapy at some point before transplantation Molecular or early relapse allowed if donor available Persistent or refractory disease considered on a case-by-case basis Chronic myelogenous leukemia (CML) in chronic or accelerated phase Prior autograft after high-dose therapy or prior intensive chemotherapy for either peripheral blood stem cell mobilization or treatment of advanced CML allowed if in complete remission, chronic phase, or accelerated phase Myelodysplastic syndrome (MDS) All patients with MDS eligible except those with frank AML (more than 30% blasts in bone marrow aspirate) Over age 50: Must meet the 1 of the following criteria: Hematologic disease that is treatable by allogeneic stem cell transplantation (AlloSCT) B-cell malignancies that cannot be cured by autologous SCT (AuSCT) Age 50 and under: Must meet 1 of the following criteria: Hematologic malignancy that is treatable by AlloSCT and, through preexisting medical conditions or prior therapy, is considered at high risk for regimen-related toxicity associated with conventional transplantation Refuse conventional SCT for hematologic malignancy OR Diagnosis of renal cell carcinoma Clear cell, papillary, or medullary subtype Any age Must meet 1 of the following criteria: Disease that is not amenable to surgical cure Metastatic disease by radiological and histological criteria No bulky disease resulting in severely limited performance status (Karnofsky less than 70%) No vertebral instability 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.
PATIENT CHARACTERISTICS: Age: See Disease Characteristics Any age Performance status: See Disease Characteristics Karnofsky 50-100% Life expectancy: For patients with hematologic malignancy: Not specified For patients with renal cell carcinoma: At least 6 months 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
PRIOR CONCURRENT THERAPY: See Disease Characteristics
United States, California | |
Cancer Center and Beckman Research Institute, City of Hope | |
Los Angeles, California, United States, 91010-3000 | |
Stanford University | |
Stanford, California, United States, 94305 | |
United States, Colorado | |
University of Colorado Cancer Center | |
Denver, Colorado, United States, 80010 | |
United States, Texas | |
Baylor University Medical Center | |
Dallas, Texas, United States, 75246 | |
United States, Utah | |
Huntsman Cancer Institute | |
Salt Lake City, Utah, United States, 84112 | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109-1024 | |
Germany | |
Universitaet Leipzig | |
Leipzig, Germany, D-04103 |
Study Chair: | Michael B. Maris, MD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | CDR0000067770, FHCRC-1463.00, NCI-G00-1762 |
Study First Received: | June 2, 2000 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00005799 |
Health Authority: | United States: Federal Government |
stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma isolated plasmacytoma of bone extramedullary plasmacytoma refractory multiple myeloma stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer Waldenstrom macroglobulinemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia |
relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia small intestine lymphoma chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia meningeal chronic myelogenous leukemia untreated adult acute lymphoblastic leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission polycythemia vera chronic idiopathic myelofibrosis essential thrombocythemia clear cell renal cell carcinoma untreated hairy cell leukemia progressive hairy cell leukemia, initial treatment |
Sezary syndrome Chronic myelogenous leukemia Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Urogenital Neoplasms Ileal Diseases Lymphoma, large-cell, immunoblastic Preleukemia Leukemia, Prolymphocytic Hemorrhagic Disorders Hemorrhagic thrombocythemia Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis Thrombocythemia, Hemorrhagic Kidney Diseases |
Essential thrombocytosis Myelodysplastic syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Acute myelogenous leukemia Leukemia, Myeloid Carcinoma Waldenstrom Macroglobulinemia Plasmacytoma Leukemia, Myeloid, Accelerated Phase B-cell lymphomas Anaplastic large cell lymphoma Fludarabine |
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Pathologic Processes Jejunal Diseases Therapeutic Uses Syndrome Cardiovascular Diseases |