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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
This study is ongoing, but not recruiting participants.
First Received: June 2, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005799
  Purpose

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
Chronic Myeloproliferative Disorders
Kidney Cancer
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Small Intestine Cancer
Biological: therapeutic allogeneic lymphocytes
Drug: fludarabine phosphate
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase I
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Bone Marrow Transplantation Cancer Fungal Infections Hodgkin's Disease Intestinal Cancer Kidney Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma Radiation Therapy
Drug Information available for: Fludarabine Fludarabine monophosphate
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 1999
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005799

Locations
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
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Study Chair: Michael B. Maris, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067770, FHCRC-1463.00, NCI-G00-1762
Study First Received: June 2, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00005799     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Urogenital Neoplasms
Mantle Cell Lymphoma
Ileal Diseases
Preleukemia
Leukemia, Prolymphocytic
Hemorrhagic Disorders
Lymphoma, Large-Cell, Anaplastic
Neoplasm Metastasis
Thrombocythemia, Hemorrhagic
Kidney Diseases
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Blood Coagulation Disorders
Leukemia, Myeloid
Carcinoma
Waldenstrom Macroglobulinemia
Plasmacytoma
Leukemia, Myeloid, Accelerated Phase
Fludarabine
Chronic Myelogenous Leukemia
Lymphoma, Non-Hodgkin
Neoplasms, Glandular and Epithelial
Immunologic Factors
Precancerous Conditions
Blood Protein Disorders
Lymphoma, Follicular
Sezary Syndrome
Lymphoblastic Lymphoma
Lymphoma, B-Cell

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Ileal Diseases
Duodenal Neoplasms
Preleukemia
Neoplasms by Site
Hemorrhagic Disorders
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Kidney Diseases
Immunoproliferative Disorders
Digestive System Neoplasms
Immune System Diseases
Hematologic Diseases
Myeloproliferative Disorders
Carcinoma
Multiple Myeloma
Neoplasms
Gastrointestinal Neoplasms
Fludarabine
Lymphoma, Non-Hodgkin
Neoplasms, Glandular and Epithelial
Antimetabolites
Immunologic Factors
Precancerous Conditions
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 07, 2009