Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer
|ClinicalTrials.gov Identifier: NCT00002553|
Recruitment Status : Completed
First Posted : April 26, 2004
Last Update Posted : November 30, 2011
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation using unrelated bone marrow donors in treating patients who have hematologic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Drug: cyclophosphamide Procedure: allogeneic bone marrow transplantation Radiation: low-LET cobalt-60 gamma ray therapy||Phase 2|
OBJECTIVES: I. Determine whether the use of donors with a one non crossreactive group (CREG) mismatch for HLA-A or B in patients less than 36 years of age is associated with more frequent graft versus host disease (GVHD) of grades III-IV than previously observed with donors with one CREG mismatch. II. Determine whether the use of donors with a one CREG mismatch for HLA-A or B in patients 36-50 years of age is associated with more frequent GVHD of grades III-IV than previously observed with matched donors. III. Determine the relevance of HLA-A allele mismatching in bone marrow transplants from donors matched for HLA-A, B, and DR phenotypes.
OUTLINE: This is a parallel, open label study. Patients are assigned to 1 of 3 treatment arms. Arm I: Patients receive cyclophosphamide IV on days -7 and -6 and total body irradiation (TBI) 3 times a day on days -4 through -1. Allogeneic bone marrow (ABM) is infused on day 0. Arm II: Patients receive therapy as in arm I, except TBI is administered twice a day on day -1 only. ABM is infused on day 0. Arm III: Patients receive cyclophosphamide IV on days -6 and -5 and TBI twice a day on days -3 through -1. ABM is infused on day 0. Males with ALL receive an additional radiation boost to the testes during TBI. Patients are followed at least every 6 months for 2 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 50 patients under 36 years old and 50 patients 36-50 years old will be accrued for this study within 5 years. Additional patients will be accrued for the standard therapy arm of this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Official Title:||TREATMENT OF PATIENTS WITH HEMATOLOGIC MALIGNANCIES USING MARROW TRANSPLANTATION FROM UNRELATED DONORS MATCHED FOR HLA OR INCOMPATIBLE FOR ONE HLA LOCUS ANTIGEN|
|Study Start Date :||August 1990|
|Study Completion Date :||June 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002553
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Study Chair:||Claudio Anasetti, MD||Fred Hutchinson Cancer Research Center|