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Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer

This study has been completed.

Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002553
  Purpose

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 Intervention Phase
Leukemia
Lymphoma
Drug: cyclophosphamide
Procedure: allogeneic bone marrow transplantation
Procedure: low-LET cobalt-60 gamma ray therapy
Phase II

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Hodgkin's Disease    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma   

ChemIDplus related topics:   Cyclophosphamide    Cobalt   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   TREATMENT OF PATIENTS WITH HEMATOLOGIC MALIGNANCIES USING MARROW TRANSPLANTATION FROM UNRELATED DONORS MATCHED FOR HLA OR INCOMPATIBLE FOR ONE HLA LOCUS ANTIGEN

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

Estimated Enrollment:   50
Study Start Date:   August 1990

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   up to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Hematologic malignancies of the following types: Chronic myelogenous leukemia (CML) in chronic or accelerated phase Newly diagnosed acute leukemia at high risk of relapse following chemotherapy alone Early referral encouraged so that donor search can begin as soon as possible Acute leukemia failing one cycle of induction chemotherapy Acute leukemia beyond first remission High-risk Hodgkin's disease and non-Hodgkin's lymphoma in first remission Hodgkin's disease, non-Hodgkin's lymphoma, or other malignant lymphoproliferative disease after first remission No suitable related donor available (i.e., no HLA genotypically identical sibling) No haploidentical relative with no more than 1 unshared haplotype for an HLA-A, -B, or -D locus Acute leukemia in relapse and CML in blast crisis eligible only under the following conditions: Patient's clinical condition is likely to remain stable for the 2-6 month period necessary to find a marrow donor Remission induction has been attempted Local physician and patient accept that the search or transplant may be canceled if the patient's condition deteriorates during the search No leukoencephalopathy Donor requirements: Age less than 60 In good health Phenotypically identical for HLA-A, -B, and -DRB1 1-antigen mismatch for HLA-A, -B, or -DRB1 locus allowed for patients below age 36 Patients for whom TBI is contraindicated may be treated on protocol FHCRC-739 Severe aplastic anemia should be transplanted according to protocols FHCRC-174.2 or FHCRC-800 Myelodysplastic syndrome should be transplanted according to protocol FHCRC-179.3 or FHCRC-844

PATIENT CHARACTERISTICS: Age: Under 56 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No acute hepatitis No other severe hepatic disease Renal: Creatinine less than 2 times normal for age, weight, and sex Cardiovascular: No symptomatic cardiac disease Pulmonary: No active pulmonary disease No history of pulmonary fibrosis No severe hypoxemia (pO2 less than 70 mm Hg and DLCO less than 70%) No mild hypoxemia (pO2 less than 80 mm Hg and DLCO less than 60%) Other: HIV negative No severe limitations due to diseases other than malignancy

PRIOR CONCURRENT THERAPY: No more than 3,000 cGy to the whole brain No more than 1,500 cGy to the chest or abdomen At least 6 months since involved-field irradiation to the chest or abdomen

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002553

Locations
United States, Washington
Fred Hutchinson Cancer Research Center    
      Seattle, Washington, United States, 98109

Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Claudio Anasetti, MD     Fred Hutchinson Cancer Research Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Other Publications:

Study ID Numbers:   CDR0000063397, FHCRC-160.06, NCI-H94-0372
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002553
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV adult Hodgkin lymphoma  
recurrent childhood acute lymphoblastic leukemia  
recurrent adult Hodgkin lymphoma  
Waldenstrom macroglobulinemia  
stage IV childhood lymphoblastic lymphoma  
recurrent childhood lymphoblastic lymphoma  
recurrent childhood acute myeloid leukemia  
recurrent adult acute myeloid leukemia  
recurrent adult acute lymphoblastic leukemia  
relapsing chronic myelogenous leukemia  
chronic phase chronic myelogenous leukemia  
accelerated phase chronic myelogenous leukemia  
blastic phase chronic myelogenous leukemia  
untreated adult acute lymphoblastic leukemia  
untreated adult acute myeloid leukemia  
untreated childhood acute myeloid leukemia and other myeloid malignancies
untreated childhood acute lymphoblastic leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood acute lymphoblastic leukemia in remission
stage IV childhood Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma
recurrent adult non-Hodgkin lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma

Study placed in the following topic categories:
Blast Crisis
Leukemia, Lymphoid
Hodgkin's disease
Chronic myelogenous leukemia
Hematologic Neoplasms
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Cyclophosphamide
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid, Acute
Small non-cleaved cell lymphoma
Lymphoma, large-cell, immunoblastic
Acute lymphoblastic leukemia, adult
Lymphoma, large-cell
Lymphoma, B-Cell
Burkitt's lymphoma
Leukemia
Cobalt
Lymphoma, Large-Cell, Immunoblastic
Waldenstrom macroglobulinemia
Acute myeloid leukemia, adult
Acute myelocytic leukemia
Hodgkin Disease
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on September 05, 2008




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