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Total-Body Irradiation and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer and Other Diseases

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ClinicalTrials.gov Identifier: NCT00317785
Recruitment Status : Completed
First Posted : April 25, 2006
Last Update Posted : May 7, 2010
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Study Description
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Brief Summary:

RATIONALE: Giving total-body irradiation and chemotherapy, such as cyclophosphamide, before a donor stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of cancer or abnormal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving immunosuppressive therapy before or after transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving total-body irradiation together with cyclophosphamide works in treating patients who are undergoing donor stem cell transplant for hematologic cancer and other diseases.


Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Myelodysplastic Syndromes Drug: cyclophosphamide Drug: cyclosporine Drug: methotrexate Drug: mycophenolate mofetil Drug: sirolimus Drug: tacrolimus Other: pharmacological study Procedure: allogeneic bone marrow transplantation Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Radiation: total-body irradiation Phase 2

Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the potential efficacy of targeting cyclophosphamide to a metabolic endpoint when given together with total-body irradiation, in terms of day 200 nonrelapse mortality, in patients with hematologic cancer and other diseases who are undergoing allogeneic hematopoietic stem cell transplantation.

Secondary

  • Determine the overall survival of patients treated with this regimen.
  • Determine the rate of relapse in patients treated with this regimen.
  • Determine the occurrence of sinusoidal obstruction syndrome in patients treated with this regimen.
  • Determine the occurrence of acute renal failure in these patients.
  • Determine the occurrence of respiratory failure in these patients.

OUTLINE:

  • Conditioning regimen: Patients undergo total-body irradiation twice daily on days -6 to -4. Patients also receive cyclophosphamide IV over 1 hour on day -3 and then IV at a metabolism-based dose* on day -2.

NOTE: *Patients undergo frequent blood sampling after completion of the first cyclophosphamide infusion for pharmacokinetic studies in order to determine the dose for the second cyclophosphamide infusion.

  • Allogeneic stem cell transplantation: Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.
  • Graft-versus-host disease (GVHD) prophylaxis: Patients receive GVHD prophylaxis as per the attending physician, including one of the following regimens: cyclosporine and methotrexate; tacrolimus and methotrexate; tacrolimus and mycophenolate mofetil; or sirolimus, tacrolimus, and methotrexate (as per the GVHD prophylaxis regimen chosen for each patient).

After completion of study treatment, patients are followed periodically for at least 200 days.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Total Body Irradiation Plus Metabolism-Based Cyclophosphamide Dosing as Preparative Therapy for Allogeneic Hematopoietic Cell Transplant for Patients With Hematological Malignancy
Study Start Date : May 2005
Actual Primary Completion Date : November 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Non-relapse mortality (NRM) at 200 days

Secondary Outcome Measures :
  1. Overall survival
  2. Relapse rate
  3. Sinusoidal obstruction syndrome (SOS)
  4. Acute renal failure
  5. Respiratory failure
  6. Cause of death

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of a hematologic cancer or other disease that is unlikely to respond to conventional treatment, including any of the following:

    • Chronic myelogenous leukemia
    • Acute myeloid leukemia
    • Acute lymphocytic leukemia
    • Myelodysplastic syndromes
    • Lymphoma
  • Patients who have bulky tumor mass must not require additional involved-field irradiation
  • Planning to undergo conditioning for transplantation at the Seattle Cancer Care Alliance and University of Washington Medical Center

  • Must have an HLA-matched donor available

    • No donors who are mismatched for > 1 HLA class I antigen or allele
    • Negative anti-donor lymphocytotoxic crossmatch

PATIENT CHARACTERISTICS:

  • Life expectancy must not be severely limited by diseases other than malignancy
  • No moribund patients
  • Creatinine ≤ 1.2 mg/dL
  • Oxygen saturation on room air ≥ 93%
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No HIV positivity
  • No cirrhosis
  • No hepatic fibrosis with bridging
  • No fulminant hepatic failure
  • No acute liver injury
  • No persistent cholestasis
  • No infection requiring systemic antibiotic or antifungal therapy
  • No coronary artery disease
  • No congestive heart failure requiring therapy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior hematopoietic stem cell transplantation
  • No prior radiation therapy to the liver or adjacent organs
  • More than 30 days since prior cytoreductive chemotherapy for patients with a large body burden of tumor cells
  • No concurrent enrollment in a phase I study
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317785


Locations
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United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: George B. McDonald, MD Fred Hutchinson Cancer Research Center
More Information
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ClinicalTrials.gov Identifier: NCT00317785     History of Changes
Other Study ID Numbers: 1998.00
FHCRC-1998.00
CDR0000471840 ( Registry Identifier: PDQ )
First Posted: April 25, 2006    Key Record Dates
Last Update Posted: May 7, 2010
Last Verified: May 2010
Keywords provided by Fred Hutchinson Cancer Research Center:
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
blastic phase chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
 noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II marginal zone lymphoma
noncontiguous stage II small lymphocytic lymphoma
previously treated myelodysplastic syndromes
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent adult Burkitt lymphoma
recurrent adult Hodgkin lymphoma
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Preleukemia
Myelodysplastic Syndromes
Syndrome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
 Precancerous Conditions
Cyclosporine
Sirolimus
Mycophenolic Acid
Cyclophosphamide
Methotrexate
Tacrolimus
Cyclosporins
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action