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Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer

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ClinicalTrials.gov Identifier: NCT00062140
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : September 21, 2010
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Study Description
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Brief Summary:

RATIONALE: Adjusting the dose of drugs used in chemotherapy such as cyclophosphamide may decrease side effects while stopping cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells.

PURPOSE: Phase I trial to study the effect on the body of dose-adjusted cyclophosphamide combined with total-body irradiation and donor stem cell transplantation in treating patients who have hematologic cancer.


Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Drug: cyclophosphamide Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy Phase 1

Detailed Description:

OBJECTIVES:

  • Determine a safe and reproducible method of adjusting the dose of cyclophosphamide based on its metabolism when given in combination with total body irradiation and hematopoietic stem cell transplantation in patients with hematologic malignancy.

OUTLINE:

  • Preparative regimen: Patients undergo total body irradiation twice daily on days -6 to -4. Patients then receive dose-adjusted (based on metabolism) cyclophosphamide IV over 1 hour on days -3 and -2.
  • Hematopoietic stem cell (HSC) infusion: Patients undergo allogeneic HSC transplantation on day 0.

Patients receive graft-versus-host disease prophylaxis, CNS prophylaxis, and testicular irradiation as per institutional standard practices.

Patients are followed daily until day 80 after transplantation and then regularly thereafter for survival.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial Of Total Body Irradiation, Cyclophosphamide Dose-Adjustment Based On Its Metabolism, And Hematopoietic Stem Cell Transplantation For Patients With Hematological Malignancy
Study Start Date : April 2003
Actual Study Completion Date : July 2004

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of hematological malignancy, including any of the following:

    • Chronic myeloid leukemia
    • Acute myeloid leukemia
    • Acute lymphocytic leukemia
    • Myelodysplastic syndromes
    • Lymphoma
  • Unlikely to respond to conventional treatment and would benefit from hematopoietic stem cell transplantation
  • No bulky tumor mass requiring additional involved field radiotherapy
  • No large body burden of tumor cells requiring cytoreductive chemotherapy before total body irraditation and cyclophosphamide
  • Undergoing conditioning for transplantation at the University of Washington Medical Center

  • Availability of 1 of the following types of allogeneic donors:

    • HLA-identical family members

    • Unrelated donors

      • Allele match (match grade 1)
      • One allele mismatch for A, B, C, DRB1 or DQB1 (match grades 2.1 or 2.2)

PATIENT CHARACTERISTICS:

Age

  • 18 to 65

Performance status

  • Not specified

Life expectancy

  • Not severely limited by diseases other than malignancy
  • Not moribund

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin no greater than 1.2 mg/dL
  • No cirrhosis
  • No hepatic fibrosis with bridging

Renal

  • Creatinine no greater than 1.2 mg/dL

Cardiovascular

  • No coronary artery disease
  • No congestive heart failure requiring therapy

Pulmonary

  • Oxygen saturation at least 93% (on room air)

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No concurrent infection requiring systemic antibiotic or antifungal therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior hematopoietic stem cell transplantation

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No prior radiotherapy to the liver or adjacent organs

Surgery

  • Not specified

Other

  • No concurrent aspirin or nonsteroidal anti-inflammatory medications such as ibuprofen (e.g., Motrin® or Advil®)
  • No other concurrent phase I study enrollment
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): NCT00062140


Locations
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United States, Washington
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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Study Chair: George B. McDonald, MD Fred Hutchinson Cancer Research Center
More Information
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ClinicalTrials.gov Identifier: NCT00062140    
Other Study ID Numbers: 1797.00
FHCRC-1797.00
CDR0000304522 ( Registry Identifier: PDQ )
First Posted: June 6, 2003    Key Record Dates
Last Update Posted: September 21, 2010
Last Verified: September 2010
Keywords provided by Fred Hutchinson Cancer Research Center:
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
 noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
stage III adult lymphoblastic lymphoma
stage IV adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV adult Burkitt lymphoma
recurrent adult acute myeloid leukemia
untreated adult acute myeloid leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Preleukemia
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
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
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists