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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00062140
First received: June 5, 2003
Last updated: September 20, 2010
Last verified: September 2010

June 5, 2003
September 20, 2010
April 2003
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Complete list of historical versions of study NCT00062140 on ClinicalTrials.gov Archive Site
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Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer
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

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.

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.

Interventional
Phase 1
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • Drug: cyclophosphamide
  • Procedure: allogeneic bone marrow transplantation
  • Procedure: peripheral blood stem cell transplantation
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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July 2004
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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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00062140
1797.00, FHCRC-1797.00, CDR0000304522
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Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Study Chair: George B. McDonald, MD Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP