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


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Bone Marrow Diseases




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

This study is no longer recruiting patients.

Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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 Treatment or Intervention Phase
Leukemia
Lymphoma
myelodysplastic and myeloproliferative diseases
 Drug: cyclophosphamide
 Procedure: allogeneic bone marrow transplantation
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: bone marrow transplantation
 Procedure: chemotherapy
 Procedure: peripheral blood stem cell transplantation
 Procedure: radiation therapy
Phase I

MedlinePlus related topics:  Blood and Blood Disorders;   Cancer;   Cancer Alternative Therapy;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Total-Body Irradiation, Dose-Adjusted Cyclophosphamide, and Hematopoietic Stem Cell Transplantation in Patients With Hematologic Malignancy

Further Study Details: 

OBJECTIVES:

OUTLINE:

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.

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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

Pulmonary

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

Other

PRIOR CONCURRENT THERAPY: Biologic therapy

  • No prior hematopoietic stem cell transplantation

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

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

Location Information


Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States

Study chairs or principal investigators

George B. McDonald, MD,  Study Chair,  Fred Hutchinson Cancer Research Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000304522; FHCRC-1797.00
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  June 5, 2003
ClinicalTrials.gov Identifier:  NCT00062140
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 3, 2008



Page Updated: October 1, 2005
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