Status:

COMPLETED

Cyclophosphamide in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Fanconi's Anemia

Lead Sponsor:

Fred Hutchinson Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Fanconi Anemia

Eligibility:

All Genders

Phase:

PHASE1

Brief Summary

RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide, before a donor bone marrow transplant helps stop the growth of abnormal cells. It also stops the patient's immune system from rej...

Detailed Description

OBJECTIVES: * Decrease the conditioning-related toxicity of cyclophosphamide without decreasing the engraftment rate to \< 90% in patients undergoing allogeneic bone marrow transplantation for Fancon...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of Fanconi's anemia by chromosome fragility with a diepoxybutane (DEB) or mitomycin C test
  • Hemoglobin ≤ 8.0 g/dL, absolute granulocyte count ≤ 1,000/mm\^3, or platelet count ≤ 50,000/mm\^3
  • No refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, or acute leukemia
  • HLA-identical related donor available
  • PATIENT CHARACTERISTICS:
  • Glomerular filtration rate ≥ 30% predicted for age
  • No liver disease (e.g., active hepatitis or moderate to severe portal fibrosis/cirrhosis by biopsy)
  • No symptomatic cardiac insufficiency or symptomatic arrhythmia
  • No other diseases that would severely limit the probability of survival
  • No HIV seropositivity
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY:
  • Not specified

Exclusion

    Key Trial Info

    Start Date :

    June 1 1998

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    25 Patients enrolled

    Trial Details

    Trial ID

    NCT00317876

    Start Date

    June 1 1998

    Last Update

    April 20 2012

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Seattle Cancer Care Alliance

    Seattle, Washington, United States, 98109-1023

    2

    Fred Hutchinson Cancer Research Center

    Seattle, Washington, United States, 98109-1024

    3

    Universidade Federal do Parana

    Curitiba, Paraná, Brazil, 80.060-000