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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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