Status:
COMPLETED
Total-Body Irradiation, Thiotepa, and Fludarabine in Treating Young Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
Up to 20 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Chemotherapy, such as fludarabine and thiotepa, and radiation therapy may destroy cancerous blood-forming cells (stem cells) in the blood and bone marrow. Giving healthy stem cells from a d...
Detailed Description
OBJECTIVES: Primary * Determine the safety of a conditioning regimen without anti-thymocyte globulin comprising total body irradiation, thiotepa, and fludarabine followed by CD34-positive-selected h...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of a life-threatening hematologic malignancy, including any of the following:
- Acute leukemia advanced beyond first remission
- Acute leukemia in first remission\* with very high-risk prognostic features, including any of the following:
- Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL)
- ALL or acute myeloid leukemia (AML) with 11q23 chromosomal abnormality
- Hypodiploid ALL
- Failed to achieve first remission within 1 month after induction therapy
- Secondary AML
- Myelodysplastic syndromes with International Prognostic Index score \> 1
- Chronic myelogenous leukemia in accelerated or blast phase NOTE: \*Must be approved by PCC
- Haploidentical family donor available
- No suitable HLA-matched related or unrelated donor available
- No related donor mismatched for a single HLA-A, -B, -C, -DRB1, or -DQB1 antigen available
- PATIENT CHARACTERISTICS:
- Age
- Under 21
- Performance status
- Not specified
- Life expectancy
- At least 6 months
- Hematopoietic
- Not specified
- Hepatic
- SGPT and SGOT \< 2 times upper limit of normal (ULN)\*
- Bilirubin \< 2 times ULN\* NOTE: \*Unless due to malignancy
- Renal
- Not specified
- Cardiovascular
- Ejection fraction ≥ 45%
- Pulmonary
- DLCO ≥ 60% of predicted
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No second bone marrow transplantation, after a first regimen containing total body irradiation
- No concurrent growth factors until day 21 post-transplantation
- Chemotherapy
- Not specified
- Endocrine therapy
- Not specified
- Radiotherapy
- See Biologic therapy
- Surgery
- Not specified
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00112567
Start Date
April 1 2003
End Date
July 1 2007
Last Update
September 21 2010
Active Locations (2)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
2
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023