Status:
COMPLETED
Total-Body Irradiation and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer and Other Diseases
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving total-body irradiation and chemotherapy, such as cyclophosphamide, before a donor stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells an...
Detailed Description
OBJECTIVES: Primary * Evaluate the potential efficacy of targeting cyclophosphamide to a metabolic endpoint when given together with total-body irradiation, in terms of day 200 nonrelapse mortality,...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of a hematologic cancer or other disease that is unlikely to respond to conventional treatment, including any of the following:
- Chronic myelogenous leukemia
- Acute myeloid leukemia
- Acute lymphocytic leukemia
- Myelodysplastic syndromes
- Lymphoma
- Patients who have bulky tumor mass must not require additional involved-field irradiation
- Planning to undergo conditioning for transplantation at the Seattle Cancer Care Alliance and University of Washington Medical Center
- Must have an HLA-matched donor available
- No donors who are mismatched for \> 1 HLA class I antigen or allele
- Negative anti-donor lymphocytotoxic crossmatch
- PATIENT CHARACTERISTICS:
- Life expectancy must not be severely limited by diseases other than malignancy
- No moribund patients
- Creatinine ≤ 1.2 mg/dL
- Oxygen saturation on room air ≥ 93%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No HIV positivity
- No cirrhosis
- No hepatic fibrosis with bridging
- No fulminant hepatic failure
- No acute liver injury
- No persistent cholestasis
- No infection requiring systemic antibiotic or antifungal therapy
- No coronary artery disease
- No congestive heart failure requiring therapy
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior hematopoietic stem cell transplantation
- No prior radiation therapy to the liver or adjacent organs
- More than 30 days since prior cytoreductive chemotherapy for patients with a large body burden of tumor cells
- No concurrent enrollment in a phase I study
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00317785
Start Date
May 1 2005
Last Update
May 7 2010
Active Locations (2)
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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