Status:
COMPLETED
Sirolimus, Tacrolimus, and Methotrexate in Preventing Acute Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplantation
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Sirolimus, tacrolimus, and methotrexate may be effective in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation. PURPOSE: This phase I...
Detailed Description
OBJECTIVES: Primary * Determine the safety and efficacy of sirolimus when administered with tacrolimus and methotrexate for the prevention of acute graft-versus-host disease (GVHD) in patients with ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of hematological malignancy
- No chronic phase chronic myelogenous leukemia, de novo acute leukemia in first remission, or myelodysplastic syndromes with refractory anemia
- Scheduled for hematopoietic stem cell transplantation from unrelated donors
- Currently receiving conditioning regimen comprising cyclosporine and total body radiotherapy (1,200 to 1,350 cGy) or busulfan and cyclosporine
- Donor must be typed to the highest level of resolution
- One single non-serologic disparity for A, B, or C alleles allowed provided the disparity is within the third or fourth digit of the allele
- No mismatch at DRB1 or DQB1
- PATIENT CHARACTERISTICS:
- Age
- Per primary treatment protocol
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- SGOT and SGPT ≤ 2.0 times upper limit of normal
- Bilirubin normal
- Hepatitis B and C virus negative
- Renal
- Creatinine clearance ≥ 70 mL/min
- Cardiovascular
- No cardiac insufficiency requiring treatment
- No coronary artery disease
- Pulmonary
- No acute pulmonary infection by chest x-ray
- No severe hypoxemia with pO\_2 \< 70 mm Hg AND DLCO \< 70% of predicted
- No mild hypoxemia with pO\_2 \< 80 mm Hg AND DLCO \< 60% of predicted
- Other
- Not pregnant or nursing
- Negative pregnancy test
- HIV negative
- No active systemic infection
- No known hypersensitivity to macrolide antibiotics (e.g., erythromycin, azithromycin, or clarithromycin)
- No prior intolerance or unresponsiveness to sirolimus
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- No concurrent T-cell depleted transplantations
- Chemotherapy
- See Disease Characteristics
- Endocrine therapy
- Not specified
- Radiotherapy
- See Disease Characteristics
- Surgery
- Not specified
- Other
- No concurrent grapefruit juice
- No concurrent voriconazole
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00089037
Start Date
June 1 2003
End Date
April 1 2005
Last Update
July 15 2011
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024