Overview
Sirolimus, Tacrolimus, and Methotrexate in Preventing Acute Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplantation
Status:
Completed
Completed
Trial end date:
2005-04-01
2005-04-01
Target enrollment:
0
0
Participant gender:
All
All
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/II trial is studying the side effects of sirolimus when given together with tacrolimus and methotrexate and to see how well they work in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation for hematologic cancer.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Fred Hutchinson Cancer Research CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Everolimus
Methotrexate
Sirolimus
Tacrolimus
Criteria
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