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
Trial end date:
2005-04-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
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