Overview

Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers

Status:
Completed
Trial end date:
2002-04-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bone marrow transplantation may be able to replace immune cells that have been destroyed by radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Mycophenolate mofetil and tacrolimus may be an effective treatment for graft-versus-host disease caused by bone marrow transplantation. PURPOSE: Phase II trial to study the effectiveness of total-body irradiation, tacrolimus, and mycophenolate mofetil plus bone marrow transplantation in treating patients with hematologic cancers.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborator:
National Cancer Institute (NCI)
Treatments:
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
Criteria
DISEASE CHARACTERISTICS: Must have a 6 antigen HLA identical related donor and one of the
following diseases: -Acute myelogenous leukemia in high risk first complete remission or
second or greater complete remission -Acute lymphocytic leukemia in high risk first
complete remission or second or greater remission -Chronic myelogenous leukemia in chronic
phase -Indolent non-Hodgkin's lymphoma (NHL) or aggressive NHL in complete or partial
remission, not eligible for autologous bone marrow transplant (ABMT) -Multiple myeloma in
complete or partial response -Myelodysplastic syndrome -Stage III or IV chronic lymphocytic
leukemia -Hodgkin's disease after first complete remission Patients must also have one of
the following high risk features: -Age 55-70 -Age 18-54 must have one of the following
conditions: LVEF 35-44% FEV1 or FVC 40-49% Bilirubin 2.1-3.0 mg/dL, AST 71-175, or ALT
81-200 Creatinine 2.1-3.0 mg/dL Disease recurrence less than 1 year after ABMT Between 18
to 24 months of prior chemotherapy (12 to 24 months for multiple myeloma)

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3.1 mg/dL Renal:
Creatinine less than 3.1 mg/dL Cardiovascular: LVEF at least 35% Pulmonary: FEV1 and FVC at
least 40% of predicted (60% for patients who have received thoracic or mantle radiotherapy)
Other: Not pregnant Fertile patients must use effective contraception Not HIV positive

PRIOR CONCURRENT THERAPY: See Disease Characteristics