Overview

Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

Status:
Completed
Trial end date:
2001-09-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus donor bone marrow transplantation in treating patients who have hematologic cancer.
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:
Busulfan
Cyclophosphamide
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
DISEASE CHARACTERISTICS: Diagnosis of any of the following: Chronic myelogenous leukemia
(CML) in first chronic phase Myelodysplastic syndrome Refractory anemia with excess blasts
(RAEB) RAEB in transformation Secondary leukemias untreated or in complete remission 1
(CR1) Acute myeloid leukemia in complete remission 2 (CR2) Acute lymphocytic leukemia (ALL)
in CR2 High-risk acute leukemia in CR1 Ph+ ALL in CR1 or consolidation after induction
chemotherapy Must qualify for allogeneic bone marrow transplantation (BMT) No HLA-matched,
sibling donor for BMT available No current CNS disease No history of more than 2 episodes
of active CNS disease

PATIENT CHARACTERISTICS: Age: 19 to 55 Performance status: ECOG 0 or 1 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 mg/dL Renal:
Creatinine no greater than 2 mg/dL Cardiovascular: LVEF at least 45% No active congestive
heart failure, arrhythmia, or angina pectoris No myocardial infarction within the past 12
months Pulmonary: FEV1 and FVC at least 50% predicted (75% predicted if received prior
thoracic or mantle radiotherapy) Other: No active serious infection (e.g., mucormycosis,
uncontrolled aspergillosis, or tuberculosis) HIV negative Not pregnant Fertile patients
must use effective contraception No concurrent debilitating medical or psychiatric illness
that would preclude compliance No prior malignancy except curatively treated skin cancer or
carcinoma of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior autologous
or allogeneic bone marrow transplantation No prior transfusions from donor Chemotherapy:
See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified
Surgery: Not specified