Overview

Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Status:
Completed
Trial end date:
2000-07-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of treated donor stem cell transplantation in treating patients who have hematologic cancer.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Northwestern University
Collaborator:
National Cancer Institute (NCI)
Treatments:
Antilymphocyte Serum
Cladribine
Cyclophosphamide
Etoposide
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Tacrolimus
Criteria
DISEASE CHARACTERISTICS: Histologically proven hematologic malignancy with relapse after
allogeneic bone marrow transplantation (BMT) or autologous BMT if no HLA matched sibling
donor is available OR Histologically proven acute myeloid leukemia (AML) without an
available HLA matched sibling donor and with one of the following: Failure of induction,
defined as inability to obtain remission with 2 courses of induction or failure during
treatment Second or greater remission OR Histologically proven acute lymphocytic leukemia
(ALL) in an adult over age 15 without an available HLA matched sibling donor and with one
of the following: Philadelphia chromosome positivity by cytogenetics or PCR Relapse or
second or greater remission Two or more prognostic features (over age 30, WBC on
presentation over 35,000/mm3, time to complete response over 4 weeks, t(4:11), or B-cell
ALL) OR Histologically proven chronic myelogenous leukemia In chronic phase without an A,
B, and DR unrelated matched donor OR In accelerated phase, defined as new cytogenetic
abnormalities or difficulty maintaining a normal WBC due to dose limiting cytopenias
(thrombocytopenias or anemia) from hydroxyurea or interferon OR In blast transformation OR
Histologically proven aplastic anemia without an available HLA matched sibling donor and
failure of an immunosuppressive therapy regimen using either cyclosporine, antithymocyte
globulin, or both OR Histologically proven lymphoma without an available HLA matched donor
and failure of at least 2 different chemotherapy regimens OR Histologically proven
cutaneous T-cell lymphoma without an available HLA matched donor and failure of interferon
and PUVA (psoralen and ultraviolet A radiation) OR Histologically proven myelodysplastic
syndrome without an available HLA matched sibling donor and with one of the following: 5%
or greater blasts in marrow Multiple cytogenetic abnormalities History of infections from
neutropenia 1, 2, or 3 antigen mismatched related donor available

PATIENT CHARACTERISTICS: Age: Physiologic age 45 and under Performance status: ECOG 0-2
Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic:
Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2 times upper limit of
normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No myocardial infarction
within the past 6 months No coronary artery disease requiring medical therapy Resting LVEF
at least 40% Pulmonary: FEV1/FVC at least 60% predicted DLCO at least 60% predicted Other:
HIV negative No prior malignancy except basal cell or squamous cell skin cancer Other
malignancies for which the patient is cured by local surgical therapy, such as head and
neck cancer or stage I breast cancer, are considered on an individual basis Not pregnant
Negative pregnancy test Fertile patients must use effective contraception No psychiatric
illness or mental deficiency that would preclude compliance or informed consent

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See
Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified
Surgery: Not specified