Overview
Mycophenolate Mofetil, Tacrolimus, Daclizumab, and Donor Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Status:
Completed
Completed
Trial end date:
2001-11-01
2001-11-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Monoclonal antibodies such as daclizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation from a brother or sister may be effective treatment for hematologic cancer. Sometimes the transplanted cells can be rejected by the body's tissue. Mycophenolate mofetil, tacrolimus, and donor white blood cells may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of mycophenolate mofetil, tacrolimus, daclizumab, and donor peripheral stem cell transplantation in treating patients who have hematologic cancer.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of Maryland Greenebaum Cancer Center
University of Maryland, BaltimoreTreatments:
Daclizumab
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
Criteria
DISEASE CHARACTERISTICS: Diagnosis of any of the following hematologic malignancies:Multiple myeloma Non-Hodgkin's lymphoma Indolent OR Relapsed or primary refractory high
grade or intermediate grade in complete remission (CR) or partial remission (PR) after
salvage chemotherapy or autologous bone marrow transplantation Hodgkin's disease Relapsed
or primary refractory in CR or PR after salvage chemotherapy or autologous bone marrow
transplantation Chronic lymphocytic leukemia Chronic myeloid leukemia Myelodysplastic
syndrome Acute myeloid leukemia with high risk CR1 or second or greater CR Acute
lymphocytic leukemia with high risk CR1 or second or greater CR Must have a 6 antigen HLA
identical sibling donor Must have one of the following conditions that confer an increased
risk for undergoing allogeneic bone marrow transplantation after myeloablative preparative
regimen: Over 55 years of age AST or ALT greater than 2.5 times upper limit of normal (ULN)
Bilirubin greater than 1.8 times ULN Renal dysfunction with creatinine greater than 1.5
mg/dL (after 12 courses of prior cytotoxic therapy) Undergone one or more prior autologous
bone marrow transplantations Refuse to undergo allogeneic bone marrow transplantation using
a myeloablative preparative regimen A new classification scheme for adult non-Hodgkin's
lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma
will replace the former terminology of "low", "intermediate", or "high" grade lymphoma.
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: See Disease Characteristics Renal: See
Disease Characteristics Other: Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See
Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified
Surgery: Not specified