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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00003572
First received: November 1, 1999
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Biological: peripheral blood lymphocyte therapy
Drug: mycophenolate mofetil
Drug: tacrolimus
Procedure: allogeneic bone marrow transplantation
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Non-Myeloablative Allogeneic Bone Marrow Transplant for Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Estimated Enrollment: 20
Study Start Date: August 1998
Study Completion Date: April 2002
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine whether sustained engraftment of HLA identical sibling marrow can be achieved in patients treated with total body irradiation before transplant and tacrolimus and mycophenolate mofetil after transplant. II. Document the nonhematologic toxicities of this regimen. III. Characterize immune reconstitution of patients during this treatment regimen. IV. Document the incidence of aplasia and graft-versus-host disease associated with donor leukocyte infusions when administered after this regimen.

OUTLINE: Patients receive total body irradiation in a single fraction on day -1. Tacrolimus is given orally twice per day on days -1 to 50. Mycophenolate mofetil is given orally on day 0 and twice per day on days 1 to 28. Patients receive donor bone marrow infusion on day 0. Patients are evaluated on days 56, 180, 292, and 365. If there is donor engraftment, donor chimerism is less than 80%, there is no active graft-versus-host disease, no disease progression, less than 50% decrease in donor cell chimerism from last measurement, and the patient is not taking immunosuppressive agents, then donor leukocyte infusions are administered on days 70, 194, and 306. Patients are followed annually for 5 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003572

Locations
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Ephraim J. Fuchs, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003572     History of Changes
Other Study ID Numbers: CDR0000066639, J9845, R01CA067782, P30CA006973, JHOC-98070603, JHOC-9845, NCI-H98-0023
Study First Received: November 1, 1999
Last Updated: May 1, 2014
Health Authority: United States: Federal Government

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
Waldenstrom macroglobulinemia
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
chronic phase chronic myelogenous leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage I adult diffuse small cleaved cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage I adult diffuse large cell lymphoma
stage I adult immunoblastic large cell lymphoma
stage I adult lymphoblastic lymphoma
stage I adult Burkitt lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Plasmacytoma
Lymphoma
Leukemia
Syndrome
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions
Lymphatic Diseases
Disease
Pathologic Processes
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 19, 2014