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Bone Marrow Transplantation With Specially Treated Bone Marrow in Treating Patients With Hematologic Cancer That Has Not Responded to Previous Therapy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 5, 2000
Last updated: May 16, 2009
Last verified: May 2009

RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Treatment of the donor bone marrow with the patient's white blood cells and a monoclonal antibody may prevent this from happening.

PURPOSE: Phase I trial to study the effectiveness of bone marrow transplantation with specially treated bone marrow in treating patients who have hematologic cancer that has not responded to previous therapy.

Condition Intervention Phase
Graft Versus Host Disease
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Drug: cyclophosphamide
Drug: cyclosporine
Drug: leucovorin calcium
Drug: methotrexate
Drug: methylprednisolone
Procedure: in vitro-treated bone marrow transplantation
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: A Phase I Open-Label, Safety Study of Haploidentical Bone Marrow Transplantation (BMT) After Ex Vivo Treatment of Bone Marrow With Anti-B7.1 and Anti-B7.2 Antibodies

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2000
Detailed Description:

OBJECTIVES: I. Determine if patients with refractory, high risk hematologic malignancies or bone marrow failure who receive HLA haploidentical bone marrow treated with anti-B7 antibody have normal engraftment. II. Determine if these patients are free of hyperacute graft versus host disease (GVHD), defined as grade D GVHD in the first 10 posttransplant days, when treated with this regimen. III. Determine if these patients have an acceptable incidence of life threatening grade D GHVD in the first 50 posttransplant days following this treatment regimen. IV. Determine the safety and tolerability of this treatment regimen in this patient population.

OUTLINE: This is a multicenter study. Patients undergo leukapheresis to collect white blood cells which are incubated with donor bone marrow cells in the presence of anti-B7.1 and anti-B7.2 antibodies for 36 hours. Patients receive total body irradiation twice daily on days -6 to -3, cyclophosphamide IV daily on days -2 and -1, and methylprednisolone IV every 12 hours for a total of 4 doses on days -2 to 0. Patients are infused with the treated donor bone marrow on day 0. Patients then receive methotrexate IV on days 1, 3, 6, and 11 and leucovorin calcium IV 24 hours after each dose of methotrexate every 6 hours for 3-8 doses each time. Patients also receive cyclosporine IV or orally twice daily on days -2 to 100. Patients are followed every 2 months for 1 year.

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


Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Any of the following hematologic malignancies or bone marrow failure syndromes: Acute myelogenous leukemia after induction failure, in relapse, or in second or greater complete remission (CR) Acute lymphocytic leukemia after induction failure, in relapse, in second or greater CR, or in first CR with t(9;22), t(8;14), or t(4;11) Non-Hodgkin's lymphoma (intermediate or high grade) that has failed to achieve CR with at least 2 induction regimens, in relapse, or in second or greater CR Multiple myeloma with poor prognostic features (elevated beta-2 microglobulin or high labeling index) Hodgkin's disease in relapse or that failed to achieve CR after 2 chemotherapy regimens Congenital or acquired bone marrow failure that is poorly responsive to or intolerant of current therapy Myelodysplastic syndrome of all subtypes except refractory anemia No Fanconi's anemia Patients must have a haploidentical donor and meet the following criteria: Likely to have clinical deterioration and rapid disease progression during an unrelated donor search OR Already had an unproductive donor search OR Ineligible for or has refused autologous transplant Lack an HLA A, B, DR, and DQ matched related donor (evaluated via both genotype and phenotype) Lack an HLA A, B, and DR matched unrelated donor (evaluated via both genotype and phenotype) 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: 40 and under Performance status: ECOG 0-2 OR Lansky 50-100% for patients under 16 years Life expectancy: At least 12 weeks Hematopoietic: Blood differential count with greater than 25% blasts at time of leukapheresis Hepatic: ALT and AST no greater than 5.0 times upper limit of normal (ULN) Bilirubin no greater than 2 times ULN unless due to Gilbert's syndrome or hemolytic anemia Renal: Creatinine less than 2 times ULN Cardiovascular: Adequate cardiac function for age Pulmonary: Adequate pulmonary function for age Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 1 month prior to study until at least 2 months after study No active uncontrolled infection HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplant No other concurrent monoclonal antibody therapies or ex vivo T-cell depletion therapies Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

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Please refer to this study by its identifier: NCT00005988

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: Eva Guinan, MD Dana-Farber Cancer Institute
  More Information

Publications: Identifier: NCT00005988     History of Changes
Other Study ID Numbers: CDR0000067977  DFCI-99205  GENE-C9909-38  NCI-G00-1801 
Study First Received: July 5, 2000
Last Updated: May 16, 2009

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia
recurrent adult Hodgkin lymphoma
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
stage I childhood lymphoblastic lymphoma
stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
childhood diffuse large cell lymphoma
childhood immunoblastic large cell lymphoma
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood acute lymphoblastic leukemia in remission
recurrent/refractory childhood Hodgkin 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
chronic myelomonocytic leukemia
stage III grade 3 follicular lymphoma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Graft vs Host Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Cyclophosphamide processed this record on March 01, 2017