Donor Stem Cell Transplant After Conditioning Therapy in Treating Patients With Hematologic Cancer, Recurrent or Metastatic Solid Tumor, or Other Disease

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00521430
First received: August 24, 2007
Last updated: March 25, 2013
Last verified: October 2007
  Purpose

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and methotrexate before and after transplant may stop this from happening.

PURPOSE: This clinical trial is studying the side effects and how well donor stem cell transplant works when given after conditioning therapy in treating patients with hematologic cancer, recurrent or metastatic solid tumor, or other disease.


Condition Intervention
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Nonmalignant Neoplasm
Unspecified Adult Solid Tumor, Protocol Specific
Biological: anti-thymocyte globulin
Drug: busulfan
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: methotrexate
Drug: methylprednisolone
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: NON-T-CELL DEPLETED HLA-HAPLOIDENTICAL FAMILIAL DONOR HEMATOPOIETIC CELL TRANSPLANTATION AFTER REDUCED INTENSITY CONDITIONING

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Leukemia, Myeloid Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Multiple Myeloma Acute Myeloid Leukemia, Adult Lymphoma, Small Cleaved-cell, Diffuse Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Acute Lymphoblastic Leukemia Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Follicular Lymphoma Lymphoma, Large-cell Myelodysplastic Syndromes Leukemia, T-cell, Chronic Acute Lymphoblastic Leukemia, Childhood Mycosis Fungoides Sezary Syndrome Cutaneous T-cell Lymphoma Lymphoblastic Lymphoma B-cell Lymphomas Burkitt Lymphoma Lymphoma, Large-cell, Immunoblastic Plasmablastic Lymphoma Hodgkin Lymphoma Mantle Cell Lymphoma Acute Myeloid Leukemia, Childhood Waldenstrom Macroglobulinemia Anaplastic Large Cell Lymphoma Small Non-cleaved Cell Lymphoma Hodgkin Lymphoma, Childhood Lymphomatoid Granulomatosis Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Lymphosarcoma Aplastic Anemia Sideroblastic Anemia Pyridoxine-refractory Autosomal Recessive Anaplastic Plasmacytoma
U.S. FDA Resources

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

Primary Outcome Measures:
  • Engraftment (neutrophil, platelet, and red blood cells) [ Designated as safety issue: No ]
  • Frequency and kinetics of mixed chimerism as assessed by polymerase chain reaction [ Designated as safety issue: No ]
  • Frequency and severity of regimen-related toxicities [ Designated as safety issue: Yes ]
  • Frequency of acute and chronic graft-versus-host disease [ Designated as safety issue: No ]
  • Immune reconstitution [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response rate [ Designated as safety issue: No ]
  • Duration of tumor response [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2004
Study Completion Date: September 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the safety and efficacy of non-T-cell depleted, HLA-haploidentical related donor hematopoietic stem cell transplantation after a reduced-intensity conditioning regimen comprising busulfan, fludarabine phosphate, anti-thymocyte globulin, and methylprednisolone in patients with hematologic cancer, recurrent or metastatic solid tumors, or other diseases.

OUTLINE:

  • Reduced-intensity conditioning regimen: Patients receive busulfan IV 4 times daily on days -7 and -6; fludarabine phosphate IV over 30 minutes on days -7 to -2; and methylprednisolone IV over 30 minutes followed by anti-thymocyte globulin IV over 4 hours on days -4 to -1.
  • Donor hematopoietic stem cell transplantation: Patients receive donor peripheral blood stem cells IV over 1 hour on days 0 and 1.
  • Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2-4 hours or orally twice daily beginning on day -1 and continuing until day 60, followed by a taper in the absence of GVHD. Patients also receive methotrexate IV on days 2, 4, 7, and 12.

After the transplant, patients are followed periodically.

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • High-risk acute leukemia, including any of the following:

      • Refractory acute leukemia
      • Acute leukemia beyond first remission
      • Acute leukemia in first remission with poor prognostic features (e.g., chromosomal changes suggesting poor prognosis)
    • Chronic myelogenous leukemia in second chronic, accelerated, or blastic phase
    • Severe aplastic anemia that is not responsive to immunosuppressive therapy
    • Myelodysplastic syndromes, including any of the following:

      • Refractory anemia (RA) or RA with ringed sideroblasts with severe cytopenia
      • RA with excess blasts (RAEB)
      • RAEB in transformation
      • Chronic myelomonocytic leukemia
    • Refractory or relapsed non-Hodgkin or Hodgkin lymphoma
    • Multiple myeloma
    • Biopsy proven measurable solid tumor meeting 1 of the following criteria:

      • Recurrent disease after primary treatment and deemed incurable to standard treatment
      • Metastatic disease for which no known standard therapy that is potentially curative or definitely capable of extending life expectancy exists
  • Must have a related HLA-haploidentical mismatched (3/6 or fewer loci) donor available

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Bilirubin < 2.0 mg/dL
  • AST < 3 times upper limit of normal
  • Creatinine < 2.0 mg/dL
  • Ejection fraction > 40% by MUGA

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: NCT00521430

Locations
Korea, Republic of
Asan Medical Center - University of Ulsan College of Medicine
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Study Chair: Kyoo H. Lee, MD Asan Medical Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00521430     History of Changes
Other Study ID Numbers: CDR0000561542, AMC-UUCM-2004-0029
Study First Received: August 24, 2007
Last Updated: March 25, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood grade III lymphomatoid granulomatosis
childhood diffuse large cell lymphoma
recurrent childhood large cell lymphoma
childhood immunoblastic large cell lymphoma
recurrent childhood lymphoblastic lymphoma
childhood nasal type extranodal NK/T-cell lymphoma
recurrent childhood small noncleaved cell lymphoma
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
aplastic anemia
recurrent childhood acute lymphoblastic leukemia
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
refractory anemia with excess blasts in transformation
refractory anemia with excess blasts
refractory anemia with ringed sideroblasts
refractory anemia
refractory multiple myeloma
chronic myelomonocytic leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
recurrent adult Hodgkin lymphoma
recurrent adult T-cell leukemia/lymphoma

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Plasmacytoma
Lymphoma
Leukemia
Syndrome
Neoplasms by Histologic Type
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
Fludarabine
Fludarabine phosphate
Methotrexate
Methylprednisolone Hemisuccinate
Prednisolone

ClinicalTrials.gov processed this record on September 22, 2014