Donor Stem Cell Transplant After Conditioning Therapy in Treating Patients With Hematologic Cancer, Recurrent or Metastatic Solid Tumor, or Other Disease
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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 |
- 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 ]
- 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) |
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 |
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| Korea, Republic of | |
| Asan Medical Center - University of Ulsan College of Medicine | |
| Seoul, Korea, Republic of, 138-736 | |
| 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 Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Lymphoma, Large-Cell, Immunoblastic Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders |
Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions Lymphoma, Non-Hodgkin Antilymphocyte Serum Busulfan Cyclosporins Cyclosporine Methotrexate Fludarabine monophosphate |
ClinicalTrials.gov processed this record on May 16, 2013