High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
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ClinicalTrials.gov Identifier: NCT00003116 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : June 11, 2010
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving busulfan, cyclophosphamide, and filgrastim together with peripheral stem cell transplantation from a sibling donor works in treating patients with hematologic cancer.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases | Biological: filgrastim Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation | Phase 2 |
OBJECTIVES:
- Determine the safety and feasibility of using allogeneic peripheral blood progenitor cell infusions obtained from normal histocompatible sibling donors for reconstituting bone marrow and immunologic function when given after high-dose busulfan/cyclophosphamide in patients with a hematologic malignancy.
- Determine the efficacy of this treatment in these patients.
- Determine the ability to mobilize hematopoietic progenitor cells from normal donors given filgrastim (G-CSF) by determining the hematopoietic progenitor cell content of allogeneic peripheral blood progenitor cell collections.
- Determine the incidence of engraftment failures in these patients.
- Determine the incidence of severe acute graft-versus-host disease in these patients.
OUTLINE: Patients receive high-dose oral busulfan every 6 hours on days -8 to -5, cyclophosphamide IV twice a day on days -4 and -3, and cyclosporine IV over 6 hours on day -1 and then 10 hours on day 0 for 2 doses (allogeneic only). Allogeneic peripheral blood progenitor cells IV are administered on day 0.
Filgrastim (G-CSF) is administered subcutaneously twice a day beginning 3 hours after completion of cell infusion and continuing until blood counts recover.
Patients are followed every month for 2 months, every 3 months for 6 months, and then every 6 months until disease progression.
PROJECTED ACCRUAL: A total of 40 patients will be accrued over a 15 month period.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 66 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Allogeneic Peripheral Blood Progenitor Cell Transplantation Using Histocompatible Sibling-Matched Donor Cells After High-Dose Busulfan/Cyclophosphamide as Therapy for Hematologic Malignancies |
Study Start Date : | May 1997 |
Actual Primary Completion Date : | March 2006 |
Actual Study Completion Date : | June 2009 |

- Biological: filgrastim
Filgrastim (G-CSF) is administered subcutaneously twice a day beginning 3 hours after completion of cell infusion and continuing until blood counts recover.
- Drug: busulfan
high-dose oral busulfan every 6 hours on days -8 to -5
- Drug: cyclophosphamide
cyclophosphamide IV twice a day on days -4 and -3
- Drug: cyclosporine
cyclosporine IV over 6 hours on day -1 and then 10 hours on day 0 for 2 doses (allogeneic only)
- Procedure: bone marrow ablation with stem cell support
- Procedure: peripheral blood stem cell transplantation
Allogeneic peripheral blood progenitor cells IV are administered on day 0.
- Hematopoietic reconstitution measured daily during transplant [ Time Frame: at months 2, 4, 7, and 10, and then every 6 months until disease progression ]

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Ages Eligible for Study: | 4 Years to 55 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Histologically diagnosed:
- Acute myeloid leukemia in first, second, or third complete remission or first or second early relapse
- Acute lymphoblastic leukemia in first, second, or third complete remission or first or second early relapse
- Hodgkin's lymphoma in second or third remission or first, second, or third relapse, or refractory
- Non-Hodgkin's lymphoma in second or third remission or first, second, or third relapse, or refractory
- Multiple myeloma and plasma cell leukemia in second or third remission or first, second, or third relapse, or refractory
- Myelodysplastic syndrome deemed suitable for allogeneic bone marrow transplantation
- No symptoms or signs of CNS involvement and CNS is disease free on lumbar puncture and brain CT scan
- No active meningeal cancer
PATIENT CHARACTERISTICS:
Age:
- 4 to 55 (4 to 60 if donor is identical twin)
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- SGOT/SGPT less than 3 times normal
- Bilirubin less than 2.0 mg/dL
Renal:
- Creatinine less than 2.1 mg/dL
- Creatinine clearance at least 60 mL/min (no greater than 1.5 times normal for children under 40 kg)
Cardiovascular:
- No uncontrolled hypertension
- No uncontrolled congestive heart failure
- No active angina pectoris requiring nitrates
- At least 6 months since prior myocardial infarction
- No major ventricular arrhythmia
- Left ventricular ejection fraction at least 45% on MUGA
Pulmonary:
- No severe or symptomatic restrictive or obstructive lung disease
- FEV_1 greater than 50% of predicted
- DLCO greater than 50% of predicted
Neurologic:
- No severe central or peripheral neurologic abnormality
Other:
- Must have HLA-A,B,C,D/DR identical sibling age 4 to 65, in good health
- No insulin-dependent diabetes mellitus
- No major thyroid or major adrenal dysfunction
- No active infection
- No other active malignancy
- Not pregnant
- HIV negative
- HTLV-I and HTLV-II negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No excessive anthracycline exposure, unless endomyocardial biopsy shows less than grade 2 drug effect and cardiac scan shows at least 50% ejection fraction
- At least 1 year since prior autologous bone marrow or peripheral blood progenitor cell transplant or allogeneic bone marrow transplant
Chemotherapy:
- At least 3 weeks since prior chemotherapy
- No prior excessive carmustine and bleomycin
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 3 weeks since prior radiotherapy
Surgery:
- Not specified
Other:
- No concurrent nitroglycerin for angina pectoris
- No concurrent anti-arrhythmic drugs for major ventricular dysrhythmias

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003116
United States, Ohio | |
Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Study Chair: | Hillard M. Lazarus, MD | Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center |
Responsible Party: | Hillard Lazarus, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00003116 |
Other Study ID Numbers: |
CWRU1995T P30CA043703 ( U.S. NIH Grant/Contract ) CASE-CWRU-1995 NCI-G97-1354 CASE1995T ( Other Identifier: Case Comprehensive Cancer Center ) |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | June 11, 2010 |
Last Verified: | June 2010 |
recurrent childhood acute lymphoblastic leukemia recurrent adult Hodgkin lymphoma refractory multiple myeloma recurrent childhood lymphoblastic lymphoma recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia 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 recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma recurrent mantle cell lymphoma atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable recurrent marginal zone lymphoma |
Lymphoma Leukemia Multiple Myeloma Neoplasms, Plasma Cell Preleukemia Myelodysplastic Syndromes Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Syndrome Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Disease Pathologic Processes Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions Cyclosporine Cyclophosphamide Busulfan Cyclosporins |