- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003116
High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Allogeneic Peripheral Blood Progenitor Cell Transplantation Using Histocompatible Sibling-Matched Donor Cells After High-Dose Busulfan/Cyclophosphamide as Therapy for Hematologic Malignancies
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.
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
Ohio
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Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hematopoietic reconstitution measured daily during transplant
Time Frame: at months 2, 4, 7, and 10, and then every 6 months until disease progression
|
at months 2, 4, 7, and 10, and then every 6 months until disease progression
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Hillard M. Lazarus, MD, Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- 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)
- childhood acute lymphoblastic leukemia in remission
- childhood acute myeloid leukemia in remission
- childhood myelodysplastic syndromes
- recurrent adult acute myeloid leukemia
- atypical chronic myeloid leukemia
- myelodysplastic/myeloproliferative disease, unclassifiable
- adult acute myeloid leukemia in remission
- recurrent adult Hodgkin lymphoma
- recurrent/refractory childhood Hodgkin lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent mantle cell lymphoma
- refractory multiple myeloma
- recurrent adult acute lymphoblastic leukemia
- recurrent childhood acute lymphoblastic leukemia
- adult acute lymphoblastic leukemia in remission
- recurrent childhood acute myeloid leukemia
- recurrent childhood lymphoblastic lymphoma
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Precancerous Conditions
- Lymphoma
- Syndrome
- Myelodysplastic Syndromes
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Leukemia
- Preleukemia
- Plasmacytoma
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Cyclophosphamide
- Busulfan
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- CWRU1995T
- P30CA043703 (U.S. NIH Grant/Contract)
- CASE-CWRU-1995
- NCI-G97-1354
- CASE1995T (Other Identifier: Case Comprehensive Cancer Center)
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