NCT00003116

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2 leukemia

Timeline
Completed

Started May 1997

Longer than P75 for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1997

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 11, 2010

Status Verified

June 1, 2010

Enrollment Period

8.8 years

First QC Date

November 1, 1999

Last Update Submit

June 9, 2010

Conditions

LeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Diseases

Keywords

recurrent childhood acute lymphoblastic leukemiarecurrent adult Hodgkin lymphomarefractory multiple myelomarecurrent childhood lymphoblastic lymphomarecurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiaadult acute myeloid leukemia in remissionadult acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood acute lymphoblastic leukemia in remissionrecurrent/refractory childhood Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesrecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomarecurrent mantle cell lymphomaatypical chronic myeloid leukemiamyelodysplastic/myeloproliferative disease, unclassifiablerecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomaadult acute myeloid leukemia with t(8;21)(q22;q22)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with t(15;17)(q22;q12)childhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

  • Hematopoietic reconstitution measured daily during transplant

    at months 2, 4, 7, and 10, and then every 6 months until disease progression

Interventions

filgrastimBIOLOGICAL

Filgrastim (G-CSF) is administered subcutaneously twice a day beginning 3 hours after completion of cell infusion and continuing until blood counts recover.

busulfanDRUG

high-dose oral busulfan every 6 hours on days -8 to -5

cyclophosphamideDRUG

cyclophosphamide IV twice a day on days -4 and -3

cyclosporineDRUG

cyclosporine IV over 6 hours on day -1 and then 10 hours on day 0 for 2 doses (allogeneic only)

bone marrow ablation with stem cell supportPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Allogeneic peripheral blood progenitor cells IV are administered on day 0.

Eligibility Criteria

Age4 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesPrecursor Cell Lymphoblastic Leukemia-LymphomaHodgkin DiseaseLeukemia, Myeloid, AcuteRecurrenceLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaDendritic Cell Sarcoma, InterdigitatingLymphoma, Mantle-CellLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellCongenital Abnormalities

Interventions

FilgrastimBusulfanCyclophosphamideCyclosporinePeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow DiseasesLeukemia, LymphoidLeukemia, MyeloidDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsHistiocytic Disorders, MalignantHistiocytosisChronic DiseaseLeukemia, B-CellCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsButylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Hillard M. Lazarus, MD

    Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

May 1, 1997

Primary Completion

March 1, 2006

Study Completion

June 1, 2009

Last Updated

June 11, 2010

Record last verified: 2010-06

Locations

US(1)