NCT00004086

Brief Summary

RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and either kill them or deliver cancer killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer 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 cancer cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody plus combination chemotherapy and peripheral stem cell transplantation in treating patients who have recurrent or B-cell cancer.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1997

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

April 15, 2004

Completed
Last Updated

June 9, 2009

Status Verified

December 1, 2001

First QC Date

December 10, 1999

Last Update Submit

June 6, 2009

Conditions

LeukemiaLymphoma

Keywords

Waldenstrom macroglobulinemiarefractory chronic lymphocytic leukemiaB-cell chronic lymphocytic leukemiarefractory hairy cell leukemiarecurrent 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 lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

filgrastimBIOLOGICAL
cisplatinDRUG
cytarabineDRUG
etoposideDRUG
ifosfamideDRUG
autologous bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE
indium In 111 LL2 IgGRADIATION
yttrium Y 90 epratuzumabRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent or refractory B-cell malignancy that has failed at least one standard therapy Stage II to IV non-Hodgkin's lymphoma B-cell chronic lymphocytic leukemia, hairy cell leukemia, or Waldenstrom's macroglobulinemia allowed if: Autologous bone marrow or peripheral blood stem cells (PBSC) with no greater than 5% tumor involvement available Estimated radiation dose to marrow no greater than 3,000 cGy (bone marrow involvement of greater than 25% is allowed provided stem cell contamination and predicted marrow radiation doses are below the above cited cut off values) At least 1 confirmed site of tumor targeted by pretherapy indium In 111 humanized LL2 Autologous peripheral blood stem cells (PBSC) or bone marrow available No active brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2 mg/dL Renal: Creatinine less than 1.5 times upper limit of normal Cardiovascular: Cardiac ejection fraction greater than 50% Pulmonary: DLCO greater than 60% predicted Forced vital capacity greater than 60% predicted Other: No severe anorexia, nausea, or vomiting HIV negative No prisoners No concurrent significant medical complication that would preclude study compliance Not pregnant Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: Prior low dose radioimmunotherapy allowed Chemotherapy: No prior high dose chemotherapy with PBSC rescue At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: At least 2 weeks since prior corticosteroids and recovered Radiotherapy: Prior low dose radioimmunotherapy allowed Prior radiotherapy to less than 35% of red marrow allowed At least 4 weeks since prior radiotherapy to index lesion Surgery: At least 4 weeks since major surgery

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

Sponsors & Collaborators

Study Sites (1)

Garden State Cancer Center

Belleville, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaWaldenstrom MacroglobulinemiaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaLymphoma, Mantle-CellLymphoma, B-Cell, Marginal Zone

Interventions

FilgrastimCisplatinCytarabineEtoposideIfosfamidePeripheral Blood Stem Cell TransplantationIndium

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, OperativeMetals, HeavyElementsMetals

Study Officials

  • Jack D. Burton, MD

    Garden State Cancer Center at the Center for Molecular Medicine and Immunology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 1999

First Posted

April 15, 2004

Study Start

June 1, 1997

Last Updated

June 9, 2009

Record last verified: 2001-12

Locations

US(1)