NCT00310128

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as etoposide, methylprednisolone, cytarabine, and cisplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them without harming normal cells. Giving more than one drug (combination chemotherapy) together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed or refractory AIDS-related non-Hodgkin's lymphoma.

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

First QC Date

March 29, 2006

Last Update Submit

February 1, 2016

Conditions

AIDS-related LymphomaAdult Non-Hodgkin's LymphomaAnaplastic Large Cell Lymphoma

Keywords

AIDS-related diffuse large cell lymphomaAIDS-related peripheral/systemic lymphomaAIDS-related small noncleaved cell lymphomaAIDS-related diffuse mixed cell lymphomaAIDS-related immunoblastic large cell lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomacontiguous stage II adult Burkitt's lymphomanoncontiguous stage II adult Burkitt's lymphomarecurrent adult Burkitt's lymphomastage I adult Burkitt's lymphomastage III adult Burkitt's lymphomastage IV adult Burkitt's lymphomaanaplastic large cell lymphomacontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomarecurrent adult diffuse large cell lymphomastage I adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomacontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomarecurrent adult diffuse mixed cell lymphomastage I adult diffuse mixed cell lymphomastage III adult diffuse mixed cell lymphomastage IV adult diffuse mixed cell lymphomacontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomarecurrent adult immunoblastic large cell lymphomastage I adult immunoblastic large cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphoma

Interventions

cisplatinDRUG
cytarabineDRUG
etoposideDRUG
methylprednisoloneDRUG
rituximabDRUG
yttrium Y 90 ibritumomab tiuxetanDRUG
antibody therapyPROCEDURE
biological therapyPROCEDURE
chemotherapyPROCEDURE
monoclonal antibody therapyPROCEDURE
radiation therapyPROCEDURE
radioimmunotherapyPROCEDURE
radioisotope therapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically documented B-cell non-Hodgkin's lymphoma, including any of the following histologic types: * Follicular large B-cell lymphoma (follicular, grade 3) * Follicular mixed cell lymphoma (follicular, grade 2) * Diffuse mixed cell lymphoma * Diffuse large B-cell lymphoma * Immunoblastic lymphoma * Burkitt or Burkitt-like lymphoma * Anaplastic large cell lymphoma * Primary effusion lymphoma * All stages eligible * Seropositive for HIV by any approved test or positive HIV-1 RNA in plasma at anytime in the past * Prior documentation of HIV seropositivity allowed * Received 1 prior anthracycline-based regimen of curative intent * No more than 1 prior regimen * Measurable or evaluable disease * Evaluable disease defined as not having bidimensional measurements (i.e., gastric or marrow involvement) but can be followed for response by other diagnostic tests, such as gallium scan, positron emission tomography (PET) imaging and/or bone marrow biopsy * No primary CNS lymphoma * Lymphomatous meningitis or brain metastasis eligible provided other measurable systemic lymphomatous disease is also present * Less than 25% bone marrow involvement with lymphoma * Concurrent effective highly active anti-retroviral therapy (HAART) required at study entry * HIV viral load \< 100,000 copies/mL if HAART was not used previously PATIENT CHARACTERISTICS: * Karnofsky performance status 50-100% * Bilirubin ≤ 2.0 mg/dL (unless elevated due to lymphomatous involvement of the liver or biliary tract OR due to other HIV medications \[e.g., indinavir or atazanavir\]) * Creatinine \< 2.0 mg/dL (\< 2.6 mg/dL if due to use of tenofovir or truvada) OR creatinine clearance ≥ 60 mL/min * Granulocyte count \> 1,000/mm\^3 (unless abnormal due to lymphomatous involvement of the bone marrow) * Platelet count \> 75,000/mm\^3 (unless abnormal due to lymphomatous involvement of the bone marrow or HIV-related thrombocytopenia) * No acute intercurrent infection that may interfere with study participation * Mycobacterium avium allowed * No second active tumor except nonmelanomatous skin cancer, carcinoma in situ of the cervix, or Kaposi's sarcoma not requiring systemic chemotherapy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment * No serious, ongoing nonmalignant disease or infection that would compromise study objectives * No antimurine antibody (HAMA) reactivity * No history of any cutaneous or mucocutaneous reaction from prior rituximab administration * No history of cutaneous or mucocutaneous reactions or diseases severe enough to cause hospitalization or an inability to eat for ≥ 2 days PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Fully recovered from all toxicities associated with prior surgery, radiotherapy, chemotherapy, or immunotherapy * Prior chronic therapy with potentially myelosuppressive agents allowed provided hematologic criteria are met at study entry * No radiotherapy within the past 4 weeks, unless for emergency conditions secondary to lymphoma (i.e., cord compression) * No anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C) * No rituximab within 6 weeks before study radioimmunotherapy * No investigational agent(s) within the past 4 weeks, unless these are antiretroviral agents available on a compassionate use basis * No prior external beam radiotherapy to \> 25% of active bone marrow (involved field or regional) * No major surgery, other than diagnostic surgery, within the past 4 weeks * No prior myeloablative therapies with autologous bone marrow transplantation, peripheral blood stem cell rescue, or failed stem cell collection * No prior radioimmunotherapy * No pegfilgrastim within 4 weeks before study radioimmunotherapy * No other growth factors within 2 weeks before and after study radioimmunotherapy * No other concurrent myelosuppressive antineoplastic agents after receipt of study radioimmunotherapy until blood counts recover * No zidovudine-containing regimens (including lamivudine and trizivir) during and for ≥ 2 months after completion of study radioimmunotherapy

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

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, AIDS-RelatedLymphoma, Non-HodgkinLymphoma, Large-Cell, AnaplasticLymphoma, FollicularBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, Immunoblastic

Interventions

CisplatinCytarabineEtoposideMethylprednisoloneRituximabibritumomab tiuxetanImmunization, PassiveBiological TherapyDrug TherapyAntibodies, MonoclonalRadiotherapyRadioimmunotherapy

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsAntibodies, Monoclonal, Murine-DerivedAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsImmunizationImmunotherapyImmunomodulationTherapeuticsImmunologic TechniquesInvestigative TechniquesCombined Modality Therapy

Study Officials

  • Alexandra M. Levine, MD

    University of Southern California

    STUDY CHAIR

  • Anil Tulpule, MD

    University of Southern California

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Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2006

First Posted

April 3, 2006

Study Start

February 1, 2006

Last Updated

February 3, 2016

Record last verified: 2016-02