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Combination Chemotherapy Followed by Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin's Lymphoma

Primary Purpose

AIDS-related Lymphoma, Adult Non-Hodgkin's Lymphoma, Anaplastic Large Cell Lymphoma

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
cisplatin
cytarabine
etoposide
methylprednisolone
rituximab
yttrium Y 90 ibritumomab tiuxetan
antibody therapy
biological therapy
chemotherapy
monoclonal antibody therapy
radiation therapy
radioimmunotherapy
radioisotope therapy
Sponsored by
AIDS Malignancy Consortium
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for AIDS-related Lymphoma focused on measuring AIDS-related diffuse large cell lymphoma, AIDS-related peripheral/systemic lymphoma, AIDS-related small noncleaved cell lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related immunoblastic large cell lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, contiguous stage II adult Burkitt's lymphoma, noncontiguous stage II adult Burkitt's lymphoma, recurrent adult Burkitt's lymphoma, stage I adult Burkitt's lymphoma, stage III adult Burkitt's lymphoma, stage IV adult Burkitt's lymphoma, anaplastic large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, recurrent adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, recurrent adult diffuse mixed cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage IV adult diffuse mixed cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage IV adult immunoblastic large cell lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 29, 2006
    Last Updated
    February 1, 2016
    Sponsor
    AIDS Malignancy Consortium
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00310128
    Brief Title
    Combination Chemotherapy Followed by Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin's Lymphoma
    Official Title
    Phase II Study of Induction Therapy Comprising Etoposide, Methylprednisolone, Cytarabine, and Cisplatin (ESHAP) Followed by Consolidation Therapy Comprising Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin's Lymphoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Drug supply unavailable
    Study Start Date
    February 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AIDS Malignancy Consortium
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    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.
    Detailed Description
    OBJECTIVES: Primary Determine the overall survival rate at one year in patients with relapsed or refractory AIDS-related non-Hodgkin's lymphoma treated with consolidation therapy comprising rituximab and yttrium Y 90 ibritumomab tiuxetan (radioimmunotherapy) given after induction therapy comprising etoposide, methylprednisolone, cytarabine, and cisplatin (ESHAP). Describe the toxicity profile of radioimmunotherapy as consolidation therapy, including changes in immunologic and virologic parameters over time, in these patients. Determine the overall disease-free survival of patients receiving ESHAP as induction therapy followed by radioimmunotherapy as consolidation therapy. Secondary Determine the effect of ESHAP as induction therapy and radioimmunotherapy as consolidation therapy on HIV-1 viral load, CD4 and CD8 cells, and quantitative immunoglobulin levels in patients on concurrent highly active antiretroviral therapy (HAART). Determine the objective response rates (complete and partial response) in patients treated with this regimen. Determine the toxicity of ESHAP as induction therapy in these patients. OUTLINE: This is a multicenter study. Induction therapy: Patients receive ESHAP chemotherapy comprising etoposide IV over 2 hours on days 1-4, methylprednisolone IV over 15-30 minutes on days 1-5, cisplatin IV continuously over 96 hours on days 1-4, and cytarabine IV over 2 hours on day 5. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Approximately 21-52 days after completion of ESHAP chemotherapy, patients proceed to consolidation therapy. Consolidation therapy: Patients receive radioimmunotherapy comprising rituximab IV over 3-4 hours followed by indium In 111 ibritumomab tiuxetan (for radioimaging) IV over 10 minutes on day 1. Patients then undergo imaging on days 1 and 2. If biodistribution is acceptable, patients receive rituximab IV over 3-4 hours followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8. After completing study treatment, patients are followed every 2 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    AIDS-related Lymphoma, Adult Non-Hodgkin's Lymphoma, Anaplastic Large Cell Lymphoma
    Keywords
    AIDS-related diffuse large cell lymphoma, AIDS-related peripheral/systemic lymphoma, AIDS-related small noncleaved cell lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related immunoblastic large cell lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, contiguous stage II adult Burkitt's lymphoma, noncontiguous stage II adult Burkitt's lymphoma, recurrent adult Burkitt's lymphoma, stage I adult Burkitt's lymphoma, stage III adult Burkitt's lymphoma, stage IV adult Burkitt's lymphoma, anaplastic large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, recurrent adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, recurrent adult diffuse mixed cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage IV adult diffuse mixed cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage IV adult immunoblastic large cell lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    cisplatin
    Intervention Type
    Drug
    Intervention Name(s)
    cytarabine
    Intervention Type
    Drug
    Intervention Name(s)
    etoposide
    Intervention Type
    Drug
    Intervention Name(s)
    methylprednisolone
    Intervention Type
    Drug
    Intervention Name(s)
    rituximab
    Intervention Type
    Drug
    Intervention Name(s)
    yttrium Y 90 ibritumomab tiuxetan
    Intervention Type
    Procedure
    Intervention Name(s)
    antibody therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    biological therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    chemotherapy
    Intervention Type
    Procedure
    Intervention Name(s)
    monoclonal antibody therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    radiation therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    radioimmunotherapy
    Intervention Type
    Procedure
    Intervention Name(s)
    radioisotope therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alexandra M. Levine, MD
    Organizational Affiliation
    University of Southern California
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Anil Tulpule, MD
    Organizational Affiliation
    University of Southern California

    12. IPD Sharing Statement

    Learn more about this trial

    Combination Chemotherapy Followed by Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin's Lymphoma

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