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

This study has been withdrawn prior to enrollment.
(Drug supply unavailable)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00310128
First received: March 29, 2006
Last updated: January 18, 2013
Last verified: January 2013

March 29, 2006
January 18, 2013
February 2006
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Complete list of historical versions of study NCT00310128 on ClinicalTrials.gov Archive Site
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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
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

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • AIDS-related Lymphoma
  • Adult Non-Hodgkin's Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Drug: cisplatin
  • Drug: cytarabine
  • Drug: etoposide
  • Drug: methylprednisolone
  • Drug: rituximab
  • Drug: yttrium Y 90 ibritumomab tiuxetan
  • Procedure: antibody therapy
  • Procedure: biological therapy
  • Procedure: chemotherapy
  • Procedure: monoclonal antibody therapy
  • Procedure: radiation therapy
  • Procedure: radioimmunotherapy
  • Procedure: radioisotope therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00310128
CDR0000467797, AMC-044
Not Provided
AIDS Malignancy Clinical Trials Consortium
AIDS Malignancy Clinical Trials Consortium
National Cancer Institute (NCI)
Study Chair: Alexandra M. Levine, MD University of Southern California
Investigator: Anil Tulpule, MD University of Southern California
AIDS Malignancy Clinical Trials Consortium
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP