Status:
WITHDRAWN
Combination Chemotherapy Followed by Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin's Lymphoma
Lead Sponsor:
AIDS Malignancy Consortium
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
AIDS-related Lymphoma
Adult Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 st...
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 rituxi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00310128
Start Date
February 1 2006
Last Update
February 3 2016
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