Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Intervention: filgrastim; pegfilgrastim; rituximab; sargramostim; cyclophosphamide; pegylated liposomal doxorubicin hydrochloride; prednisone; vincristine sulfate; immunohistochemistry staining method; laboratory biomarker analysis
Intervention description: Supportive therapy: GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.; GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.; 375 mg/m2 IV Day 1 of each cycle; GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.; 750 mg/m2 IV Day 1 of each cycle; 40 mg/m2 IV Day 1 of each cycle; 100 mg PO Days 1-5 of each cycle; 1.4 mg/m2 IV Day 1 (2.0 mg maximum) of each cycle; tissue specimen collected at baseline; tissue specimen collected at baseline
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: contiguous stage II grade 3 follicular lymphoma; noncontiguous stage II grade 3 follicular lymphoma; stage I grade 3 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 3 follicular lymphoma; AIDS-related diffuse large cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II 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; AIDS-related immunoblastic large cell lymphoma; contiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II 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; AIDS-related peripheral/systemic lymphoma

Summary:

      RATIONALE: Drugs used in chemotherapy 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, can block cancer growth in different ways. Some find cancer cells and help
      kill them or carry cancer-killing substances to them. Others interfere with the ability of
      cancer cells to grow and spread. Giving combination chemotherapy together with rituximab may
      kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together
      with rituximab works in treating patients with newly diagnosed AIDS-related B-cell
      non-Hodgkin's lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed AIDS-related B-cell non-Hodgkin's lymphoma
             (NHL), including any of the following subtypes:

               -  Grade III follicular large cell lymphoma

               -  Diffuse large B-cell lymphoma

               -  Immunoblastic lymphoma

               -  Plasmablastic lymphoma

               -  Primary effusion lymphoma

          -  Previously untreated disease

          -  Any stage disease

          -  CD20 positive disease

          -  Must have documented HIV infection

               -  Documentation may be by serology (enzyme-linked immunosorbent assay, western
                  blot), culture, or quantitative polymerase chain reaction or branched DNA assays

               -  Prior documentation of HIV seropositivity allowed

          -  Measurable or nonmeasurable disease

          -  Currently receiving effective highly active anti-retroviral therapy

          -  No primary CNS lymphoma, including parenchymal brain or spinal cord lymphoma

          -  No presence of leptomeningeal disease (positive cerebrospinal fluid for lymphoma) or
             presence of metastatic disease to brain, in terms of any mass lesion

        PATIENT CHARACTERISTICS:

          -  ECOG performance status (PS) 0-2 OR Karnofsky PS 50-100%

          -  Life expectancy ≥ 2 months

          -  Absolute granulocyte (neutrophil) count ≥ 1,000/mm³ (unless secondary to lymphomatous
             involvement of bone marrow)

          -  Platelet count ≥ 75,000/mm³ (unless secondary to lymphomatous involvement of bone
             marrow or due to HIV-related thrombocytopenia)

          -  Bilirubin ≤ 2.0 mg/dL (unless elevated secondary to lymphomatous involvement of liver
             or biliary system or due to other HIV medications [e.g., indinavir, tenofavir, or
             atazanavir])

          -  SGOT ≤ 5 times upper limit of normal

          -  Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min (unless secondary to renal
             involvement by lymphoma)

          -  LVEF normal by MUGA or echocardiogram

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 6 months after
             completion of study treatment

          -  No other malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix,
             or Kaposi's sarcoma that does not require systemic therapy

          -  No serious, ongoing, nonmalignant disease or infection that would preclude study
             compliance, in the opinion of the investigator

          -  No history of cutaneous or mucocutaneous reactions, or diseases in the past, due to
             any cause, severe enough to cause hospitalization or an inability to eat or drink for
             ≥ 2 days

          -  No acute, intercurrent infection that would preclude study treatment

               -  Patients with Mycobacterium avium are eligible

          -  No cardiovascular problems, including any of the following:

               -  Myocardial infarction within the past 6 months

               -  New York Heart Association class II-IV heart failure

               -  Uncontrolled angina

               -  Severe uncontrolled ventricular arrhythmias

               -  Clinically significant pericardial disease

               -  ECG evidence of acute ischemic or active conduction system abnormalities.

          -  No shortness of breath at rest

          -  Arterial PO_2 ≥ 70 or pulse oximeter-derived O_2 saturation ≥ 94% on room air (unless
             due to lymphomatous involvement of the lungs)

          -  Able to comply with study and provide adequate informed consent

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 4 weeks since prior major surgery (except diagnostic surgery)

          -  At least 12 months since prior rituximab unless it was only given for indications
             other than the treatment of aggressive lymphoma

          -  No prior cytotoxic chemotherapy or radiotherapy for this lymphoma

               -  Concurrent radiotherapy, with or without steroids, for emergency conditions
                  secondary to lymphoma (i.e., CNS tumor or cord compression) allowed

          -  No zidovudine or zidovudine-containing regimen (including Combivir® or Trizivir®)
             during and for 2 months after completion of chemotherapy

          -  Concurrent erythropoietin or filgrastim (G-CSF) allowed

               -  Growth factor therapy must be discontinued ≥ 24 hours prior to study entry