Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt's Lymphoma
Condition: Lymphoma
MeSH terms: Burkitt Lymphoma; Lymphoma
Intervention: filgrastim; pegfilgrastim; rituximab; cyclophosphamide; cytarabine; doxorubicin hydrochloride; etoposide; ifosfamide; leucovorin calcium; liposomal cytarabine; methotrexate; therapeutic hydrocortisone; vincristine sulfate
Intervention description: given subcutaneously; given subcutaneously; given IV; given IV; given intrathecally; given IV; given IV; given IV; given IV; given intrathecally; given intrathecally; given intrathecally; given IV
Intervention MeSH terms: Leucovorin; Cytarabine; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Cyclophosphamide; Ifosfamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Methotrexate; Etoposide; Vincristine; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage I adult Burkitt lymphoma; stage III adult Burkitt lymphoma; stage IV adult Burkitt lymphoma; contiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult Burkitt lymphoma; AIDS-related peripheral/systemic lymphoma

Summary:

      RATIONALE: Monoclonal antibodies, such as rituximab, 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. 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. Giving rituximab together with combination chemotherapy may kill more
      cancer cells.

      PURPOSE: This phase II trial is studying how well giving rituximab together with combination
      chemotherapy works in treating patients with newly diagnosed, HIV-associated Burkitt's
      lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed Burkitt's lymphoma (BL) or new WHO 2009 criteria B-cell
             lymphoma unclassified (with features intermediated between difuse large B-cell
             lymphoma and BL)

               -  Any stage disease

               -  Newly diagnosed disease

          -  Meets 1 of the following criteria for disease risk:

               -  Low-risk disease, defined by 1 of the following:

                    -  Stage I with a single focus of disease < 10 cm AND normal lactate
                       dehydrogenase (LDH) level

                    -  Totally resected intra-abdominal disease only AND normal LDH post surgery

               -  High-risk disease, defined as not meeting criteria for low-risk disease

          -  Measurable or nonmeasurable disease

          -  HIV-positive confirmed by enzyme-linked immunosorbent assay and Western blot OR by
             measurable HIV viral load

          -  No visceral Kaposi's sarcoma

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 40-100%

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  LVEF ≥ 50% by MUGA or echocardiogram

          -  Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min

          -  Absolute neutrophil count ≥ 1,000/mm³

          -  Platelet count ≥ 50,000/mm³ (unless related to lymphoma)*

          -  Direct bilirubin ≤ 2.0 mg/dL OR total bilirubin ≤ 3.5 mg/dL AND direct bilirubin
             normal (if elevated bilirubin secondary to antiretroviral therapy)

          -  AST and ALT ≤ 3 times upper limit of normal

          -  No other malignancy within the past 5 years except curatively treated cutaneous basal
             cell or squamous cell carcinoma, carcinoma in situ of the cervix, or cutaneous
             Kaposi's sarcoma

          -  No other medical illness unrelated to non-Hodgkin's lymphoma, including any of the
             following:

               -  Uncontrolled infection (including opportunistic infection)

               -  Chronic renal insufficiency

               -  Myocardial infarction within the past 6 months

               -  Unstable angina

               -  Cardiac arrhythmias other than chronic atrial fibrillation

          -  Patients with active hepatitis B infection are eligible provided they receive
             concurrent dual antiviral therapy NOTE: *Patients with bone marrow involvement are
             eligible irrespective of blood count

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior therapy for this disease except for 1 of the following :

               -  Seven consecutive days of steroids alone or in combination with a non-CHOP
                  regimen necessary for patient stabilization (e.g., cyclophosphamide and steroids
                  steroids for normalization of disease-related hyperbilirubinemia)

               -  One course of CHOP or fractionated CHOP (e.g. CODOX) with or without rituximab

          -  No epoetin alfa or filgrastim (G-CSF) within 24 hours of study chemotherapy

          -  No concurrent zidovudine