Autologous Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: carmustine; cyclophosphamide; etoposide; peripheral blood stem cell transplantation; irradiation therapy; G-CSF; Cytarabine
Intervention description: Day -6, 300 mg/m^2 over 2 hour; NHL with radiation: Cyclophosphamide 60 mg/kg intravenous (IV) over two hours daily x 2 days.
HL without radiation: Cyclophosphamide, Days - 6 through -3, 1.5 gm/m^2 over 2 hours daily x 4 days.
Cyclophosphamide will be dosed based on actual body weight (ABW) unless the patient is 20% or more of ideal body weight (IBW). If more than 20% of ideal body weight, an adjusted ideal body weight (AIBW) will be used for dosing.; NHL without radiation and cyclophosphamide: Etoposide 100 mg/m2 IV over 2 hours twice daily on Day -5 through -2.
HL without radiation: 150 mg/m^2 intravenously over 4 hours every 12 hours for 6 total doses on Days -6 through -4.; Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF alone (filgrastim) or using ifosfamide/carboplatin/etoposide and with or without rituximab. Leukapheresis is to begin on Day 5.; Patients undergo total body irradiation (TBI) twice daily on days -4 to -1.
> 1000 cGy to whole lung, kidney, or abdominal bath.
> 3000 cGy to spinal cord, myocardium, mediastinum, lumbar periaortic lymph nodes.
> 3600 cGy to whole brain.; Day 5: Begin G-CSF 5μg/kg/day subcutaneously (SQ) rounded to the nearest vial size.
Continue G-CSF until absolute neutrophil count (ANC) > 1500/μl x 3 consecutive days.
If ANC falls <1000/μL, restart G-CSF.; 100 mg/m^2 over one hour BID on days -6 through -2 of BEAM conditioning regimen.
Intervention MeSH terms: Cytarabine; Cyclophosphamide; Carmustine; Etoposide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 473.0
Sex: All
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hodgkin lymphoma; non-Hodgkin lymphoma; HIV-associated lymphoma

Summary:

      RATIONALE: Drugs used in chemotherapy, such as ifosfamide, etoposide, and carboplatin, 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 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. Giving
      colony-stimulating factors, such as G-CSF, helps stem cells move from the patient's bone
      marrow to the blood so they can be collected and stored for peripheral stem cell transplant.
      Giving more chemotherapy, such as cyclophosphamide, carmustine, and etoposide, and total-body
      irradiation prepares the patient's bone marrow for the stem cell transplant. The stem cells
      are then returned to the patient to replace the blood-forming cells that were destroyed by
      the chemotherapy and radiation therapy. More radiation therapy is given after transplant to
      kill any remaining cancer cells.

      PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant
      works in treating patients with non-Hodgkin's lymphoma or Hodgkin's lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Karnofsky performance status: >80% (>60% if poor performance status is related to
             lymphoma)

          -  No evidence of serious organ dysfunction that is not attributable to tumor

               -  Central nervous system: Patients with a history of CNS involvement by lymphoma or
                  with relapsed primary lymphoma will be eligible.

               -  Infection: Patients with serious uncontrolled infections at the time of
                  transplant will be excluded.

          -  Hepatitis B: Patients who are carriers of Hepatitis B will be included in this study.
             These patients are not eligible to receive rituximab as a component of their
             chemotherapy mobilization.

          -  HIV disease. Patients with HIV disease are eligible for this study provided that:

               -  Patients will be seen in the infectious disease (ID)/HIV clinic prior to
                  enrollment on study for the purpose of determining eligibility and for local
                  coordination of HIV care during the peri-transplant period.

               -  Must be on a maximally active anti-HIV regimen

               -  CD4+ ≥ 50/μL

               -  HIV RNA viral load ≤ 100,000 copies per mL on each of samples 4 weeks apart. The
                  most recent level must be within one month of enrollment.

          -  Non-Hodgkin's lymphoma (NHL). Patients with chemo-sensitive histologically confirmed
             NHL.

               -  Precursor B-cell or Precursor T-cell NHL

                    -  Lymphoblastic lymphoma

                         -  All patients will be eligible in second or greater complete remission
                            (CR) or first or subsequent partial remission (PR)

               -  Mature B-cell Lymphomas:

                    -  Small lymphocytic lymphoma (SLL) or Chronic Lymphocytic Leukemia (CLL)

                    -  Follicular Lymphoma

                    -  Diffuse Large B-cell Lymphoma

                    -  Mantle Cell Lymphoma

                    -  Burkitt's/Burkitt's like

               -  Mature T-cell lymphoma

          -  Hodgkin's lymphoma (HL)

               -  patients with histologically proven HL will be eligible for transplantation after
                  failing prior therapy.

        Exclusion Criteria:

          -  Patients eligible for any higher priority transplant protocols

          -  Women who are pregnant or breast feeding

          -  Patients with chemotherapy resistant disease