R-ICE and High-Dose Cyclophosphamide With PET/CT for Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Intervention: Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Ifosfamide; Carboplatin; Etoposide; High-dose cyclophosphamide; PET scan
Intervention description: 375 mg/m^2 on Day 1 of each cycle as part of R-CHOP or R-ICE. Also given 375 mg/m^2 on Days 1, 30, and 37 as part of HiCy.; 750 mg/m^2 on Day 1 of each cycle as part of R-CHOP.; 50 mg/m^2 on Day 1 of each cycle as part of R-CHOP.; 1.4 mg/m^2 on Day 1 of each cycle as part of R-CHOP.; 100 mg/day on Days 1-5 of each cycle as part of R-CHOP.; 2000 mg/m^2/day on Days 1-3 of each cycle as part of R-CHOP.; Given on Day 2 of each cycle as part of R-CHOP. Dosed according to renal function.; 100 mg/m^2/day on Days 1-3 of each cycle as part of R-CHOP.; 50 mg/kg/day on Days 2-5 of HiCy.; Performed once between Days 16-20 of cycle 3 of R-CHOP.
Intervention MeSH terms: Prednisone; Cyclophosphamide; Ifosfamide; Rituximab; Carboplatin; Doxorubicin; Etoposide; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: B-Cell; non-Hodgkin's; Lymphoma

Summary:

      This research is being done to see if a PET scan that is obtained after 3 cycles of a
      standard chemotherapy regimen can help guide treatment for patients with a blood disease
      called Non-Hodgkin's Lymphoma.

      The standard treatment for newly diagnosed lymphoma is 6 to 8 cycles of chemotherapy like the
      CHOP combination (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). This regimen
      can cure about half of patients with lymphoma, but in many others disease relapses (comes
      back). Relapses are generally treated with more chemotherapy.

      We believe that a PET scan (a type of imaging study that "lights up" in areas of cells with
      high activity such as lymphoma), may identify patients early who are at high risk of relapse.

      The purpose of this research study is to find out if people whose treatment is changed early
      to an intensification regimen (high dose chemotherapy) based on a positive PET scan will have
      longer remissions than they would if they did not receive that high dose chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  One of the following Biopsy-confirmed, aggressive non-Hodgkin's lymphoma

               1. Diffuse large B-cell lymphoma

               2. Mediastinal (thymic) B-cell lymphoma

          -  Any stage (I through IV) as defined by the Ann Arbor staging system

          -  ECOG performance status of 0 to 2

          -  Radiographically measurable disease

          -  No more than 3 cycles of chemotherapy for lymphoma

          -  Greater than or equal to 18 years

          -  Adequate pulmonary, cardiac, hepatic, or renal function

          -  HIV antibody negative

          -  Women- Not pregnant or breastfeeding

          -  Men of reproductive potential must agree to use contraception

        Exclusion Criteria:

          -  Patients with the following aggressive lymphomas are not eligible:

               1. Mantle cell

               2. Lymphoblastic

               3. Burkitt's

               4. Mycosis fungoides/Sezary's syndrome

               5. HTLV-1 associated T-cell leukemia/lymphoma

               6. Primary CNS lymphoma

               7. HIV-associated lymphoma

               8. Transformed lymphomas

               9. Immunodeficiency-associated lymphomas

          -  Previous diagnosis of another hematologic malignancies

          -  Progressive disease on CHOP or Rituximab-CHOP

          -  Active CNS involvement by lymphoma

          -  Serious co-morbid disease that could preclude full participation in study