Fludeoxyglucose F 18 Positron Emission Tomography in Predicting Risk of Relapse in Patients With Non-Hodgkin's Lymphoma Who Are Undergoing Combination Chemotherapy With or Without Autologous Stem Cell or Bone Marrow Transplant
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

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. Giving more than one
      drug (combination chemotherapy) may kill more cancer cells. Giving chemotherapy with an
      autologous stem cell or bone marrow transplant may allow more chemotherapy to be given so
      that more cancer cells are killed. Procedures, such as fludeoxyglucose F 18 positron emission
      tomography (FDG-PET) (done during chemotherapy) may help doctors predict a patient's risk of
      relapse and help plan the best treatment.

      PURPOSE: This phase II trial is studying how well FDG-PET works in predicting risk of relapse
      in patients with aggressive non-Hodgkin's lymphoma who are undergoing combination
      chemotherapy with or without autologous stem cell or bone marrow transplant.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine event-free survival of patients with aggressive non-Hodgkin's lymphoma treated
           with early high-dose therapy and autologous peripheral blood stem cell (PBSC) or bone
           marrow transplantation (BMT) based on positive fludeoxyglucose F 18 positron emission
           tomography (FDG-PET) results obtained during first-line chemotherapy.

        -  Compare event-free survival of patients treated with this regimen with historical
           event-free survival of patients with positive FDG-PET results obtained during first-line
           chemotherapy that are not treated with early high-dose therapy.

      Secondary

        -  Compare overall survival of patients treated with a standard treatment regimen vs early
           high-dose therapy and autologous PBSC or BMT based on FDG-PET results obtained during
           first-line chemotherapy.

        -  Determine the predictive value of an early negative FDG-PET result in these patients.

        -  Correlate International Prognostic Index risk category with FDG-PET results and overall
           outcome in these patients.

      OUTLINE: This is a pilot study.

        -  First-line chemotherapy: Patients receive cyclophosphamide IV, doxorubicin IV, and
           vincristine IV on day 1, oral prednisone on days 1-5, and rituximab IV on day 1
           (patients with CD20-positive disease only) OR another standard first-line chemotherapy
           regimen. Treatment repeats every 14-21 days for 2 or 3 courses in the absence of disease
           progression or unacceptable toxicity.

        -  Radiographic staging: Between days 11-20 of course 2 or 3 OR days 11-13 of course 3 of
           first-line chemotherapy, patients receive fludeoxyglucose F 18 (FDG) IV. One hour later,
           patients undergo whole-body FDG-positron emission tomography (PET) and CT scan. Patients
           with no evidence of malignant disease by FDG-PET (i.e., negative result) receive a
           standard treatment regimen that may include localized radiotherapy for limited stage or
           bulky disease followed, 4-6 weeks later, by a repeat whole-body FDG-PET and CT scan.
           Patients with progressive disease after first-line chemotherapy are removed from the
           study. Patients with evidence of malignant disease by FDG-PET (i.e., positive result)
           and stable disease or better proceed to ESHAP chemotherapy.

        -  ESHAP chemotherapy: Patients receive etoposide IV over 2 hours, methylprednisolone IV,
           and cisplatin IV over 3 hours on days 1-4 followed by cytarabine IV over 2 hours on day
           5. Patients with CD20-positive disease also receive rituximab IV on day 1. Treatment
           repeats every 14-21 days for 2 courses in the absence of disease progression or
           unacceptable toxicity. Beginning 1 day after completion of course 2, patients receive
           filgrastim (G-CSF) subcutaneously once daily followed by leukapheresis to collect
           peripheral blood stem cells (PBSC). Some patients may also undergo bone marrow (BM)
           harvest if sufficient PBSC are not collected. Patients with a sufficient number of stem
           cells proceed to high-dose therapy and autologous PBSC transplantation (PBSCT) or BM
           transplantation (BMT).

        -  High-dose therapy and PBSCT or BMT: No more than 4 weeks after completion of PBSC
           collection or BM harvest, patients receive high-dose therapy that may include
           cyclophosphamide and total-body irradiation OR busulfan and cyclophosphamide. Patients
           then undergo PBSCT or BMT. Between 4-6 weeks after completion of PBSCT or BMT, patients
           undergo repeat whole-body FDG-PET and CT scan. Patients may also undergo consolidative
           radiotherapy to the sites of bulky disease at the discretion of the physician.

      After completion of study treatment, patients are followed at 4 weeks, every 3 months for 2
      years, every 6 months for 1 year, and then annually for 2 years.

      PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 18 months.
    

Intervention name(s): filgrastim; rituximab; busulfan; cisplatin; cyclophosphamide; cytarabine; doxorubicin hydrochloride; etoposide; methylprednisolone; prednisone; vincristine sulfate; autologous bone marrow transplantation; peripheral blood stem cell transplantation; positron emission tomography; fludeoxyglucose F 18; radiation therapy
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Procedure; Procedure; Radiation; Radiation
Intervention MeSH terms: Cytarabine; Prednisone; Methylprednisolone; Cyclophosphamide; Busulfan; Rituximab; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Fluorodeoxyglucose F18
Primary purpose: Diagnostic
Keywords: 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; 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; anaplastic large cell lymphoma; stage I adult T-cell leukemia/lymphoma; stage II adult T-cell leukemia/lymphoma; stage III adult T-cell leukemia/lymphoma; stage IV adult T-cell leukemia/lymphoma