Combination Chemotherapy With or Without Total-Body Irradiation Followed By Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: carmustine; cyclophosphamide; etoposide; autologous hematopoietic stem cell transplantation; peripheral blood stem cell transplantation; total-body irradiation; G-CSF
Intervention description: Unique to the Carmustine in Conditioning arm; Used in Both Arms; Used in Both Arms; Both arms are given autologous stem cell transplantation; Both arms are given peripheral blood stem cell transplantation (Peripheral blood stem cells are the material, autologous transplant is the modality).; Unique to the Radiation in Conditioning Arm; G-CSF is given in both treatment arms, both to mobilize stem cells before apheresis, and to promote recovery of granulocytes after stem-cell re-infusion.
Intervention MeSH terms: Cyclophosphamide; Carmustine; Etoposide; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 16 Years
Maximum age: 59 Years
Healthy volunteers: No
Keywords: stage III adult diffuse mixed cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV mantle cell lymphoma; stage III mantle cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; stage III adult Burkitt lymphoma; stage IV adult Burkitt lymphoma

Summary:

      RATIONALE: Giving chemotherapy and radiation therapy to the entire body before an autologous
      peripheral stem cell transplant stops the growth of cancer cells by stopping them from
      dividing or killing them. The patient's stem cells are then returned to the patient to
      replace the blood-forming cells that were destroyed by the chemotherapy and radiation
      therapy.

      PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy
      together with or without total-body irradiation followed by a stem cell transplant and to see
      how well it works in treating patients with non-Hodgkin lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DISEASE CHARACTERISTICS:

          -  Biopsy-proven diagnosis of high-grade (small noncleaved cell lymphoma [SNCCL] or
             immunoblastic lymphoma) or intermediate-grade non-Hodgkin lymphoma (NHL) including
             mantle cell lymphoma (MCL)

          -  SNCCL patients with all of the following factors at presentation of disease:

               -  Lactate dehydrogenase (LDH) > 500 IU/L

               -  Unresectable bulky mass > 10 cm

               -  Stage IV disease with bone marrow involvement

          -  MCL Patients with stage IV disease or in International Prognostic Index (IPI) high- or
             high-intermediate-risk group at the time of diagnosis

          -  Considered at diagnosis to be high- (3 risk factors) or high-intermediate-risk (2 risk
             factors) based on an age-adjusted IPI

          -  Poor prognostic factors at diagnosis include stage III or IV disease, lactate
             dehydrogenase (LDH) level above normal, or ECOG performance status (PS) 2-4

          -  Patients with primary mediastinal large cell lymphoma with or without sclerosis who at
             diagnosis had elevated LDH level with bulky mediastinal mass > 10 cm associated with a
             pleural effusion on chest radiography or computer tomography, or who have persistent
             mediastinal mass with positive disease by post-treatment gallium GA 67 scan

          -  Must have attained a complete response or partial response to first-line standard
             conventional chemotherapy

          -  ECOG PS 0-1 OR Karnofsky PS 80-100%

          -  Serum creatinine < 1.5 mg/dL OR creatinine clearance > 60 mL/min

          -  FEV_1 > 65% of predicted measurement or DLCO ≥ 45% of predicted measurement

          -  Cardiac ejection fraction > 50% by echocardiogram

          -  Bilirubin ≤ 1.5 x normal

          -  SGOT or SGPT ≤ 2 x normal

        Exclusion Criteria:

          -  Evidence of lymphoma or < 10% lymphomatous involvement of bone by bilateral bone
             marrow aspiration and biopsy

          -  Abnormal cytogenetic study of bone marrow aspirate sample NOTE: A new classification
             scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of
             "indolent" or "aggressive" lymphoma will replace the former terminology of "low",
             "intermediate", or "high" grade lymphoma. However, this protocol uses the former
             terminology.

          -  Positive HIV antibody

          -  Prior malignancies except for adequately treated basal cell or squamous cell carcinoma
             of the skin

          -  Hepatitis B surface antigen positivity

          -  Prior bone marrow transplantation

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior bone marrow transplantation