Peripheral Stem Cell Transplantation Plus Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
      may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
      Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing
      substances to them without harming normal cells.

      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation
      plus combination chemotherapy and rituximab in treating patients with non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the 1 and 2 year event free survival of patients with poor prognosis,
      relapsed or refractory intermediate or high grade B-cell non-Hodgkin's lymphoma who receive
      high dose carmustine and melphalan plus gemcitabine followed by rituximab (IDEC-C2B8
      monoclonal antibody; anti-CD20 monoclonal antibody) plus sargramostim and consolidation
      chemotherapy with alternating dexamethasone/cyclophosphamide/ etoposide/cisplatin plus
      gemcitabine and paclitaxel/cisplatin and compare these figures to a historical control
      population. II. Evaluate the ability of posttransplant rituximab therapy in combination with
      sargramostim (GM-CSF) to control and further treat residual lymphoma remaining after high
      dose therapy in these patients. III. Evaluate quality of life parameters and assess the risk
      of secondary malignancies following this treatment regimen in these patients.

      OUTLINE: Patients receive high dose gemcitabine IV over 100 minutes on day -5 and again
      approximately 6 hours after carmustine IV over 2 hours on day -2. On day -1, patients receive
      melphalan IV over 20 minutes followed 24 hours later (day 0) with peripheral blood stem cells
      transplantation. Patients then receive sargramostim (GM-CSF) subcutaneously beginning on day
      4 until granulocyte count is greater than 1,000/mm3 for 2 consecutive days. At weeks 5-8
      posttransplant, patients receive rituximab (IDEC-C2B8 monoclonal antibody; anti-CD20
      monoclonal antibody) IV over 3-4 hours weekly. Prior to rituximab treatment at week 4
      posttransplant, patients receive sargramostim (GM-CSF) subcutaneously 3 times a week
      continuing through rituximab therapy. At approximately 3 and 9 months posttransplant,
      patients receive dexamethasone orally every day for days 1-4, and cyclophosphamide,
      etoposide, and cisplatin by continuous infusion for 4 days (days 1-4), and gemcitabine IV
      over 100 minutes on days 1 and 5. At approximately 6 and 12 months posttransplant, patients
      receive paclitaxel IV over 6 hours on day 2 and cisplatin IV over 24 hours on day 3. Patients
      are followed at least every 6 weeks to 3 months until death.

      PROJECTED ACCRUAL: An estimated 25 patients per year will be accrued into this study.
    

Intervention name(s): filgrastim; rituximab; sargramostim; carmustine; cisplatin; cyclophosphamide; dexamethasone; etoposide; gemcitabine hydrochloride; melphalan; paclitaxel; bone marrow ablation with stem cell support; peripheral blood stem cell transplantation
Intervention type(s): Biological; Biological; Biological; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Dexamethasone; Paclitaxel; Etoposide; Cyclophosphamide; Rituximab; Gemcitabine; Melphalan; Carmustine; Sargramostim
Primary purpose: Treatment
Keywords: stage I grade 3 follicular lymphoma; stage I adult diffuse small cleaved cell lymphoma; stage I adult diffuse mixed cell lymphoma; stage I adult diffuse large cell lymphoma; stage I adult immunoblastic large cell lymphoma; stage I adult lymphoblastic lymphoma; stage I adult Burkitt lymphoma; stage III grade 3 follicular lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage III adult lymphoblastic lymphoma; stage III adult Burkitt lymphoma; stage IV grade 3 follicular lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult lymphoblastic lymphoma; stage IV adult Burkitt lymphoma; recurrent grade 3 follicular lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent adult Burkitt lymphoma; stage I mantle cell lymphoma; contiguous stage II grade 3 follicular lymphoma; contiguous stage II adult diffuse small cleaved cell lymphoma; contiguous stage II mantle cell lymphoma; contiguous stage II adult diffuse mixed cell lymphoma; contiguous stage II adult immunoblastic large cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; contiguous stage II adult Burkitt lymphoma; contiguous stage II adult lymphoblastic lymphoma; noncontiguous stage II grade 3 follicular lymphoma; noncontiguous stage II adult diffuse small cleaved cell lymphoma; noncontiguous stage II mantle cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult lymphoblastic lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; recurrent mantle cell lymphoma