Peripheral Stem Cell Transplantation Plus Combination Chemotherapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Condition: Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
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.

      PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation
      plus combination chemotherapy in treating patients who have low-grade non-Hodgkin's lymphoma
      or chronic lymphocytic leukemia.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the complete and partial response rates to treatment with peripheral
      blood stem cell supported high dose carmustine and melphalan followed by consolidation
      therapy with dexamethasone/cyclophosphamide/etoposide/cisplatin (DCEP) and dexamethasone,
      paclitaxel, and cisplatin in patients with poor prognosis low grade non-Hodgkin's lymphoma or
      chronic lymphocytic leukemia and no greater than 12 months of prior standard therapy. II.
      Evaluate the incidence of early deaths (less than 60 days posttransplant) in comparison with
      historical experience in this patient population. III. Evaluate the toxicity of
      posttransplantation chemotherapy with DCEP and dexamethasone, paclitaxel, and cisplatin in
      these patients.

      OUTLINE: Patients receive carmustine IV over 2 hours on day -2 and melphalan IV on day -1
      followed by peripheral blood stem cell infusion on day 0. At 3 months and 9 months after
      completion of autologous transplantation, patients receive cyclophosphamide, etoposide, and
      cisplatin by continuous IV infusion for 4 days plus dexamethasone orally every day for 4
      days. At 6 and 12 months after completion of autologous transplantation, patients receive
      dexamethasone orally every day for 4 days, paclitaxel continuous IV infusion over 6 hours on
      day 2, and cisplatin continuous IV infusion over 24 hours on day 3.

      PROJECTED ACCRUAL: There will be 12-35 patients accrued into this study over 1-2.5 years.
    

Intervention name(s): carmustine; cisplatin; cyclophosphamide; dexamethasone; etoposide; melphalan; paclitaxel; bone marrow ablation with stem cell support; peripheral blood stem cell transplantation
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Dexamethasone; Paclitaxel; Etoposide; Cyclophosphamide; Melphalan; Carmustine
Primary purpose: Treatment
Keywords: Waldenstrom macroglobulinemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; refractory chronic lymphocytic leukemia; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; recurrent mantle cell lymphoma