Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma or 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 or bone marrow
      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 combination chemotherapy followed by
      autologous bone marrow transplantation or peripheral stem cell transplantation in treating
      patients who have non-Hodgkin's lymphoma or Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of intensive high dose chemotherapy consisting of topotecan,
           ifosfamide, and etoposide followed by autologous bone marrow or peripheral blood stem
           cell transplantation in terms of response rate, progression free survival, and overall
           survival in patients with high risk non-Hodgkin's lymphoma or Hodgkin's lymphoma.

        -  Determine the pharmacokinetic profile of high dose topotecan and etoposide in these
           patients.

        -  Determine the pharmacodynamics and toxicity of this regimen in these patients.

        -  Determine the role of either an up or down regulation of DNA topoisomerase I or II
           amount and/or activity in terms of clinical response and toxicity in patients treated
           with this regimen.

      OUTLINE: Patients receive intensive high dose chemotherapy consisting of ifosfamide IV over 2
      hours followed by topotecan IV over 30 minutes on days -8 to -6 and etoposide IV continuously
      over 24 hours on days -5 to -3. Patients undergo autologous bone marrow or peripheral blood
      stem cell transplantation on day 0.

      Patients are followed at 3, 6, and 12 months, annually until disease relapse, and then every
      6 months until death.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.
    

Intervention name(s): etoposide; ifosfamide; topotecan hydrochloride; autologous bone marrow transplantation; Mesna
Intervention type(s): Drug; Drug; Drug; Procedure; Drug
Intervention description(s): Etoposide IV 500 mg/m2/day over 24 hours Days -5, -4, -3; Ifosfamide 3,333 mg/m2/day IV over 2 hours (total dose 10,000 mg/m2)Days -8, -7, -6; Topotecan 21.3 mg/m2/day (total dose 64 mg/m2 ) IV over 30 minutes Days -8, -7, -6; Mesna 1,111 mg/m2/dose IV over 30 minutes; 30 minutes before and 4 and 8 hours after ifosfamide (total dose 10,000 mg/m2) Days -8, -7, -6
Other intervention name(s): vepesid(R); VP-16; Ifex(R); topotecan; Mesnex(R)
Intervention MeSH terms: Etoposide; Topotecan; Ifosfamide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; recurrent adult Hodgkin lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular 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 Burkitt lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma