Topotecan Hydrochloride in Treating Children With Meningeal Cancer That Has Not Responded to Previous Treatment
Condition: AIDS-related Diffuse Large Cell Lymphoma; AIDS-related Diffuse Mixed Cell Lymphoma; AIDS-related Diffuse Small Cleaved Cell Lymphoma; AIDS-related Immunoblastic Large Cell Lymphoma; AIDS-related Lymphoblastic Lymphoma; AIDS-related Peripheral/Systemic Lymphoma; AIDS-related Primary CNS Lymphoma; AIDS-related Small Noncleaved Cell Lymphoma; Childhood Diffuse Large Cell Lymphoma; Childhood Immunoblastic Large Cell Lymphoma; HIV-associated Hodgkin Lymphoma; Leptomeningeal Metastases; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Recurrent Childhood Large Cell Lymphoma; Recurrent Childhood Lymphoblastic Lymphoma; Recurrent Childhood Medulloblastoma; Recurrent Childhood Small Noncleaved Cell Lymphoma; Recurrent/Refractory Childhood Hodgkin Lymphoma; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Non-Hodgkin; Hodgkin Disease; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Medulloblastoma; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop
      growing or die. This phase II trial is studying how well topotecan hydrochloride works in
      treating children with meningeal cancer that has not responded to previous treatment
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine the therapeutic activity of intrathecal topotecan, in terms of response rate and
      time to central nervous system (CNS) progression, in pediatric patients with recurrent or
      refractory neoplastic meningitis.

      II. Determine the safety and toxicity of this regimen in these patients. III. Evaluate the
      concentration of matrix metalloproteinases (MMPs) in the cerebrospinal fluid (CSF) of these
      patients.

      OUTLINE: Patients are stratified according to disease type (acute lymphoblastic leukemia vs.
      other leukemia/lymphoma vs medulloblastoma vs other solid tumors). (Recurrent CNS acute
      lymphoblastic leukemia stratum only open to accrual as of 11/30/04)

      INDUCTION: Patients receive topotecan hydrochloride intrathecally (IT) over 5 minutes twice
      weekly for 6 weeks.

      CONSOLIDATION: Beginning 1 week after completion of induction, patients receive topotecan
      hydrochloride IT over 5 minutes weekly for 4 weeks in the absence of disease progression or
      unacceptable toxicity.

      MAINTENANCE: Beginning 2 weeks after completion of consolidation, patients receive topotecan
      hydrochloride IT over 5 minutes twice monthly for 4 months and then monthly through year 1.

      After completion of study treatment, patients are followed up monthly for 3 months, every 3
      months for 1 year, every 6 months for 3 years, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 14-77 patients will be accrued for this study.
    

Intervention name(s): topotecan hydrochloride; laboratory biomarker analysis
Intervention type(s): Drug; Other
Intervention description(s): Given IT; Correlative studies
Other intervention name(s): hycamptamine; Hycamtin; SKF S-104864-A; TOPO
Intervention MeSH terms: Topotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment