Oxaliplatin and Irinotecan in Treating Young Patients With Refractory Solid Tumors or Lymphomas
Condition: Childhood Burkitt Lymphoma; Childhood Central Nervous System Germ Cell Tumor; Childhood Diffuse Large Cell Lymphoma; Childhood Grade III Lymphomatoid Granulomatosis; Childhood Immunoblastic Large Cell Lymphoma; Recurrent Childhood Brain Stem Glioma; Recurrent Childhood Cerebellar Astrocytoma; Recurrent Childhood Cerebral Astrocytoma; Recurrent Childhood Ependymoma; Recurrent Childhood Grade III Lymphomatoid Granulomatosis; Recurrent Childhood Large Cell Lymphoma; Recurrent Childhood Liver Cancer; Recurrent Childhood Lymphoblastic Lymphoma; Recurrent Childhood Malignant Germ Cell Tumor; Recurrent Childhood Medulloblastoma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Childhood Small Noncleaved Cell Lymphoma; Recurrent Childhood Soft Tissue Sarcoma; Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor; Recurrent Childhood Visual Pathway Glioma; Recurrent Colon Cancer; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Melanoma; Recurrent Nasopharyngeal Cancer; Recurrent Neuroblastoma; Recurrent Osteosarcoma; Recurrent Wilms Tumor and Other Childhood Kidney Tumors; Recurrent/Refractory Childhood Hodgkin Lymphoma; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Burkitt Lymphoma; Lymphoma; Neoplasms; Sarcoma; Glioma; Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neuroblastoma; Lymphoma, Large B-Cell, Diffuse; Neoplasms, Germ Cell and Embryonal; Astrocytoma; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Osteosarcoma; Rhabdomyosarcoma; Sarcoma, Ewing; Ependymoma; Medulloblastoma; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive; Wilms Tumor; Lymphomatoid Granulomatosis; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Lymphoma, Extranodal NK-T-Cell; Neuroectodermal Tumors, Primitive, Peripheral; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial is studying the side effects and best dose of oxaliplatin when given
      together with irinotecan in treating young patients with refractory solid tumors or
      lymphomas. Drugs used in chemotherapy, such as oxaliplatin and irinotecan, work in different
      ways to stop the growth of cancer cells, either by killing the cells or by stopping them from
      dividing. Oxaliplatin may help irinotecan kill more cancer cells by making cancer cells more
      sensitive to the drug. Giving oxaliplatin together with irinotecan may kill more cancer
      cells.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine the maximum tolerated dose of oxaliplatin when administered with irinotecan in
      pediatric patients with refractory solid tumors or lymphomas.

      II. Determine the toxic effects of this regimen in these patients. III. Determine the
      pharmacokinetics of this regimen in these patients.

      SECONDARY OBJECTIVES:

      I. Determine, preliminarily, the antitumor activity of this regimen in these patients.

      II. Correlate UGT and BCRP genotype with the toxicity of this regimen in these patients.

      OUTLINE: This is a multicenter, dose-escalation study of oxaliplatin.

      Patients receive oxaliplatin IV over 2 hours on days 1 and 8 and irinotecan IV over 1 hour on
      days 1-5 and 8-12. Treatment repeats every 21 days for up to 17 courses in the absence of
      disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-limiting toxicity.
    

Intervention name(s): irinotecan hydrochloride; oxaliplatin
Intervention type(s): Drug; Drug
Intervention description(s): Given IV; Given IV
Other intervention name(s): Campto; Camptosar; CPT-11; irinotecan; U-101440E; 1-OHP; Dacotin; Dacplat; Eloxatin; L-OHP
Intervention MeSH terms: Oxaliplatin; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment