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Clinical Trial Summary

This phase II trial is studying how well oxaliplatin works in treating young patients with recurrent solid tumors that have not responded to previous treatment. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.


Clinical Trial Description

OBJECTIVES:

I. Determine the response rate in children with recurrent or refractory solid tumors treated with oxaliplatin.

II. Determine the cumulative toxicity of this drug in these patients. III. Determine the pharmacokinetic profile of this drug in these patients. IV. Determine time to progression and overall survival of patients treated with this drug.

V. Correlate the extent of oxaliplatin exposure with response in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease type.

Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Adrenocortical Carcinoma
  • Astrocytoma
  • Carcinoma
  • Carcinoma, Hepatocellular
  • Carcinoma, Renal Cell
  • Childhood Central Nervous System Germ Cell Tumor
  • Childhood Extragonadal Germ Cell Tumor
  • Childhood Hepatoblastoma
  • Childhood Hepatocellular Carcinoma
  • Childhood High-grade Cerebral Astrocytoma
  • Childhood Low-grade Cerebral Astrocytoma
  • Childhood Malignant Ovarian Germ Cell Tumor
  • Childhood Malignant Testicular Germ Cell Tumor
  • Childhood Teratoma
  • Ependymoma
  • Germinoma
  • Glioma
  • Hepatoblastoma
  • Liver Neoplasms
  • Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Neuroblastoma
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Optic Nerve Glioma
  • Osteosarcoma
  • Ovarian Neoplasms
  • Recurrent Adrenocortical Carcinoma
  • Recurrent Childhood Brain Stem Glioma
  • Recurrent Childhood Cerebellar Astrocytoma
  • Recurrent Childhood Cerebral Astrocytoma
  • Recurrent Childhood Ependymoma
  • Recurrent Childhood Liver Cancer
  • Recurrent Childhood Malignant Germ Cell Tumor
  • Recurrent Childhood Rhabdomyosarcoma
  • Recurrent Childhood Soft Tissue Sarcoma
  • Recurrent Childhood Visual Pathway and Hypothalamic Glioma
  • Recurrent Colon Cancer
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Nasopharyngeal Cancer
  • Recurrent Neuroblastoma
  • Recurrent Osteosarcoma
  • Recurrent Rectal Cancer
  • Recurrent Renal Cell Cancer
  • Rhabdomyosarcoma
  • Sarcoma
  • Sarcoma, Ewing
  • Testicular Neoplasms

NCT number NCT00091182
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date October 2004

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