Trials / Completed
CompletedNCT00091182
Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment
A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- 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
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | oxaliplatin | Given IV |
Timeline
- Start date
- 2004-10-01
- Primary completion
- 2006-02-01
- First posted
- 2004-09-09
- Last updated
- 2013-06-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00091182. Inclusion in this directory is not an endorsement.