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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00091182 |
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: 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.
Condition | Intervention | Phase |
---|---|---|
Adrenocortical Carcinoma Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Colorectal Cancer Extragonadal Germ Cell Tumor Head and Neck Cancer Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Sarcoma |
Drug: oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors |
Estimated Enrollment: | 180 |
Study Start Date: | October 2004 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* solid tumor, including any of the following:
Rare tumors of interest, including any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine based on age as follows:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
At least 6 months since prior allogeneic stem cell transplantation
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Orren Beaty, DO, PhD | Mission Children's Hospital |
Investigator: | Marcio A. Malogolowkin, MD | Children's Hospital Los Angeles |
Investigator: | Stacey L. Berg, MD | Texas Children's Cancer Center |
Study ID Numbers: | CDR0000384560, COG-ADVL0421 |
Study First Received: | September 7, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00091182 |
Health Authority: | United States: Federal Government |
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent osteosarcoma recurrent childhood rhabdomyosarcoma recurrent neuroblastoma childhood high-grade cerebral astrocytoma childhood low-grade cerebral astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood cerebellar astrocytoma recurrent childhood ependymoma childhood hepatoblastoma childhood extragonadal germ cell tumor childhood malignant ovarian germ cell tumor childhood malignant testicular germ cell tumor |
childhood teratoma recurrent childhood malignant germ cell tumor childhood central nervous system germ cell tumor recurrent childhood soft tissue sarcoma childhood hepatocellular carcinoma recurrent childhood liver cancer recurrent colon cancer recurrent rectal cancer recurrent renal cell cancer recurrent adrenocortical carcinoma recurrent nasopharyngeal cancer recurrent childhood brain stem glioma recurrent childhood visual pathway and hypothalamic glioma |
Liver Diseases Neuroectodermal Tumors, Primitive Rectal Neoplasms Carcinoma, Hepatocellular Adrenocortical carcinoma Malignant mesenchymal tumor Colonic Diseases Adrenal Gland Diseases Urogenital Neoplasms Central Nervous System Neoplasms Urologic Neoplasms Osteogenic sarcoma Rectal Diseases Neoplasms, Connective and Soft Tissue Ewing's sarcoma |
Neuroepithelioma Adrenal Cortex Neoplasms Glioma Hepatoblastoma Kidney Diseases Rectal cancer Nervous System Neoplasms Rhabdomyosarcoma Endocrine Gland Neoplasms Digestive System Neoplasms Astrocytoma Genital Neoplasms, Female Endocrine System Diseases Renal cancer Testicular Neoplasms |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Nervous System Diseases Neoplasms, Neuroepithelial Pharmacologic Actions Adnexal Diseases |