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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: | NCT00004078 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying irinotecan to see how well it works in treating children with refractory solid tumors.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Neuroblastoma Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: irinotecan hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Trial of Irinotecan in Children With Refractory Solid Tumors |
Estimated Enrollment: | 225 |
Study Start Date: | October 1999 |
OBJECTIVES:
OUTLINE: Patients are stratified according to type of solid tumor (Ewings/PNET vs neuroblastoma vs osteosarcoma vs rhabdomyosarcoma vs other solid tumors excluding lymphomas and brain tumors) or brain tumor (medulloblastoma/PNET vs brain stem glioma vs ependymoma vs other CNS tumors).
Patients receive irinotecan IV over 60 minutes on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 4 years and then annually thereafter until death or until patient enters another POG study.
PROJECTED ACCRUAL: A total of 225 patients will be accrued for this study.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed CNS or solid tumors recurrent or refractory to standard therapy
Solid tumors:
CNS tumors:
Measurable disease by imaging studies
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Lisa Bomgaars, MD | Texas Children's Cancer Center |
Study ID Numbers: | CDR0000067288, COG-P9761, POG-9761, CCG-P9761 |
Study First Received: | December 10, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004078 History of Changes |
Health Authority: | United States: Federal Government |
childhood infratentorial ependymoma recurrent childhood rhabdomyosarcoma childhood supratentorial ependymoma childhood craniopharyngioma recurrent neuroblastoma childhood central nervous system germ cell tumor recurrent osteosarcoma unspecified childhood solid tumor, protocol specific childhood oligodendroglioma childhood choroid plexus tumor childhood grade I meningioma |
childhood grade II meningioma childhood grade III meningioma recurrent childhood visual pathway glioma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood medulloblastoma recurrent childhood visual pathway and hypothalamic glioma previously treated childhood rhabdomyosarcoma recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent childhood ependymoma |
Choroid Plexus Neoplasms Neuroectodermal Tumors, Primitive Irinotecan Central Nervous System Neoplasms Neuroblastoma Ependymoma Neoplasms, Connective and Soft Tissue Sarcoma, Ewing's Soft Tissue Sarcomas Neoplasms, Germ Cell and Embryonal Craniopharyngioma Osteogenic Sarcoma Neuroepithelioma Meningioma Glioma |
Ewing's Family of Tumors Nervous System Neoplasms Rhabdomyosarcoma Astrocytoma Osteosarcoma Rhabdomyosarcoma, Childhood Ewing's Sarcoma Camptothecin Recurrence Neuroectodermal Tumors Malignant Mesenchymal Tumor Peripheral Neuroectodermal Tumor Medulloblastoma Sarcoma Oligodendroglioma |
Neuroectodermal Tumors, Primitive Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Irinotecan Neoplasms, Nerve Tissue Nervous System Diseases Enzyme Inhibitors Central Nervous System Neoplasms Pharmacologic Actions Camptothecin Neuroblastoma |
Neoplasms, Connective and Soft Tissue Neuroectodermal Tumors Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Sarcoma Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Nervous System Neoplasms Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |