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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 |
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 Ewing's family of tumors Malignant mesenchymal tumor Irinotecan Central Nervous System Neoplasms Osteogenic sarcoma Neuroblastoma Ependymoma Soft tissue sarcomas Neoplasms, Connective and Soft Tissue Ewing's sarcoma Sarcoma, Ewing's Neoplasms, Germ Cell and Embryonal Craniopharyngioma |
Neuroepithelioma Meningioma Glioma Choroid Plexus neoplasms Nervous System Neoplasms Rhabdomyosarcoma Astrocytoma Osteosarcoma Camptothecin Recurrence Neuroectodermal Tumors Peripheral neuroectodermal tumor Medulloblastoma Sarcoma Oligodendroglioma |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Nervous System Diseases Enzyme Inhibitors Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Pharmacologic Actions |