Irinotecan in Treating Children With Refractory Solid Tumors
Completed · Phase 2
Conditions studied: Childhood Central Nervous System Germ Cell Tumor, Childhood Choroid Plexus Tumor, Childhood Craniopharyngioma, Childhood Grade I Meningioma, Childhood Grade II Meningioma, Childhood Grade III Meningioma, Childhood Infratentorial Ependymoma, Childhood Oligodendroglioma, Childhood Supratentorial Ependymoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Visual Pathway and Hypothalamic Glioma, Recurrent Childhood Visual Pathway Glioma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Neuroblastoma, Recurrent Osteosarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
In brief
This phase II trial is studying irinotecan to see how well it works in treating children with refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Key facts
- Study ID
- NCT00004078
- Run by
- Children's Oncology Group
- People needed
- 181
- Starts
- 1999-10-01
- Last updated by the study team
- 2013-06-14
Who can join
Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed CNS or solid tumors recurrent or refractory to standard therapy
- Solid tumors:
- Neuroblastoma
- Ewing's Sarcoma/peripheral primitive neuroectodermal tumor (PNET)
- Osteosarcoma
- Rhabdomyosarcoma
- Other extracranial solid tumors
- CNS tumors:
- Medulloblastoma/PNET
- Ependymoma
- Brain stem glioma
- Other CNS tumor
- Intrinsic brain stem tumor (biopsy required only if previously treated with radiosurgery)
- Classic optic glioma (histologic requirement waived)
- Measurable disease by imaging studies
- No lesions assessable only by radionuclide scan
- Previously irradiated lesions used to evaluate tumor response must show evidence of an interim increase in size
- Performance status - Karnofsky 50-100% if more than 10 years old
- Performance status - Lansky 50-100% if 10 years or younger
- At least 8 weeks
- Absolute neutrophil count greater than 1,000/mm\^3
- Platelet count greater than 100,000/mm\^3
- Hemoglobin greater than 8 mg/dL
- Inadequate peripheral blood counts due to bone marrow infiltration allowed
- Bilirubin no greater than 1.5 mg/dL
Where it is running
- Children's Oncology Group — Arcadia, California, United States
Full record on ClinicalTrials.gov
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