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| Descriptive Information Fields | |||||
| Brief Title † | Irinotecan in Treating Children With Refractory Solid Tumors | ||||
| Official Title † | Phase II Trial of Irinotecan in Children With Refractory Solid Tumors | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | Efficacy [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Toxicity [ Designated as safety issue: Yes ] Pharmacokinetics [ Designated as safety issue: No ] Pharmacodynamics [ Designated as safety issue: No ] |
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| Condition † | Brain and Central Nervous System Tumors Neuroblastoma Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
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| Intervention † | Drug: irinotecan hydrochloride | ||||
| MEDLINE PMIDs | 18278496, 17925558 | ||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 225 | ||||
| Start Date † | October 1999 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 1 Year to 21 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States, Australia, Canada, Puerto Rico, Switzerland | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00004078 | ||||
| Organization ID | CDR0000067288 | ||||
| Secondary IDs †† | COG-P9761, POG-9761, CCG-P9761 | ||||
| Study Sponsor † | Children's Oncology Group | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | November 2005 | ||||
| First Received Date † | December 10, 1999 | ||||
| Last Updated Date | May 23, 2008 | ||||