Irinotecan in Treating Children With Refractory Solid Tumors
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ClinicalTrials.gov Identifier: NCT00004078 |
Recruitment Status :
Completed
First Posted : January 28, 2003
Last Update Posted : June 14, 2013
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Condition or disease | Intervention/treatment | Phase |
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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 | Drug: irinotecan hydrochloride | Phase 2 |
OBJECTIVES:
I. Determine the efficacy of irinotecan in children with refractory CNS or solid tumors.
II. Assess the toxicity, pharmacokinetics, and pharmacodynamics of this regimen in this patient population.
III. Determine patient UGT1A1 genotype and correlate genotype with toxicity and pharmacokinetic parameters of this regimen in these patients.
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 181 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of Irinotecan in Children With Refractory Solid Tumors |
Study Start Date : | October 1999 |
Actual Primary Completion Date : | October 2007 |

Arm | Intervention/treatment |
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Experimental: Treatment (irinotecan hydrochloride)
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.
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Drug: irinotecan hydrochloride
Given IV
Other Names:
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- Objective response (PR or CR), recorded according to standard solid tumor response criteria [ Time Frame: Up to 8 years ]
- Toxicity, graded using the NCI CTCAE version 2.0 [ Time Frame: Up to 8 years ]
- Pharmacokinetics of irinotecan hydrochloride [ Time Frame: Day 1 of course 1 ]

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Ages Eligible for Study: | 1 Year to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Histologically or cytologically confirmed CNS or solid tumors recurrent or refractory to standard therapy
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Solid tumors:
- Neuroblastoma
- Ewing's Sarcoma/peripheral primitive neuroectodermal tumor (PNET)
- Osteosarcoma
- Rhabdomyosarcoma
- Other extracranial solid tumors
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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)
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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
- SGPT less than 5 times normal
- Creatinine normal
- Glomerular filtration rate at least 70 mL/min
- No severe uncontrolled infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study
- At least 3 weeks since prior immunotherapy and recovered
- No concurrent biologic therapy
- At least 3 weeks since prior chemotherapy (8 weeks since prior nitrosoureas) and recovered
- No more than 2 prior chemotherapy regimens
- No other concurrent chemotherapy
- Prior topotecan allowed
- No prior irinotecan
- Concurrent dexamethasone for brain tumor patients allowed if on a stable or decreasing dose for at least 2 weeks prior to study
- At least 3 weeks since prior endocrine therapy
- No other concurrent endocrine therapy
- See Disease Characteristics
- At least 8 weeks since prior extended radiotherapy (including evaluable lesions) and recovered
- No prior total body radiotherapy
- No concurrent radiotherapy
- See Disease Characteristics
- At least 3 weeks since prior investigational agents
- No other concurrent investigational agents
- No concurrent anticonvulsants
- No concurrent medications that would interfere with the P-450 enzyme system function (e.g., erythromycin, cimetidine, fluconazole)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004078
United States, California | |
Children's Oncology Group | |
Arcadia, California, United States, 91006-3776 |
Principal Investigator: | Lisa Bomgaars | Children's Oncology Group |
Responsible Party: | Children's Oncology Group |
ClinicalTrials.gov Identifier: | NCT00004078 |
Other Study ID Numbers: |
P9761 NCI-2012-02310 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000067288 ( Other Identifier: Clinical Trials.gov ) POG-9761 ( Other Identifier: Pediatric Oncology Group ) CCG-P9761 ( Other Identifier: Children's Cancer Group ) COG-P9761 ( Other Identifier: Children's Oncology Group ) U10CA098543 ( U.S. NIH Grant/Contract ) |
First Posted: | January 28, 2003 Key Record Dates |
Last Update Posted: | June 14, 2013 |
Last Verified: | June 2013 |
Neoplasms Glioma Neuroblastoma Astrocytoma Osteosarcoma Rhabdomyosarcoma Ependymoma Meningioma Sarcoma, Ewing Medulloblastoma Oligodendroglioma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Rhabdomyosarcoma, Embryonal Neuroectodermal Tumors, Primitive, Peripheral |
Craniopharyngioma Adamantinoma Choroid Plexus Neoplasms Recurrence Disease Attributes Pathologic Processes Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms, Neuroepithelial Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Bone Tissue Neoplasms, Connective Tissue |