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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (irinotecan hydrochloride) | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| irinotecan hydrochloride | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response (PR or CR), recorded according to standard solid tumor response criteria | Up to 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity, graded using the NCI CTCAE version 2.0 | Up to 8 years | |
| Pharmacokinetics of irinotecan hydrochloride | Day 1 of course 1 |
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Inclusion Criteria:
Histologically or cytologically confirmed CNS or solid tumors recurrent or refractory to standard therapy
Solid tumors:
CNS tumors:
Measurable disease by imaging studies
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)
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Bomgaars | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Oncology Group | Arcadia | California | 91006-3776 | United States |
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| ID | Term |
|---|---|
| D016545 | Choroid Plexus Neoplasms |
| D009837 | Oligodendroglioma |
| D001254 | Astrocytoma |
| C531673 | Familial ependymoma |
| D008527 | Medulloblastoma |
| D020339 | Optic Nerve Glioma |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D009447 | Neuroblastoma |
| D012516 | Osteosarcoma |
| ID | Term |
|---|---|
| D002551 | Cerebral Ventricle Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018242 | Neuroectodermal Tumors, Primitive |
| D019574 | Optic Nerve Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D010524 | Peripheral Nervous System Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009901 | Optic Nerve Diseases |
| D005128 | Eye Diseases |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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