Clinical trial · Interventional
Irinotecan in Treating Children With Refractory Solid Tumors
Phase II Trial of Irinotecan in Children With Refractory Solid Tumors
NCT00004078CI-TRIAL-00010719completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (21)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Central Nervous System Germ Cell Tumor | Childhood Central Nervous System Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Childhood Choroid Plexus Tumor | Choroid Plexus Neoplasm | ALIAS | 0.85 |
| Childhood Craniopharyngioma | Childhood Craniopharyngioma | ONTOLOGY_EXACT | 0.98 |
| Childhood Grade III Meningioma | Childhood Grade 3 Meningioma | ALIAS | 0.90 |
| Childhood Grade II Meningioma | Childhood Grade 2 Meningioma | ALIAS | 0.90 |
| Childhood Grade I Meningioma | Childhood Grade 1 Meningioma | ALIAS | 0.90 |
| Childhood Infratentorial Ependymoma | Childhood Infratentorial Ependymoma | ONTOLOGY_EXACT | 0.98 |
| Childhood Oligodendroglioma | Childhood Oligodendroglioma | ONTOLOGY_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (irinotecan hydrochloride)
- description
- 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.
- interventionNames
- Drug: irinotecan hydrochloride
Primary outcomes (1)
- measure
- Objective response (PR or CR), recorded according to standard solid tumor response criteria
- timeFrame
- Up to 8 years
Secondary outcomes (2)
- measure
- Toxicity, graded using the NCI CTCAE version 2.0
- timeFrame
- Up to 8 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria:
* 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
* 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)References
Publications (0)
Data not yet available
No reference posted for this study.