Clinical trial · Interventional
Irinotecan in Treating Children With Refractory or Progressive Solid Tumors
Pediatric Phase I and Pharmacokinetic Study of Irinotecan
NCT00016861CI-TRIAL-00011121completedPhase 1ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children who have refractory or progressive solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed solid tumor refractory to standard therapy or for which no known effective therapy exists
* Brain tumors eligible
* Histologic verification waived for brain stem gliomas
* Evaluable disease
* No bone marrow involvement
PATIENT CHARACTERISTICS:
Age:
* 1 to 21
Performance status:
* Karnofsky 50-100% (over age 10)
* Lansky 50-100% (age 10 and under)
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 8 g/dL
Hepatic:
* Bilirubin less than 1.5 mg/dL
* SGPT less than 5 times normal
Renal:
* Creatinine normal OR
* Glomerular filtration rate at least 70 mL/min
Other:
* No uncontrolled infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 6 months since prior autologous bone marrow transplantation (BMT) (not including stem cell rescue after high-dose chemotherapy)
* At least 1 week since prior growth factors
* No prior BMT with total body irradiation (stratum I)
* No prior BMT with or without total body irradiation (stratum 2)
* No prior allogeneic BMT (all strata)
* No concurrent sargramostim (GM-CSF)
* No other concurrent prophylactic growth factor support during the first course of therapy
Chemotherapy:
* At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
* No prior irinotecan
* No more than 2 prior multi-agent chemotherapy regimens (stratum 2)
* No other concurrent chemotherapy
Endocrine therapy:
* Concurrent dexamethasone allowed if on stable or decreasing dose for at least 2 weeks prior to study
Radiotherapy:
* At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of the pelvis
* At least 6 weeks since other prior substantial bone marrow radiotherapy
* No prior central axis radiotherapy, pelvic radiotherapy, and/or total abdominal radiotherapy (stratum 2)
Surgery:
* Not specified
Other:
* Recovered from all prior therapy
* No other concurrent investigational agents
* Concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine) allowed if on stable dose for at least 2 weeks prior to study (stratum 3)
* Concurrent valproic acid allowed if combined with another enzyme inducing anticonvulsant drug (stratum 3)References
Publications (0)
Data not yet available
No reference posted for this study.