Clinical trial · Interventional
Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants
A Phase I Study of Irinotecan in Patients With Refractory Solid Tumors Who Are Concomitantly Receiving Anticonvulsants
NCT00008424CI-TRIAL-00014408completedPhase 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 with refractory or advanced solid tumors who are receiving anticonvulsants.
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 |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum tolerable dose (MTD) of irinotecan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignancy refractory to conventional therapy or for which no conventional therapy exists * Histologic confirmation not required for brain stem tumors * Concurrently on anticonvulsants at a steady level for at least 2 weeks PATIENT CHARACTERISTICS: Age: * 1-21 years old Performance status: * Karnofsky 50-100% (over 10 years of age) * Lansky 50-100% (10 years of age or under) Life expectancy: * At least 8 weeks Hematopoietic: * Neutrophil count at least 1,000/mm3 * Platelet count at least 100,000/mm3 (transfusion independent) * Hemoglobin at least 8.0 g/dL (red blood cell transfusions allowed) Hepatic: * Bilirubin no greater than 1.5 times normal for age * SGPT less than 5 times normal for age * Albumin at least 2 g/dL Renal: * Creatinine no greater than 1.5 times normal for age OR * Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal for age Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled infection * No evidence of active graft-vs-host disease * Neurologic deficits for CNS tumors stable for at least 2 weeks prior to study PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 week since prior antineoplastic biologic therapy * At least 6 months since prior allogeneic stem cell transplantation * At least 1 week since prior growth factors * No concurrent sargramostim (GM-CSF) * No concurrent prophylactic growth factors during first course of study therapy * Recovered from prior immunotherapy Chemotherapy: * At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea) and recovered Endocrine therapy: * Concurrent dexamethasone for CNS tumors with increased intracranial pressure allowed if dose stable or decreasing for at least 2 weeks prior to study Radiotherapy: * At least 2 weeks since prior local palliative radiotherapy (small part) * At least 6 months since prior craniospinal radiotherapy * At least 6 months since prior radiotherapy to at least 50% of pelvis * At least 6 weeks since prior substantial bone marrow radiotherapy * Recovered from prior radiotherapy Surgery: * Not specified Other: * No other concurrent investigational agent
References
Publications (0)
Data not yet available
No reference posted for this study.