Clinical trial · Interventional
ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors
A Dose Finding Study (Phase I) of the Combination of ZD1839 (Iressa®) and an Oral Formulation of Irinotecan (Camptosar™) in Children With Refractory Solid Tumors
- 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)
The purpose of this Phase I study is to find the largest dose of the drug irinotecan, in combination with ZD1839, that can be given safely to children and to learn the good and bad effects. Studies performed in the laboratory have shown that ZD1839 helps make available the orally administered irinotecan. In this study the intravenous (given into the vein) formula of irinotecan will be given orally on days 1-5 and days 8-12. The dose of ZD1839 will be a fixed dose and will be administered orally on days 1-12. Each course of treatment will consist of 21 days. The administration of irinotecan on day 12 of course 1 and day 2 of course 2 will be an intravenous administration. All other doses and subsequent courses will consist of an orally administered dose.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Rhabdomyosarcomas | Rhabdomyosarcoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan (Camptosar), Gefitinib (Iressa) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- interventionNames
- Drug: Irinotecan (Camptosar), Gefitinib (Iressa)
Primary outcomes (1)
- measure
- To estimate the maximum tolerated dose (MTD) of the intravenous formulation of irinotecan given orally in combination with a fixed dose of oral gefitinib.
- timeFrame
- Within the first 30 days of completion of first cycle of chemotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patient's age is less than or equal to 21 years at the time of study entry. * Patient has a histologically or pathologically confirmed diagnosis of a recurrent solid tumor that did not respond to standard treatment or one for which there is no known therapy. * Patient has adequate performance status, along with adequate function of the liver, kidney and bone marrow. * Must have recovered from chemotherapy * No active GVHD nor treatment for GVHD Exclusion Criteria: * Patient is receiving other cytotoxic or investigational drug or has evidence of another active illness * Active diarrhea * Active intercurrent serious or uncontrolled illness * Pregnant or lactating * Concomitant use of medications that may interact with study drugs * Active infection * Known history of life-threatening allergy or hypersensitivity to camptothecin Active interstitial lung disease
References
Publications (0)
Data not yet available