ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors
Completed · Phase 1
Conditions studied: Glioblastoma, Rhabdomyosarcomas, Neuroblastoma, Osteosarcoma
In brief
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.
Key facts
- Study ID
- NCT00132158
- Run by
- St. Jude Children's Research Hospital
- People needed
- 19
- Starts
- 2005-09-01
- Expected to finish
- 2011-10-01
- Last updated by the study team
- 2012-04-17
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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