Status:
COMPLETED
ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
AstraZeneca
Conditions:
Glioblastoma
Rhabdomyosarcomas
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief Summary
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 pe...
Detailed Description
This is a phase I study to estimate the maximum tolerated dose and the dose limiting toxicities of the intravenous formulation of irinotecan given orally in combination with a fixed dose of oral gefit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00132158
Start Date
September 1 2005
End Date
October 1 2011
Last Update
April 17 2012
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105