Overview

ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors

Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborator:
AstraZeneca
Treatments:
Camptothecin
Gefitinib
Irinotecan
Criteria
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