Status:
COMPLETED
Therapy for Children With Neuroblastoma
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
AstraZeneca
National Institutes of Health (NIH)
Conditions:
Neuroblastoma
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief Summary
This is a phase II window study of the combination of ZD1839 (gefitinib) and irinotecan in children with high-risk neuroblastoma followed by standard induction chemotherapy, intensification with autol...
Detailed Description
The study will have five parts or phases. In the first part the combination of irinotecan and gefitinib will be studied. After that, patients who have responded well will have surgery to remove the tu...
Eligibility Criteria
Inclusion
- Patient is less than or equal to 18 years of age
- Patient is newly diagnosed with high-risk neuroblastoma
- Patient has adequate kidney and liver function
- No prior therapy, unless an emergency situation requires local tumor treatment (discuss with PI)
Exclusion
- Known severe hypersensitivity to ZD1839 or any of the excipients of this product
- Any evidence, as judged by the investigator, of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.
- Pregnant or breast feeding (women of child-bearing potential).
- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St. John's Wort.
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
- Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
- Children with INSS 4 disease, age \<12 months with all 3 favorable biologic features (non-amplified MYCN, favorable pathology and DNA index
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00135135
Start Date
August 1 2005
End Date
June 1 2007
Last Update
June 3 2008
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105