Therapy for Children With Neuroblastoma
Completed · Phase 2
Conditions studied: Neuroblastoma
In brief
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 autologous stem cell transplantation, and an oral maintenance phase with 13-cis-retinoic acid and topotecan. We hypothesize that the ZD1839 (gefitinib) and irinotecan window will be efficacious.
Key facts
- Study ID
- NCT00135135
- Run by
- St. Jude Children's Research Hospital
- People needed
- 23
- Starts
- 2005-08-01
- Expected to finish
- 2007-06-01
- Last updated by the study team
- 2008-06-03
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.