Therapy for Children With Neuroblastoma

Inclusion Criteria:

• 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 Criteria:

• 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