Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT00135135
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT00135135
Study Brief:
Protocol Section:
NCT00135135