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:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT00089258
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of neuroblastoma, as defined by 1 of the following:
* Histologically confirmed disease
* Bone marrow metastases plus high urine catecholamines
* High-risk disease meeting 1 of the following stage criteria:
* Stage IV, with 1 of the following:
* Any age with MYCN amplification
* \> 18 months of age without MYCN amplification
* Stage III, with both of the following:
* Any age with MYCN amplification
* Unresectable disease
* Stage 4S with MYCN amplification
* Measurable or evaluable soft tissue disease
* Relapsed disease resistant to standard induction chemotherapy and salvage therapy
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* No severe hepatic toxicity ≥ grade 3
Renal
* No severe renal toxicity ≥ grade 3
Cardiovascular
* No severe cardiac toxicity ≥ grade 3
Pulmonary
* No severe pulmonary toxicity ≥ grade 3
Other
* Not pregnant
* Negative pregnancy test
* No severe neurologic toxicity ≥ grade 3
* No severe gastrointestinal toxicity ≥ grade 3
* No other severe major organ dysfunction except ototoxicity
* No history of allergy to mouse proteins
* No active life-threatening infection
* No human anti-mouse antibody titer \> 1,000 ELISA units/mL
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00089258
Study Brief:
Protocol Section:
NCT00089258