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 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT00017368
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Newly diagnosed high-risk neuroblastoma
* Histologically proven AND/OR
* Bone marrow specimen showing clumps of tumor cells accompanied by elevated urinary catecholamines
* Age 1-30:
* Must meet one of the following INSS staging criteria:
* Stage IV regardless of biologic factors
* Stage IIa/IIb with MYCN oncogene amplification (greater than 10) and unfavorable pathology
* Stage III with MYCN oncogene amplification (greater than 10) or unfavorable pathology
* Initially stage I, II, or IVS, that has progressed without interval chemotherapy
* Under age 1:
* INSS stage III, IV, or IVS with MYCN amplification (greater than 10)
* Must enter neuroblastoma biology study COG-ANBL00B1 within 2 weeks of diagnosis and before entry on this study
PATIENT CHARACTERISTICS:
Age:
* 30 and under at original diagnosis
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* No more than 1 prior course of chemotherapy on the intergroup low- or intermediate-risk neuroblastoma studies prior to determination of MYCN status and Shimada histology
Endocrine therapy:
* Not specified
Radiotherapy:
* Prior emergent radiotherapy to sites of function- or life-threatening neuroblastoma allowed
Surgery:
* Not specified
Other:
* No other prior systemic therapy for neuroblastoma
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
30 Years
Study:
NCT00017368
Study Brief:
Protocol Section:
NCT00017368