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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT00002560
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Neuroblastoma diagnosed by INSS criteria, i.e., either:
* Histologic proof of disease OR
* Tumor clumps in bone marrow plus elevated catecholamine levels
* Relapsed disease with poor long-term prognosis as indicated by at least one of the following:
* N-myc amplification in tumor cells
* Diploid chromosomal content in tumor cells
* Distant skeletal metastases
* Unresectable primary tumor crossing the midline
* Bone marrow with greater than 10% tumor cells
* Documentation of measurable progressive disease or biopsy- proven stable disease at least 4 weeks after prior systemic therapy required
* No rapidly progressive disease
* Poor risk neuroblastoma (but without measurable disease) not eligible for other neuroblastoma protocols
PATIENT CHARACTERISTICS:
Age:
* 2 to 21
Performance status:
* Not specified
Life expectancy:
* Greater than 8 weeks
Hematologic:
* Not specified
Hepatic:
* No grade 3/4 toxicity
* LDH no greater than 1.5 times upper limit of normal
Renal:
* Creatinine clearance at least 60 mL/min
* No grade 3/4 toxicity
Cardiovascular:
* No grade 3/4 toxicity
Pulmonary:
* No grade 3/4 toxicity
Other:
* No grade 3/4 neurologic, gastrointestinal, or other organ toxicity except grade 3 hearing deficit
* No active life threatening infections
* No human antimouse antibody (HAMA) greater than 1,000 ELISA units/mL
* No allergy to mouse proteins
* No pain requiring opiates
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Standard chemotherapy to which disease is resistant or myeloablative therapy followed by disease recurrence required
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
21 Years
Study:
NCT00002560
Study Brief:
Protocol Section:
NCT00002560