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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT00492167
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of neuroblastoma by 1 of the following methods:
* Histopathology
* Bone marrow involvement AND elevated urinary catecholamines
* High-risk disease, defined by 1 of the following:
* Stage 4 disease with MYCN amplification (any age) or without MYCN amplification (\> 18 months of age)
* MYCN-amplified stage 3 disease (unresectable and any age)
* MYCN-amplified stage 4S disease
* Metastatic disease
* Tumor progression or persistent disease (at metastatic or primary site) after intensive conventional chemotherapy
* Must have evaluable (microscopic marrow metastasis, elevated tumor markers, positive MIBG or PET scans) or measurable (CT scan or MRI) disease documented after completion of prior systemic therapy
PATIENT CHARACTERISTICS:
* Platelet count \> 25,000/mm\^3
* ANC \> 500/mm\^3
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of allergy to mouse proteins, beta-glucan, mushrooms, or yeast
* No active life-threatening infections
* No severe major organ toxicity
* Concurrent toxicity must be ≤ grade 2 except for the following, which may be grade 3:
* Myelosuppression
* Hearing loss
* Alopecia
* Anorexia
* Nausea
* Hyperbilirubinemia from TPN
* Anxiety
* Hypomagnesemia
* No prior HAMA titer \> 1,000 U/mL by ELISA
PRIOR CONCURRENT THERAPY:
* No concurrent supplemental beta-glucan in food (e.g., bran cereals or mushrooms) or as complementary medicine
* No other concurrent systemic anticancer medications (e.g., hormonal agents, chemotherapy, investigational agents, or immunotherapy)
* Concurrent isotretinoin allowed after the second course of study treatment is completed or if the patient develops human antimouse antibody (HAMA)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
120 Years
Study:
NCT00492167
Study Brief:
Protocol Section:
NCT00492167