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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT00911560
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of neuroblastoma (NB) as defined by international criteria,\[104\] i.e., histopathology (confirmed by the MSKCC Department of Pathology) or bone marrow metastases plus high urine catecholamine levels.
* High-risk NB as defined by risk-related treatment guidelines and the International NB Staging System,\[104\] i.e., stage 4 with MYCN amplification (any age) stage 4 \>18 months old.
* High-risk NB (as defined above) and in 1) first CR at 6 ≥ months from initiation of immunotherapy using anti-GD2 antibody, or 2) second or subsequent remission. Remission is defined as complete (CR) remission, according to the International Neuroblastoma Response Criteria.\[104\] Urine catecholamine levels are no longer taken into consideration when staging.
* Absolute lymphocyte count ≥ 500/mcl and absolute neutrophil count ≥ 500/mcl.
* Patients with grade 3 toxicities or less using the Common Toxicity Criteria (Version 3.0) developed by the National Cancer Institute of the USA (CTCAE v3.0) related to cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam.
* ALT, AST and Alkaline Phosphatase ≤ 2.5 times the upper limit of normal
* Prior treatment with other immunotherapy, including antibodies, is allowed
* ≥ 3 weeks and no more than 6 months (\<180 days) between completion of systemic therapy and 1st vaccination.
* Patients previously enrolled on this trial are eligible for repeat enrollment but will be assigned to treatment as per the control arm (Group 1) and will not be included in the biostatistical analyses.
* Signed informed consent indicating awareness of the investigational nature of this program.
Exclusion Criteria:
* History of allergy to KLH, QS-21, OPT-821, or glucan.
* Active life-threatening infection.
* Inability to comply with protocol requirements.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00911560
Study Brief:
Protocol Section:
NCT00911560