Status:
ACTIVE_NOT_RECRUITING
Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Y-mAbs Therapeutics
Conditions:
Neuroblastoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
PHASE2
Brief Summary
In the first part of this study we found the highest dose of the vaccine that did not have too many side effects. We are now trying to find out what effects the vaccine has when given at the same dose...
Detailed Description
The phase II treatment schema for patients in 1st CR or ≥ 2nd CR will be the same for the vaccine as in phase I except OPT-821 will be given at a fixed dose of 150 mcg/ m\^2 and with no DLT assessment...
Eligibility Criteria
Inclusion
- 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
- History of allergy to KLH, QS-21, OPT-821, or glucan.
- Active life-threatening infection.
- Inability to comply with protocol requirements.
Key Trial Info
Start Date :
May 27 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT00911560
Start Date
May 27 2009
End Date
May 1 2026
Last Update
June 5 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065