En studie av en vaksine i kombinasjon med beta-glukan hos personer med nevroblastom
Fase II-studie av en bivalent vaksine med immunologisk adjuvans OPT-821 (QS-21), i kombinasjon med randomisering av oral β-glukan, for høyrisikoneuroblastom
The purpose of this study is to test which treatment schedule of β-glucan with bivalent vaccine is more effective for participants with high-risk neuroblastoma that is in complete remission.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Brian Kushner, MD
- Telefonnummer: 1-833-MSK-KIDS
- E-post: kushnerb@MSKCC.ORG
Studer Kontakt Backup
- Navn: Fiorella Iglasias Cardenas, MD, MS
- Telefonnummer: 1-833-MSK-KIDS
- E-post: iglesiaf@mskcc.org
Studiesteder
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New Jersey
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Basking Ridge, New Jersey, Forente stater, 07920
- Rekruttering
- Memorial Sloan Kettering at Basking Ridge (Consent only)
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Ta kontakt med:
- Brian Kushner, MD
- Telefonnummer: 833-675-5491
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Middletown, New Jersey, Forente stater, 07748
- Rekruttering
- Memorial Sloan Kettering Monmouth (Consent Only)
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Ta kontakt med:
- Brian Kushner, MD
- Telefonnummer: 833-675-5491
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Montvale, New Jersey, Forente stater, 07645
- Rekruttering
- Memorial Sloan Kettering Bergen (Consent Only)
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Ta kontakt med:
- Brian Kushner, MD
- Telefonnummer: 833-675-5491
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New York
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Commack, New York, Forente stater, 11725
- Rekruttering
- Memorial Sloan Kettering Suffolk-Commack (Consent only)
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Ta kontakt med:
- Brian Kushner, MD
- Telefonnummer: 833-675-5491
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Harrison, New York, Forente stater, 10604
- Rekruttering
- Memorial Sloan Kettering Westchester (Consent only)
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Ta kontakt med:
- Brian Kushner, MD
- Telefonnummer: 833-675-5491
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New York, New York, Forente stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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Ta kontakt med:
- Brian Kushner, MD
- Telefonnummer: 833-675-5491
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Uniondale, New York, Forente stater, 11553
- Rekruttering
- Memorial Sloan Kettering Nassau (Consent Only)
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Ta kontakt med:
- Brian Kushner, MD
- Telefonnummer: 833-675-5491
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
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Diagnosis of NB as defined by international criteria,102 i.e., histopathology (confirmed by the MSK Department of Pathology) or BM metastases plus high urine catecholamine levels, or positivity in MIBG scan.
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HR-NB as defined by risk-related treatment guidelines and international criteria,102 i.e., metastatic/non-localized disease with MYCN amplification (any age), metastatic disease >18 months old, MYCN-amplified localized disease (any age), or disease resistant to standard chemotherapy. For those patients with a positive site of disease that is poorly visualized on a scan, it can be per PI discretion to repeat the scan or proceed with enrollment without a recent scan.
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HR-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 CR (achieved after treatment for PD). CR is defined according to the International Neuroblastoma Response Criteria. Patients with positive MIBG scan but negative FDG-PET scan, and CR in BM, are eligible. For those patients with a positive MIBG scan, the negative FDG-PET scan can be per PI discretion to repeat within the 45 day window period prior to enrollment.
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Patients with grade 3 toxicities or less using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA (CTCAE v5.0) related to hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam. Plus:
- Absolute neutrophil count (ANC) ≥ 500/mcl
- Absolute lymphocyte count ≥ 500/mcl
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>21 and <180 days between completion of systemic therapy and 1st vaccination.
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A negative pregnancy test is required for patients with child-bearing capability
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Signed informed consent indicating awareness of the investigational nature of this program.
Exclusion Criteria:
- Patients with grade 4 hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam, using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA.
- History of allergy to KLH, QS-21, OPT-821, or glucan
- Prior treatment with this vaccine.
- Active life-threatening infection requiring systemic therapy.
- Inability to comply with protocol requirements.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Group 1
Participants will receive oral β-glucan (40 mg/kg/day) for 14 days on, and 14 days off, beginning with vaccination #1 and continuing until vaccination #5 (~20 weeks), then only one 14-day cycle with each of vaccinations #6-#10. |
Comprised of the immunological adjuvant OPT-821 (QS-21) Participants will be randomized to receive this agent in two different schedules |
|
Eksperimentell: Group 2
Participants will receive oral β-glucan (40 mg/kg/day) for 14 days on, and 14 days off, beginning with vaccination #1 and continuing until vaccination #7 (~52 weeks), then only one 14-day cycle with each of vaccinations #8-#10. |
Comprised of the immunological adjuvant OPT-821 (QS-21) Participants will be randomized to receive this agent in two different schedules |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mean antibody titer in ng/ml of anti-GD2 IgG1 titer
Tidsramme: up to 32 weeks
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To determine the effect of oral β-glucan schedule on anti-GD2 antibody titers among patients who are in first or second (or later) CR, i.e., have no evidence of neuroblastoma by standard studies. |
up to 32 weeks
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Brian Kushner, MD, Memorial Sloan Kettering Cancer Center
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer etter histologisk type
- Neoplasmer, kjertel og epitel
- Neoplasmer, Neuroepithelial
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Neuroektodermale svulster, primitive, perifere
- Neuroektodermale svulster, primitive
- Nevroblastom
- saponin QA-21V1
Andre studie-ID-numre
- 23-198
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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