En undersøgelse af en vaccine i kombination med beta-glucan hos mennesker med neuroblastom
Fase II-forsøg med en bivalent vaccine med det immunologiske adjuvans OPT-821 (QS-21), i kombination med randomisering af oral β-glucan, mod højrisikoneuroblastom
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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Brian Kushner, MD
- Telefonnummer: 1-833-MSK-KIDS
- E-mail: kushnerb@MSKCC.ORG
Undersøgelse Kontakt Backup
- Navn: Fiorella Iglasias Cardenas, MD, MS
- Telefonnummer: 1-833-MSK-KIDS
- E-mail: iglesiaf@mskcc.org
Studiesteder
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-
New Jersey
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Basking Ridge, New Jersey, Forenede Stater, 07920
- Rekruttering
- Memorial Sloan Kettering at Basking Ridge (Consent only)
-
Kontakt:
- Brian Kushner, MD
- Telefonnummer: 833-675-5491
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Middletown, New Jersey, Forenede Stater, 07748
- Rekruttering
- Memorial Sloan Kettering Monmouth (Consent Only)
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Kontakt:
- Brian Kushner, MD
- Telefonnummer: 833-675-5491
-
Montvale, New Jersey, Forenede Stater, 07645
- Rekruttering
- Memorial Sloan Kettering Bergen (Consent Only)
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Kontakt:
- Brian Kushner, MD
- Telefonnummer: 833-675-5491
-
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New York
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Commack, New York, Forenede Stater, 11725
- Rekruttering
- Memorial Sloan Kettering Suffolk-Commack (Consent only)
-
Kontakt:
- Brian Kushner, MD
- Telefonnummer: 833-675-5491
-
Harrison, New York, Forenede Stater, 10604
- Rekruttering
- Memorial Sloan Kettering Westchester (Consent only)
-
Kontakt:
- Brian Kushner, MD
- Telefonnummer: 833-675-5491
-
New York, New York, Forenede Stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
-
Kontakt:
- Brian Kushner, MD
- Telefonnummer: 833-675-5491
-
Uniondale, New York, Forenede Stater, 11553
- Rekruttering
- Memorial Sloan Kettering Nassau (Consent Only)
-
Kontakt:
- Brian Kushner, MD
- Telefonnummer: 833-675-5491
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 |
|
Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean antibody titer in ng/ml of anti-GD2 IgG1 titer
Tidsramme: up to 32 weeks
|
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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Brian Kushner, MD, Memorial Sloan Kettering Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 23-198
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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