Table 1.

Patients treated with bivalent vaccine and β-glucan

Serologic responseb to:
Patient No.Dose levelaMYCN amplified?Time to first relapseSites of relapseTreatment of relapseTime from relapse to vaccineMRD in BM pre/postGD2GD3Outcome (time from first vaccine)
Patients in second CR
11No11 moTibiaCPT-TMZ(×12), RT, Thalidomide-Celecoxib26 mo+/−+ (7)RFS (48 mo)
21No15 moBrain, abdomenGTR, CPT, RT, CPT-TMZ(×2), IT-3F8, CIT, oral TMZ(×5), CRA, Ritux-Cyclo34 mo+/n.d.+ (3)+ (7)RFS (47 mo)
32No17 moAbdomenGTR, CPT-TMZ(×5), RT, Lenalidomide-Celecoxib7 mo+/++ (4)+ (3)RFS (46 mo)
42No23 moAbdomenGTR, CTV(×2), CIT, RT, 3F8, CRA25 mo−/−+ (4)RFS (45 mo)
52No23 moMandible, skullICE, RT, CPT-TMZ(×10), CRA23 mo+/−+ (4)+ (7)RFS (44 mo)
64Yes59 moPelvic nodesGTR, CTV(×3), RT, CPT-TMZ,15 mo−/−+ (6)RFS (39 mo)
3F8, CRA
74No22 moThorax, bonesCTV(x2), GTR, CIT, CPT-TMZ(×9), RT, Ritux-Cyclo, 3F8, CRA40 mo−/−RFS (39 mo)
84Yes30 moFemur, BMCTV(×2), RT, CPT-TMZ(×5), CRA, ABT-751 (×3 yr)63 mo+/++ (4)+ (6)RFS (35 mo)
94No8 moParaspinal soft tissue, ribCAV(×3), P/E(×2), GTR, CTV, RT, 3F8, CRA19 mo+/−RFS (33 mo)
104No12 moSkullCPT-TMZ(×7), RT, Ritux-Cyclo6 mo+/+RFS (33 mo)
114Yes26 moSphenoid, BMCTV(×2), ICE, RT, Bevacizumab-CPT-TMZ(×5)9 mo+/−+ (4)+ (3)Relapse (ischium; 2 mo). DoD (26 mo)
Patients in ≥3rd CR
121Yes15 moThoraxGTR, RT, CPT/TMZ(×5), 3F8, CRA, Thalidomide-Celecoxib15 mo−/−+ (3)+ (7)RFS (48 mo)
133No47 moThoraxCyclo-Topo(×8), Lenalidomide-Celecoxib15 mo+/−+ (2)Relapse (BM, paravertebral; 5 mo); alive in CR (42 mo)
143Yes21 moTibiaCCV(×2), RT, Cyclo-Topo(×2), Ritux, Lenalidomide-Celecoxib10 mo+/++ (4)+ (4)RFS (40 mo)
153No17 moR supra-clavicular131I-MIBG, RT3 mo+/−+ (7)Relapse (neck; 21 mo); alive in CR
(42 mo)

Abbreviations: BM, bone marrow; CAV, high-dose Cyclo-doxorubicin-vincristine; CCV, high-dose Cyclo-CPT-vincristine (7); CIT, high-dose carboplatin-CPT-TMZ (6); CPT, irinotecan; CRA, 13-cis-retinoic acid; CTV, high-dose Cyclo-Topo-vincristine (5); Cyclo, cyclophosphamide; DoD, died of disease; GTR, gross total resection; ICE, high-dose ifosfamide-carboplatin-etoposide (8); IT-3F8, intrathecal 131I-3F8 (4); MRD, minimal residual disease; n.d., not done; P/E, cisplatin-etoposide; RFS, relapse-free survival; Ritux, rituximab; RT, local radiotherapy; TMZ, temozolomide; Topo, topotecan.

  • aOPT-821 dose level 1 = 50 μg/m2, dose level 2 = 75 μg/m2, dose level 3 = 100 μg/m2, and dose level 4 = 150 μg/m2.

  • bNumber of prior vaccine injections on this protocol is in parentheses.