Table 1.

Patient characteristics

Patient subject no.Tumor pathAgeGenderKPSDendritic cell dose (× 106)Tumor status at dendritic cell vaccinePre-vaccine therapy*Post-vaccine therapyAdverse events
1GBM33M901NDReoperation, TemodarConstipation/diarrhea
2GBM§33M801PDTemodar + Accutane, TamoxifenReoperation, CPT-11Headache, nausea/vomiting, low-grade fever
3GBM§23F1001NDTamoxifen, Reoperation, Temodar, CarboplatinFatigue, nausea/vomiting
4GBM§20F905SDReoperationLow-grade fever, constipation/diarrhea
5GBM23F1005SDTemodarFatigue, myalgia, nausea/vomiting, pain/itching at injection site, lymph node swelling, allergic rhinitis
6GBM42F1005SDTemodar + AccutaneLymph node swelling
7GBM§48M8010PD“Intra-cellular hyperthermia”Reoperation, Temodar, GleevecHeadache, fatigue
8GBM§55F6010SDSRS, Thalidomide, Accutane, TamoxifenTemodarFatigue
9GBM43F9010NDTemodarErythema at injection site
11GBM57M9010PDTemodar + VP16
12GBM§43F7010PDTemodar, TamoxifenCCNUSeizure, hyponatremia
  • Abbreviations: SD, stable disease; PD, progressive disease; ND, no measurable disease; KPS, Karnofsky performance score.

  • * Pre-vaccination therapy refers to additional treatments besides surgery and standard external beam radiation therapy (up to 60 Gy); Temodar, temozolamide; Accutane, isotretinoin; “Intracellular hyperthermia” was an experimental protocol in Switzerland; CPT-11, irinotecan; Gleevec, imatinib mesylate; VP-16, etoposide; CCNU = lomustine; and SRS = stereotactic radiosurgery.

  • All adverse experiences related to protocol were of mild severity (National Cancer Institute grades 1 and 2). Adverse events that were of higher severity were determined to be not related to protocol and likely due to tumor progression.

  • Newly diagnosed glioblastoma multiforme.

  • § Recurrent glioblastoma multiforme.

  • Patients 8 and 9 received only one injection of 107 dendritic cells because insufficient numbers of HLA-DR+/CD-14 dendritic cells were generated to complete all three injections.