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Table 1.

Patient characteristics

Patient subject no.Tumor pathAgeGenderKPSDendritic cell dose (× 106)Tumor status at dendritic cell vaccinePre-vaccine therapy*Post-vaccine therapyAdverse events
GBM 33 90 ND  Reoperation, Temodar Constipation/diarrhea 
GBM§ 33 80 PD Temodar + Accutane, Tamoxifen Reoperation, CPT-11 Headache, nausea/vomiting, low-grade fever 
GBM§ 23 100 ND  Tamoxifen, Reoperation, Temodar, Carboplatin Fatigue, nausea/vomiting 
GBM§ 20 90 SD  Reoperation Low-grade fever, constipation/diarrhea 
GBM 23 100 SD  Temodar Fatigue, myalgia, nausea/vomiting, pain/itching at injection site, lymph node swelling, allergic rhinitis 
GBM 42 100 SD  Temodar + Accutane Lymph node swelling 
GBM§ 48 80 10 PD “Intra-cellular hyperthermia” Reoperation, Temodar, Gleevec Headache, fatigue 
8 GBM§ 55 60 10 SD SRS, Thalidomide, Accutane, Tamoxifen Temodar Fatigue 
9 GBM 43 90 10 ND  Temodar Erythema at injection site 
10 GBM 65 90 10 PD  Temodar Fatigue 
11 GBM 57 90 10 PD  Temodar + VP16  
12 GBM§ 43 70 10 PD Temodar, Tamoxifen CCNU Seizure, hyponatremia 
Patient subject no.Tumor pathAgeGenderKPSDendritic cell dose (× 106)Tumor status at dendritic cell vaccinePre-vaccine therapy*Post-vaccine therapyAdverse events
GBM 33 90 ND  Reoperation, Temodar Constipation/diarrhea 
GBM§ 33 80 PD Temodar + Accutane, Tamoxifen Reoperation, CPT-11 Headache, nausea/vomiting, low-grade fever 
GBM§ 23 100 ND  Tamoxifen, Reoperation, Temodar, Carboplatin Fatigue, nausea/vomiting 
GBM§ 20 90 SD  Reoperation Low-grade fever, constipation/diarrhea 
GBM 23 100 SD  Temodar Fatigue, myalgia, nausea/vomiting, pain/itching at injection site, lymph node swelling, allergic rhinitis 
GBM 42 100 SD  Temodar + Accutane Lymph node swelling 
GBM§ 48 80 10 PD “Intra-cellular hyperthermia” Reoperation, Temodar, Gleevec Headache, fatigue 
8 GBM§ 55 60 10 SD SRS, Thalidomide, Accutane, Tamoxifen Temodar Fatigue 
9 GBM 43 90 10 ND  Temodar Erythema at injection site 
10 GBM 65 90 10 PD  Temodar Fatigue 
11 GBM 57 90 10 PD  Temodar + VP16  
12 GBM§ 43 70 10 PD Temodar, Tamoxifen CCNU Seizure, 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.

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