American Association for Cancer Research

Table 1.

Patient characteristics

Patient subject no.	Tumor path	Age	Gender	KPS	Dendritic cell dose (× 10⁶)	Tumor status at dendritic cell vaccine	Pre-vaccine therapy*	Post-vaccine therapy	Adverse events^†
1	GBM^‡	33	M	90	1	ND		Reoperation, Temodar	Constipation/diarrhea
2	GBM^§	33	M	80	1	PD	Temodar + Accutane, Tamoxifen	Reoperation, CPT-11	Headache, nausea/vomiting, low-grade fever
3	GBM^§	23	F	100	1	ND		Tamoxifen, Reoperation, Temodar, Carboplatin	Fatigue, nausea/vomiting
4	GBM^§	20	F	90	5	SD		Reoperation	Low-grade fever, constipation/diarrhea
5	GBM^†	23	F	100	5	SD		Temodar	Fatigue, myalgia, nausea/vomiting, pain/itching at injection site, lymph node swelling, allergic rhinitis
6	GBM^†	42	F	100	5	SD		Temodar + Accutane	Lymph node swelling
7	GBM^§	48	M	80	10	PD	“Intra-cellular hyperthermia”	Reoperation, Temodar, Gleevec	Headache, fatigue
8^∥	GBM^§	55	F	60	10	SD	SRS, Thalidomide, Accutane, Tamoxifen	Temodar	Fatigue
9^∥	GBM^†	43	F	90	10	ND		Temodar	Erythema at injection site
10	GBM^†	65	M	90	10	PD		Temodar	Fatigue
11	GBM^†	57	M	90	10	PD		Temodar + VP16
12	GBM^§	43	F	70	10	PD	Temodar, Tamoxifen	CCNU	Seizure, hyponatremia

Patient subject no.	Tumor path	Age	Gender	KPS	Dendritic cell dose (× 10⁶)	Tumor status at dendritic cell vaccine	Pre-vaccine therapy*	Post-vaccine therapy	Adverse events^†
1	GBM^‡	33	M	90	1	ND		Reoperation, Temodar	Constipation/diarrhea
2	GBM^§	33	M	80	1	PD	Temodar + Accutane, Tamoxifen	Reoperation, CPT-11	Headache, nausea/vomiting, low-grade fever
3	GBM^§	23	F	100	1	ND		Tamoxifen, Reoperation, Temodar, Carboplatin	Fatigue, nausea/vomiting
4	GBM^§	20	F	90	5	SD		Reoperation	Low-grade fever, constipation/diarrhea
5	GBM^†	23	F	100	5	SD		Temodar	Fatigue, myalgia, nausea/vomiting, pain/itching at injection site, lymph node swelling, allergic rhinitis
6	GBM^†	42	F	100	5	SD		Temodar + Accutane	Lymph node swelling
7	GBM^§	48	M	80	10	PD	“Intra-cellular hyperthermia”	Reoperation, Temodar, Gleevec	Headache, fatigue
8^∥	GBM^§	55	F	60	10	SD	SRS, Thalidomide, Accutane, Tamoxifen	Temodar	Fatigue
9^∥	GBM^†	43	F	90	10	ND		Temodar	Erythema at injection site
10	GBM^†	65	M	90	10	PD		Temodar	Fatigue
11	GBM^†	57	M	90	10	PD		Temodar + VP16
12	GBM^§	43	F	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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