First-in-man application of a novel therapeutic cancer vaccine formulation with the capacity to induce multi-functional T cell responses in ovarian, breast and prostate cancer patients

Berinstein, Neil L; Karkada, Mohan; Morse, Michael A; Nemunaitis, John J; Chatta, Gurkamal; Kaufman, Howard; Odunsi, Kunle; Nigam, Rita; Sammatur, Leeladhar; MacDonald, Lisa D; Weir, Genevieve M; Stanford, Marianne M; Mansour, Marc

doi:10.1186/1479-5876-10-156

Table 1 Age, disease status, stage, response to last therapy and clinical outcome for subjects receiving a complete set of three injections

From: First-in-man application of a novel therapeutic cancer vaccine formulation with the capacity to induce multi-functional T cell responses in ovarian, breast and prostate cancer patients

Subject ID	Age (years)	Treatment history	Stage	Response to Prior Treatment	Dose (mL)	Immune Response	Time to Progression* (months)
Breast Cancer
01-13	44	cytotoxic therapy, hormonal therapy, immunotherapy (Avastin), radiation	IV	SD	0.25	Yes	2 ^a
04-06	61	concurrent hormonal therapy	IV	SD	0.25	Yes	> 8
04-19	46	cytotoxic therapy, concurrent hormonal therapy, radiation	IV	SD	1.0	Yes	2.5 ^a
Ovarian Cancer
05-14	50	platinin-based cytotoxic therapy	III	CR	0.25	Yes	4 ^a
05-15	48	platinin-based cytotoxic therapy	III	CR	0.25	Yes	5 ^a
02-01	49	platinin-based cytotoxic therapy	III	CR	0.25	No	> 9
05-07	54	platinin-based cytotoxic therapy	III	CR	1.0	Yes	> 8
02-09	67	platinin-based cytotoxic therapy, immunotherapy (Avastin)	IV	CR	1.0	Yes	> 8.5
01-22	49	platinin-based cytotoxic therapy	III	CR	1.0	Yes	> 8
Prostate Cancer
03-17	60	hormonal therapy, anti-androgen therapy	Unknown	PD	0.25	Yes	2 ^a
01-04	67	hormonal therapy, cytotoxic therapy, anti-androgen therapy, immunotherapy (Provenge), radiation	IV	PD	0.25	No	2 ^a
02-05	63	ongoing hormonal therapy, cytotoxic therapy, concurrent anti-androgen therapy	IV	PD	0.25	Unknown	UE ^b
03-16	65	hormonal therapy, cytotoxic therapy, anti-androgen therapy, radiation	IV	PD	0.25	No	2.3 ^a
02-02	66	hormonal therapy, cytotoxic therapy, anti-androgen therapy, radiation	IV	PD	0.25	Unknown	5.7 ^a
01-03	76	hormonal therapy, anti-androgen therapy, radiation	IV	SD	0.25	No	UE ^b
02-12	54	hormonal therapy, concurrent anti-androgen therapy, radiation	IV	SD	1.0	Unknown	2.3 ^a
01-18	68	hormonal therapy, anti-androgen therapy, radiation	IV	PD	1.0	Yes	2.3 ^a
02-20	64	hormonal therapy, anti-androgen therapy, radiation	IV	Unknown	1.0	Unknown	2.3 ^a
03-21	74	hormonal therapy, anti-androgen therapy, radiation	IV	PD	1.0	No	2.3 ^a
04-10	63	hormonal therapy, concurrent anti-androgen therapy, radiation	IV	PD	1.0	Yes	3.5 ^c
03-08	60	hormonal therapy, anti-androgen therapy, radiation	IV	PD	1.0	No	6.5 ^a
02-11	68	hormonal therapy, anti-androgen therapy, radiation	IV	PD	1.0	No	7.3 ^a

CR complete response, SD stable disease, PD progressive disease, UE unevaluable.
*since study day 0.
^aDisease progression necessitating some other type of treatment.
^bWithdrawal of consent.
^cDeath due to disease progression.

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ISSN: 1479-5876

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