Phase I clinical trial of the vaccination for the patients with metastatic melanoma using gp100-derived epitope peptide restricted to HLA-A*2402

Table 2 Clinical observations on enrolled patients

Patients	Times of vaccination (course)	Follow-up	Adverse events	Clinical anti-tumor responses		Vitiligo
				After 1 course	Final
P1	12 (3)	13 months	Induration, Rubor, Itching, CNS hemorrhage*	PD	PD	None
P2	8 (2)	8 months	Induration, Rubor, vitiligo, Anemia*	PD	PD	+
P3	8 (2)	7 months	Induration, Rubor, Local pain, vitiligo	PD	PD	+
P4	4 (1)	2 months	Induration, Hypoxia*	PD	PD	None
P5	2 (1)	1 month	Rubor, Pyrexia	incomplete	( - )	None
P6	4 (1)	4 months	Rubor	PD	PD	None

The results of this clinical trial for six patients individually are summarized in this table. P1 showed evidence of an anti-tumor effect. Vitiligo appeared in two patients (P2 and P3) throughout the body. Both anti-tumor effect and vitiligo were defined as the clinical and immunological responses.

ISSN: 1479-5876