Table 1.

Patient characteristics at baseline

CharacteristicJS1/34.5-/47-/GM-CSF dose groupAll patients (n = 17)
Cohort 1 (n = 4)Cohort 2 (n = 4)Cohort 3 (n = 4)Cohort 4 (n = 5)
No.No.No.No.No. (%)
Age, years
    Median59.054.561.047.058.0
    Range55-6450-7450-6441-5941-74
Sex
    Male433515 (88)
    Female01102 (12)
Race
    White444517 (100)
    Black00000 (0)
    Other00000 (0)
ECOG performance status
    0312511 (65)
    113206 (35)
Primary tumor site (subsite)
    Oropharynx (palatine tonsil)12339 (53)
    Oropharynx (base of tongue)10124 (24)
    Supraglottis11002 (12)
    Hypopharynx (pyriform fossa)11002 (12)
T stage
    T000000 (0)
    T100000 (0)
    T2232411 (65)
    T311114 (23)
    T410102 (12)
N stage
    N000000 (0)
    N100011 (6)
    N2a00101 (6)
    N2b02125 (29)
    N2c32117 (41)
    N310113 (18)
Tumor stage
    III00011 (6)
    IVA343313 (78)
    IVB10113 (18)
    IVC00000 (0)

NOTE: Cohort 1, 106 pfu/mL on four occasions, to a maximum of 4 mL per dose. Cohort 2, 106 pfu/mL on one occasion followed by 107 on three occasions, to a maximum of 4 mL per dose. Cohort 3, 106 pfu/mL on one occasion followed by 108 on three occasions, to a maximum of 4 mL per dose. Cohort 4, 106 pfu/mL on one occasion followed by 108 on three occasions, to a maximum of 8 mL per dose.