The human cytotoxic T-cell line TALL-104 has been used successfully to trea
t cancer in experimental mouse models with implanted tumors and in dogs wit
h spontaneously occurring malignancies. This study investigated the efficac
y of TALL-104 cells given in an adjuvant setting to dogs with appendicular
osteosarcoma after surgery and chemotherapy. Of the 23 dogs enrolled in the
study, 20 had undergone amputation of the affected limb, and 3 had undergo
ne limb salvage surgery. After surgery, all dogs but one received cisplatin
(CDDP) chemotherapy (60 mg/m(2) i.v. every 21 days x 1-4 cycles). Four dog
s also received one to six cycles of CDDP before limb amputation. After CDD
P therapy, dogs without overt metastasis received gamma-irradiated (40 Gy)
TALL-104 cells systemically (10(8)/kg) for 5 consecutive days, followed by
2-day monthly boosts (at the same dose) for a total of 9 months, Of the 23
dogs treated, 9 survive disease-free at 12.1-29.5 months after surgery, 11
died of metastatic disease between 5 and 21.5 months, 1 experienced a relap
se in the lung 9.5 months after surgery but is still alive without further
treatment at 13 months, 1 developed severe discopathy at 4 months after sur
gery, and 1 developed progressive neuropathy at 5.9 months after surgery. T
he overall median survival time is 11.5 months, and the median disease-free
interval is 9.8 months. Our cell therapy results compare favorably with hi
storical median survival times (up to 9 months) and disease-free intervals
(up to 7.5 months) of dogs with osteosarcoma receiving standard therapy (su
rgery and chemotherapy) and support the effectiveness of adjuvant TALL-104
cell administration in preventing or delaying disease recurrence in these d
ogs.