Trials with TALL-1O4 Cells for Treatment of Metastatic Breast Cancer
Final rept. 1 Oct 1997-30 Sep 1999 on phase 1
WISTAR INST OF ANATOMY AND BIOLOGY PHILADELPHIA PA
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The human cytotoxic T cell line TALL-104 has displayed anti-tumor effects in several animal species. A Phase I trial was conducted to determine toxicity of TALL-104 cells in women with refractory breast cancer. Fifteen patients with metastatic infiltrating ductal Nl2, lobular N2 or medullary N1 carcinoma received escalating doses of lethally irradiated TALL-l04 cells 106, 3 x 106, l07, 3 x l07 and l08 cellskg for 5 consecutive days. Patients without progressive disease received monthly maintenance 2-day infusions at the same dose level. Mild grade 111 toxicity developed in 11 patients regardless of cell dose. One grade IV toxicity consequent to hepatic tumor necrosis occurred in a patient given 108 cellskg, 3 weeks after the induction course. Nine patients progressed within one month from induction and 5 patients had stable disease for 2-6 months. One patient at 3 X 107kg had improvement of liver metastases and ascites, and a second patient at 106kg experienced a dramatic relief in bone pain. Increases in blood NK cell activity and levels of IFN-y, interleukin IL-10 and activation markers sIL-2R and sICAM-l were often seen. Only 1 patient developed anti-HLA class I antibody responses against TALL-104 cells specific CTL activity developed in 3 patients during induction and in 4 patients during the maintenance boosts. In conclusion, TALL-104 cells were well tolerated by patients with metastatic breast cancer at the doses and regimen tested.
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