Accession Number : ADA382838


Title :   Trials with TALL-1O4 Cells for Treatment of Metastatic Breast Cancer


Descriptive Note : Final rept. 1 Oct 1997-30 Sep 1999 on phase 1


Corporate Author : WISTAR INST OF ANATOMY AND BIOLOGY PHILADELPHIA PA


Personal Author(s) : Santoli, Daniela


Full Text : https://apps.dtic.mil/dtic/tr/fulltext/u2/a382838.pdf


Report Date : Oct 1999


Pagination or Media Count : 61


Abstract : 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 (N=l2), lobular (N=2) or medullary (N=1) carcinoma received escalating doses of lethally irradiated TALL-l04 cells (10(6), 3 x 10(6), l0(7), 3 x l0(7) and l0(8) cells/kg) for 5 consecutive days. Patients without progressive disease received monthly maintenance 2-day infusions at the same dose level. Mild grade 1/11 toxicity developed in 11 patients regardless of cell dose. One grade IV toxicity consequent to hepatic tumor necrosis occurred in a patient given 10(8) cells/kg, 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 107/kg) had improvement of liver metastases and ascites, and a second patient (at 106/kg) 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.


Descriptors :   *CELLS(BIOLOGY) , *METASTASIS , *BREAST CANCER , STABILITY , ACTIVATION , TOXICITY , DISEASES , NEOPLASMS , DISPLAY SYSTEMS , DOSAGE , ANIMALS , MARKERS , PAIN , PATIENTS , LIVER , WOMEN , BLOOD , NECROSIS , BONES , ASCITES


Subject Categories : Medicine and Medical Research


Distribution Statement : APPROVED FOR PUBLIC RELEASE