Phase I study of the intravenous administration of attenuated Salmonella typhimurium to patients with metastatic melanoma.

ABSTRACT:

Purpose

A strain of Salmonella typhimurium (VNP20009), attenuated by chromosomal deletion of the purI and msbB genes, was found to target to tumor and inhibit tumor growth in mice. These findings led to the present phase I study of the intravenous infusion of VNP20009 to patients with metastatic cancer.

Patients and methods

In cohorts consisting of three to six patients, 24 patients with metastatic melanoma and one patient with metastatic renal cell carcinoma received 30-minute intravenous bolus infusions containing 10(6) to 10(9) cfu/m(2) of VNP20009. Patients were evaluated for dose-related toxicities, selective replication within tumors, and antitumor effects.

Results

The maximum-tolerated dose was 3 x 10(8) cfu/m(2). Dose-limiting toxicity was observed in patients

SUBMITTER: Toso JF 

PROVIDER: S-EPMC2064865 | biostudies-literature | 2002 Jan

REPOSITORIES: biostudies-literature