A Phase I Trial of a Live, Genetically Modified Salmonella Typhimurium (VNP20009) for the Treatment of Cancer by Intravenous Administration
OBJECTIVES:
- Determine the maximum tolerated dose or minimum effective dose and associated toxic
effects of VNP20009 in patients with advanced solid tumors.
- Determine whether VNP20009 can be detected in tumors after treatment in these patients.
- Determine the pharmacokinetics of this treatment regimen in these patients.
- Determine the antitumor effects of this treatment regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive VNP20009 IV over 4 hours on day 1. Treatment continues in the absence of
disease progression or unacceptable toxicity. Patients with stable disease or partial or
complete response (CR) may receive additional courses every 35 days for up to 12 total doses
or 2 courses past a CR.
Cohorts of 3-6 patients receive escalating doses of VNP20009 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity. An additional 6-9 patients are treated at the
MTD.
PROJECTED ACCRUAL: A total of 14-45 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Mario Sznol, MD
Study Chair
Vion Pharmaceuticals
United States: Federal Government
CDR0000068187
NCT00006254
May 2000
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |