VNP20009 in Treating Patients With Advanced Solid Tumors
RATIONALE: Biological therapies such as VNP20009 use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase I trial to study the effectiveness of VNP20009 in treating patients who have advanced solid tumors.
|Unspecified Adult Solid Tumor, Protocol Specific||Biological: salmonella VNP20009||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Trial of a Live, Genetically Modified Salmonella Typhimurium (VNP20009) for the Treatment of Cancer by Intravenous Administration|
|Study Start Date:||May 2000|
|Study Completion Date:||January 2008|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006254
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Mario Sznol, MD||Vion Pharmaceuticals|