VNP20009 in Treating Patients With Advanced Solid Tumors
Summary
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.
Description
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.
Study Design
Primary Purpose: Treatment
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Intervention
salmonella VNP20009
Location
Beth Israel Deaconess Medical Center
Boston
Massachusetts
United States
02215
Status
Completed
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00006254
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Salmonella Phages
Viruses whose host is Salmonella. A frequently encountered Salmonella phage is BACTERIOPHAGE P22.
Salmonella Typhimurium
A serotype of Salmonella enterica that is a frequent agent of Salmonella gastroenteritis in humans. It also causes PARATYPHOID FEVER.
Nephroma, Mesoblastic
A solid, unencapsulated tumor of the KIDNEY composed of spindle mesenchymal cells that resemble FIBROBLASTS or muscle cells. The homogeneous mass typically extends into the renal parenchyma and replaces most of the kidney. In most cases, mesoblastic nephroma is benign and occurs in the fetus or newborn, and rarely in the older child or the adult.
Salmonella Paratyphi A
A serotype of SALMONELLA ENTERICA that causes mild PARATYPHOID FEVER in humans.
Salmonella Typhi
A serotype of SALMONELLA ENTERICA which is the etiologic agent of TYPHOID FEVER.
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