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VNP20009 in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006254
Recruitment Status : Completed
First Posted : September 3, 2003
Last Update Posted : July 18, 2013
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Biological: salmonella VNP20009 Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
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
Actual Study Completion Date : January 2008

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed advanced and/or metastatic solid tumors refractory to standard curative or palliative therapy and for which no other conventional therapy exists
  • Measurable or evaluable metastatic disease
  • No brain metastases unless previously treated and no evidence of recurrence
  • No lymphoma or other hematologic malignancy



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 3 months


  • Granulocyte count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hematocrit at least 30% (transfusion allowed)
  • No known bleeding disorder


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present)
  • Alkaline phosphatase no greater than 1.5 times ULN (3 times ULN if liver metastases present)
  • PT and PTT no greater than 1.5 times ULN
  • Hepatitis B surface antigen negative
  • No chronic active hepatitis B
  • No end-stage liver disease


  • Creatinine no greater than 2.0 mg/dL
  • No urinary tract stones
  • No end-stage renal disease


  • No known valvular disease
  • No known clinically significant atherosclerotic disease, peripheral vascular disease, or arterial aneurysm
  • No unstable angina
  • No artificial heart valves


  • No severe oxygen-dependent chronic obstructive pulmonary disease


  • No artificial implant that cannot be removed (e.g., prosthetic hips or knees or other devices)
  • No permanent central venous catheters
  • No gallstones
  • No active infection
  • No documented Salmonella infection
  • No tumor fever or fever of unknown origin or cause
  • Daily maximum temperature no greater than 38.0 degrees Celsius
  • HIV negative
  • No documented immunodeficiency
  • No other life-threatening illness
  • No history of allergic reaction or hypersensitivity to quinolone or cephalosporin antibiotics
  • No commercial food handlers, day-care workers, or health-care workers
  • No patients unable to avoid close personal contact with severely immunosuppressed individuals (e.g., other patients on myelosuppressive cancer chemotherapy)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • At least 4 weeks since prior biologic therapy and recovered


  • At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered

Endocrine therapy:

  • At least 2 weeks since prior hormonal therapy and recovered
  • No concurrent steroids that could depress the immune system unless indicated for severe reactions


  • At least 4 weeks since prior radiotherapy and recovered


  • At least 2 weeks since prior surgery and recovered
  • No prior splenectomy
  • No concurrent palliative surgery


  • Recovered from any other prior anticancer therapies
  • No concurrent antibiotics
  • No concurrent immunosuppressives or any other medications that could suppress the immune system
  • No other concurrent treatment for malignancy
  • No requirement for immediate palliative treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006254

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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
Sponsors and Collaborators
Vion Pharmaceuticals
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Study Chair: Mario Sznol, MD Vion Pharmaceuticals
Layout table for additonal information Identifier: NCT00006254    
Other Study ID Numbers: VION-CLI-008
CDR0000068187 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 3, 2003    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: December 2007
Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific