VNP20009 in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006254
First received: September 11, 2000
Last updated: July 17, 2013
Last verified: December 2007
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Biological: salmonella VNP20009
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2000
Study Completion Date: January 2008
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 3 months

Hematopoietic:

  • 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

Hepatic:

  • 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

Renal:

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

Cardiovascular:

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

Pulmonary:

  • No severe oxygen-dependent chronic obstructive pulmonary disease

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior biologic therapy and recovered

Chemotherapy:

  • 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

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered

Surgery:

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

Other:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006254

Locations
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
Investigators
Study Chair: Mario Sznol, MD Vion Pharmaceuticals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006254     History of Changes
Other Study ID Numbers: VION-CLI-008, CDR0000068187, CCF-IRB-3663, NCI-V00-1622
Study First Received: September 11, 2000
Last Updated: July 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on September 30, 2014