VNP20009 in Treating Patients With Advanced Solid Tumors

Sponsor

Vion Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00006254

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

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

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

Study Type:

Interventional

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 1, 2000

Actual Study Completion Date :

Jan 1, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
2	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

Vion Pharmaceuticals

Investigators

Study Chair: Mario Sznol, MD, Vion Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00006254

Other Study ID Numbers:

VION-CLI-008
CDR0000068187
CCF-IRB-3663
NCI-V00-1622

First Posted:

Sep 3, 2003

Last Update Posted:

Jul 18, 2013

Last Verified:

Dec 1, 2007

Keywords provided by , ,

unspecified adult solid tumor, protocol specific

Study Results

No Results Posted as of Jul 18, 2013