Clinical trial · Interventional
VNP20009 in Treating Patients With Advanced Solid Tumors
A Phase I Trial of a Live, Genetically Modified Salmonella Typhimurium (VNP20009) for the Treatment of Cancer by Intravenous Administration
NCT00006254CI-TRIAL-00011422completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| salmonella VNP20009 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.