Clinical trial · Interventional
VNP20009 in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Therapy
A Phase I Trial of a Live, Genetically Modified Salmonella Typhimurium (VNP20009) for the Treatment of Cancer by Intratumoral Injection
NCT00004216CI-TRIAL-00011416completedPhase 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 or metastatic solid tumors that have not responded to previous therapy.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cefixime | Drug | — | UNRESOLVED |
| ceftriaxone sodium | Drug | — | UNRESOLVED |
| ciprofloxacin | Drug | — | UNRESOLVED |
| salmonella VNP20009 | Biological | — | UNRESOLVED |
| trimethoprim-sulfamethoxazole | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically proven advanced or metastatic solid tumors that have failed prior therapy and no other therapy is available At least 1 tumor mass of a size that makes intratumoral injection feasible and biopsy or fine needle aspiration possible Major surgery for cancer not required No lymphoma No concurrent brain metastases (previously treated brain metastases with no evidence of recurrence allowed) PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: Karnofsky 70-100% OR ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hematocrit at least 30% (transfusion allowed) No bleeding disorder Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT/AST no greater than 1.5 times ULN (3 times ULN in the presence of liver metastases) Alkaline phosphatase no greater than 1.5 times ULN (3 times ULN in the presence of liver metastases) PT and aPTT no greater than 1.5 times ULN No end stage liver disease Renal: Creatinine no greater than 1.5 times ULN No urinary tract stones No end stage renal disease Cardiovascular: No known valvular disease or ischemic peripheral vascular disease No clinically significant atherosclerotic disease or arterial aneurysm(s) No unstable angina No active coronary artery disease requiring medication No myocardial infarction within the past 6 months No congenital heart failure or cardiac arrhythmia requiring medication Pulmonary: No severe oxygen-dependent chronic obstructive pulmonary disease Other: HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Permanent central venous catheters and other indwelling devices allowed if easily removed or replaced No gallstones No active infection No Salmonella infection within the past 6 months No fever caused by tumor or unknown cause (daily temperature no greater than 38 degrees C) No immunodeficiency No other life-threatening illness No commercial food handler, day-care worker, or health-care worker who plans to continue employment during protocol treatment No allergy to quinolone or cephalosporin antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since any prior bone marrow transplantation At least 4 weeks since prior biologic therapy and recovered No other concurrent biologic therapy No prior allogeneic transplants Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered No concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior hormonal therapy No concurrent steroids Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics At least 2 weeks since prior surgery and recovered No artificial implant (e.g., heart valves or prosthetic hips or knees) No prior splenectomy Other: No other concurrent antibiotics No concurrent immunosuppressives No concurrent medications that directly or indirectly suppress the immune system
References
Publications (0)
Data not yet available
No reference posted for this study.