A Study of GL-ONC1, an Oncolytic Vaccinia Virus, in Patients With Advanced Peritoneal Carcinomatosis (NCT01443260) | Clinical Trial Compass
CompletedPhase 1/2
A Study of GL-ONC1, an Oncolytic Vaccinia Virus, in Patients With Advanced Peritoneal Carcinomatosis
Germany9 participantsStarted 2012-02
Plain-language summary
The purpose of this study is to determine whether GL-ONC1, an attenuated vaccinia virus, is safe when administered to patients with peritoneal carcinomatosis via an infusion within the abdominal cavity through an implanted catheter. The study seeks also to arrive at a recommended dose and schedule for future investigations, evidence of anti-tumor activity, detection of virus in body fluids, analysis of viral delivery to tumor and normal cells, and to evaluate if there is an antibody response to vaccinia virus.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Diagnosis of histologically or cytologically documented, advanced stage of peritoneal carcinomatosis that is refractory to standard therapy, exhibiting a likely survival of \> 4 months as being judged clinically.
✓. Evidence of measurable disease.
✓. Age ≥ 18 years.
✓. ECOG (Eastern Cooperative Oncology Group Performance Status) ≤ 2.
✓. Required baseline laboratory data include:
✓. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, implantation of the indwelling peritoneal catheter, as well as the respective drainage procedures.
✓. All patients must agree to use highly effective contraception.
Exclusion criteria
✕. Patients exhibiting objective evidence at baseline of brain metastases are excluded from participating.
✕. Pregnant or breast-feeding women.
✕. Primary tumors and metastases to tissues/organs which, under clinical judgment, will likely hinder survival for at least the next 4 months.
✕. Patients with fever, any active immunosuppressive systemic infection or a suppressed immune system, including known HIV, as assessed within 14 days prior to study enrolment.
✕. Concurrent vaccination or immunotherapy for 28 days before study therapy and during study treatment.
What they're measuring
1
Determine safety of administering GL-ONC1 intraperitoneally by the evaluation of the number of patients experiencing Adverse Events (type, frequency, and severity)
Timeframe: Change from baseline over 24 hours, on days 2, 3, 4,5,6, 7 post treatment (Cycle 1) and change from baseline for Cycles 2- 4 CX/Days 1, 2, 3, 5, 8 post-treatment. Each cycle is 4 weeks and treatment will occur for a total of 4 cycles.
✕. Patients on immunosuppressive therapy or with immune system disorders, including autoimmune diseases. Concurrent steroid use of not more than an equivalent of 20 mg/day prednisolone is allowed.