Status:
COMPLETED
A Study of GL-ONC1, an Oncolytic Vaccinia Virus, in Patients With Advanced Peritoneal Carcinomatosis
Lead Sponsor:
Genelux GmbH
Conditions:
Peritoneal Carcinomatosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 cavit...
Detailed Description
Peritoneal carcinomatosis includes a variety of tumors with extensive metastasis throughout the peritoneal cavity (inside surface of the abdomen) and can be found with gall bladder, liver, colon, appe...
Eligibility Criteria
Inclusion
- 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:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
- Platelets ≥ 75 ×109/L
- Haemoglobin ≥ 9.5 g/dL
- Serum creatinine ≤ 2 × upper limit of normal(ULN)
- Total Bilirubin ≤ 5 × ULN
- AST/ALT ≤ 7.5 × ULN
- Negative pregnancy test for females of childbearing potential
- Serum albumin ≥ 2.5 g/dL.
- If serum albumin level is \< 2.5/dL,albumin substitution should take place until the threshold of ≥ 2.5 g/dL.
- 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
- 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.
- 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.
- Prior splenectomy.
- Previous organ transplantation.
- Fully therapeutic coagulation therapy that does not allow the intraperitoneal insertion of a permanent catheter.
- Patients with clinically significant dermatological disorders(e.g., eczema or psoriasis), any skin lesions or ulcers, any history of atopic dermatitis, or any history of Darier's disease (Keratosis Follicularis).
- Clinically significant cardiac disease (New York Heart Association, Class III or IV: see Appendix 10)
- Known allergy to ovalbumin or other egg products.
- Concurrent use of antiviral agents active against vaccinia virus.
- Prior gene therapy treatment or prior therapy with cytolytic virus of any type.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01443260
Start Date
February 1 2012
End Date
September 1 2014
Last Update
April 30 2025
Active Locations (1)
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1
University Hospital Tuebingen
Tübingen, Germany, D-72076