A Study of GL-ONC1, an Oncolytic Vaccinia Virus, in Patients With Advanced Peritoneal Carcinomatosis

NCT01443260 | Completed Phase 1 DMC

• 2 other identifiers: Genelux - PO22010-022680-35
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Peritoneal Carcinomatosis

Keywords

oncolytic virus; oncolytic; GL-ONC1; Vaccinia; Vaccinia virus; Genelux; Genelux GmbH; peritoneal; peritoneal carcinomatosis; cancer; abdominal cancer; imaging

Outcome Measures

Primary Outcomes (1)

• Determine safety of administering GL-ONC1 intraperitoneally by the evaluation of the number of patients experiencing Adverse Events (type, frequency, and severity)

  The safety of GL-ONC1 will be assessed by the evaluation of the type, frequency, and severity of adverse events (AEs), changes in laboratory tests (haematological, chemistry, urinary), immunogenicity and physical examination

  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.

Secondary Outcomes (2)

• Dose Level and Dose Schedule

  End of Phase I (at 18 mo.), at monthly treatments, and after study completion (expected at 36 mo.)

• Detection of Anti-tumor Activity

  Tumor imaging [pre-study, mid-term (Day 43), after last treatment (Day 106), for 1 year @ 12-week intervals for patients with stable disease/better); Tumor markers and peritoneal cytologies collected on average over 4 months

Interventions

GL-ONC1 BIOLOGICAL

A genetically-engineered vaccinia virus administered via intraperitoneal infusion through an indwelling catheter every 4 weeks for 4 cycles.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genelux GmbH: lead

Study Sites (1)

University Hospital Tuebingen

Tübingen, D-72076, Germany

Location

Related Publications (1)

• Lauer UM, Schell M, Beil J, Berchtold S, Koppenhofer U, Glatzle J, Konigsrainer A, Mohle R, Nann D, Fend F, Pfannenberg C, Bitzer M, Malek NP. Phase I Study of Oncolytic Vaccinia Virus GL-ONC1 in Patients with Peritoneal Carcinomatosis. Clin Cancer Res. 2018 Sep 15;24(18):4388-4398. doi: 10.1158/1078-0432.CCR-18-0244. Epub 2018 May 17.

  PMID: 29773661 DERIVED

Related Links

• Click here for Related Information

MeSH Terms

Conditions

Peritoneal Neoplasms; Vaccinia; Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Ulrich M. Lauer, Prof. Dr. med.

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

• Michael Bitzer, Prof.Dr.med.

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 29, 2011
• Study Start: February 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

DE (1)