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Peritoneal CarcinomatosisPhase 1/2NCT01443260

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

A Phase 1/2 study testing GL-ONC1 in people with Peritoneal Carcinomatosis, run by Genelux GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peritoneal Carcinomatosis
What is being tested?
GL-ONC1
How many people
9 participants
Where
1 siteGermany
Study dates
Feb 2012to Sep 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Tuebingen

    Tübingen, D-72076

Other trials in Germany

About this study

Official title: Phase I/II Study of Intraperitoneal Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients With Peritoneal Carcinomatosis

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.

Read the 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, appendix, ovarian, pancreas, mesothelioma, pseudomyxoma peritonei, rectal, small bowel and stomach cancers. It broadly includes multiple tumors that develop in and line the peritoneal abdominal cavity and linings. These tumors may be difficult to completely remove surgically and may recur despite conventional systemic chemotherapy, thereby resulting in poor patient outcomes. In preclinical studies, GL-ONC1, an oncolytic vaccinia virus, has shown the ability to preferentially locate, colonize and destroy tumor cells in more than 30 different human tumors. A Phase I clinical study focusing on the safety and tolerability of GL-ONC1 intravenously administered to patients with a variety of solid tumor entities has shown that GL-ONC1 is well-tolerated at therapeutic dose levels, with documented evidence of antitumor activity. This additional Phase I/II study seeks to evaluate GL-ONC1 administered repetitively every 4 weeks up to 4 cycles via infusion using an implanted catheter in the peritoneal cavity. In Phase I, patients will be individually assessed for safety and dose limiting toxicity. The study aims of Phase II portion are continued collection of safety information to better define the tolerability of GL-ONC1, as well as viral replication and the action or effect of GL-ONC1 in humans at the selected dose level and dosing schedule for future trials. Throughout both phases of the study, anti-tumor effects will be evaluated.

Being tested
GL-ONC1
Keywords
oncolytic virus, oncolytic, GL-ONC1, Vaccinia, Vaccinia virus, Genelux, Genelux GmbH, peritoneal, peritoneal carcinomatosis, cancer, abdominal cancer, imaging
Medical subject headings
Peritoneal Neoplasms, Vaccinia, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GL-ONC1Biological

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)

  1. Dose Level and Dose Schedule

    Determination of recommended dose and schedule for phase II portion of trial and future investigations by analysis of safety and efficacy data

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

  2. Detection of Anti-tumor Activity

    Sampling of evidence of anti-tumor activity via standard imaging practices, viral delivery to tumor and normal cells, and immune response activity.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2011 (estimated)
  2. Study startFeb 2012
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01443260
Sponsor's protocol ID
Genelux - PO2
Other IDs
2010-022680-35
Status last verified
Apr 2025
First submitted
20 Sep 2011
Last updated
30 Apr 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29773661

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GL-ONC1 in people with Peritoneal Carcinomatosis, run by Genelux GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine safety of administering GL-ONC1 intraperitoneally by the evaluation of the number of patients experiencing Adverse Events (type, frequency, and severity) (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01443260, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.

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