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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Peritoneal Carcinomatosis

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Trial Information

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

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.

Inclusion Criteria:

1. 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.

2. Evidence of measurable disease.

3. Age ≥ 18 years.

4. ECOG (Eastern Cooperative Oncology Group Performance Status) ≤ 2.

5. 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.

6. 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.

7. All patients must agree to use highly effective contraception.

Exclusion Criteria:

1. Patients exhibiting objective evidence at baseline of brain metastases are excluded
from participating.

2. Pregnant or breast-feeding women.

3. Primary tumors and metastases to tissues/organs which, under clinical judgment, will
likely hinder survival for at least the next 4 months.

4. Patients with fever, any active immunosuppressive systemic infection or a suppressed
immune system, including known HIV, as assessed within 14 days prior to study

5. Concurrent vaccination or immunotherapy for 28 days before study therapy and during
study treatment.

6. 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.

7. Prior splenectomy.

8. Previous organ transplantation.

9. Fully therapeutic coagulation therapy that does not allow the intraperitoneal
insertion of a permanent catheter.

10. 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).

11. Clinically significant cardiac disease (New York Heart Association, Class III or IV:
see Appendix 10)

12. Known allergy to ovalbumin or other egg products.

13. Concurrent use of antiviral agents active against vaccinia virus.

14. Prior gene therapy treatment or prior therapy with cytolytic virus of any type.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome 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.

Safety Issue:


Principal Investigator

Ulrich M. Lauer, Prof. Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Tuebingen


Germany: Paul-Ehrlich-Institut

Study ID:

Genelux - PO2



Start Date:

February 2012

Completion Date:

November 2013

Related Keywords:

  • Peritoneal Carcinomatosis
  • oncolytic virus
  • oncolytic
  • GL-ONC1
  • Vaccinia
  • Vaccinia virus
  • Genelux
  • Genelux GmbH
  • peritoneal
  • peritoneal carcinomatosis
  • cancer
  • abdominal cancer
  • imaging
  • Vaccinia
  • Carcinoma