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Cited by 257Ovarian cancer diagnosis and treatmentMonoclonal and Polyclonal Antibodies ResearchIntraperitoneal and Appendiceal Malignancies

Effective Relief of Malignant Ascites in Patients with Advanced Ovarian Cancer by a Trifunctional Anti-EpCAM × Anti-CD3 Antibody: A Phase I/II Study

Burges, Alexander, Wimberger, Pauline, Kümper, Carolin, Gorbounova, Vera, Sommer, Harald, Schmalfeldt, Barbara, Pfisterer, Jacobus, Lichinitser, Michail +10 more·2007·Clinical Cancer Research
DOI 10.1158/1078-0432.ccr-06-2769
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Abstract

Purpose: Malignant ascites in ovarian carcinoma patients is associated with poor prognosis and reduced quality of life. The trifunctional antibody catumaxomab (anti-EpCAM × anti-CD3) enhances the antitumor activity by redirecting T cells and Fcγ receptor I/III–positive accessory cells to the tumor. This multicenter phase I/II dose-escalating study investigated tolerability and efficacy of i.p. catumaxomab application in ovarian cancer patients with malignant ascites containing epithelial cell adhesion molecule (EpCAM)–positive tumor cells. Experimental Design: Twenty-three women with recurrent ascites due to pretreated refractory ovarian cancer were treated with four to five i.p. infusions of catumaxomab in doses of 5 to 200 μg within 9 to 13 days. Results: The maximum tolerated dose was defined at 10, 20, 50, 200, and 200 μg for the first through fifth doses. Side effects included transient fever (83%), nausea (61%), and vomiting (57%), mostly CTCAE (Common Terminology Criteria for Adverse Events) grade 1 or 2. A total of 39 grade 3 and 2 grade 4 treatment-related adverse events (AE), 9 of them after the highest dose level (200 μg), were observed in 16 patients. Most AEs were reversible without sequelae. Treatment with catumaxomab resulted in significant and sustained reduction of ascites flow rate. A total of 22/23 patients did not require paracentesis between the last infusion and the end of study at day 37. Tumor cell monitoring revealed a reduction of EpCAM-positive malignant cells in ascites by up to 5 log. Conclusion: I.p. immunotherapy with catumaxomab prevented the accumulation of ascites and efficiently eliminated tumor cells with an acceptable safety profile. This suggests that catumaxomab is a promising treatment option in ovarian cancer patients with malignant ascites.

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Crossref · 10.1158/1078-0432.ccr-06-2769

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  • In a Phase 1/2 clinical trial, 22/23 ovarian cancer patients with malignant ascites treated with intraperitoneal triomab did not require paracentesis between the last infusion and the end of study at day 37.

    “In a Phase 1/2 clinical trial, patients in ovarian cancer patients with malignant ascites were treated with IP administration of triomab (4 to 5 doses of 5 to 200 μg); 22/23 patients did not require paracentesis between the last infusion and the end of study at day 37.”

    From Bispecific antibodies for cancer therapy: The light at the end of the tunnel? (2009) · cites this paper as [26]

  • Moderate anti mouse and anti rat responses were seen in the majority of patients but do not seem to affect the efficiency of the treatment.

    “Moderate anti mouse and anti rat responses were seen in the majority of the patients but they do not seem to affect the efficiency of the treatment. 26”

    From Bispecific antibodies for cancer therapy: The light at the end of the tunnel? (2009) · cites this paper as [26]

  • Tumor cell monitoring revealed a reduction of EpCAM-positive malignant cells in ascites by up to 5 logs.

    “Tumor cell monitoring revealed a reduction of EpCAM-positive malignant cells in ascites by up to 5 logs. 26”

    From Bispecific antibodies for cancer therapy: The light at the end of the tunnel? (2009) · cites this paper as [26]

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Authors
Burges, A., Wimberger, P., Kümper, C., Gorbounova, V., Sommer, H., Schmalfeldt, B., Pfisterer, J., Lichinitser, M., Makhson, A., Moiseyenko, V., Lahr, A., Schulze, E., Jäger, M., Ströhlein, M. A., Heiss, M. M., Gottwald, T., Lindhofer, H., & Kimmig, R.
Affiliations
  • 1Obstetrics and Gynecology and Departments of
  • University of Duisburg-Essen (DE)
  • 4Research Center for Oncology and
  • Ludwig-Maximilians-Universität München (DE)
  • Technical University of Munich (DE)
  • Christian-Albrechts-Universität zu Kiel (DE)
  • 5Oncology Clinical Hospital, Moscow, Russia;
  • 11Scientific Oncology Institute, St. Petersburg, Russia; and
  • Neovii Biotech (Germany) (DE)
  • 12TRION Research GmbH, Martinsried, Germany
  • 2Surgery, Ludwig-Maximilans University, Munich Groβhadern, Germany;
  • 9TRION Pharma GmbH, Munich, Germany;
ORCID
Venue
Clinical Cancer Research
Publisher
American Association for Cancer Research (AACR)
Published
2007-07-01
Volume
13
Issue
13
Pages
3899-3905
ISSN
  • 1078-0432 (ISSN-L)
  • 1557-3265
DOI
10.1158/1078-0432.ccr-06-2769
OpenAlex
W2157691319
Cited by
257
References
37
Citations by year
2026: 6 · 2025: 9 · 2024: 9 · 2023: 10 · 2022: 6 · 2021: 11 · 2020: 8 · 2019: 8 · 2018: 10 · 2017: 10 · 2016: 12 · 2015: 20 · 2014: 16 · 2013: 20 · 2012: 19
FWCI
20.24
Type
journal article
Language
en
Open access
closed
Locations
  • Clinical Cancer Research (publishedVersion)
  • PubMed (publishedVersion)
  • mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
Topics
  • Health Sciences › Medicine › Reproductive Medicine › Ovarian cancer diagnosis and treatment
  • Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
  • Health Sciences › Medicine › Surgery › Intraperitoneal and Appendiceal Malignancies
Keywords
catumaxomab, malignant ascites, advanced ovarian cancer, EpCAM, anti-CD3 antibody, trifunctional antibody, intraperitoneal immunotherapy, T cell redirection, maximum tolerated dose, treatment-related adverse events, refractory ovarian cancer
MeSH terms
Epithelial Cell Adhesion Molecule, Adult, Aged, Aged, 80 and over, Antibodies, Antigens, Neoplasm, Ascites, Female, Humans, Immunotherapy, Middle Aged, Ovarian Neoplasms, Time Factors, Cell Adhesion Molecules, CD3 Complex, Leukocyte Common Antigens, Maximum Tolerated Dose

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