SECIMAS: Safety Study of Second Intraperitoneal (I.P.) Infusion Cycle of Catumaxomab in Patients With Malignant Ascites
Study Details
Study Description
Brief Summary
This phase II single arm, open-label study investigate the safety of a second cycle of catumaxomab in patients with malignant ascites due to carcinoma, requiring their first therapeutic puncture after treatment in the CASIMAS study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
Up to 30 evaluable patients from the CASIMAS study will be enrolled. Catumaxomab will be infused intraperitoneally with 3hour constant-rate infusions 4 times within 11 days with ascending dosages (10 - 20 - 50 - 150 µg).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: catumaxomab
|
Drug: catumaxomab
4 intraperitoneal infusions within 11 days administered over 3 hours via an indwelling catheter at the following doses: 10 - 20 - 50 - 150 µg catumaxomab
Other Names:
|
Outcome Measures
Primary Outcome Measures
- proportion of patients who are able to receive a second cycle of catumaxomab [1 month]
Secondary Outcome Measures
- puncture free survival [1-3 months]
- incidence and severity of adverse events [1 month]
- Quality of Life [1 month]
- Development of human-anti-mouse antibodies [1 month]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
patients who have completed 4 infusions of catumaxomab in the CASIMAS study
-
age >= 18 years
-
Karnofsky index >= 60 %
-
patients with malignant ascites requiring their first therapeutic ascites paracentesis after at least 60days following last catumaxomab infusion in the CASIMAS study
-
Patients where standard therapy is either not available or no longer feasible
Exclusion Criteria:
-
acute or chronic infection
-
concomitant treatment with investigational products other than catumaxomab, cancer, chemo- or radiotherapy
-
previous treatment with entirely murine monoclonal antibodies other than catumaxomab
-
liver metastases with volume >70 % of liver metastasized tissue
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Charité Campus Virchow Clinic | Berlin | Germany | 13353 |
Sponsors and Collaborators
- Neovii Biotech
Investigators
- Principal Investigator: Jalid Sehouli, MD, Prof, Charité Campus Virchow Clinic Berlin
Study Documents (Full-Text)
None provided.More Information
Publications
- Heiss MM, Ströhlein MA, Jäger M, Kimmig R, Burges A, Schoberth A, Jauch KW, Schildberg FW, Lindhofer H. Immunotherapy of malignant ascites with trifunctional antibodies. Int J Cancer. 2005 Nov 10;117(3):435-43.
- Riesenberg R, Buchner A, Pohla H, Lindhofer H. Lysis of prostate carcinoma cells by trifunctional bispecific antibodies (alpha EpCAM x alpha CD3). J Histochem Cytochem. 2001 Jul;49(7):911-7.
- Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34.
- Zeidler R, Mysliwietz J, Csánady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6.
- Zeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52.
- IP-CAT-AC-04
- 2009-014076-22