Clinical trial NCT01065246: Safety Study of Second Intraperitoneal (I.P.) Infusion Cycle of Catumaxomab in Patients With Malignant Ascites
Official title: Phase II Open Label Study to Evaluate the Safety of a Second I.P. Infusion Cycle of Catumaxomab in Patients With Malignant Ascites Due to Carcinoma, Requiring Their First Therapeutic Puncture After Treatment in the CASIMAS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Ascites Due to Epithelial Carcinoma
Keywords: malignant ascites
second cycle
trifunctional
Lead sponsor: Neovii Biotech
Sponsor class: INDUSTRY
First posted: 2010-02-09
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Eligibility 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

Primary outcomes:
measure: proportion of patients who are able to receive a second cycle of catumaxomab
timeFrame: 1 month
Secondary outcomes:
measure: puncture free survival
timeFrame: 1-3 months
measure: incidence and severity of adverse events
timeFrame: 1 month
measure: Quality of Life
timeFrame: 1 month
measure: Development of human-anti-mouse antibodies
timeFrame: 1 month
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Campus Virchow Clinic
Study officials:
affiliation: Charité Campus Virchow Clinic Berlin
name: Jalid Sehouli, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heiss MM, Strohlein MA, Jager 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. doi: 10.1002/ijc.21165.
citation: Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34. doi: 10.1182/blood.v98.8.2526.
citation: 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. doi: 10.1177/002215540104900711.
citation: Zeidler R, Mysliwietz J, Csanady 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. doi: 10.1054/bjoc.2000.1237.
citation: 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.