Safety Study of Second Intraperitoneal (I.P.) Infusion Cycle of Catumaxomab in Patients With Malignant Ascites
NCT ID: NCT01065246
Last Updated: 2012-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
8 participants
INTERVENTIONAL
2009-11-30
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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catumaxomab
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Neovii Biotech
INDUSTRY
Responsible Party
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Principal Investigators
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Jalid Sehouli, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Charité Campus Virchow Clinic Berlin
Locations
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Charité Campus Virchow Clinic
Berlin, , Germany
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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2009-014076-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IP-CAT-AC-04
Identifier Type: -
Identifier Source: org_study_id