Study in EpCAM Positive Patients With Symptomatic Malignant Ascites Using Removab Versus an Untreated Control Group
NCT ID: NCT00836654
Last Updated: 2009-02-05
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/PHASE3
258 participants
INTERVENTIONAL
2004-09-30
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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1 Catumaxomab
Patient received Catumaxomab and paracentesis
Catumaxomab (Removab)
Puncture free survival
paracentesis
2:
Patient treated by paracentesis alone, but after the second paracentesis the patient is able to cross-over in the Catumaxomab-arm
No interventions assigned to this group
Interventions
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Catumaxomab (Removab)
Puncture free survival
paracentesis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* symptomatic malignant ascites
* EpCAM positive tumor
* EOCG 0-2
* negative pregnancy
Exclusion Criteria
* exposure to investigational product, cancer chemo- or radiotherapy within the last 28 days
* previous treatment with mouse monoclonal antibodies
* known or suspected hypersensitivity to Removab or similar antibodies
* inadequate renal function
* inadequate hepatic function (AST, ALt, GTP,\< x ULN; bilirubin \<1.5xULN)
* Platelets \> 80000 cells/mm3; absolute neutrophil count (ANC) \< 1500 cells/mm3
* BMI \< 17
* Patients with reduced nutritional status
* Ileus within the last 30 days
* Brain metastases in cancer history
* Pregnant and nursing women
* history of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia within previous 3 months
* inadequate respiratory function in option of investigator
18 Years
ALL
No
Sponsors
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Neovii Biotech
INDUSTRY
References
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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.
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.
Wimberger P, Gilet H, Gonschior AK, Heiss MM, Moehler M, Oskay-Oezcelik G, Al-Batran SE, Schmalfeldt B, Schmittel A, Schulze E, Parsons SL. Deterioration in quality of life (QoL) in patients with malignant ascites: results from a phase II/III study comparing paracentesis plus catumaxomab with paracentesis alone. Ann Oncol. 2012 Aug;23(8):1979-1985. doi: 10.1093/annonc/mds178. Epub 2012 Jun 24.
Other Identifiers
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60117
Identifier Type: -
Identifier Source: org_study_id
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