Study of the Trifunctional Antibody Catumaxomab to Treat Recurrent Symptomatic Malignant Ascites
NCT ID: NCT00326885
Last Updated: 2018-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2006-06-30
2010-08-31
Brief Summary
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Detailed Description
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Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells (DCs) and natural killer (NK) cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Catumaxomab
catumaxomab
Catumaxomab is administered intraperitoneally via an indwelling catheter (or port) as a 3-hour infusion 4 times (Days 0, 3, 7, and 10) in ascending doses (10 mcg, 20 mcg, 50 mcg, and 150 mcg, respectively).
Interventions
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catumaxomab
Catumaxomab is administered intraperitoneally via an indwelling catheter (or port) as a 3-hour infusion 4 times (Days 0, 3, 7, and 10) in ascending doses (10 mcg, 20 mcg, 50 mcg, and 150 mcg, respectively).
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed diagnosis of epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer; any stage at diagnosis \[International Federation of Gynecology and Obstetrics (FIGO) Stages I through IV\].
* Progression on or ≤ 12 months after primary platinum-based systemic or intraperitoneal (IP) chemotherapy OR relapse following reinduction ≥ 12 months after primary chemotherapy.
* Have refused, failed, or have been deemed not suitable candidates for gemcitabine or liposomal doxorubicin.
* Recurrent symptomatic malignant ascites requiring therapeutic paracentesis
* At least 1 therapeutic paracentesis within 4 weeks prior to baseline paracentesis
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Life expectancy ≥ 16 weeks
* Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, and total bilirubin ≤ 1.5 x ULN
* Absolute neutrophil count (ANC) ≥ 1,500/mm3 and platelet count ≥ 75,000/mm3
* Negative serum pregnancy test result at screening in women of childbearing potential (applies to patients without documented menopause or sterility).
* Willingness of patients of childbearing potential to use an effective contraceptive method (i.e., oral contraceptive, cervical cap, diaphragm with spermicide, condom with spermicide, or intrauterine device) during the study and for at least 6 months after the last infusion.
Exclusion Criteria
* Exposure to investigational drugs, chemotherapy or radiotherapy 21 days prior to the first dose of catumaxomab
* Major surgery 2 weeks prior to first dose
* Previous treatment with mouse or rat antibodies
* Known or suspected hypersensitivity to catumaxomab or other monoclonal antibodies
* Body mass index (BMI) \< 19 (body weight after paracentesis to be used for calculation of BMI)
* Serum albumin level \< 2.0 g/dL
* Reduced nutritional status requiring predominantly parenteral nutrition (\> 50% of energy intake). Permanent naso-gastric (NG) feeding tube.
* Ileus in a location that precludes paracentesis
* Extensive liver metastases (\> 70% organ volume comprises malignancy)
* Documented brain metastases
* History of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia 3 months prior to the first dose of catumaxomab
* Portal vein obstruction or portal vein thrombosis diagnosed by computed tomography (CT) scan at screening
* Persistent massive pleural effusion or inadequate respiratory function of any other etiology (except if related to ascites symptoms) in the opinion of the investigator
* Any other condition which, according to the investigator, results in an undue risk to the patient by participating in the study
* Prior exposure to catumaxomab
18 Years
FEMALE
No
Sponsors
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Fresenius Biotech North America
INDUSTRY
Neovii Biotech
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan Berek, MD MMSc
Role: STUDY_CHAIR
Stanford University Hospital and Clinics, Department of Obstetrics and Gynecology
Locations
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University of Arizona Cancer Center
Tucson, Arizona, United States
University of San Diego
La Jolla, California, United States
Stanford University Hospital and Clinics
Stanford, California, United States
University of Miami
Miami, Florida, United States
Florida Hospital Cancer Center
Orlando, Florida, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
University of Louisville Cancer Center
Louisville, Kentucky, United States
Johns Hopkins Medical Institute
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
Dartmouth-Hitchock Medical Center
Lebanon, New Hampshire, United States
Columbia University Cancer center
New York, New York, United States
Wake-Forest University
Winston-Salem, North Carolina, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States
Magee Women's Hospital, University of Pittsburgh
Pittsburgh, Pennsylvania, United States
The Methodist Hospital
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
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.
Heiss MM, Murawa P, Koralewski P, Kutarska E, Kolesnik OO, Ivanchenko VV, Dudnichenko AS, Aleknaviciene B, Razbadauskas A, Gore M, Ganea-Motan E, Ciuleanu T, Wimberger P, Schmittel A, Schmalfeldt B, Burges A, Bokemeyer C, Lindhofer H, Lahr A, Parsons SL. The trifunctional antibody catumaxomab for the treatment of malignant ascites due to epithelial cancer: Results of a prospective randomized phase II/III trial. Int J Cancer. 2010 Nov 1;127(9):2209-21. doi: 10.1002/ijc.25423.
Ruf P, Kluge M, Jager M, Burges A, Volovat C, Heiss MM, Hess J, Wimberger P, Brandt B, Lindhofer H. Pharmacokinetics, immunogenicity and bioactivity of the therapeutic antibody catumaxomab intraperitoneally administered to cancer patients. Br J Clin Pharmacol. 2010 Jun;69(6):617-25. doi: 10.1111/j.1365-2125.2010.03635.x.
Berek JS, Edwards RP, Parker LP, DeMars LR, Herzog TJ, Lentz SS, Morris RT, Akerley WL, Holloway RW, Method MW, Plaxe SC, Walker JL, Friccius-Quecke H, Krasner CN. Catumaxomab for the treatment of malignant ascites in patients with chemotherapy-refractory ovarian cancer: a phase II study. Int J Gynecol Cancer. 2014 Nov;24(9):1583-9. doi: 10.1097/IGC.0000000000000286.
Other Identifiers
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IP-REM-AC-02-US
Identifier Type: -
Identifier Source: org_study_id
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