Safety and Efficacy Study With Catumaxomab in Patients After Curative Resection of a Gastric Adenocarcinoma
NCT ID: NCT00352833
Last Updated: 2007-10-26
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
40 participants
INTERVENTIONAL
2006-07-31
2007-09-30
Brief Summary
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Detailed Description
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Treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively as an intraperitoneal bolus on day 0 and of four following ascending doses (10-20-50-150 µg) which will be administered as an i.p.-infusion via a provided indwelling catheter on the days 7, 10, 13 and 16, respectively.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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catumaxomab
Eligibility Criteria
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Inclusion Criteria
* Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
* Intended curative gastrectomy ('en-bloc´-R0-resection considering the standard D2-scheme)
* Serosal infiltration (T3/T4, N+/-, M0) confirmed by immediate section with histopathologic assessment during surgery
* Karnofsky index \>= 70
* Negative pregnancy blood test at screening in women with childbearing potential
Exclusion Criteria
* Macroscopic and microscopic residual tumor present after surgery
* State after pancreas resection or thoracotomy
* Exposure to prior cancer therapy or planned adjuvant chemo-or radiotherapy of the current gastric cancer
* Previous treatment with non-humanized mouse or rat monoclonal antibodies
* Known/suspected hypersensitivity to catumaxomab or similar antibodies
* Any cancer disease or any cancer treatments within the last 5 years
* Presence of constant immunosuppressive therapy
* Inadequate renal function (creatinine \> 1.5 x ULN)
* Inadequate hepatic function (AST or ALT \> 2.5 x ULN or bilirubin \>= 1.5 x ULN)
* Platelets \< 75000 cells/mm³; absolute neutrophil count \< 1500 cells/mm³
* Patient had a bowel obstruction within the last 30 days
* Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method during the study and at least contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms)
* Presence of any acute or chronic systemic infection
* Any further condition which according to the investigator results in an undue risk to the patient during participating in the present study
* Patient is an employee of any involved study investigator or any involved institution including the study sponsor
* Parallel participation in another clinical trial or previous participation in this study
* Treatment with another investigational product during this study or during the last 30 days prior to study start
18 Years
ALL
No
Sponsors
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Neovii Biotech
INDUSTRY
Principal Investigators
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Marcus Heiss, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Cologne, Germany
Locations
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Hospital of Cologne-Merheim, Surgical Department
Cologne, , 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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IP-REM-GC-02
Identifier Type: -
Identifier Source: org_study_id