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Study in EpCAM Positive Patients With Symptomatic Malignant Ascites Using Removab Versus an Untreated Control Group

Primary Purpose

EpCam Positive Tumor (e.g.Ovarian, Gastric, Colon, Breast), Malignant Ascites

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Catumaxomab (Removab)
paracentesis
Sponsored by
Neovii Biotech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for EpCam Positive Tumor (e.g.Ovarian, Gastric, Colon, Breast) focused on measuring EpCAM positive tumor, malignant ascites, intraperitoneal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • histological confirmed diagnosis cancer
  • symptomatic malignant ascites
  • EpCAM positive tumor
  • EOCG 0-2
  • negative pregnancy

Exclusion Criteria:

  • acute or chronic infection
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    1 Catumaxomab

    2:

    Arm Description

    Patient received Catumaxomab and paracentesis

    Patient treated by paracentesis alone, but after the second paracentesis the patient is able to cross-over in the Catumaxomab-arm

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 3, 2009
    Last Updated
    February 4, 2009
    Sponsor
    Neovii Biotech
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00836654
    Brief Title
    Study in EpCAM Positive Patients With Symptomatic Malignant Ascites Using Removab Versus an Untreated Control Group
    Official Title
    Two-Arm, Randomized (2:1), Open-Label Phase II/III Study in EpCAM Positive Cancer Patients With Symptomatic Malignant Ascites Using the Trifuncitonal Bispecific Antibody Removab (Anti-EpCAM x Anti-CD3) Versus an Untreated Control Group
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2004 (undefined)
    Primary Completion Date
    November 2006 (Actual)
    Study Completion Date
    November 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Neovii Biotech

    4. Oversight

    5. Study Description

    Brief Summary
    The study will be performed to obtain further efficacy and safety data in order to obtain a marketing authorization (pivotal study). In addition, health economic data are to be collected.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    EpCam Positive Tumor (e.g.Ovarian, Gastric, Colon, Breast), Malignant Ascites
    Keywords
    EpCAM positive tumor, malignant ascites, intraperitoneal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    258 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1 Catumaxomab
    Arm Type
    Active Comparator
    Arm Description
    Patient received Catumaxomab and paracentesis
    Arm Title
    2:
    Arm Type
    No Intervention
    Arm Description
    Patient treated by paracentesis alone, but after the second paracentesis the patient is able to cross-over in the Catumaxomab-arm
    Intervention Type
    Biological
    Intervention Name(s)
    Catumaxomab (Removab)
    Other Intervention Name(s)
    Removab
    Intervention Description
    Puncture free survival
    Intervention Type
    Procedure
    Intervention Name(s)
    paracentesis

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: histological confirmed diagnosis cancer symptomatic malignant ascites EpCAM positive tumor EOCG 0-2 negative pregnancy Exclusion Criteria: acute or chronic infection 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11588051
    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.
    Results Reference
    background
    PubMed Identifier
    11410615
    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.
    Results Reference
    background
    PubMed Identifier
    10901380
    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.
    Results Reference
    background
    PubMed Identifier
    10415020
    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.
    Results Reference
    background
    PubMed Identifier
    15906359
    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.
    Results Reference
    background
    PubMed Identifier
    22734013
    Citation
    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.
    Results Reference
    derived

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    Study in EpCAM Positive Patients With Symptomatic Malignant Ascites Using Removab Versus an Untreated Control Group

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