NCT01065246

Brief Summary

This phase II single arm, open-label study investigate the safety of a second cycle of catumaxomab in patients with malignant ascites due to carcinoma, requiring their first therapeutic puncture after treatment in the CASIMAS study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 3, 2012

Status Verified

August 1, 2012

Enrollment Period

1.4 years

First QC Date

January 13, 2010

Last Update Submit

October 2, 2012

Conditions

Malignant Ascites Due to Epithelial Carcinoma

Keywords

malignant ascitessecond cycletrifunctional

Outcome Measures

Primary Outcomes (1)

  • proportion of patients who are able to receive a second cycle of catumaxomab

    1 month

Secondary Outcomes (4)

  • puncture free survival

    1-3 months

  • incidence and severity of adverse events

    1 month

  • Quality of Life

    1 month

  • Development of human-anti-mouse antibodies

    1 month

Study Arms (1)

catumaxomab

EXPERIMENTAL
Drug: catumaxomab

Interventions

catumaxomabDRUG

4 intraperitoneal infusions within 11 days administered over 3 hours via an indwelling catheter at the following doses: 10 - 20 - 50 - 150 µg catumaxomab

Also known as: Removab
catumaxomab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who have completed 4 infusions of catumaxomab in the CASIMAS study
  • 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

You may not qualify if:

  • acute or chronic infection
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Campus Virchow Clinic

Berlin, 13353, Germany

Location

Related Publications (5)

  • 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.

    PMID: 15906359BACKGROUND

  • 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.

    PMID: 11588051BACKGROUND

  • 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.

    PMID: 11410615BACKGROUND

  • 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.

    PMID: 10901380BACKGROUND

  • 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.

    PMID: 10415020BACKGROUND

MeSH Terms

Interventions

catumaxomab

Study Officials

  • Jalid Sehouli, MD, Prof

    Charité Campus Virchow Clinic Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2010

First Posted

February 9, 2010

Study Start

November 1, 2009

Primary Completion

April 1, 2011

Study Completion

October 1, 2011

Last Updated

October 3, 2012

Record last verified: 2012-08

Locations

DE(1)