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OpenTrials
Completed

NCT Number: NCT01065246

Safety Study of Second Intraperitoneal (I.P.) Infusion Cycle of Catumaxomab in Patients With Malignant Ascites

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.

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Key information

Conditions

Malignant Ascites Due to Epithelial Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charité Campus Virchow Clinic

Berlin, 13353, Germany

About this study

Up to 30 evaluable patients from the CASIMAS study will be enrolled. Catumaxomab will be infused intraperitoneally with 3hour constant-rate infusions 4 times within 11 days with ascending dosages (10 - 20 - 50 - 150 µg).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

catumaxomab

Drug

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

Other names: Removab

Primary outcomes

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

    Time frame: 1 month

Secondary outcomes

  1. puncture free survival

    Time frame: 1-3 months

  2. incidence and severity of adverse events

    Time frame: 1 month

  3. Quality of Life

    Time frame: 1 month

  4. Development of human-anti-mouse antibodies

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Neovii Biotech

Industry

Registry information

Official study title

Phase II Open Label Study to Evaluate the Safety of a Second I.P. Infusion Cycle of Catumaxomab in Patients With Malignant Ascites Due to Carcinoma, Requiring Their First Therapeutic Puncture After Treatment in the CASIMAS Study

Acronym: SECIMAS

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 9, 2010
Registry last updated
Oct 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.