Malignant Ascites Due to Epithelial Carcinoma Clinical Trial
— SECIMASOfficial 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
| Verified date | August 2012 |
| Source | Neovii Biotech |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Paul-Ehrlich-Institut |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | October 2011 |
| Est. primary completion date | April 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Charité Campus Virchow Clinic | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Neovii Biotech |
Germany,
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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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | proportion of patients who are able to receive a second cycle of catumaxomab | 1 month | Yes | |
| Secondary | puncture free survival | 1-3 months | No | |
| Secondary | incidence and severity of adverse events | 1 month | Yes | |
| Secondary | Quality of Life | 1 month | No | |
| Secondary | Development of human-anti-mouse antibodies | 1 month | No |