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

Malignant Ascites Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836654
• Other study ID #: 60117
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 3, 2009
• Last updated: February 4, 2009
• Start date: September 2004
• Est. completion date: November 2006

Study information

• Verified date: February 2009
• Source: Neovii Biotech
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Biological:
• Catumaxomab (Removab)
Puncture free survival

Procedure:
• paracentesis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Neovii Biotech

References & Publications (5)

Heiss MM, Ströhlein MA, Jäger 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. — View 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. — View 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. — View Citation

Zeidler R, Mysliwietz J, Csánady 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. — View 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. — View Citation