Study of MOC31-PE in Antigen Positive Carcinomas

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Immunotoxins (ITs), monoclonal antibodies conjugated to plant or bacterial toxins, have been extensively investigated for their possible use as anti-tumor agents although not in carcinoma patients with minimal residual disease. Various ITs have been tested in early clinical trials and recent studies demonstrate anti-tumor activity of IT treatment in patients with glioblastoma and different solid tumors. Systemic treatment with immunotoxins directed against carefully selected epithelial cell surface molecules may have a potential for eradicating also dormant metastatic tumor cells, as their action is independent of cell proliferation. The effector moieties of the IT used here, the Pseudomonas exotoxin A (PE), inhibits protein synthesis in eukaryotic cells by catalytic inactivation (ribosylation) of elongation factor 2 in the ribosome complex.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital

Criteria

Inclusion Criteria:

• Histologically confirm epithelial carcinoma, verified to be positive for the targeting antigen(Ep-CAM/epithelial glyco protein 2)according to the criteria given below.

• Tumor specimens verified to be positive for the targeting antibody,i.e.EGP2 positive (MOC31) by immunocytochemical or histochemical staining.

• Signed written informed consent

• Patients with no clinically symptomatic central nervous system (CNS) involvement.

• Both gender, age 18 -75 years old.

• Life expectancy of at least 3 months

• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

• Adequate hematologic, renal and hepatic function defined as: Neutrophils > 1.5 x 10^9/L;Platelets > 100 x 10^9/L; Creatinine < 120 umol/L; Total bilirubin within normal range. Liver enzymes (ALAT and ASAT <2.5 UNL: alkaline phosphatase < 1.5 UNL and yGT < 1.5 UNL).

• Coagulation parameters (pT, PTT) within normal range.

Exclusion Criteria:

• No medical history of Hepatitis B or C infection

• Patients must have no ECG abnormalities

• Patients must not be HIV positive

• Female premenopausal patients should not be pregnant (must have a negative pregnancy test prior to inclusion) and should not be lactating.

• Patients must use effective contraception if of reproductive potential.

• Prior chemotherapy and/or radiation should be completed for at least 4 weeks prior to study enrolment