Study of MOC31-PE in Antigen Positive Carcinomas

University of Oslo (UIO)

Status and phase

Completed

Phase 1

Conditions

Carcinoma

Treatments

Drug: MOC31-PE

Study type

Interventional

Funder types

Other

Identifiers

NCT01061645

MOC31-PE

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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