Study of MOC31-PE in Antigen Positive Carcinomas

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.

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Key information

Conditions

Carcinoma Anemia Anemia, Dyserythropoietic, Congenital Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Norwegian Radium Hospital, Department of Clinical Cancer Research

Oslo, NO-0310, Norway

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

MOC31-PE

Drug

Immunotoxines

Primary outcomes

The documentation of the Maximum Tolerated Dose (MID)

Time frame: 2 years
The identification of the dose limiting toxicity (DLT)

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Phase I Study of MOC31-PE in Antigen Positive Carcinomas

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Feb 3, 2010
Registry last updated: May 8, 2023

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.

Published trials that share one or more normalized conditions with this study.

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