Study of MOC31-PE in Antigen Positive Carcinomas

NCT ID: NCT01061645

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-02-29

Brief 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.

Conditions

Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MOC31-PE

Group Type: EXPERIMENTAL

MOC31-PE

Intervention Type: DRUG

Immunotoxines

Interventions

MOC31-PE

Immunotoxines

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Svein Dueland

Senior Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Norwegian Radium Hospital, Department of Clinical Cancer Research

Oslo, , Norway

Countries

Norway

Other Identifiers

MOC31-PE

Identifier Type: -

Identifier Source: org_study_id