Study of MOC31-PE in Antigen Positive Carcinomas

Carcinoma Clinical Trial

Official title:

Phase I Study of MOC31-PE in Antigen Positive Carcinomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061645
• Other study ID #: MOC31-PE
• Status: Completed
• Phase: Phase 1
• Start date: September 2010
• Est. completion date: February 2012

Study information

• Verified date: May 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma

Intervention

Drug:
• MOC31-PE
Immunotoxines

Locations

Country	Name	City	State
Norway	The Norwegian Radium Hospital, Department of Clinical Cancer Research	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The documentation of the Maximum Tolerated Dose (MID)		2 years
Primary	The identification of the dose limiting toxicity (DLT)		2 years