Study of MOC31-PE in Antigen Positive Carcinomas

Study Overview
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Brief Summary
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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.

Official Title
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Phase I Study of MOC31-PE in Antigen Positive Carcinomas

Conditions
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Carcinoma

Intervention / Treatment
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* Drug: MOC31-PE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MOC31-PE<br> | Drug: MOC31-PE<br>* Immunotoxines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The documentation of the Maximum Tolerated Dose (MID) |  | 2 years | 
| The identification of the dose limiting toxicity (DLT) |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDT and DLT