Clinical trial NCT01061645: Study of MOC31-PE in Antigen Positive Carcinomas
Official title: Phase I Study of MOC31-PE in Antigen Positive Carcinomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma
Keywords: MDT and DLT
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-02-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The documentation of the Maximum Tolerated Dose (MID)
timeFrame: 2 years
measure: The identification of the dose limiting toxicity (DLT)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: The Norwegian Radium Hospital, Department of Clinical Cancer Research
Study officials:
References: