Carcinoma
Conditions
Keywords
MDT and DLT
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.
Interventions
DRUGMOC31-PE
Immunotoxines
Sponsors
Oslo University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The documentation of the Maximum Tolerated Dose (MID) | 2 years |
| The identification of the dose limiting toxicity (DLT) | 2 years |
Countries
Norway
Outcome results
None listed