Study of MOC31-PE in Antigen Positive Carcinomas

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01061645
First received: February 2, 2010
Last updated: May 3, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Carcinoma
Drug: MOC31-PE
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of MOC31-PE in Antigen Positive Carcinomas

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • The documentation of the Maximum Tolerated Dose (MID) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • The identification of the dose limiting toxicity (DLT) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: September 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MOC31-PE Drug: MOC31-PE
Immunotoxines

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061645

Locations
Norway
The Norwegian Radium Hospital, Department of Clinical Cancer Research
Oslo, Norway, NO-0310
Sponsors and Collaborators
Oslo University Hospital
  More Information

No publications provided

Responsible Party: Svein Dueland, The Norwegian Radium Hospital, Division of Cancer Medicine and Radiotherapy
ClinicalTrials.gov Identifier: NCT01061645     History of Changes
Other Study ID Numbers: MOC31-PE
Study First Received: February 2, 2010
Last Updated: May 3, 2012
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
MDT and DLT

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014