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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014