Study of MOC31-PE in Antigen Positive Carcinomas

NCT01061645 | Completed Phase 1

• 1 other identifier: MOC31-PE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma

Keywords

MDT and DLT

Outcome Measures

Primary Outcomes (2)

• The documentation of the Maximum Tolerated Dose (MID)

  2 years

• The identification of the dose limiting toxicity (DLT)

  2 years

Study Arms (1)

MOC31-PE

EXPERIMENTAL

Drug: MOC31-PE

Interventions

MOC31-PE DRUG

Immunotoxines

MOC31-PE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• No medical history of Hepatitis B or C infection
• Patients must have no ECG abnormalities
• Patients must not be HIV positive
• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

The Norwegian Radium Hospital, Department of Clinical Cancer Research

Oslo, NO-0310, Norway

Location

MeSH Terms

Conditions

Carcinoma; Anemia, Dyserythropoietic, Congenital

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 3, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: May 8, 2023

Record last verified: 2023-05

Locations

NO (1)