Immunotoxin in Peritoneal Carcinomatosis- ImmunoPeCa Trial (ImmunoPeCa)

May 24, 2017 updated by: Svein Dueland, Oslo University Hospital

Phase I/II Trial of MOC31PE Immunotoxin in Peritoneal Carcinomatosis From Colorectal Carcinoma

The purpose of this study is through a phase I/II clinical trial to assess the safety and toxicity of intraperitoneally administered MOC31PE immunotoxin, given on the 1.postoperative day after cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for peritoneal metastases from colorectal cancer (CRC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

MOC31PE is an immunotoxin that has previously been evaluated in a phase I clinical study involving patients with advanced EpCAM positive carcinoma to assess the safety and tolerability profile and the pharmacokinetic behavior of the compound. In this study, the compound was administered intravenously and was well tolerated. MOC31PE will now be evaluated on the same parameters in a new phase I/II clinical trial, where the drug will be administered intraperitoneally to patients with peritoneal metastases from EpCAM positive colorectal carcinomas.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital- The Norwegian Radium Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Histologically verified EpCAM positive colorectal cancer
  • Ambulatory with Eastern Cooperative Oncology Group (ECOG) performance status 0-1 at the time of surgery
  • At least 18 years of age
  • Suspected isolated peritoneal carcinomatosis upon radiologic work-up
  • Complete cytoreduction at surgery and mitomycin C given as standard HIPEC procedure
  • Peritoneal Cancer Index (PCI) ≤ 20

  • Laboratory values at inclusion:

    • Absolute neutrophil count (ANC) > 1.5 x 10^9/L
    • Platelets > 100 x 10^9/L
    • Hb > 9g/dL
    • Creatinine ≤ 2x upper limit of normal
    • Bilirubin < 2.0x the upper limit of normal
    • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2. 5x the upper limit of normal
    • Albumin levels > 30 g/L
    • International normalised ratio (INR) <1.3
  • Signed informed consent and expected cooperation with respect to treatment and follow-up must be obtained and documented according to International Conference of Harmonisation- Good clinical Practice (ICH GCP), and national/local regulations.

Exclusion criteria:

  • Other synchronous metastatic lesions. Patients may be included if they have had curative resection of metastatic CRC disease more than 2 years prior to inclusion and have no relapse at this location is detected.
  • History of prior other malignant disease the last 3 years, except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer.
  • History of central nervous system (CNS)- or bone metastases
  • Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
  • History of any liver disease including Hepatitis B or C infection
  • Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment
  • BMI > 35
  • Pregnant or breast-feeding patients
  • Alcohol or drug abuse
  • Use of drugs that can influence hepatic function (e.g. phenytoin or phenobarbital)
  • Use of anticoagulants
  • Any reason why, in the opinion of the investigator, the patient should not participate in the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MOC31PE Immunotoxin
Drug to be instilled on day 1 after cytoreductive surgery and HIPEC.
Drug: MOC31PE Immunotoxin
Patients who meet inclusion criteria will be treated with a single intraperitoneal MOC31PE immunotoxin instillation for 6 hours on the first day after CRS and HIPEC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 5 years or until disease progression
Follow-up: 5 years from administration of study drug, or until disease progression
5 years or until disease progression

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax, Tmax
Time Frame: 8 weeks
Measurements will be done at 0, 3, 6, 12, 24, 48 and 72 hours after administration of study drug
8 weeks
Neutralizing anti-immunotoxin antibody response
Time Frame: 8 weeks
Measurements of neutralizing anti-immunotoxin antibody response will be done at 4 and 8 weeks after administration of study drug
8 weeks
Biomarkers of disease recurrence
Time Frame: 5 years or until disease progression
Serum samples for identification of biomarkers of disease recurrence will be taken at every follow-up for 5 years or until disease progression
5 years or until disease progression
Overall survival
Time Frame: 5 years
Overall survival of all patients will be assessed after 5 years
5 years
Disease free survival
Time Frame: 5 years
Follow up period of 5 years, or until disease progression
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Svein Dueland, MD PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

December 10, 2016

Study Completion (Actual)

December 10, 2016

Study Registration Dates

First Submitted

August 8, 2014

First Submitted That Met QC Criteria

August 18, 2014

First Posted (Estimate)

August 19, 2014

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ImmunoPeCa Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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