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Immunotoxin in Peritoneal Carcinomatosis- ImmunoPeCa Trial (ImmunoPeCa)

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
MOC31PE Immunotoxin
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Peritoneal Carcinomatosis, Peritoneal Metastasis, Colorectal Cancer, Cytoreductive surgery, HIPEC, Intraperitoneal treatment, Immunotoxin, MOC31PE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University Hospital- The Norwegian Radium Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MOC31PE Immunotoxin

Arm Description

Drug to be instilled on day 1 after cytoreductive surgery and HIPEC.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 8, 2014
Last Updated
May 24, 2017
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02219893
Brief Title
Immunotoxin in Peritoneal Carcinomatosis- ImmunoPeCa Trial
Acronym
ImmunoPeCa
Official Title
Phase I/II Trial of MOC31PE Immunotoxin in Peritoneal Carcinomatosis From Colorectal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 10, 2016 (Actual)
Study Completion Date
December 10, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Peritoneal Carcinomatosis, Peritoneal Metastasis, Colorectal Cancer, Cytoreductive surgery, HIPEC, Intraperitoneal treatment, Immunotoxin, MOC31PE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MOC31PE Immunotoxin
Arm Type
Experimental
Arm Description
Drug to be instilled on day 1 after cytoreductive surgery and HIPEC.
Intervention Type
Drug
Intervention Name(s)
MOC31PE Immunotoxin
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
Follow-up: 5 years from administration of study drug, or until disease progression
Time Frame
5 years or until disease progression
Secondary Outcome Measure Information:
Title
Cmax, Tmax
Description
Measurements will be done at 0, 3, 6, 12, 24, 48 and 72 hours after administration of study drug
Time Frame
8 weeks
Title
Neutralizing anti-immunotoxin antibody response
Description
Measurements of neutralizing anti-immunotoxin antibody response will be done at 4 and 8 weeks after administration of study drug
Time Frame
8 weeks
Title
Biomarkers of disease recurrence
Description
Serum samples for identification of biomarkers of disease recurrence will be taken at every follow-up for 5 years or until disease progression
Time Frame
5 years or until disease progression
Title
Overall survival
Description
Overall survival of all patients will be assessed after 5 years
Time Frame
5 years
Title
Disease free survival
Description
Follow up period of 5 years, or until disease progression
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjersti Flatmark, MD PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Svein Dueland, MD PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital- The Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

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Immunotoxin in Peritoneal Carcinomatosis- ImmunoPeCa Trial

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