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Trial record 2 of 2 for:    MOC31-PE

Immunotoxin in Peritoneal Carcinomatosis- ImmunoPeCa Trial (ImmunoPeCa)

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ClinicalTrials.gov Identifier: NCT02219893
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Svein Dueland, Oslo University Hospital

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).

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: MOC31PE Immunotoxin Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of MOC31PE Immunotoxin in Peritoneal Carcinomatosis From Colorectal Carcinoma
Study Start Date : August 2014
Actual Primary Completion Date : December 10, 2016
Actual Study Completion Date : December 10, 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Overall survival [ Time Frame: 5 years ]
    Overall survival of all patients will be assessed after 5 years

  5. Disease free survival [ Time Frame: 5 years ]
    Follow up period of 5 years, or until disease progression



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219893


Locations
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Norway
Oslo University Hospital- The Norwegian Radium Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Kjersti Flatmark, MD PhD Oslo University Hospital
Principal Investigator: Svein Dueland, MD PhD Oslo University Hospital

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Responsible Party: Svein Dueland, Senior consultant medical oncology, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02219893     History of Changes
Other Study ID Numbers: ImmunoPeCa Trial
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by Svein Dueland, Oslo University Hospital:
Peritoneal Carcinomatosis
Peritoneal Metastasis
Colorectal Cancer
Cytoreductive surgery
HIPEC
Intraperitoneal treatment
Immunotoxin
MOC31PE

Additional relevant MeSH terms:
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Colorectal Neoplasms
Carcinoma
Peritoneal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Peritoneal Diseases
Immunotoxins
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs