Immunotoxin in Peritoneal Carcinomatosis- ImmunoPeCa Trial

Phase 1

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Drug: MOC31PE Immunotoxin

• Registration Number: NCT02219893
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-08
• Study First Submitted QC: 2014-08-18
• Study First Posted: 2014-08-19
• Primary Completion: 2016-12-10
• Study Completion: 2016-12-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MOC31PE Immunotoxin	MOC31PE Immunotoxin	Drug to be instilled on day 1 after cytoreductive surgery and HIPEC.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Oslo University Hospital- The Norwegian Radium Hospital; 🇳🇴 Oslo, Norway