Spots Global Cancer Trial Database for Immunotoxin in Peritoneal Carcinomatosis- ImmunoPeCa Trial
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Trial Identification
Brief Title: Immunotoxin in Peritoneal Carcinomatosis- ImmunoPeCa Trial
Official Title: Phase I/II Trial of MOC31PE Immunotoxin in Peritoneal Carcinomatosis From Colorectal Carcinoma
Study ID: NCT02219893
Conditions
Interventions
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Oslo University Hospital- The Norwegian Radium Hospital, Oslo, , Norway
Contact Details
Name: Kjersti Flatmark, MD PhD
Affiliation: Oslo University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Svein Dueland, MD PhD
Affiliation: Oslo University Hospital
Role: PRINCIPAL_INVESTIGATOR
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