Colorectal NeoplasmsPhase 1/2ImmunoPeCaNCT02219893
Immunotoxin in Peritoneal Carcinomatosis- ImmunoPeCa Trial
A Phase 1/2 study testing MOC31PE Immunotoxin in people with Colorectal Neoplasms, run by Oslo University Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- MOC31PE Immunotoxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2014to 10 Dec 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital- The Norwegian Radium Hospital
Oslo, 0424
About this study
Official title: 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).
Read the 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.
- Conditions
- Colorectal Neoplasms
- Being tested
- MOC31PE Immunotoxin
- Keywords
- Peritoneal Carcinomatosis, Peritoneal Metastasis, Colorectal Cancer, Cytoreductive surgery, HIPEC, Intraperitoneal treatment, Immunotoxin, MOC31PE
- Medical subject headings
- Colorectal Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOC31PE ImmunotoxinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| MOC31PE Immunotoxin | Experimental | Drug to be instilled on day 1 after cytoreductive surgery and HIPEC. Receives: Drug: MOC31PE Immunotoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years or until disease progression
Secondary outcomes (5)
Cmax, Tmax
Measurements will be done at 0, 3, 6, 12, 24, 48 and 72 hours after administration of study drug
Measured: 8 weeks
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
Measured: 8 weeks
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
Measured: 5 years or until disease progression
Overall survival
Overall survival of all patients will be assessed after 5 years
Measured: 5 years
Disease free survival
Follow up period of 5 years, or until disease progression
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startAug 2014
- Primary completion10 Dec 2016
- Study completion10 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svein Dueland, Oslo University Hospital
- Investigators
- Kjersti Flatmark, MD PhD, Principal investigator, Oslo University HospitalSvein Dueland, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219893
- Sponsor's protocol ID
- ImmunoPeCa Trial
- Acronym
- ImmunoPeCa
- Status last verified
- May 2017
- First submitted
- 8 Aug 2014
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of MOC31PE Immunotoxin in Peritoneal Carcinomatosis From Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT02219893
- Acronym / sponsor ID
- ImmunoPeCa / ImmunoPeCa Trial
- Conditions
- Colorectal Neoplasms
- Keywords
- Peritoneal Carcinomatosis, Peritoneal Metastasis, Colorectal Cancer, Cytoreductive surgery, HIPEC, Intraperitoneal treatment, Immunotoxin, MOC31PE
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 10 Dec 2016 (actual)
- Study completion
- 10 Dec 2016 (actual)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOC31PE Immunotoxin | Experimental | Drug: MOC31PE ImmunotoxinDrug to be instilled on day 1 after cytoreductive surgery and HIPEC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOC31PE ImmunotoxinPatients 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 | Drug | MOC31PE Immunotoxin |
Primary outcome
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 secondary outcomes
Cmax, Tmax
Time frame: 8 weeks
Neutralizing anti-immunotoxin antibody response
Time frame: 8 weeks
Biomarkers of disease recurrence
Time frame: 5 years or until disease progression
Overall survival
Time frame: 5 years
Disease free survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjersti Flatmark, MD PhD principal investigator
Oslo University Hospital
Svein Dueland, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MOC31PE Immunotoxin in people with Colorectal Neoplasms, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 5 years or until disease progression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.