Colorectal NeoplasmsPhase 1PRIT2008NCT00860860
Study of Pretargeted Radioimmunotherapy of a Anti-CEA Bispecific Antibody and Lu177-labeled Peptide in Colorectal Cancer
A Phase 1 study testing TF2 and IMP-288 labeled with In111 and Lu177 in people with Colorectal Neoplasms, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
This study will investigate the toxicity, safety and pharmacokinetics of pretargeted radioimmunotherapy with anti-CEA x anti-hapten bispecific antibody TF2 and Lu-177-labeled di-HSG-DOTA peptide IMP-288. 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?
- TF2 and IMP-288 labeled with In111 and Lu177
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2009to Oct 2011
- Phase
- Phase 1
- 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
- Patients with CEA expressing advanced colorectal tumors for which no standard treatment is available
- WHO performance status: 0 or 1
- Having normal hematological function: Neutrophils > 1.5 x 109/l; Platelet count > 150 x 109/l, without transfusion during the previous month; Hemoglobin > 5.6 mmol/l
- Total bilirubin < 2 x upper limit of normal (ULN)
- ASAT, ALAT < 3 x ULN
- Serum creatinine < 2 x ULN
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- Cockcroft clearance > 50 ml/min
- Negative pregnancy test for women of child¬bearing potential (urine or serum)
- Age over 18 years
- Ability to provide written informed consent
Who cannot join
- Known metastases to the brain
- Chemotherapy, external beam radiation or immunotherapy within 4 weeks prior to study. Limited field external beam radiotherapy to prevent pathological fractures is allowed, when unirradiated, evaluable lesions elsewhere are present.
- Prior angiogenesis inhibitors within 4 weeks; bevacizumab within 8 weeks
- Cardiac disease with New York Heart Association classification of III or IV
- Patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception
- Any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgement of the investigator will significantly affect patients' clinical status
- Life expectancy shorter than 6 months.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6525 GA
About this study
Official title: Phase I Clinical Study of the Feasibility of Pretargeted Radioimmunotherapy of an Anti-CEA Bispecific Antibody and Lu-177-labeled Peptide in Patients With Advanced Colorectal Cancer
This study will investigate the toxicity, safety and pharmacokinetics of pretargeted radioimmunotherapy with anti-CEA x anti-hapten bispecific antibody TF2 and Lu-177-labeled di-HSG-DOTA peptide IMP-288. Furthermore, the sensitivity of pretargeted imaging with In-111-labeled IMP-288 as compared to standard methods of tumor detection, and the preliminary efficacy of the therapy.
Read the detailed description
Pretherapy cycle with IMP-288 labeled In111.
- Conditions
- Colorectal Neoplasms
- Being tested
- TF2, IMP-288 labeled with In111 and Lu177
- Keywords
- radioimmunotherapy, pretargeting, bispecific antibody, lutetium 177, phase I clinical trial
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TF2Drug
TF2: 75-300 mg
IMP-288 labeled with In111 and Lu177Drug
IMP-288: 100 microgram
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity defined by NCI Common Terminology Criteria for Adverse Events version 3.0
Measured: first three weeks: daily, thereafter: weekly
Secondary outcomes (1)
pharmacokinetics and biodistribution of TF2 and Lu-177-labeled IMP-288, sensitivity of pretargeted imaging with In-111-labeled IMP-288, and tumor response using RECIST criteria
Measured: Pk/biodistr: first week after administration; imaging: first 5 days after administration of IMP-288-In111; tumor respone: every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2011
- Study completionOct 2011
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 Radboud University Medical CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- O C Boerman, PhD, Study chair, RUNMC Department of Nuclear MedicineR Schoffelen, MD, Study chair, RUNMC Department of Nuclear MedicineW JG Oyen, MD PhD, Principal investigator, RUNMC Department of Nuclear MedicineW TA van der Graaf, MD PhD, Principal investigator, RUNMC Department of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860860
- Sponsor's protocol ID
- RUNMC-PRIT2008
- Acronym
- PRIT2008
- Status last verified
- Aug 2010
- First submitted
- 11 Mar 2009
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of the Feasibility of Pretargeted Radioimmunotherapy of an Anti-CEA Bispecific Antibody and Lu-177-labeled Peptide in Patients With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00860860
- Acronym / sponsor ID
- PRIT2008 / RUNMC-PRIT2008
- Conditions
- Colorectal Neoplasms
- Keywords
- radioimmunotherapy, pretargeting, bispecific antibody, lutetium 177, phase I clinical trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 12 Mar 2009 (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.
This study will investigate the toxicity, safety and pharmacokinetics of pretargeted radioimmunotherapy with anti-CEA x anti-hapten bispecific antibody TF2 and Lu-177-labeled di-HSG-DOTA peptide IMP-288. Furthermore, the sensitivity of pretargeted imaging with In-111-labeled IMP-288 as compared to standard methods of tumor detection, and the preliminary efficacy of the therapy.
Detailed description
Pretherapy cycle with IMP-288 labeled In111.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with CEA expressing advanced colorectal tumors for which no standard treatment is available
- WHO performance status: 0 or 1
- Having normal hematological function: Neutrophils > 1.5 x 109/l; Platelet count > 150 x 109/l, without transfusion during the previous month; Hemoglobin > 5.6 mmol/l
- Total bilirubin < 2 x upper limit of normal (ULN)
- ASAT, ALAT < 3 x ULN
Key exclusion criteria (7 listed)
- Known metastases to the brain
- Chemotherapy, external beam radiation or immunotherapy within 4 weeks prior to study. Limited field external beam radiotherapy to prevent pathological fractures is allowed, when unirradiated, evaluable lesions elsewhere are present.
- Prior angiogenesis inhibitors within 4 weeks; bevacizumab within 8 weeks
- Cardiac disease with New York Heart Association classification of III or IV
- Patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception
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 |
|---|---|---|
| TF2TF2: 75-300 mg | Drug | – |
| IMP-288 labeled with In111 and Lu177IMP-288: 100 microgram | Drug | – |
Primary outcome
Toxicity defined by NCI Common Terminology Criteria for Adverse Events version 3.0
Time frame: first three weeks: daily, thereafter: weekly
1 secondary outcome
pharmacokinetics and biodistribution of TF2 and Lu-177-labeled IMP-288, sensitivity of pretargeted imaging with In-111-labeled IMP-288, and tumor response using RECIST criteria
Time frame: Pk/biodistr: first week after administration; imaging: first 5 days after administration of IMP-288-In111; tumor respone: every 8 weeks
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 19 Mar 2012.
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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.
O C Boerman, PhD study chair
RUNMC Department of Nuclear Medicine
R Schoffelen, MD study chair
RUNMC Department of Nuclear Medicine
W JG Oyen, MD PhD principal investigator
RUNMC Department of Nuclear Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TF2 and IMP-288 labeled with In111 and Lu177 in people with Colorectal Neoplasms, run by Radboud University Medical Center at 1 site in Netherlands.
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 10 inclusion and 7 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 19 Mar 2012. 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 Netherlands. 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 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.
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?
Toxicity defined by NCI Common Terminology Criteria for Adverse Events version 3.0 (time frame: first three weeks: daily, thereafter: weekly). 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 19 Mar 2012.