GlioblastomaPhase 2NCT01898273
Imaging Trial With I-124-CLR1404 in Patients With Newly Diagnosed or Recurrent Glioblastoma
A Phase 2 study testing I-124-CLR1404 in people with Glioblastoma, run by Cellectar Biosciences, Inc. at 9 sites in United States.
Trial summary
The primary objective of this trial is to determine the optimal dose and imaging time point(s) of I-124-CLR1404 in subjects with newly diagnosed and recurrent glioma to be used in future trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- I-124-CLR1404
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2014to Dec 2015
- Phase
- Phase 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
- newly diagnosed glioblastoma or recurrent/suspected recurrent glioblastoma
- scheduled to undergo a clinically-indicated surgery or biopsy (specific cohorts)
- ECOG performance status of 0 to 2 (Appendix C)
- 18 years of age or older
- has the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits
- has the ability to read, understand and provide written informed consent for the initiation of any study related procedures (or legal representative)
- if female of childbearing potential must have a negative pregnancy test within 24 hours of enrollment
- Women of childbearing potential and men who are able to father a child, must agree to use an effective method of contraception (e.g., oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device, Norplant, Depo-Provera) during the study and for 45 days following the last dose of the study drug.
Who cannot join
- ongoing grade 2 or greater toxicities due to previous therapies. However, tolerable grade 2 adverse (e.g. neuropathy) events may be allowed at the discretion of the investigator.
- has following laboratory abnormalities
- Platelets < 100,000/μL
- WBC < 3000/μL
- Hematocrit < 22%
- Serum creatinine > 2.5 mg/dL
Show all 15Show fewer
- ALT > 1.5 x ULN
- Bilirubin > 1.5 x ULN
- ongoing chronic immunosuppressive therapy
- history of hypersensitivity to iodine
- any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test drug
- women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial
- pregnancy or breast-feeding
- inability to comply with the protocol
- use of any investigational drug within 4 weeks of dosing (unless a longer time period is required by local regulations or the investigational agent)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University Medical Center
Columbus, Ohio, 43210
City of Hope
Duarte, California, 91010
Kettering Medical Center
Kettering, Ohio, 45429
University of Wisconsin
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53228
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Phase 2, Open-Label, Imaging Trial of I-124-CLR1404 in Patients With Newly Diagnosed or Recurrent Glioblastoma
The primary objective of this trial is to determine the optimal dose and imaging time point(s) of I-124-CLR1404 in subjects with newly diagnosed and recurrent glioma to be used in future trials.
- Conditions
- Glioblastoma
- Being tested
- I-124-CLR1404
- Keywords
- Glioma, Glioblastoma Multiforme, PET, Imaging, Radiopharmaceutical, Diagnostic
- Medical subject headings
- Glioblastoma, Glioma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-124-CLR1404Drug
Also called I-124-NM404
single-dose, intravenous
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | I-124-CLR1404, open-label Receives: Drug: I-124-CLR1404 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Imaging Parameters - Dose
Up to two dose levels (5 mCi and 7.5 mCi) will be evaluated in conjunction with multiple imaging time points to determine the optimal parameters for PET/CT brain imaging. Dosing will begin at 5 mCi and if the images are deemed inadequate, as assessed by count statistics and image quality, the 7.5 mCi dose level will be evaluated.
Measured: 8 days
Secondary outcomes (1)
Optimal Imaging Parameters - Imaging Time Point
Multiple imaging time points (Day 2, Day 3, and Day 4-8) will be evaluated to determine the optimal parameters for PET/CT brain imaging.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startFeb 2014
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellectar Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Kuo, MD, PhD, Principal investigator, University of Wisconsin, MadisonJana Portnow, MD, Principal investigator, City of Hope Medical CenterAbass Alavi, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898273
- Sponsor's protocol ID
- DCL-13-002
- Status last verified
- Sep 2015
- First submitted
- 8 Jul 2013
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Open-Label, Imaging Trial of I-124-CLR1404 in Patients With Newly Diagnosed or Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT01898273
- Acronym / sponsor ID
- DCL-13-002
- Conditions
- Glioblastoma
- Keywords
- Glioma, Glioblastoma Multiforme, PET, Imaging, Radiopharmaceutical, Diagnostic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Cellectar Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Jul 2013 (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 primary objective of this trial is to determine the optimal dose and imaging time point(s) of I-124-CLR1404 in subjects with newly diagnosed and recurrent glioma to be used in future trials.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Drug: I-124-CLR1404I-124-CLR1404, open-label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- newly diagnosed glioblastoma or recurrent/suspected recurrent glioblastoma
- scheduled to undergo a clinically-indicated surgery or biopsy (specific cohorts)
- ECOG performance status of 0 to 2 (Appendix C)
- 18 years of age or older
- has the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits
Key exclusion criteria (15 listed)
- ongoing grade 2 or greater toxicities due to previous therapies. However, tolerable grade 2 adverse (e.g. neuropathy) events may be allowed at the discretion of the investigator.
- has following laboratory abnormalities
- ongoing chronic immunosuppressive therapy
- history of hypersensitivity to iodine
- any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test drug
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 |
|---|---|---|
| I-124-CLR1404Also: I-124-NM404single-dose, intravenous | Drug | Single |
Primary outcome
Optimal Imaging Parameters - Dose
Time frame: 8 days
Up to two dose levels (5 mCi and 7.5 mCi) will be evaluated in conjunction with multiple imaging time points to determine the optimal parameters for PET/CT brain imaging. Dosing will begin at 5 mCi and if the images are deemed inadequate, as assessed by count statistics and image quality, the 7.5 mCi dose level will be evaluated.
1 secondary outcome
Optimal Imaging Parameters - Imaging Time Point
Time frame: 8 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
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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.
John Kuo, MD, PhD principal investigator
University of Wisconsin, Madison
Jana Portnow, MD principal investigator
City of Hope Medical Center
Abass Alavi, MD principal investigator
University of Pennsylvania
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing I-124-CLR1404 in people with Glioblastoma, run by Cellectar Biosciences, Inc. at 9 sites in United States.
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 8 inclusion and 15 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: stopped early, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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 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 was stopped early. Results are not available in the source record.
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?
Optimal Imaging Parameters - Dose (time frame: 8 days). 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 9 Sep 2015.