A Phase 1/2 interventional study of Cetuximab and Cetuximab-IRDye 800CW in Brain Neoplasm and Malignant Glioma, sponsored by Eben Rosenthal. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-31.
Sponsored by Eben Rosenthal · Phase 1/2, Interventional, and Diagnostic
This study is a phase 1-2 trial that evaluates the best dose of cetuximab-IRDye 800CW and how well it works in detecting tumors in patients with malignant glioma who are undergoing surgery. Cetuximab-IRDye 800CW is an optical imaging agent that may help detect tumor cells when a special camera is used.
This is a dose-escalation study of cetuximab-IRDye 800CW. Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients receive cetuximab intravenously (IV) over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
COHORT II: Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2-5.
After completion of study, patients are followed up at days 10 and 30.
PRIMARY OBJECTIVE:
Determine the efficacy of cetuximab-IRDye 800CW (cetuximab IRDye800) in intraoperatively identifying malignant glioma compared to surrounding normal central nervous system tissue, as measured by tumor-to-background ratio.
SECONDARY OBJECTIVE:
Determine the tolerability of the cetuximab IRDye800 as an imaging agent in subjects undergoing resection of malignant glioma.
2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.
This study's enrollment of 3 is below the median of 40 across 1,831 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Eben Rosenthal is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0. All patients undergo standard of care surgical resection of tumor on days 2 to 5.
Biological: Cetuximab · Drug: Cetuximab-IRDye 800CW · Procedure: Tumor resection
Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0. All patients undergo standard of care surgical resection of tumor on days 2 to 5.
Biological: Cetuximab · Drug: Cetuximab-IRDye 800CW · Procedure: Tumor resection
Administered intravenously (IV)
Also known as: Erbitux, Chimeric Anti-epidermal growth factor receptor (EGFR0 monoclonal antibody, Chimeric Monoclonal Antibody (MoAb) C225, IMC-C225
Administered intravenously (IV)
Also known as: Cetuximab-IRDye 800, Cetuximab-IRDye800, Cetuximab-IRDye800CW
Standard of care treatment
Also known as: Conventional Surgery
Tumor to Background Ratio (TBR)
Tumor to background ratios (TBR) will be generated from still images by comparing the relative fluorescence of normal and tumor tissue. The average fluorescence will be compared to the average fluorescence of the surrounding tissue using the paired student's T test for each specimen.
Time frame: 1 day
Incidence of Adverse Events
The incidence of serious and non-serious adverse events is reported as the number of adverse events (Grade 2 or higher), as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Data are reported by number of events by treatment level.
Time frame: Up to 30 days
| Milestone | Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery) | Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery) |
|---|---|---|
| Started | 2 | 1 |
| Completed | 2 | 1 |
| Not completed | 0 | 0 |
Tumor to background ratios (TBR) will be generated from still images by comparing the relative fluorescence of normal and tumor tissue. The average fluorescence will be compared to the average fluorescence of the surrounding tissue using the paired student's T test for each specimen.
| Fluorescence Tumor to background ratio | Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery) | Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery) |
|---|---|---|
| Tumor to Background Ratio (TBR) | 1.39 (1.20 to 1.58) | 2.65 (2.65 to 2.65) |
The incidence of serious and non-serious adverse events is reported as the number of adverse events (Grade 2 or higher), as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Data are reported by number of events by treatment level.
| Adverse events | Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery) | Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery) |
|---|---|---|
| Incidence of Adverse Events | 0 | 0 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery) | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery) | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery) | Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery) |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 1/2 | 1/1 |
| Lymphocyte count decreasedInvestigations | 1/2 | 1/1 |
| HypoalbuminemiaMetabolism and nutrition disorders | 1/2 | 1/1 |
| HypocalcemiaMetabolism and nutrition disorders | 2/2 | 1/1 |
| HyponatremiaMetabolism and nutrition disorders | 2/2 | 0/1 |
| Alanine aminotransferase increasedInvestigations | 1/2 | 0/1 |
| AlkalosisMetabolism and nutrition disorders | 1/2 | 0/1 |
| Nervous system disorders - Other, ImbalanceNervous system disorders | 1/2 | 0/1 |
| HypertensionVascular disorders | 1/2 | 0/1 |
| Age, Categorical(Participants) | Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery) | Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery) | Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 2 | 1 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery) | Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 1 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery) | Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 1 | 1 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery) | Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery) | Total |
|---|---|---|---|
| United States | 2 | 1 | 3 |
Ran from Oct 2016 to primary completion in Nov 2016, 1 month.
Results were first posted in May 2018, 1 year 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Cetuximab-IRDye 800CW
Eben Rosenthal