Trial Outcomes & Findings for Intraarterial Infusion Of Erbitux and Bevacizumab For Relapsed/Refractory Intracranial Glioma In Patients Under 22 (NCT NCT01884740)
NCT ID: NCT01884740
Last Updated: 2022-08-09
Results Overview
Overall Survival (OS) will be measured from the date of the first dose of SIACI Cetuximab/Avastin to the date of death.
TERMINATED
PHASE1/PHASE2
13 participants
2 Years
2022-08-09
Participant Flow
Participant milestones
| Measure |
SIACI of Erbitux and Bevacizumab
Superselective Intraarterial Cerebral Infusion (SIACI) of Erbitux (200 mg/m\^2) and Bevacizumab (15 mg/kg)
SIACI of Erbitux and Bevacizumab: Subjects will receive a single intra-arterial dose of Cetuximab (200 mg/m\^2) and Bevacizumab (15 mg/kg) via Superselective Intraarterial Cerebral Infusion (SIACI).
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|---|---|
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Overall Study
STARTED
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13
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Overall Study
COMPLETED
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13
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SIACI of Erbitux and Bevacizumab
n=13 Participants
Superselective Intraarterial Cerebral Infusion (SIACI) of Erbitux (200 mg/m\^2) and Bevacizumab (15 mg/kg)
SIACI of Erbitux and Bevacizumab: Subjects will receive a single intra-arterial dose of Cetuximab (200 mg/m\^2) and Bevacizumab (15 mg/kg) via Superselective Intraarterial Cerebral Infusion (SIACI).
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|---|---|
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Age, Categorical
<=18 years
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13 Participants
n=13 Participants
|
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=13 Participants
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Age, Categorical
>=65 years
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0 Participants
n=13 Participants
|
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Sex: Female, Male
Female
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7 Participants
n=13 Participants
|
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Sex: Female, Male
Male
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6 Participants
n=13 Participants
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Region of Enrollment
United States
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13 participants
n=13 Participants
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PRIMARY outcome
Timeframe: 2 YearsOverall Survival (OS) will be measured from the date of the first dose of SIACI Cetuximab/Avastin to the date of death.
Outcome measures
| Measure |
SIACI of Erbitux and Bevacizumab
n=13 Participants
Superselective Intraarterial Cerebral Infusion (SIACI) of Erbitux (200 mg/m\^2) and Bevacizumab (15 mg/kg)
SIACI of Erbitux and Bevacizumab: Subjects will receive a single intra-arterial dose of Cetuximab (200 mg/m\^2) and Bevacizumab (15 mg/kg) via Superselective Intraarterial Cerebral Infusion (SIACI).
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|---|---|
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Median Overall Survival (OS)
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185 days
Interval 41.0 to 448.0
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PRIMARY outcome
Timeframe: 6 MonthsPopulation: The data for this outcome was not collected.
The overall response proportion along with a 95% confidence interval will be estimated via binomial proportions. The investigator will define "evaluable" patients as patients who met eligibility requirements and have initiated therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysAll treatment emergent adverse events will be assessed and graded according to Common Terminology Criteria for Adverse Events (CTCAE)v. 4.0 terminology for severity, duration, and relationship to research protocol treatment.
Outcome measures
| Measure |
SIACI of Erbitux and Bevacizumab
n=13 Participants
Superselective Intraarterial Cerebral Infusion (SIACI) of Erbitux (200 mg/m\^2) and Bevacizumab (15 mg/kg)
SIACI of Erbitux and Bevacizumab: Subjects will receive a single intra-arterial dose of Cetuximab (200 mg/m\^2) and Bevacizumab (15 mg/kg) via Superselective Intraarterial Cerebral Infusion (SIACI).
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|---|---|
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Number of Treatment Emergent Adverse Events
Grade 1
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4 adverse events
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Number of Treatment Emergent Adverse Events
Grade 2
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0 adverse events
|
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Number of Treatment Emergent Adverse Events
Grade 3
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0 adverse events
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Number of Treatment Emergent Adverse Events
Grade 4
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0 adverse events
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SECONDARY outcome
Timeframe: 2 YearsPopulation: The data for this outcome was not collected.
PFS will be assessed by Kaplan-Meier survival analysis, assuming adequate follow-up time. PFS will be measured from the date of the first dose of SIACI Cetuximab/Avastin to the date of progression.
Outcome measures
Outcome data not reported
Adverse Events
SIACI of Erbitux and Bevacizumab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SIACI of Erbitux and Bevacizumab
n=13 participants at risk
Superselective Intraarterial Cerebral Infusion (SIACI) of Erbitux (200 m/m\^2) and Bevacizumab (15 mg/kg)
SIACI of Erbitux and Bevacizumab: Subjects will receive a single intra-arterial dose of Cetuximab (200 m/m\^2) and Bevacizumab (15 mg/kg) via Superselective Intraarterial Cerebral Infusion (SIACI).
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|---|---|
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Surgical and medical procedures
Epistaxis
|
15.4%
2/13 • Number of events 2 • Adverse events were collected for 28 days following treatment procedure with the exception of grade 5 adverse events that were followed for a period of 2 years following treatment.
Patients were closely monitored for toxicity. The primary observation period after IA therapy was 28 days. After the 28 day period, the patient started treatment as recommended by patient's neurooncologist. Toxicities were monitored by history, physical examination, blood tests, and chest x-ray as outlined in the protocol. Within the 28 day period, AEs were assessed on day 0, day 1, and 1 month post-procedure. Participants were followed for grade 5 AEs (death) for 2 years.
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Skin and subcutaneous tissue disorders
Rash
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15.4%
2/13 • Number of events 2 • Adverse events were collected for 28 days following treatment procedure with the exception of grade 5 adverse events that were followed for a period of 2 years following treatment.
Patients were closely monitored for toxicity. The primary observation period after IA therapy was 28 days. After the 28 day period, the patient started treatment as recommended by patient's neurooncologist. Toxicities were monitored by history, physical examination, blood tests, and chest x-ray as outlined in the protocol. Within the 28 day period, AEs were assessed on day 0, day 1, and 1 month post-procedure. Participants were followed for grade 5 AEs (death) for 2 years.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place