Trial Outcomes & Findings for Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme (NCT NCT00390299)
NCT ID: NCT00390299
Last Updated: 2020-01-02
Results Overview
The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include hematologic events grade 3 or higher (except grade 3 ANC lasting \< 72 hours), non-hematologic events graded 3 or higher (except grade 3 nausea, vomiting, or diarrhea were to be considered DLT only if patient was receiving the max supportive care and alopecia was not considered dose limiting), neurologic toxicity grade 2 or higher, grade 2 allergic reactions asymptomatic bronchospasm and/or urticarial, grade 3 or higher allergic reactions, viremia lasting for 6 weeks or more from last viral administration deemed at least possibly related to treatment. The number of patients reporting a dose-limiting event are reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
2 weeks
Results posted on
2020-01-02
Participant Flow
Participant milestones
| Measure |
Arm A (Resection Cavity) - Dose Level 1
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^5 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 2
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^6 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 3
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^7 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 1
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^6 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^6 TCID50 MV-CEA in resection cavity on day 5.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 2
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^7 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^7 TCID50 MV-CEA in resection cavity on day 5.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
3
|
10
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm A (Resection Cavity) - Dose Level 1
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^5 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 2
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^6 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 3
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^7 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 1
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^6 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^6 TCID50 MV-CEA in resection cavity on day 5.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 2
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^7 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^7 TCID50 MV-CEA in resection cavity on day 5.
|
|---|---|---|---|---|---|
|
Overall Study
Cancellation
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme
Baseline characteristics by cohort
| Measure |
Arm A (Resection Cavity) - Dose Level 1
n=4 Participants
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^5 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 2
n=3 Participants
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^6 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 3
n=3 Participants
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^7 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 1
n=3 Participants
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^6 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^6 TCID50 MV-CEA in resection cavity on day 5.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 2
n=10 Participants
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^7 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^7 TCID50 MV-CEA in resection cavity on day 5.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
Age Group · <40 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Age, Customized
Age Group · 40-60 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Age, Customized
Age Group · >60 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
ECOG Performance Status
0
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
ECOG Performance Status
1
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
ECOG Performance Status
2
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Excludes cancel patient (never started treatment).
The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include hematologic events grade 3 or higher (except grade 3 ANC lasting \< 72 hours), non-hematologic events graded 3 or higher (except grade 3 nausea, vomiting, or diarrhea were to be considered DLT only if patient was receiving the max supportive care and alopecia was not considered dose limiting), neurologic toxicity grade 2 or higher, grade 2 allergic reactions asymptomatic bronchospasm and/or urticarial, grade 3 or higher allergic reactions, viremia lasting for 6 weeks or more from last viral administration deemed at least possibly related to treatment. The number of patients reporting a dose-limiting event are reported.
Outcome measures
| Measure |
Arm A (Resection Cavity) - Dose Level 1
n=3 Participants
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^5 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 2
n=3 Participants
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^6 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 3
n=3 Participants
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^7 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 1
n=3 Participants
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^6 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^6 TCID50 MV-CEA in resection cavity on day 5.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 2
n=10 Participants
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^7 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^7 TCID50 MV-CEA in resection cavity on day 5.
|
|---|---|---|---|---|---|
|
Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) Maximum Tolerated Dose (MTD) (Phase I) as Measured by the Number of Participants With Dose Limiting Toxicities
|
0 patients
|
0 patients
|
0 patients
|
0 patients
|
0 patients
|
PRIMARY outcome
Timeframe: Up to 2 weeksPopulation: Per protocol analysis population; excludes cancel patient (never started treatment). Per section 16.2 of the protocol, this analysis will be performed by arm (for Arms A and B).
The number of patients experiencing grade 3+ adverse events (overall and by arm) will be tabulated and summarized in this patient population.
Outcome measures
| Measure |
Arm A (Resection Cavity) - Dose Level 1
n=9 Participants
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^5 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 2
n=13 Participants
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^6 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 3
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^7 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 1
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^6 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^6 TCID50 MV-CEA in resection cavity on day 5.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 2
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^7 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^7 TCID50 MV-CEA in resection cavity on day 5.
|
|---|---|---|---|---|---|
|
Number of Patients Experiencing Grade 3+ Adverse Events, Per NCI CTCAE Version 3.0
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 weeksPopulation: Per protocol analysis population; excludes cancel patient (never started treatment). Per section 16.2 of the protocol, this analysis will be performed by arm (for Arms A and B).
The number of responses will be summarized by simple descriptive summary statistics delineating response type. CR = total disappearance of all tumor with patient off corticosteroids or only on adrenal replacement maintenance. PR= 50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose. REGR = unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. SD = failure to qualify for CR, PR, REGR, or PROG. PROG = \>25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions and/or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions.
Outcome measures
| Measure |
Arm A (Resection Cavity) - Dose Level 1
n=9 Participants
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^5 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 2
n=13 Participants
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^6 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 3
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^7 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 1
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^6 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^6 TCID50 MV-CEA in resection cavity on day 5.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 2
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^7 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^7 TCID50 MV-CEA in resection cavity on day 5.
|
|---|---|---|---|---|---|
|
Best Response, Defined as the Best Objective Status Recorded From the Start of the Treatment Until Disease Progression/Recurrence
SD
|
8 Participants
|
12 Participants
|
—
|
—
|
—
|
|
Best Response, Defined as the Best Objective Status Recorded From the Start of the Treatment Until Disease Progression/Recurrence
PD
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Length of time from date of registration to a) date of progression or death due to any cause or b) last follow-up, assessed up to 6 monthsPopulation: Per protocol analysis population; excludes cancel patient (never started treatment). Per section 16.2 of the protocol, this analysis will be performed by arm (for Arms A and B).
Percentage of patients who are progression free at 3 and 6 months (PFS3 and PFS6) will be summarized descriptively. Progression-free survival is defined as the length of time from date of registration to a) date of progression or death due to any cause or b) last follow-up. Progression is defined as a \>25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions, and/or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions.
Outcome measures
| Measure |
Arm A (Resection Cavity) - Dose Level 1
n=9 Participants
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^5 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 2
n=13 Participants
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^6 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 3
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^7 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 1
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^6 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^6 TCID50 MV-CEA in resection cavity on day 5.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 2
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^7 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^7 TCID50 MV-CEA in resection cavity on day 5.
|
|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
PFS at 3 months
|
55.6 percentage of patients
Interval 31.0 to 99.7
|
61.5 percentage of patients
Interval 40.0 to 94.6
|
—
|
—
|
—
|
|
Progression-free Survival (PFS)
PFS at 6 months
|
22.2 percentage of patients
Interval 6.6 to 75.4
|
23.1 percentage of patients
Interval 8.6 to 62.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 13 yearsPopulation: Per protocol analysis population; excludes cancel patient (never started treatment). Per section 16.2 of the protocol, this analysis will be performed by arm (for Arms A and B).
Overall survival is defined as the length of time from date of registration to a) death due to any cause or b) last follow-up. Reported using standard Kaplan-Meier estimation method.
Outcome measures
| Measure |
Arm A (Resection Cavity) - Dose Level 1
n=9 Participants
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^5 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 2
n=13 Participants
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^6 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 3
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^7 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 1
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^6 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^6 TCID50 MV-CEA in resection cavity on day 5.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 2
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^7 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^7 TCID50 MV-CEA in resection cavity on day 5.
|
|---|---|---|---|---|---|
|
Survival
|
11.8 months
Interval 4.4 to
The 95% confidence interval upper limit was not reached.
|
11.4 months
Interval 4.3 to
The 95% confidence interval upper limit was not reached.
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 15 yearsDescriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to day 28Descriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to day 5Descriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to day 28Descriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to day 28Descriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 15 yearsDescriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to day 28Descriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to day 28Descriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to day 5Descriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Resection Cavity) - Dose Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Arm A (Resection Cavity) - Dose Level 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Arm A (Resection Cavity) - Dose Level 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Arm B (Intratumoral/Resection Cavity) - Dose Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Arm B (Intratumoral/Resection Cavity) - Dose Level 2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 10 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A (Resection Cavity) - Dose Level 1
n=3 participants at risk
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^5 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 2
n=3 participants at risk
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^6 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm A (Resection Cavity) - Dose Level 3
n=3 participants at risk
Patients undergo en block resection of their tumor (after confirming diagnosis) followed by 10\^7 TCID50 MV-CEA administered into the resection cavity on day 1.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 1
n=3 participants at risk
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^6 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^6 TCID50 MV-CEA in resection cavity on day 5.
|
Arm B (Intratumoral/Resection Cavity) - Dose Level 2
n=10 participants at risk
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of 10\^7 TCID50 MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of 10\^7 TCID50 MV-CEA in resection cavity on day 5.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
66.7%
2/3 • Number of events 3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
66.7%
2/3 • Number of events 2 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
66.7%
2/3 • Number of events 2 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
100.0%
3/3 • Number of events 6 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
80.0%
8/10 • Number of events 12 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/10 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
66.7%
2/3 • Number of events 6 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
100.0%
3/3 • Number of events 3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
70.0%
7/10 • Number of events 17 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
General disorders
Localized edema
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Infections and infestations
Pneumonia(gr 3/4 ANC)
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/10 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Investigations
Leukocyte count decreased
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
30.0%
3/10 • Number of events 3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 2 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 2 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
66.7%
2/3 • Number of events 2 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
40.0%
4/10 • Number of events 7 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 2 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/10 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Nervous system disorders
Ataxia
|
66.7%
2/3 • Number of events 6 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 2 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
10.0%
1/10 • Number of events 3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 2 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
66.7%
2/3 • Number of events 4 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
40.0%
4/10 • Number of events 7 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
66.7%
2/3 • Number of events 6 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
66.7%
2/3 • Number of events 3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
10.0%
1/10 • Number of events 3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/10 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
20.0%
2/10 • Number of events 3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Nervous system disorders
Seizure
|
66.7%
2/3 • Number of events 4 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
50.0%
5/10 • Number of events 7 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Nervous system disorders
Speech disorder
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
66.7%
2/3 • Number of events 2 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
30.0%
3/10 • Number of events 6 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/10 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Psychiatric disorders
Confusion
|
33.3%
1/3 • Number of events 2 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
10.0%
1/10 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 2 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/10 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/3 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
33.3%
1/3 • Number of events 1 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
0.00%
0/10 • Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place