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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01198 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| MC0671 | Other Identifier | Mayo Clinic | |
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| P50CA108961 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase I trial studies the side effects and best dose of carcinoembryonic antigen-expressing measles virus (MV-CEA) in treating patients with glioblastoma multiforme that has come back. A virus, called MV-CEA, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells.
PRIMARY OBJECTIVES:
I. To assess the safety and toxicity of intratumoral and resection cavity administration of an Edmonston's strain measles virus genetically engineered to produce CEA (MV-CEA) in patients with recurrent glioblastoma multiforme.
II. To determine the maximum tolerated dose (MTD) of MV-CEA. III. To characterize viral gene expression at each dose level as manifested by CEA titers.
IV. To assess viremia, viral replication, and measles virus shedding/persistence following intratumoral administration.
V. To assess humoral and cellular immune response to the injected virus. VI. To assess in a preliminary fashion antitumor efficacy of this approach.
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 sequential treatment arms.
ARM A (RESECTION CAVITY ADMINISTRATION): Patients undergo en block resection of their tumor (after confirming diagnosis) on day 1, followed by MV-CEA administered into the resection cavity.
ARM B (INTRATUMORAL AND RESECTION CAVITY ADMINISTRATION): Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by carcinoembryonic antigen-expressing measles virus intratumorally (IT) through the catheter over 10 minutes on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques on day 5, followed by MV-CEA administered around the tumor bed.
After completion of study treatment, patients are followed up at 28 days (non-cohort I patients), 7 weeks (patients in cohort I only), every 2 months until progression, every 3 and 12 months after progression, and then yearly thereafter for up to 15 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (resection cavity administration) | Experimental | Patients undergo en block resection of their tumor (after confirming diagnosis) on day 1, followed by MV-CEA administered into the resection cavity. |
|
| Arm B (intratumoral and resection cavity administration) | Experimental | Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by MV-CEA IT through the catheter over 10 minutes on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques on day 5, followed by MV-CEA administered around the tumor bed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carcinoembryonic Antigen-Expressing Measles Virus | Biological | Given via injection into resection cavity or around tumor bed and/or IT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 2 weeks |
| Number of Patients Experiencing Grade 3+ Adverse Events, Per NCI CTCAE Version 3.0 | The number of patients experiencing grade 3+ adverse events (overall and by arm) will be tabulated and summarized in this patient population. | Up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Best Response, Defined as the Best Objective Status Recorded From the Start of the Treatment Until Disease Progression/Recurrence | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| CEA Titers | Descriptive 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. | Up to 15 years |
| Change in CD4 Counts |
Inclusion Criteria:
Exclusion Criteria:
Any of the following:
Active infection =< 5 days prior to registration
History of tuberculosis or history of purified protein derivative (PPD) positivity
Any of the following therapies:
Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
New York Heart Association classification III or IV
Requiring blood product support
Inadequate seizure control
Expected communication between ventricles and resection cavity as a result of surgery
Human immunodeficiency virus (HIV)-positive test result, or history of other immunodeficiency
History of organ transplantation
History of chronic hepatitis B or C
Other concurrent chemotherapy, immunotherapy, radiotherapy or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation)
Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
Allergy to measles vaccine or history of severe reaction to prior measles vaccination
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| Name | Affiliation | Role |
|---|---|---|
| Evanthia Galanis | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38216554 | Derived | Galanis E, Dooley KE, Keith Anderson S, Kurokawa CB, Carrero XW, Uhm JH, Federspiel MJ, Leontovich AA, Aderca I, Viker KB, Hammack JE, Marks RS, Robinson SI, Johnson DR, Kaufmann TJ, Buckner JC, Lachance DH, Burns TC, Giannini C, Raghunathan A, Iankov ID, Parney IF. Carcinoembryonic antigen-expressing oncolytic measles virus derivative in recurrent glioblastoma: a phase 1 trial. Nat Commun. 2024 Jan 12;15(1):493. doi: 10.1038/s41467-023-43076-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Arm A (Resection Cavity) - Dose Level 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2016 |
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|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Therapeutic Conventional Surgery | Procedure | Undergo en bloc resection |
|
| Up to 2 weeks |
| Progression-free Survival (PFS) | 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. | 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 months |
| Survival | 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. | Up to 13 years |
Descriptive 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. |
| Baseline to day 28 |
| Change in CD46 Status | Descriptive 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. | Baseline to up to day 5 |
| Change in CD8 Counts | Descriptive 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. | Baseline to day 28 |
| Change in Viral Shedding | Descriptive 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. | Baseline to day 28 |
| Change in Viremia | Descriptive 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. | Baseline to up to 15 years |
| Measles Virus Specific Immunity, in Terms of Change in Interferon Gamma | Descriptive 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. | Baseline to day 28 |
| Measles Virus Specific Immunity, in Terms of Change in Lymphoproliferative Assay Results | Descriptive 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. | Baseline to day 28 |
| Viral Propagation in Tumor | Descriptive 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. | Up to day 5 |
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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| ECOG Performance Status | Eastern Cooperative Oncology Group PS Scale: 0)Fully active, able to carry on all pre-disease performance without restriction; 1)Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2)Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3)Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4)Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Excludes cancel patient (never started treatment). | Posted | Number | patients | 2 weeks |
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| Primary | Number of Patients Experiencing Grade 3+ Adverse Events, Per NCI CTCAE Version 3.0 | The number of patients experiencing grade 3+ adverse events (overall and by arm) will be tabulated and summarized in this patient population. | 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). | Posted | Count of Participants | Participants | Up to 2 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Response, Defined as the Best Objective Status Recorded From the Start of the Treatment Until Disease Progression/Recurrence | 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. | 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). | Posted | Count of Participants | Participants | Up to 2 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | 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. | 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). | Posted | Number | 95% Confidence Interval | percentage of patients | 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 months |
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| Secondary | Survival | 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. | 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). | Posted | Median | 95% Confidence Interval | months | Up to 13 years |
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| Other Pre-specified | CEA Titers | Descriptive 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. | Not Posted | Up to 15 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in CD4 Counts | Descriptive 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. | Not Posted | Baseline to day 28 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in CD46 Status | Descriptive 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. | Not Posted | Baseline to up to day 5 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in CD8 Counts | Descriptive 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. | Not Posted | Baseline to day 28 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Viral Shedding | Descriptive 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. | Not Posted | Baseline to day 28 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Viremia | Descriptive 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. | Not Posted | Baseline to up to 15 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Measles Virus Specific Immunity, in Terms of Change in Interferon Gamma | Descriptive 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. | Not Posted | Baseline to day 28 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Measles Virus Specific Immunity, in Terms of Change in Lymphoproliferative Assay Results | Descriptive 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. | Not Posted | Baseline to day 28 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Viral Propagation in Tumor | Descriptive 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. | Not Posted | Up to day 5 | Participants |
Up to 2 weeks
All patients who received treatment were assessed at the end of two weeks for adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 3 | 3 | 0 | 3 | 3 | 3 |
| EG001 | 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. | 3 | 3 | 0 | 3 | 3 | 3 |
| EG002 | 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. | 3 | 3 | 0 | 3 | 3 | 3 |
| EG003 | 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. | 3 | 3 | 0 | 3 | 3 | 3 |
| EG004 | 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. | 10 | 10 | 0 | 10 | 10 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 9 | Systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | MedDRA 9 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9 | Systematic Assessment |
| |
| Localized edema | General disorders | MedDRA 9 | Systematic Assessment |
| |
| Pneumonia(gr 3/4 ANC) | Infections and infestations | MedDRA 9 | Systematic Assessment |
| |
| Leukocyte count decreased | Investigations | MedDRA 9 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 9 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 9 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 9 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Pyramidal tract syndrome | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 9 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 9 | Systematic Assessment |
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| Confusion | Psychiatric disorders | MedDRA 9 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 9 | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA 9 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evanthia Galanis, M.D. | Mayo Clinic | +1 (507) 266-0584 | Galanis.Evanthia@mayo.edu |
| Nov 26, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D009837 | Oligodendroglioma |
| D005910 | Glioma |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| 40-60 years |
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| >60 years |
|
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 |
|
| 2 |
|
| Maximum Tolerated Dose (x 10^7 TCID50) |
| 1 |
| 2-Sided |
| Other |
|
|
Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by intratumoral administration of MV-CEA on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques followed by injection of MV-CEA in resection cavity on day 5. |
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