Anaplastic AstrocytomaPhase 1NCT00390299
Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme
A Phase 1 study testing Carcinoembryonic Antigen-Expressing Measles Virus, Laboratory Biomarker Analysis and Therapeutic Conventional Surgery in people with Anaplastic Astrocytoma and Anaplastic Oligodendroglioma, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Mixed Glioma
- What is being tested?
- Carcinoembryonic Antigen-Expressing Measles Virus, Laboratory Biomarker Analysis and Therapeutic Conventional Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2006to 30 Nov 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent grade 3 or 4 glioma, including astrocytoma, oligodendroglioma or mixed glioma with histologic confirmation at initial diagnosis or recurrence
- Candidate for gross total or subtotal resection
- Absolute neutrophil count (ANC) >= 1500/uL
- Platelets (PLT) >= 100,000/uL
- Total bilirubin =< 1.5 x upper normal limit (ULN)
- Aspartate aminotransferase (AST) =< 2 x ULN
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- Creatinine =< 2.0 x ULN
- Hemoglobin (Hgb) >= 9.0 gm/dL
- Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.3 x ULN
- Ability to provide informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- Anti-measles virus immunity as demonstrated by immunoglobulin G (IgG) anti-measles antibody levels of >= 1.1 EU/ml as determined by enzyme immunoassay
- Normal serum CEA levels (< 3 ng/ml) at the time of registration
- Willing to provide biologic specimens as required by the protocol
- Negative serum pregnancy test done =< 7 days prior to registration (for women of childbearing potential only)
Who cannot join
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Active infection =< 5 days prior to registration
- History of tuberculosis or history of purified protein derivative (PPD) positivity
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- Any of the following therapies:
- Chemotherapy =< 4 weeks prior to registration (6 wks for nitrosourea-based chemotherapy)
- Immunotherapy =< 4 weeks prior to registration
- Biologic therapy =< 4 weeks prior to registration
- Bevacizumab =< 12 weeks prior to registration
- Non-cytotoxic antitumor drugs, i.e., small molecule cell cycle inhibitors =< 2 weeks prior to registration
- Radiation therapy =< 6 weeks prior to registration
- Any viral or gene therapy prior to registration
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Trial of a Measles Virus Derivative Producing CEA (MV-CEA) in Patients With Recurrent Glioblastoma Multiforme (GBM)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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.
- Conditions
- Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Mixed Glioma, Recurrent Glioblastoma
- Being tested
- Carcinoembryonic Antigen-Expressing Measles Virus, Laboratory Biomarker Analysis, Therapeutic Conventional Surgery
- Medical subject headings
- Astrocytoma, Oligodendroglioma, Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carcinoembryonic Antigen-Expressing Measles VirusBiological
Also called MV-CEA
Given via injection into resection cavity or around tumor bed and/or IT
Laboratory Biomarker AnalysisOther
Correlative studies
Therapeutic Conventional SurgeryProcedure or surgery
Undergo en bloc resection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Carcinoembryonic Antigen-Expressing Measles Virus; Other: Laboratory Biomarker Analysis; Procedure: Therapeutic Conventional Surgery |
| 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. Receives: Biological: Carcinoembryonic Antigen-Expressing Measles Virus; Other: Laboratory Biomarker Analysis; Procedure: Therapeutic Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 2 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study start23 Oct 2006
- Primary completion29 Nov 2018
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anaplastic AstrocytomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Evanthia Galanis, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390299
- Sponsor's protocol ID
- MC0671
- Other IDs
- NCI-2009-01198, MC0671, P30CA015083, P50CA108961
- Status last verified
- Jan 2019
- First submitted
- 18 Oct 2006
- Last updated
- 2 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 38216554
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of a Measles Virus Derivative Producing CEA (MV-CEA) in Patients With Recurrent Glioblastoma Multiforme (GBM)
- ClinicalTrials.gov ID
- NCT00390299
- Acronym / sponsor ID
- MC0671
- Conditions
- Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Mixed Glioma, Recurrent Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Oct 2006 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 19 Oct 2006 (estimated)
- Results
- Posted 2 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (resection cavity administration) | Experimental | Biological: Carcinoembryonic Antigen-Expressing Measles Virus, Other: Laboratory Biomarker Analysis, Procedure: Therapeutic Conventional SurgeryPatients 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 | Biological: Carcinoembryonic Antigen-Expressing Measles Virus, Other: Laboratory Biomarker Analysis, Procedure: Therapeutic Conventional SurgeryPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Recurrent grade 3 or 4 glioma, including astrocytoma, oligodendroglioma or mixed glioma with histologic confirmation at initial diagnosis or recurrence
- Candidate for gross total or subtotal resection
- Absolute neutrophil count (ANC) >= 1500/uL
- Platelets (PLT) >= 100,000/uL
- Total bilirubin =< 1.5 x upper normal limit (ULN)
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carcinoembryonic Antigen-Expressing Measles VirusAlso: MV-CEAGiven via injection into resection cavity or around tumor bed and/or IT | Biological | Arm A (resection cavity administration), Arm B (intratumoral and resection cavity administration) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm A (resection cavity administration), Arm B (intratumoral and resection cavity administration) |
| Therapeutic Conventional SurgeryUndergo en bloc resection | Procedure or surgery | Arm A (resection cavity administration), Arm B (intratumoral and resection cavity administration) |
Primary outcome
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
Time frame: 2 weeks
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.
Number of Patients Experiencing Grade 3+ Adverse Events, Per NCI CTCAE Version 3.0
Time frame: Up to 2 weeks
The number of patients experiencing grade 3+ adverse events (overall and by arm) will be tabulated and summarized in this patient population.
3 secondary outcomes
Best Response, Defined as the Best Objective Status Recorded From the Start of the Treatment Until Disease Progression/Recurrence
Time frame: Up to 2 weeks
Progression-free Survival (PFS)
Time frame: 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
Time frame: Up to 13 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38216554Galanis 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evanthia Galanis principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Carcinoembryonic Antigen-Expressing Measles Virus, Laboratory Biomarker Analysis and Therapeutic Conventional Surgery in people with Anaplastic Astrocytoma and Anaplastic Oligodendroglioma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00390299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.