Phase 1
N=23
Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme
Anaplastic Astrocytoma · Anaplastic Oligodendroglioma · Mixed Glioma · Recurrent Glioblastoma
Bottom Line
View on ClinicalTrials.gov: NCT00390299 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: 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 — 0; 0; 0; 0 patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Carcinoembryonic Antigen-Expressing Measles Virus (Biological); Laboratory Biomarker Analysis (Other); Therapeutic Conventional Surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
0; 0; 0; 0; 0 | — |
| PRIMARY Number of Patients Experiencing Grade 3+ Adverse Events, Per NCI CTCAE Version 3.0 |
6; 5 | — |
| SECONDARY Best Response, Defined as the Best Objective Status Recorded From the Start of the Treatment Until Disease Progression/Recurrence |
8; 12; 1; 1 | — |
| SECONDARY Progression-free Survival (PFS) |
55.6; 61.5; 22.2; 23.1 | — |
| SECONDARY Survival |
11.8; 11.4 | 0.28 |
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.
Eligibility Criteria
Inclusion Criteria
- 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 = = 9.0 gm/dL
- Prothrombin time (PT) and activated partial thromboplastin time (aPTT) = = 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)
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00390299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.