Recurrent Glioblastoma Clinical Trial
Official title:
Phase I Trial of a Measles Virus Derivative Producing CEA (MV-CEA) in Patients With Recurrent Glioblastoma Multiforme (GBM)
Verified date | January 2019 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | November 30, 2019 |
Est. primary completion date | November 29, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 =< 1.5 x upper normal limit (ULN) - Aspartate aminotransferase (AST) =< 2 x ULN - 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) 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | 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. | Baseline to day 28 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
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. | 2 weeks | |
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. | 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. | 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. | 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 | |
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. | Up to 13 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05577091 -
Tris-CAR-T Cell Therapy for Recurrent Glioblastoma
|
Phase 1 | |
Recruiting |
NCT05284643 -
Spectroscopic MRI, Proton Therapy, and Avastin for Recurrent Glioblastoma
|
N/A | |
Recruiting |
NCT05039281 -
Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT04988750 -
Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System With Re-irradiation for rGBM Patients
|
N/A | |
Recruiting |
NCT06058988 -
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
|
Phase 2 | |
Completed |
NCT00503204 -
Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour
|
Phase 1 | |
Completed |
NCT03216499 -
HIF-2 Alpha Inhibitor PT2385 in Treating Patients With Recurrent Glioblastoma
|
Phase 2 | |
Not yet recruiting |
NCT04717999 -
Pilot Study of NKG2D CAR-T in Treating Patients With Recurrent Glioblastoma
|
N/A | |
Not yet recruiting |
NCT05540275 -
Tislelizumab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for Bevacizumab Refractory Recurrent Glioblastoma
|
Phase 2 | |
Recruiting |
NCT04528680 -
Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma
|
Phase 1/Phase 2 | |
Completed |
NCT04044937 -
Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms
|
Phase 2 | |
Recruiting |
NCT04888611 -
Neoadjuvant PD-1 Antibody Alone or Combined With DC Vaccines for Recurrent Glioblastoma
|
Phase 2 | |
Recruiting |
NCT05463848 -
Surgical Pembro +/- Olaparib w TMZ for rGBM
|
Phase 2 | |
Active, not recruiting |
NCT04479241 -
LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma
|
Phase 2 | |
Active, not recruiting |
NCT00777153 -
Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma
|
Phase 3 | |
Withdrawn |
NCT05017610 -
Inducing a Hypothyroxinemic State in Patients With Recurrent Glioblastoma or Gliosarcoma
|
Early Phase 1 | |
Recruiting |
NCT04323046 -
Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults
|
Phase 1 | |
Active, not recruiting |
NCT05324501 -
A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma
|
Phase 1 | |
Withdrawn |
NCT05666349 -
Reirradiation and Niraparib in Patients With Recurrent Glioblastoma
|
Phase 1 | |
Active, not recruiting |
NCT04440358 -
Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM
|
Phase 1/Phase 2 |