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Table 1 Summary of clinical trials of oncolytic viral therapy for patients with glioblastoma

From: Emerging therapies for glioblastoma: current state and future directions

Treatment

Status

Enrolled Patients

Primary outcome measures

NCT number

Genetically Engineered

Adenovirus DNX-2440

Recruiting

phase I

24

Safety, OS, and ORR

NCT03714334

Combination of modified vaccinia

virus TG6002 and 5-FC

unknown

phase I/II

78

DLTs and tumor progression at 6 months

NCT03294486

Adenovirus DNX-2401 ± IFN-γ

Completed

phase I

37

ORR by interval tumor size

NCT02197169

DNX2401 and TMZ

Completed

phase I

31

Number of patients with AEs

NCT01956734

Genetically Engineered HSV-1

MVR-C5252 (C5252)

Not yet recruiting

phase I

51

Safety and tolerability

DLTs and MTD

NCT05095441

New Castle Disease Virus

Study withdrawn for unknown reasons

phase I/II

0

PFS

NCT01174537

Recombinant nonpathogenic polio-rhinovirus chimera (PVSRIPO) administered by CED into tumor

Active, not recruiting

phase I

61

MTD, DLTs and RP2D

NCT01491893

Adenovirus DNX-2401 and surgery

Recruiting

phase I

36

MTD and Incidence of AEs

NCT03896568

Genetically Engineered HSV-1 G207

Completed

phase I/II

65

Not provided

NCT00028158

Replication-competent Adenovirus (Delta-24-RGD) administered by CED into tumor

Completed

phase I/II

20

treatment related serious AEs

NCT01582516

Neural stem cells (NSCs) loaded with an oncolytic adenovirus

Active, not recruiting

phase I

13

maximum number of NSCs loaded with oncolytic adenovirus

NCT03072134

H-1 Parvovirus (H-1PV)

Completed

phase I/II

18

Safety and tolerability

NCT01301430

HSV-1 mutant HSV1716

Study terminated for unknown reasons

phase I

2

MTD

NCT02031965

Combination Adenovirus change NCT02798406 DNX2401 and pembrolizumab

Completed

phase II

49

ORR by interval tumor size

 

AdV-tk (adenoviral vector expressing HSV-TK) plus valacyclovir (antiviral drug) and SOC

Completed

phase II

52

Safety and OS

NCT00589875

Genetically Engineered HSV-1 C134

Recruiting

phase I

24

Safety and tolerability

NCT03657576

Oncolytic viral vector rQNestin34.5v.2

Recruiting

phase I

56

MTD

NCT03152318

PVSRIPO

Active, not recruiting

phase I

12

Toxicity within 14 days after PVSRIPO treatment

NCT03043391

Genetically Engineered HSV-1 M032

Recruiting

phase I

36

MTD

NCT02062827

Single dose of G207 infused through catheters into tumors

Not yet recruiting

phase II

30

OS

NCT04482933

PVSRIPO administered by CED into tumor

Active, not recruiting

phase II

122

ORR rate and DORR at 24 and 36 months

NCT02986178

Single dose of G207 infused through catheters into tumors

Recruiting

phase I

15

Safety and tolerability

NCT03911388

Single dose of G207 infusedthrough catheters into tumors

Active, not recruiting

phase I

12

Safety and tolerability

NCT02457845

Live, replication-competent wild-type reovirus REOLYSIN®

Completed

phase I

18

MTD, DLTs and 6- month response rate

NCT00528684

Combination of PVSRIPO and atezolizumab

withdrawn

Re-submission Planned

phase I/II

0

AEs within 14 days after atezolizumab treatment,

proportion patients alive at 24 months after PVSRIPO infusion

NCT03973879

Toca511 & Toca FC versus SOC

Study terminated for unknown reasons

phase II/III

403

OS

NCT02414165

  1. Most data were obtained from findings from www.clinicaltrials.gov using the search terms “glioblastoma” and “oncolytic”; 5-FC 5-flucytosine, TMZ temozolomide, OS overall survival, ORR objective response rate, IFN-γ interferon Gamma, SOC Standard of Care, DLT dose limiting toxicities, AE adverse event, MTD maximum tolerated dose, PFS progression-free survival, HSV herpes simplex virus, CED convection-enhanced delivery, NSC neural stem cells, RP2D recommended phase 2 dose, ORR objective radiographic response, DORR duration of objective radiographic response