Basic Information


GTO ID GTC0193
Trial ID NCT02062827
Disease Recurrent Glioblastoma Multiforme | Anaplastic Astrocytoma or Gliosarcoma
Altered gene IL-12
Therapeutic/Target gene Therapeutic gene
TherapyGene transfer
Treatment M032|NSC 733972
PhasePhase1
Recruitment statusActive, Not Recruiting
TitleA Phase 1 Study of M032 (NSC 733972), a Genetically Engineered HSV-1 Expressing IL-12, in Patients With Recurrent/Progressive Glioblastoma Multiforme, Anaplastic Astrocytoma, or Gliosarcoma
Year2014
CountryUnited States
Company sponsorUniversity of Alabama at Birmingham
Other ID(s)UAB-1317|R01CA217179
Vector information
Vectorherpes simplex virus

Clinical Result

Cohort1: dose level 1
Administration route intratumoral injection
Dosage 1E5 plaque-forming units
Pts 4
Age Adult, Older_Adult
Adverse reactions 4/4(All-cause mortality)
References PMID: 27314913
Cohort2: dose level 2
Administration route intratumoral injection
Dosage 1E6 plaque-forming units
Pts 1
Age Adult, Older_Adult
Adverse reactions 1/1(All-cause mortality)
References PMID: 27314913
Cohort3: dose level 3
Administration route intratumoral injection
Dosage 1E7 plaque-forming units
Pts 1
Age Adult, Older_Adult
Adverse reactions 1/1(All-cause mortality)
References PMID: 27314913
Cohort4: dose level 4
Administration route intratumoral injection
Dosage 1E7.5 plaque-forming units
Pts 2
Age Adult, Older_Adult
Adverse reactions 2/2(All-cause mortality); 1/2(General disorders)
References PMID: 27314913
Cohort5: dose level 5
Administration route intratumoral injection
Dosage 1E8 plaque-forming units
Pts 6
Age Adult, Older_Adult
Adverse reactions 6/6(All-cause mortality); 1/6(Gastrointestinal disorders; Nervous system disorders; Respiratory, thoracic and mediastinal disorders)
References PMID: 27314913
Cohort6: dose level 6
Administration route intratumoral injection
Dosage 1E8.5 plaque-forming units
Pts 1
Age Adult, Older_Adult
Adverse reactions 1/1(All-cause mortality); 1/1(Surgical and medical procedures)
References PMID: 27314913
Cohort7: dose level 7
Administration route intratumoral injection
Dosage 1E9 plaque-forming units
Pts 6
Age Adult, Older_Adult
Adverse reactions 4/6(All-cause mortality); 2/6(Skin and subcutaneous tissue disorders; Vascular disorders)
References PMID: 27314913

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