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M032-HSV-1NCT02062827

Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma

StatusCompleted
PhasePhase 1
Primary completion
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Record History

All 28 versions: 25 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial completed
    • Study completion date changed from estimate of Sep 2027 to Sep 2026
    • Eligibility criteria expanded, about 19 words
  2. Study completion date: Sep 2025 to Sep 2027v27
  3. Study completion date: Sep 2024 to Sep 2025v25
  4. Results first posted: Feb 2, 2024v24 Show 4 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 24 to 29
    • Primary completion date: Jun 2022 to Sep 2022
    • Secondary endpoints revised (3)
  5. Primary completion date changed from estimate of Sep 2023 to Jun 2022
    • Collaborators expanded, about 4 words
    v23
Show 19 earlier versionsHide 19 earlier versions
  1. Primary completion date: Sep 2022 to Sep 2023
    • Study completion date: Sep 2023 to Sep 2024
    v22
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 36 to confirmed 24
    • Site details revised
    v21
  3. Primary completion date: Sep 2021 to Sep 2022
    • Start date: Sep 2014 to Nov 25, 2013
    v20
  4. Eligibility criteria shortened, about 2 wordsv18
  5. Primary completion date: Sep 2020 to Sep 2021
    • Study completion date: Sep 2022 to Sep 2023
    • Eligibility criteria expanded, about 149 words
    v17
  6. Primary completion date: Sep 2019 to Sep 2020
    • Study completion date: Sep 2020 to Sep 2022
    v16
  7. Site contact updatedv15
  8. Primary completion date: Mar 2019 to Sep 2019
    • Study completion date: Mar 2020 to Sep 2020
    v14
  9. Primary completion date: Oct 2018 to Mar 2019
    • Study completion date: Oct 2018 to Mar 2020
    v12
  10. Trial status: Suspended to Recruiting
    • Primary and study completion dates: Jul 2018 to Oct 2018
    • Site details revised
    v11
  11. Trial status: Recruiting to Suspended Sponsor's reason: Updating Protocol, will resume in a few months
    • Primary and study completion dates: Jul 2017 to Jul 2018
    • Site details revised
    v10
  12. Primary and study completion dates pushed to Jul 2017v9
  13. Study title expanded, about 7 wordsv8
  14. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v7
  15. Primary completion date: Jul 2015 to Jul 2016
    • Study completion date: Jun 2016 to Jun 2017
    v6
  16. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  17. Site contact updatedv4
  18. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 2014 to Sep 2014
    • Site details revised
    • Eligibility criteria expanded, about 1 word
    v3
  19. Start date: Apr 2014 to Aug 2014v2
  1. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Maximum Tolerated Dose (MTD) of M032
Timeframe: baseline to12 months

Secondary (3)

Time to Progression Assessment
The Time of Survival Assessment
The Time of Biologic Assessment

Arms and interventions

Group A single dose of HSV-1 (M032)Experimental

single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI

Biologicals: M032 (NSC 733972)

Sites

1 site in 1 country

  • University of Alabama at BirminghamBirmingham, Alabama, United States