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Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Oct 2026 to Oct 2028 Completion date: Oct 2027 to Oct 2029v18 Show 1 more changeShow less
    • Completion date: Oct 2027 to Oct 2029
  2. Primary completion date: Oct 2025 to Oct 2026 Completion date: Oct 2026 to Oct 2027v17 Show 1 more changeShow less
    • Completion date: Oct 2026 to Oct 2027
  3. Primary completion date: Oct 2023 to Oct 2025 Completion date: Oct 2024 to Oct 2026v16 Show 1 more changeShow less
    • Completion date: Oct 2024 to Oct 2026
  4. Primary completion date: Oct 2022 to Oct 2023 Completion date: Oct 2023 to Oct 2024v15 Show 1 more changeShow less
    • Completion date: Oct 2023 to Oct 2024
  5. Primary completion date: Oct 2021 to Oct 2022 Completion date: Oct 2022 to Oct 2023v14 Show 1 more changeShow less
    • Completion date: Oct 2022 to Oct 2023
Show 12 earlier versionsHide 12 earlier versions
  1. Primary completion date: Oct 2020 to Oct 2021 Completion date: Oct 2021 to Oct 2022v13 Show 1 more changeShow less
    • Completion date: Oct 2021 to Oct 2022
  2. Primary completion date: Oct 2018 to Oct 2020 Completion date: Oct 2018 to Oct 2021v12 Show 1 more changeShow less
    • Completion date: Oct 2018 to Oct 2021
  3. Primary and study completion dates: Oct 2017 to Oct 2018v11
  4. 2 versions Re-verified since Jul 25, 2016, no change to tracked fieldsv9-v10
  5. Primary completion date: Oct 2015 to Oct 2017 Completion date: Oct 2016 to Oct 2017v8 Show 1 more changeShow less
    • Completion date: Oct 2016 to Oct 2017
  6. Collaborators: 2 to 1v7 See this version in full on ClinicalTrials.gov ↗
  7. Collaborators revised (2)v6 See this version in full on ClinicalTrials.gov ↗
  8. Primary endpoints revised (2) Secondary endpoint revised · Site contact updatedv5 Show 2 more changesShow less
    • Secondary endpoint revised
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  9. Lead sponsor: Weill Medical College of Cornell University to Northwell Health Enrollment target: 100 to 54 · Primary completion date: Oct 2014 to Oct 2015 · Completion date: Oct 2015 to Oct 2016 · 5 morev4 Show 8 more changesShow less
    • Enrollment target: 100 to 54
    • Primary completion date: Oct 2014 to Oct 2015
    • Completion date: Oct 2015 to Oct 2016
    • Eligibility criteria shortened, about 17 words
    • Study description shortened, about 391 words
    • Study site revised
    • Collaborators expanded, about 8 words
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  10. Re-verified, no change to tracked fieldsv3
  11. Site contact updatedv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Northwell Health
133 trials monitored
See 10 trials at risk
Glioblastoma
670 trials monitored
See 44 trials at risk
Glioma
668 trials monitored
See 40 trials at risk
The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of tumors also exhibits the most aggressive behavior, resulting in median overall survival durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy consists of either surgical resection, external beam radiation or both. All patients experience a recurrence after first-line therapy, so improvements in both first-line and salvage therapy are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently used intravenous (IV) therapies even cross the blood brain barrier (BBB). The investigators have shown in a previous phase I trial that a single Super-selective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (up to 15mg/kg) is safe and effective in the treatment of recurrent GBM. Therefore, this phase I/II clinical research trial is an extension of that trial in that the investigators seek to test the hypothesis that repeated dosing of intraarterial Bevacizumab is safe and effective in the treatment of recurrent malignant glioma. By achieving the aims of this study the investigators will also determine if IV therapy with Bevacizumab should be combined with repeated selected intraarterial Bevacizumab to improve progression free and overall survival. The investigators expect that this project will provide important information regarding the utility of repeated SIACI Bevacizumab therapy for malignant glioma, and may alter the way these drugs are delivered to the patients in the near future.
Trial Details
NCT Number NCT01269853
Lead Sponsor Northwell Health
Collaborators: Feinstein Institute for Medical Research
Conditions Glioblastoma Multiforme, Anaplastic Astrocytoma
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov