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Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors

Study acronym: MEMMAT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Interventions modified Site details revised at 5 of 22 sites · Publications: details revised at 1 of 2 entriesv25 Show 2 more changesShow less
    • Site details revised at 5 of 22 sites
    • Publications: details revised at 1 of 2 entries
  2. Enrollment target: 100 to 232 Interventions: Bevacizumab (Drug), Celecoxib (Drug), Cyclophosphamide (Drug), Cytarabine (Drug), Etoposide (Drug), Etoposide phosphate (Drug), Fenofibric… to Bevacizumab (Drug), Celecoxib (Drug), Cyclophosphamide (Drug), Cytarabine (Drug), Etoposide (Drug), Etoposide phosphate (Drug), Fenofibric… · Eligibility criteria expanded, about 82 words · Site details revised at 19 of 22 sites · 2 morev24 Show 5 more changesShow less
    • Interventions: Bevacizumab (Drug), Celecoxib (Drug), Cyclophosphamide (Drug), Cytarabine (Drug), Etoposide (Drug), Etoposide phosphate (Drug), Fenofibric… to Bevacizumab (Drug), Celecoxib (Drug), Cyclophosphamide (Drug), Cytarabine (Drug), Etoposide (Drug), Etoposide phosphate (Drug), Fenofibric…
    • Eligibility criteria expanded, about 82 words
    • Site details revised at 19 of 22 sites
    • Study arms: 0 to 2
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary and study completion dates: Apr 2026 to Apr 2030 Site details revised at 19 of 22 sitesv23 Show 1 more changeShow less
    • Site details revised at 19 of 22 sites
  4. 2 versions Re-verified since Apr 19, 2023, no change to tracked fieldsv21-v22
  5. Site contacts updated at 1 of 22 sitesv20
Show 18 earlier versionsHide 18 earlier versions
  1. Site contacts updated at 2 of 22 sitesv19
  2. Study sites: 21 to 22v18
  3. Primary completion date: Apr 2021 to Apr 2026 Completion date: Apr 2023 to Apr 2026 · Site details revised at 2 of 21 sitesv17 Show 2 more changesShow less
    • Completion date: Apr 2023 to Apr 2026
    • Site details revised at 2 of 21 sites
  4. Enrollment target: 40 to 100 Eligibility criteria expanded, about 6 words · Site contacts updated at 1 of 21 sites · Study title revisedv16 Show 3 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Site contacts updated at 1 of 21 sites
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 20 to 21v15
  6. Study sites: 18 to 20v14
  7. Site contacts updated at 1 of 18 sitesv13
  8. Study sites: 17 to 18v12
  9. Primary completion date: Apr 2019 to Apr 2021 Completion date: Apr 2022 to Apr 2023 · Interventions: Bevacizumab (Drug), Celecoxib (Drug), Cyclophosphamide (Drug), Etoposide (Drug), Etoposide phosphate (Drug), Fenofibric acid (Drug)… to Bevacizumab (Drug), Celecoxib (Drug), Cyclophosphamide (Drug), Cytarabine (Drug), Etoposide (Drug), Etoposide phosphate (Drug), Fenofibric… · Site details revised at 5 of 17 sitesv11 Show 3 more changesShow less
    • Completion date: Apr 2022 to Apr 2023
    • Interventions: Bevacizumab (Drug), Celecoxib (Drug), Cyclophosphamide (Drug), Etoposide (Drug), Etoposide phosphate (Drug), Fenofibric acid (Drug)… to Bevacizumab (Drug), Celecoxib (Drug), Cyclophosphamide (Drug), Cytarabine (Drug), Etoposide (Drug), Etoposide phosphate (Drug), Fenofibric…
    • Site details revised at 5 of 17 sites
  10. Study sites: 12 to 17v10
  11. Study sites: 9 to 12v9
  12. Study sites revised (9)v8 See this version in full on ClinicalTrials.gov ↗
  13. Study sites: 1 to 9 Collaborators shortened, about 12 wordsv7 Show 1 more changeShow less
    • Collaborators shortened, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  14. Re-verified, no change to tracked fieldsv6
  15. Eligibility criteria expanded, about 80 wordsv5 See this version in full on ClinicalTrials.gov ↗
  16. Primary completion date: Apr 2017 to Apr 2019 Start date: Apr 2011 to Apr 2014 · Completion date: Apr 2018 to Apr 2022 · Eligibility criteria expanded, about 80 words · 2 morev4 Show 5 more changesShow less
    • Start date: Apr 2011 to Apr 2014
    • Completion date: Apr 2018 to Apr 2022
    • Eligibility criteria expanded, about 80 words
    • Secondary endpoints: details revised at 7 of 7 entries
    • Collaborators: 1 to 4

    See this version in full on ClinicalTrials.gov ↗

  17. Site contact updatedv3
  18. Secondary endpoints: details revised at 1 of 7 entries Site contact updated · Eligibility criteria expanded, about 5 wordsv2 Show 2 more changesShow less
    • Site contact updated
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  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.
Patients with with recurrent or progressive medulloblastoma, ependymoma, atypical teratoid rhabdoid tumor (ATRT), and CNS tumors of various histologies have a very poor prognosis whether treated with conventional chemotherapy, high-dose chemotherapy with stem cell rescue, irradiation or combinations of these modalities. Antiangiogenesis therapy has emerged as a new treatment option in solid malignancies. The frequent delivery of low doses of chemotherapy, referred to as metronomic or antiangiogenic chemotherapy, targets endothelial cells while reducing the toxicity associated with standard dose chemotherapy. The aim of the study is to extend therapy options for children with recurrent or progressive medulloblastoma, ependymoma, ATRT, and CNS tumors of various histologies, for whom no known curative therapy exists, by prolonging survival while maintaining good quality of life. The study will be conducted in independent strata. Stratum I (recurrent medulloblastoma): recently completed (Peyrl, 2023). Stratum II (recurrent ependymoma), III (recurrent ATRT) and V (recurrent CNS tumors of various histologies, patients with exclusion criteria and adult patients): The primary objective is to determine the response rate defined as the percentage of patients with complete response (CR), partial response (PR), stable disease (SD) or lack of recurrence at 6 months after start of antiangiogenic treatment. Stratum IV (recurrent medulloblastoma): To determine whether temozolomide, irinotecan, bevacizumab, thalidomide, celecoxib, fenofibrate, etoposide ivt, cytarabine ivt can increase the response rate after 6 months of treatment, compared with etoposid, cyclophosphamide, bevacizumab, thalidomide, celecoxib, fenofibrate, etoposide ivt, cytarabine ivt. Additionally, PFS, OS, toxicity, QoL, performance status, predictive and prognostic markers will be examined. In stratum II and III, the study will follow an open label, single arm phase 2 design, and an open label randomized two-arm phase 2 design in Stratum IV, and the exploratory Stratum V.
Trial Details
NCT Number NCT01356290
Lead Sponsor Medical University of Vienna
Conditions Medulloblastoma Recurrent, Ependymoma Recurrent, ATRT Recurrent, Rare CNS Tumor Recurrent
Enrollment 232 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov