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Lonafarnib and Temozolomide in Treating Patients with Glioblastoma Multiforme That is Recurrent or Did Not Respond to Previous Treatment with Temozolomide

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 17, 2024 (before its estimated March 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Enrollment target: 35 to 34 Primary completion date: Dec 1, 2025 to Mar 1, 2025v34 Show 1 more changeShow less
    • Primary completion date: Dec 1, 2025 to Mar 1, 2025
  2. Primary and study completion dates: Dec 1, 2022 to Dec 1, 2025v33
  3. 2 versions Re-verified since Jun 12, 2020, no change to tracked fieldsv31-v32
  4. Primary completion date: Dec 1, 2019 to Dec 1, 2022 Completion date: Dec 1, 2020 to Dec 1, 2022v30 Show 1 more changeShow less
    • Completion date: Dec 1, 2020 to Dec 1, 2022
  5. Primary endpoints: 1 to 2 Primary completion date: Dec 2019 to Dec 1, 2019 · Completion date: Dec 2020 to Dec 1, 2020 · Start date: Dec 2004 to Dec 21, 2004 · 7 morev29 Show 10 more changesShow less
    • Primary completion date: Dec 2019 to Dec 1, 2019
    • Completion date: Dec 2020 to Dec 1, 2020
    • Start date: Dec 2004 to Dec 21, 2004
    • Interventions: Sarasar (Drug), Temodar (Drug) to Lonafarnib (Drug), Temozolomide (Drug)
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: 1 to 4
    • Study description shortened, about 515 words
    • Study site revised
    • Collaborator revised
    • Study title expanded, about 14 words

    See this version in full on ClinicalTrials.gov ↗

Show 27 earlier versionsHide 27 earlier versions
  1. Study description shortened, about 56 wordsv28 See this version in full on ClinicalTrials.gov ↗
  2. Re-verified, no change to tracked fieldsv27
  3. Primary completion date: Dec 2018 to Dec 2019 Completion date: Dec 2018 to Dec 2020v26 Show 1 more changeShow less
    • Completion date: Dec 2018 to Dec 2020
  4. Primary completion date: Dec 2017 to Dec 2018 Completion date: Dec 2018v25 Show 1 more changeShow less
    • Completion date: Dec 2018
  5. Primary completion date: Dec 2016 to Dec 2017v24
  6. 2 versions Re-verified since Mar 13, 2015, no change to tracked fieldsv22-v23
  7. Primary completion date: Dec 2015 to Dec 2016 Eligibility criteria revised · Study description expanded, about 56 words · Study site revisedv21 Show 3 more changesShow less
    • Eligibility criteria revised
    • Study description expanded, about 56 words
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  8. Primary endpoint revised Secondary endpoint revisedv20 Show 1 more changeShow less
    • Secondary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  9. Primary completion date: Dec 2014 to Dec 2015v19
  10. 2 versions Re-verified since Jul 6, 2012, no change to tracked fieldsv17-v18
  11. Primary completion date: Dec 2012 to Dec 2014v16
  12. Re-verified, no change to tracked fieldsv15
  13. Study description shortened, about 57 wordsv14 See this version in full on ClinicalTrials.gov ↗
  14. Primary completion date: Dec 2011 to Dec 2012v13
  15. Primary completion date: Dec 2010 to Dec 2011v12
  16. Re-verified, no change to tracked fieldsv11
  17. Study site revisedv10 See this version in full on ClinicalTrials.gov ↗
  18. Primary completion date: Dec 2008 to Dec 2010v9
  19. Re-verified, no change to tracked fieldsv8
  20. Primary endpoint revised Secondary endpoint revised · Study description shortened, about 30 wordsv7 Show 2 more changesShow less
    • Secondary endpoint revised
    • Study description shortened, about 30 words

    See this version in full on ClinicalTrials.gov ↗

  21. Re-verified, no change to tracked fieldsv6
  22. Primary endpoints: 3 to 1 Primary completion date: Dec 2008 · Secondary endpoints expanded, about 21 words · Study arms: 0 to 1v5 Show 3 more changesShow less
    • Primary completion date: Dec 2008
    • Secondary endpoints expanded, about 21 words
    • Study arms: 0 to 1

    See this version in full on ClinicalTrials.gov ↗

  23. Re-verified, no change to tracked fieldsv4
  24. Trial status: Recruiting to Active, Not Recruiting Interventions: Sarasar (lonafarnib, SCH66336) (Drug), Temodar (temozolomide) (Drug) to Sarasar (Drug), Temodar (Drug) · Eligibility criteria expanded, about 382 words · Study description expanded, about 640 words · 2 morev3 Show 5 more changesShow less
    • Interventions: Sarasar (lonafarnib, SCH66336) (Drug), Temodar (temozolomide) (Drug) to Sarasar (Drug), Temodar (Drug)
    • Eligibility criteria expanded, about 382 words
    • Study description expanded, about 640 words
    • Study site revised
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  25. Trial status: Suspended to Recruiting Enrollment target: 12 to 35 · Site details revisedv2 Show 2 more changesShow less
    • Enrollment target: 12 to 35
    • Site details revised
  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.
This phase I trial studies the side effects and best dose of lonafarnib when given together with temozolomide and to see how well they work in treating patients with glioblastoma multiforme that is has come back or did not respond to previous treatment with temozolomide. Lonafarnib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving lonafarnib together with temozolomide may kill more tumor cells.
Trial Details
NCT Number NCT00102648
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Malignant Supratentorial Neoplasm, Recurrent Glioblastoma, Recurrent Gliosarcoma
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov