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

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.

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Record History

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  1. Enrollment target: 35 to 34
    • Primary completion date: Dec 1, 2025 to Mar 1, 2025
    v34
  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 and study completion dates pushed to Dec 1, 2022v30
  5. Primary endpoints: 1 to 2v29 Show 10 more changesShow less
    • Primary completion date: Dec 2019 to Dec 1, 2019
    • Study 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
Show 27 earlier versionsHide 27 earlier versions
  1. Study description shortened, about 56 wordsv28
  2. Re-verified, no change to tracked fieldsv27
  3. Primary completion date: Dec 2018 to Dec 2019
    • Study completion date: Dec 2018 to Dec 2020
    v26
  4. Primary completion date: Dec 2017 to Dec 2018
    • Study completion date: Dec 2018
    v25
  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 revised
    v21
  8. Primary endpoint revised
    • Secondary endpoint revised
    v20
  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
  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
  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 words
    v7
  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 1
    v5
  23. Re-verified, no change to tracked fieldsv4
  24. Trial status: Recruiting to Active, Not Recruitingv3 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
  25. Trial status: Suspended to Recruiting
    • Enrollment target: 12 to 35
    • Site details revised
    v2
  1. Study First Submitted
  • 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.
M.D. Anderson Cancer Center
1,232 trials monitored
See 84 trials at risk
Glioma
1,260 trials monitored
See 93 trials at risk
Glioblastoma
714 trials monitored
See 57 trials at risk
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
(from sponsor)		 Malignant Supratentorial Neoplasm, Recurrent Glioblastoma, Recurrent Gliosarcoma
Related terms Glioblastoma, Gliosarcoma, Supratentorial Neoplasms
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov