Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma

StatusCompleted
PhasePhase 3
Started

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Record History

The 50 most recent of 264 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints: details revised at 1 of 14 entriesv264
  2. Start date: Aug 6, 2007 to Oct 22, 2007
    • Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Dec 31, 2028 to Sep 30, 2025
    v263
  3. Study sites revised (145)v262
  4. Study sites revised (145)v261
  5. Study sites: 136 to 145v260 Show 5 more changesShow less
    • Study completion date: Dec 31, 2028
    • Start date: Oct 22, 2007 to Aug 6, 2007
    • Interventions: autologous hematopoietic stem cell transplantation (Procedure), carboplatin (Drug), cisplatin (Drug), cyclophosphamide (Drug), etoposide… to Autologous Hematopoietic Stem Cell Transplantation (Procedure), Carboplatin (Drug), Cisplatin (Drug), Cyclophosphamide (Drug), Etoposide…
    • Eligibility criteria expanded, about 351 words
    • Study description shortened, about 117 words
Show 45 earlier versionsHide 45 earlier versions
  1. 3 versions Re-verified since Apr 28, 2020, no change to tracked fieldsv257-v259
  2. Trial status: Completed to Active, Not Recruiting
    • Study completion date: Dec 31, 2016 to not stated
    • Secondary endpoints revised (14)
    • Study description shortened, about 25 words
    v256
  3. Results first posted: Oct 24, 2018v255 Show 4 more changesShow less
    • Start date: Aug 2007 to Oct 22, 2007
    • Primary endpoint revised
    • Enrollment target: estimated 96 to confirmed 91
    • Secondary endpoints revised (14)
  4. Secondary endpoints: 5 to 14v254
  5. Trial status: Active, Not Recruiting to Completed
    • Study completion date: Dec 31, 2016
    v253
  6. Primary completion date: Dec 2016 to Dec 31, 2016v252
  7. Primary completion date: Mar 2016 to Dec 2016v251
  8. Primary completion date changed from estimate of Sep 2018 to Mar 2016v250
  9. Re-verified, no change to tracked fieldsv249
  10. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 136 of 136 sites
    v248
  11. Site contacts updated at 1 of 136 sitesv247
  12. Primary endpoint revisedv246 Show 5 more changesShow less
    • Study sites: 127 to 136
    • Interventions: carboplatin (Drug), cisplatin (Drug), cyclophosphamide (Drug), etoposide (Drug), leucovorin calcium (Drug), methotrexate (Drug), thiotepa… to autologous hematopoietic stem cell transplantation (Procedure), carboplatin (Drug), cisplatin (Drug), cyclophosphamide (Drug), etoposide…
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints: 1 to 5
    • Study description expanded, about 4 words
  13. Study sites: 128 to 127v245
  14. Re-verified, no change to tracked fieldsv244
  15. Study sites: 127 to 128v243
  16. Study sites: 126 to 127v242
  17. Site contacts updated at 1 of 126 sitesv241
  18. Study sites: 125 to 126v240
  19. Study sites: 124 to 125v239
  20. Study sites revised (124)v238
  21. Site contacts updated at 1 of 124 sitesv237
  22. Site contacts updated at 1 of 124 sitesv236
  23. Primary completion date: Aug 2011 to Sep 2018
    • Study sites: 116 to 124
    v235
  24. Site contacts updated at 1 of 116 sitesv234
  25. Study sites revised (116)v233
  26. Site details revised at 1 of 116 sitesv232
  27. Site contacts updated at 2 of 116 sitesv231
  28. Study sites: 114 to 116v230
  29. 2 versions Re-verified since Jun 8, 2011, no change to tracked fieldsv228-v229
  30. Study sites: 113 to 114v227
  31. Study sites: 112 to 113v226
  32. Study sites revised (112)v225
  33. Site contacts updated at 1 of 112 sitesv224
  34. Re-verified, no change to tracked fieldsv223
  35. Study sites: 111 to 112v222
  36. Site contacts updated at 1 of 111 sitesv221
  37. Re-verified, no change to tracked fieldsv220
  38. Study sites revised (111)v219
  39. Re-verified, no change to tracked fieldsv218
  40. Site contacts updated at 1 of 111 sitesv217
  41. Site contacts updated at 1 of 111 sitesv216
  42. Re-verified, no change to tracked fieldsv215
  • 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.
Children's Oncology Group
95 trials monitored
See 5 trials at risk
Glioma
1,260 trials monitored
See 93 trials at risk
This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma when given before additional intense chemotherapy followed by peripheral blood stem cell rescue. It is not yet known which combination chemotherapy regimen is more effective when given before a peripheral stem cell transplant in treating supratentorial primitive neuroectodermal tumors or medulloblastoma.
Trial Details
NCT Number NCT00336024
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Anaplastic Medulloblastoma, Medulloblastoma, Supratentorial Embryonal Tumor, Not Otherwise Specified, Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor
Related terms Medulloblastoma
Enrollment 91 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov