N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Lead sponsor: Children's Hospital Los Angeles to New Approaches to Neuroblastoma Therapy Consortiumv27
  2. Lead sponsor: New Approaches to Neuroblastoma Therapy Consortium to Children's Hospital Los Angeles
    • Study title expanded, about 1 word
    v26
  3. Study Status, Referencesv25
  4. Trial status: Active, Not Recruiting to Completed
    • Primary completion date: Jul 2006
    v24
  5. 5 versions Re-verified since Jun 17, 2008, no change to tracked fieldsv19-v23
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  1. Interventions: antibiotic therapy (Procedure), cefixime (Drug), chemoprotection (Procedure), chemosensitization/potentiation therapy (Procedure)… to cefixime (Drug), irinotecan hydrochloride (Drug), temozolomide (Drug)v18
  2. Interventions: antibiotic therapy (Procedure), cefixime (Drug), chemoprotection (Procedure), chemosensitization/potentiation therapy (Procedure)… to antibiotic therapy (Procedure), cefixime (Drug), chemoprotection (Procedure), chemosensitization/potentiation therapy (Procedure)…v17
  3. Re-verified, no change to tracked fieldsv16
  4. Interventions: antibiotic therapy (Procedure), cefixime (Drug), chemoprotection (Procedure), chemosensitization/potentiation (Procedure), chemotherapy… to antibiotic therapy (Procedure), cefixime (Drug), chemoprotection (Procedure), chemosensitization/potentiation therapy (Procedure)…v15
  5. Interventions: antibiotic therapy (Procedure), cefixime (Drug), chemoprotection (Procedure), chemosensitization/potentiation (Procedure), chemotherapy… to antibiotic therapy (Procedure), cefixime (Drug), chemoprotection (Procedure), chemosensitization/potentiation (Procedure), chemotherapy…v14
  6. Lead sponsor: National Cancer Institute (NCI) to New Approaches to Neuroblastoma Therapy Consortium
    • Enrollment target: 30
    • Start date: May 2004
    • Collaborators expanded, about 4 words
    v13
  7. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 13 of 13 sites
    v12
  8. Re-verified, no change to tracked fieldsv11
  9. Study sites: 9 to 13v10
  10. Re-verified, no change to tracked fieldsv9
  11. Study sites revised (9)v8
  12. Site contacts updated at 2 of 9 sitesv7
  13. Study sites: 7 to 9v6
  14. Interventions: antibiotic therapy (Procedure), cefixime (Drug), chemoprotection (Procedure), chemosensitization/potentiation (Procedure), chemotherapy… to antibiotic therapy (Procedure), cefixime (Drug), chemoprotection (Procedure), chemosensitization/potentiation (Procedure), chemotherapy…v5
  15. Study sites: 6 to 7v4
  16. 2 versions Re-verified since Jul 8, 2005, no change to tracked fieldsv2-v3
  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.
RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Temozolomide may help irinotecan kill more tumor cells by making them more sensitive to the drug. Cefixime may be effective in preventing diarrhea that is caused by treatment with irinotecan. PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with temozolomide and cefixime in treating young patients with recurrent or resistant neuroblastoma.
Trial Details
NCT Number NCT00093353
Lead Sponsor New Approaches to Neuroblastoma Therapy Consortium
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Diarrhea, Drug/Agent Toxicity by Tissue/Organ, Neuroblastoma
Related terms Diarrhea, Drug-Related Side Effects and Adverse Reactions, Neuroblastoma
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Updated on ClinicalTrials.gov