Phase 2
N=83
Combination of Irinotecan and Temozolomide in Children With Brain Tumors.
Glioma · Medulloblastoma
Bottom Line
View on ClinicalTrials.gov: NCT00404495 ↗Enrolled (actual)
83
Serious AEs
43.4%
Results posted
Feb 2012
Primary outcome: Primary: Percentage of Participants With Objective Response of Complete Response or Partial Response — 32.6; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Irinotecan (Drug); Temozolomide (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response of Complete Response or Partial Response |
32.6; 0 | — |
| SECONDARY Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment |
34.9; 11.8 | — |
| SECONDARY Duration of Response |
22.4; 36.3 | — |
| SECONDARY Time to Treatment Failure (TTF) |
3.8; 1.6 | — |
| SECONDARY Time to Tumor Progression (TTP) |
5.6; 1.6 | — |
| SECONDARY Overall Survival (OS) |
16.7; 9.4 | — |
Summary
This study will assess the rate of objective confirmed tumor response of irinotecan in combination with temozolomide in children with recurrent or refractory medulloblastoma and in children with newly diagnosed high-grade glioma.
Eligibility Criteria
Inclusion Criteria
- Cohort 1: Recurrent or refractory medulloblastoma in which current standard treatment approaches have failed; biopsy is not required for recurrent disease.
- Cohort 2: Newly-diagnosed high-grade glioma (World Health Organization [WHO] grade 3 or 4)
- Life expectancy ≥ 3 months
Exclusion Criteria
- Diagnosis of brainstem glioma
- Concurrent administration of any other anti-tumor therapy
- Pre-existing uncontrolled diarrhea
Data sourced from ClinicalTrials.gov (NCT00404495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.