Trial · NCT00404495
Combination of Irinotecan and Temozolomide in Children With Brain Tumors.
NCT00404495, Phase 2, Completed, Pfizer; results first posted 2012-02-17
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Combination of Irinotecan and Temozolomide in Children With Brain Tumors. Trials, record NCT00404495. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00404495
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination of Irinotecan and Temozolomide in Children With Brain Tumors.
- NCT number
- NCT00404495
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 83 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Glioma, Medulloblastoma
- Interventions
- Irinotecan, Temozolomide
- First posted
- 2006-11-28
- Last updated
- 2012-04-18
- Results first posted
- 2012-02-17
- Limitations and caveats
- This study had one treatment arm but two distinct cohorts with different diagnostics and treatment durations.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Objective Response of Complete Response or Partial Response | Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma) | Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR persisted on repeat imaging study at least (≥) 4 weeks after initial documentation of response. PR, for bidimensionally measurable disease, was a decrease by ≥50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response recorded any time while the participant was receiving treatment. External Response Review Committee (ERRC) assessment. |
| Secondary | Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment | Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma) | Percentage of participants with objective response based assessment of confirmed CR or confirmed PR. CR persisted on repeat imaging study ≥4 weeks after initial documentation of response. PR, in case of bidimensionally measurable disease, was a decrease by ≥50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response could be recorded any time while the participant was receiving treatment. Investigator's assessment. |
| Secondary | Duration of Response | Baseline to Date of Tumor Response (Up to 1 Year) | Median duration (50%) of tumor response for participants with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for duration of response (DR). DR was defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurred first. DR (calculated in Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7. Investigator's assessment. |
| Secondary | Time to Treatment Failure (TTF) | Baseline to Date of Treatment Failure (Up to 1 Year) | TTF was defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD), the date of treatment discontinuation except completion of treatment, or date of death due to cancer. Investigator's assessment. |
| Secondary | Time to Tumor Progression (TTP) | Baseline to Date of Progression (Up to 1 Year) | TTP was defined as the time in months from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever came first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7 multiplied by 4.33. Tumor progression was determined from oncologic assessment data (where data met the criteria for PD). Investigator's assessment. |
| Secondary | Overall Survival (OS) | Baseline to Date of Death (Up to 1 Year After Treatment) | Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7 multiplied by 4.33. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). Investigator's assessment. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Objective Response of Complete Response or Partial Response | Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma) | Primary Evaluable Population: subset of evaluable population predetermined by 2-stage Optimum Simon design. Medulloblastoma cohort: n=consecutive evaluable participants up to 46 if 6 responses obtained in first 15 evaluable participants. Glioma cohort: n=consecutive evaluable participants up to 29 if 1 response in first 10 evaluable participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment | Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma) | Evaluable local population: Participants received at least 1 dose of study medication, had measurable disease under study, at least 1 on-study objective tumor assessment, completed at least 2 cycles of study treatment or progressed. Based on investigator's assessment. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | Baseline to Date of Tumor Response (Up to 1 Year) | Evaluable local population. Number of participants analyzed=number of participants who responded. | weeks | MEDIAN |
| SECONDARY | Time to Treatment Failure (TTF) | Baseline to Date of Treatment Failure (Up to 1 Year) | Evaluable local population | months | MEDIAN |
| SECONDARY | Time to Tumor Progression (TTP) | Baseline to Date of Progression (Up to 1 Year) | Evaluable local population | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Baseline to Date of Death (Up to 1 Year After Treatment) | All participants. One participant in the Temozolomide + Irinotecan for Medulloblastoma cohort did not have recurrent or refractory medulloblastoma and 3 participants in the Temozolomide + Irinotecan for High-Grade Glioma cohort did not have high-grade glioma, and were not considered evaluable for survival. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Objective Response of Complete Response or Partial Response | Temozolomide + Irinotecan for Medulloblastoma | 32.6 | 95% Confidence Interval 19.5 to 48.0 | percentage of participants | |
| Percentage of Participants With Objective Response of Complete Response or Partial Response | Temozolomide + Irinotecan for High-Grade Glioma | 0 | 95% Confidence Interval 0 to 30.8 | percentage of participants | |
| Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment | Temozolomide + Irinotecan for Medulloblastoma | 34.9 | 95% Confidence Interval 23.3 to 48.0 | percentage of participants | |
| Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment | Temozolomide + Irinotecan for High-Grade Glioma | 11.8 | 95% Confidence Interval 1.5 to 36.4 | percentage of participants | |
| Duration of Response | Temozolomide + Irinotecan for Medulloblastoma | 22.4 | Full Range 6.9 to 46.6 | weeks | |
| Duration of Response | Temozolomide + Irinotecan for High-Grade Glioma | 36.3 | Full Range 4.0 to 68.6 | weeks | |
| Time to Treatment Failure (TTF) | Temozolomide + Irinotecan for Medulloblastoma | 3.8 | 95% Confidence Interval 2.9 to 5.4 | months | |
| Time to Treatment Failure (TTF) | Temozolomide + Irinotecan for High-Grade Glioma | 1.6 | 95% Confidence Interval 1.3 to 2.4 | months | |
| Time to Tumor Progression (TTP) | Temozolomide + Irinotecan for Medulloblastoma | 5.6 | 95% Confidence Interval 3.8 to 7.4 | months | |
| Time to Tumor Progression (TTP) | Temozolomide + Irinotecan for High-Grade Glioma | 1.6 | 95% Confidence Interval 1.3 to 7.5 | months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Temozolomide + Irinotecan for Medulloblastoma | 66 | |
| Overall Study | STARTED | Temozolomide + Irinotecan for High-Grade Glioma | 17 | |
| Overall Study | COMPLETED | Temozolomide + Irinotecan for Medulloblastoma | 22 | |
| Overall Study | COMPLETED | Temozolomide + Irinotecan for High-Grade Glioma | 6 | |
| Overall Study | NOT COMPLETED | Temozolomide + Irinotecan for Medulloblastoma | 44 | |
| Overall Study | NOT COMPLETED | Temozolomide + Irinotecan for High-Grade Glioma | 11 |
Source ClinicalTrials.gov
Adverse events574
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Temozolomide + Irinotecan for Medulloblastoma | 10 | 66 | |
| other | Anaemia | Blood and lymphatic system disorders | Temozolomide + Irinotecan for High-Grade Glioma | 1 | 17 | |
| other | Eosinopenia | Blood and lymphatic system disorders | Temozolomide + Irinotecan for Medulloblastoma | 1 | 66 | |
| other | Eosinopenia | Blood and lymphatic system disorders | Temozolomide + Irinotecan for High-Grade Glioma | 0 | 17 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Temozolomide + Irinotecan for Medulloblastoma | 1 | 66 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Temozolomide + Irinotecan for High-Grade Glioma | 0 | 17 | |
| other | Leukopenia | Blood and lymphatic system disorders | Temozolomide + Irinotecan for Medulloblastoma | 6 | 66 | |
| other | Leukopenia | Blood and lymphatic system disorders | Temozolomide + Irinotecan for High-Grade Glioma | 0 | 17 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Temozolomide + Irinotecan for Medulloblastoma | 1 | 66 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Temozolomide + Irinotecan for High-Grade Glioma | 0 | 17 |
1 to 10 of 574Source ClinicalTrials.gov
See all 574 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Temozolomide + Irinotecan for Medulloblastoma | ||
| Total, all-cause mortality | Temozolomide + Irinotecan for High-Grade Glioma | ||
| Total, other adverse events | Temozolomide + Irinotecan for Medulloblastoma | 64 | 66 |
| Total, other adverse events | Temozolomide + Irinotecan for High-Grade Glioma | 17 | 17 |
| Total, serious adverse events | Temozolomide + Irinotecan for Medulloblastoma | 31 | 66 |
| Total, serious adverse events | Temozolomide + Irinotecan for High-Grade Glioma | 5 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Temozolomide + Irinotecan for Medulloblastoma vs Temozolomide + Irinotecan for High-Grade Glioma: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00404495
GET https://conductscience.org/api/trials/v1/NCT00404495/events?page=2