Trial · NCT00876993
Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors
NCT00876993, Phase 1, Completed, Johns Hopkins All Children's Hospital; results first posted 2019-08-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors. Trials, record NCT00876993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00876993
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors
- NCT number
- NCT00876993
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 26 participants, actual
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Conditions
- Central Nervous System Tumors
- Interventions
- Bevacizumab, Irinotecan, Temozolomide
- First posted
- 2009-04-07
- Last updated
- 2023-07-03
- Results first posted
- 2019-08-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Measurement of Number of Adverse Events | Two 28-day cycles | Collect and grade the all of the adverse events to evaluate for safety. This data was collected for the first 2 cycles for each participant. |
| Secondary | Best Response of Children With Recurrent or Refractory Central Nervous System Tumors With This Combination of Chemotherapy Agents. | Every 2 cycles up to 24 cycles | Best response by MRIs per definitions in the protocol (complete response, partial response, stable disease, progressive disease). MRI's were obtained every 2 cycles and the best response was reported. |
| Secondary | 2 Year Event Free Survival With Children Treated With This Regimen. | 2 year | 2 year actual event free survival.with children treated with this protocol |
| Secondary | To Provide Safety and Efficacy Data for to Recommend Further Larger Studies. | Two 28 day cycles | Number participants with grade 3 and 4 hematologic and non-hematologic toxicities. All toxicities are for end of cycle 2. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Measurement of Number of Adverse Events | Two 28-day cycles | Adverse events | NUMBER | |
| SECONDARY | Best Response of Children With Recurrent or Refractory Central Nervous System Tumors With This Combination of Chemotherapy Agents. | Every 2 cycles up to 24 cycles | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 2 Year Event Free Survival With Children Treated With This Regimen. | 2 year | Count of participants | NUMBER | |
| SECONDARY | To Provide Safety and Efficacy Data for to Recommend Further Larger Studies. | Two 28 day cycles | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group85
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Measurement of Number of Adverse Events | Cohort 1 - Dose Level 1 | Grade 1 adverse events | 4 | Adverse events | |
| Measurement of Number of Adverse Events | Cohort 2 - Dose Level 0 | Grade 1 adverse events | 6 | Adverse events | |
| Measurement of Number of Adverse Events | Cohort 3 - Dose Level 1 | Grade 1 adverse events | 3 | Adverse events | |
| Measurement of Number of Adverse Events | Cohort 4 - Dose Level 2 | Grade 1 adverse events | 5 | Adverse events | |
| Measurement of Number of Adverse Events | Cohort 5 - Dose Level 1 | Grade 1 adverse events | 3 | Adverse events | |
| Measurement of Number of Adverse Events | Cohort 1 - Dose Level 1 | Grade 2 adverse events | 4 | Adverse events | |
| Measurement of Number of Adverse Events | Cohort 2 - Dose Level 0 | Grade 2 adverse events | 3 | Adverse events | |
| Measurement of Number of Adverse Events | Cohort 3 - Dose Level 1 | Grade 2 adverse events | 3 | Adverse events | |
| Measurement of Number of Adverse Events | Cohort 4 - Dose Level 2 | Grade 2 adverse events | 5 | Adverse events | |
| Measurement of Number of Adverse Events | Cohort 5 - Dose Level 1 | Grade 2 adverse events | 2 | Adverse events |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 - Dose Level 1 | 5 | |
| Overall Study | STARTED | Cohort 2 - Dose Level 0 | 6 | |
| Overall Study | STARTED | Cohort 3 - Dose Level 1 | 5 | |
| Overall Study | STARTED | Cohort 4 - Dose Level 2 | 5 | |
| Overall Study | STARTED | Cohort 5 - Dose Level 1 | 5 | |
| Overall Study | COMPLETED | Cohort 1 - Dose Level 1 | 4 | |
| Overall Study | COMPLETED | Cohort 2 - Dose Level 0 | 6 | |
| Overall Study | COMPLETED | Cohort 3 - Dose Level 1 | 3 | |
| Overall Study | COMPLETED | Cohort 4 - Dose Level 2 | 5 | |
| Overall Study | COMPLETED | Cohort 5 - Dose Level 1 | 3 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events85
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 | Leukocytes | Blood and lymphatic system disorders | Cohort 1 - Dose Level 1 | 2 | 5 | 2 |
| other | Leukocytes | Blood and lymphatic system disorders | Cohort 2 - Dose Level 0 | 0 | 6 | 0 |
| other | Leukocytes | Blood and lymphatic system disorders | Cohort 3 - Dose Level 1 | 0 | 5 | 0 |
| other | Leukocytes | Blood and lymphatic system disorders | Cohort 4 - Dose Level 2 | 0 | 5 | 0 |
| other | Leukocytes | Blood and lymphatic system disorders | Cohort 5 - Dose Level 1 | 0 | 5 | 0 |
| other | Neutrophils | Blood and lymphatic system disorders | Cohort 1 - Dose Level 1 | 2 | 5 | 2 |
| other | Neutrophils | Blood and lymphatic system disorders | Cohort 2 - Dose Level 0 | 0 | 6 | 0 |
| other | Neutrophils | Blood and lymphatic system disorders | Cohort 3 - Dose Level 1 | 0 | 5 | 0 |
| other | Neutrophils | Blood and lymphatic system disorders | Cohort 4 - Dose Level 2 | 1 | 5 | 1 |
| other | Neutrophils | Blood and lymphatic system disorders | Cohort 5 - Dose Level 1 | 2 | 5 | 2 |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 - Dose Level 1 | ||
| Total, all-cause mortality | Cohort 2 - Dose Level 0 | ||
| Total, all-cause mortality | Cohort 3 - Dose Level 1 | ||
| Total, all-cause mortality | Cohort 4 - Dose Level 2 | ||
| Total, all-cause mortality | Cohort 5 - Dose Level 1 | ||
| Total, other adverse events | Cohort 1 - Dose Level 1 | 4 | 5 |
| Total, other adverse events | Cohort 2 - Dose Level 0 | 1 | 6 |
| Total, other adverse events | Cohort 3 - Dose Level 1 | 2 | 5 |
| Total, other adverse events | Cohort 4 - Dose Level 2 | 3 | 5 |
| Total, other adverse events | Cohort 5 - Dose Level 1 | 3 | 5 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35260913 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00876993
GET https://conductscience.org/api/trials/v1/NCT00876993/results?page=2