Trial · NCT00381797

Bevacizumab and Irinotecan in Treating Young Patients With Recurrent, Progressive, or Refractory Glioma, Medulloblastoma, Ependymoma, or Low Grade Glioma

NCT00381797, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-01-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Bevacizumab and Irinotecan in Treating Young Patients With Recurrent, Progressive, or Refractory Glioma, Medulloblastoma, Ependymoma, or Low Grade Glioma. Trials, record NCT00381797. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00381797

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bevacizumab and Irinotecan in Treating Young Patients With Recurrent, Progressive, or Refractory Glioma, Medulloblastoma, Ependymoma, or Low Grade Glioma
NCT number: NCT00381797
Status: Completed
Phases: Phase 2
Enrollment: 97 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Childhood Cerebral Anaplastic Astrocytoma, Childhood Oligodendroglioma, Childhood Spinal Cord Neoplasm, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Ependymoma, Recurrent Childhood Medulloblastoma
Interventions: Bevacizumab, Fludeoxyglucose F-18, Irinotecan Hydrochloride
First posted: 2006-09-28
Last updated: 2017-11-28
Results first posted: 2013-01-15
Limitations and caveats: Neuroimaging data capturing Volume Enhancing and Perfusion Ratio was so limited to run any statistical model. Similarly, due to limited data, some PK and Biology objectives were not able to be addressed.

Source ClinicalTrials.gov

Registered outcomes27

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Objective Response Rate Sustained for ≥ 8 Weeks	From day 1 of treatment up to 24 weeks	Objective response is either a complete response or a partial response observed during the first four courses of treatment and sustained for 8 weeks. The objective response rate will be reported separately for patients with recurrent/progressive malignant glioma(Stratum A), recurrent/progressive instrinsic brain stem tumors(Stratum B), recurrent/progressive medulloblastoma(Stratum C), and recurrent/progressive ependymoma(Stratum D). CR is complete disappearance of all enhancing tumor. PR is \>= 50% reduction in tumor size. This outcome measures is not defined for the Stratum E in the protocol.
Primary	Sustained Disease Stabilization Rate Associated With Bevacizumab and Irinotecan in Patients With Recurrent or Progressive Low-grade Glioma (Stratum E)	From day 1 of treatment up to 24 weeks	Disease stabilization is defined as a complete response(CR) or partial response(PR) observed during the first four courses and sustained for 8 weeks; or stable disease (SD) sustained for 6 courses characterized by SD at the end of course 2, at the end of course 4 and at the end of course 6. CR is complete disappearance of all enhancing tumor. PR is \>= 50% reduction in tumor size. SD is at least stable and maintenance corticosteroid dose not increased in neurologic examination.
Secondary	Number of Study Participants With Grade 3 or 4 Treatment-related Toxicity	From day 1 of treatment until off study	Adverse events are monitored and graded according to the Common Terminology Criteria for Adverse Events. The grade 1 = mild, grade 2=moderate, grade 3 =severe, grade 4=life threatening/disabling, grade 5=death.
Secondary	Cumulative Incidence of Sustained Objective Responses	From the first imaging after treatment up to 2 years	Cumulative incidence of sustained objective response provides a percentage of participants experiencing the event of interest at a given follow-up time point (for example, 6-months, 1-year, etc.) in the presence of competing events such as progressive disease or death, and it is estimated using the event data for both the event of interest and the competing events experienced by the study participants. In this sense, it is different than the incidence rates estimated in epidemiological studies in terms of 'incidences per 1000 person years. 6-month Cumulative incidence of sustained objective responses will be reported separately for each stratum.
Secondary	Progression-free Survival	From start of treatment up to 2 years	Progression-Free survival is the interval of time between of protocol treatment and minimum date of documentation of progressive Disease,second malignancy,death due to any cause, or date of last follow-up. Progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression,OR the appearance of new tumor OR a \> 25% increase in the sum of the products of two longest perpendicular diameters of all measurable tumors. K-M method was used to estimate progression-free survival.
Secondary	Change in Perfusion Ratio Between the Baseline and Day 15 Brain Imaging	Baseline and day 15	Perfusion ratio obtained from magnetic resonance(MR) diffusion imaging may explain changes in the tumor after therapy. Changes in the perfusion ratio will be reported for those strata that have a sufficient number of participants with MR diffusion imaging. The change was calculated from perfusion ratio at Baseline to perfusion ratio at Day 15(values of perfusion ratio at Day 15 - values of perfusion ratio at baseline). The higher of perfusion ratio is worse. MR perfusion ratio is perfusion solid part of tumor from CBV divided by perfusion frontal while matter. There is no a unit available.
Secondary	Change in Diffusion Ratio Between the Baseline and Day 15 Brain Image	Baseline and day 15	Diffusion ratio obtained from magnetic resonance (MR) diffusion imaging may explain changes in the tumor after therapy. Changes in the diffusion ratio will be reported for those strata that have a sufficient number of participants with MR diffusion imaging. The change was calculated from diffusion ratio at Baseline to diffusion ratio at Day 15 (values of diffusion ratio at Day 15 -values of diffusion ration at baseline). The higher of diffusion ratio is better. MR diffusion ratio is the diffusion solid part of tumor divided by the diffusion frontal white matter. There is no a unit available.
Secondary	Association of Log-transformed Tumor Volume Based on FLAIR With Progression-free Survival (PFS) Using Hazard Ratio Estimates	From start of treatment until the earliest of progressive disease, death, second malignancy or off study OR up to 2 years	Using Cox proportional hazards models, the association of tumor volume based on FLAIR images with PFS will be investigated for those strata that have a sufficient number of participants with volume FLAIR measurements. Volumetric magnetic resonance imaging is performed to investigate surrogate markers of tumor growth. Volume FLAIR measurements were longitudinal. As we are not comparing the strata, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section. We consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor volume based on FLAIR. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.
Secondary	Association of Log-transformed Tumor Enhancing Volume With Progression-free Survival (PFS) Using Hazard Ratio Estimates	From start of treatment until the earliest of progressive disease, death, second malignancy or off study, OR up to 2 years	Using Cox Proportional hazards Models, the association of Log-transformed tumor enhancing volume with progression-free survival will be investigated. Volumetric magnetic resonance (MR) imaging is performed to investigate surrogate markers of tumor growth. Tumor enhancing volumes were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section and we consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor enhancing volume. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.
Secondary	Association of Log-transformed Volume of Cystic Necrosis With Progression-free Survival (PFS) Using Hazard Ratio Estimates	From start of treatment until the earliest of progressive disease, death, second malignancy or off study, OR up to 2 years	Using Cox Proportional Hazards Models, the association of cystic necrosis with progression-free survival will be investigated. Volumetric magnetic resonance (MR) imaging is performed to investigate surrogate markers of tumor growth. Volumes of cystic necrosis were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section and we consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor volume based on cystic necrosis. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.

1 to 10 of 27Source ClinicalTrials.gov

See all 27 registered outcomes

Outcomes27

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate Sustained for ≥ 8 Weeks	From day 1 of treatment up to 24 weeks	Two patients in the Stratum A,one patient in the Stratum C, and one patient in the Stratum D were inevaluable for this outcome measure.	participants	NUMBER
PRIMARY	Sustained Disease Stabilization Rate Associated With Bevacizumab and Irinotecan in Patients With Recurrent or Progressive Low-grade Glioma (Stratum E)	From day 1 of treatment up to 24 weeks	Patients with recurrent or progressive low grade glioma were treated with any courses.	participants	NUMBER
SECONDARY	Number of Study Participants With Grade 3 or 4 Treatment-related Toxicity	From day 1 of treatment until off study	The patients were treated with any dose treatment.	participants	NUMBER
SECONDARY	Cumulative Incidence of Sustained Objective Responses	From the first imaging after treatment up to 2 years	Two patients in the Stratum A,one patient in the Stratum C, and one patient in the Stratum D were inevaluable for this outcome measure.	Percentage of Participants	NUMBER
SECONDARY	Progression-free Survival	From start of treatment up to 2 years	The patients were treated with any dose treatment.	Months	MEDIAN
SECONDARY	Change in Perfusion Ratio Between the Baseline and Day 15 Brain Imaging	Baseline and day 15	There are no sufficient data for the analyses in the Medulloblastoma arm and Ependymoma arm.	Ratio	MEDIAN
SECONDARY	Change in Diffusion Ratio Between the Baseline and Day 15 Brain Image	Baseline and day 15	There are no sufficient data for the analyses in the Medulloblastoma arm.	Ratio	MEDIAN
SECONDARY	Association of Log-transformed Tumor Volume Based on FLAIR With Progression-free Survival (PFS) Using Hazard Ratio Estimates	From start of treatment until the earliest of progressive disease, death, second malignancy or off study OR up to 2 years	Patients had Flair volume at Pre-treatment and at least one on treatment.	Hazard Ratio	MEAN
SECONDARY	Association of Log-transformed Tumor Enhancing Volume With Progression-free Survival (PFS) Using Hazard Ratio Estimates	From start of treatment until the earliest of progressive disease, death, second malignancy or off study, OR up to 2 years	Patients had tumor enhancing volume at Pre-treatment and at least one on treatment.	Hazard Ratio	MEAN
SECONDARY	Association of Log-transformed Volume of Cystic Necrosis With Progression-free Survival (PFS) Using Hazard Ratio Estimates	From start of treatment until the earliest of progressive disease, death, second malignancy or off study, OR up to 2 years	Patients had volume of cystic necrosis at Pre-treatment and at least one on treatment.	Hazard Ratio	MEAN

1 to 10 of 27Source ClinicalTrials.gov

See all 27 outcomes

Results by group64

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Objective Response Rate Sustained for ≥ 8 Weeks	High-grade Gliomas	0		participants
Objective Response Rate Sustained for ≥ 8 Weeks	Brain Stem Tumors	0		participants
Objective Response Rate Sustained for ≥ 8 Weeks	Medulloblastoma	0		participants
Objective Response Rate Sustained for ≥ 8 Weeks	Ependymoma	0		participants
Sustained Disease Stabilization Rate Associated With Bevacizumab and Irinotecan in Patients With Recurrent or Progressive Low-grade Glioma (Stratum E)	Low Grade Glioma	23	95% Confidence Interval 17 to 28	participants
Number of Study Participants With Grade 3 or 4 Treatment-related Toxicity	High-grade Gliomas	8		participants
Number of Study Participants With Grade 3 or 4 Treatment-related Toxicity	Brain Stem Tumors	4		participants
Number of Study Participants With Grade 3 or 4 Treatment-related Toxicity	Medulloblastoma	4		participants
Number of Study Participants With Grade 3 or 4 Treatment-related Toxicity	Ependymoma	6		participants
Number of Study Participants With Grade 3 or 4 Treatment-related Toxicity	Low Grade Glioma	22		participants

1 to 10 of 64Source ClinicalTrials.gov

See all 64 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	High-grade Gliomas	18
Overall Study	STARTED	Brain Stem Tumors	17
Overall Study	STARTED	Medulloblastoma	10
Overall Study	STARTED	Ependymoma	15
Overall Study	STARTED	Low Grade Glioma	37
Overall Study	COMPLETED	High-grade Gliomas	17
Overall Study	COMPLETED	Brain Stem Tumors	16
Overall Study	COMPLETED	Medulloblastoma	10
Overall Study	COMPLETED	Ependymoma	14
Overall Study	COMPLETED	Low Grade Glioma	35

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events83

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	Acidosis	Metabolism and nutrition disorders	PBTC-022	11	92	22
other	Alanine aminotransferase increased	Investigations	PBTC-022	28	92	37
other	Alkaline phosphatase increased	Investigations	PBTC-022	6	92	13
other	Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	PBTC-022	13	92	16
other	Alopecia	Skin and subcutaneous tissue disorders	PBTC-022	8	92	8
other	Anorexia	Metabolism and nutrition disorders	PBTC-022	19	92	25
other	Aspartate aminotransferase increased	Investigations	PBTC-022	32	92	50
other	Ataxia	Nervous system disorders	PBTC-022	11	92	16
other	Blood bilirubin increased	Investigations	PBTC-022	7	92	13
other	Constipation	Gastrointestinal disorders	PBTC-022	16	92	21

1 to 10 of 83Source ClinicalTrials.gov

See all 83 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PBTC-022
Total, other adverse events	PBTC-022	91	92
Total, serious adverse events	PBTC-022	37	92

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26345283	BACKGROUND

Source PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01CA081457	Pediatric Brain Tumor Consortium (PBTC)	BOYETT, JAMES MILFORD	ST. JUDE CHILDREN'S RESEARCH HOSPITAL	NATIONAL CANCER INSTITUTE	1999 to 2013

Source NIH RePORTER

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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