Trial · NCT01217437

Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors

NCT01217437, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2019-09-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors. Trials, record NCT01217437. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01217437

On this page

Trial

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

Title: Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors
NCT number: NCT01217437
Status: Completed
Phases: Phase 2
Enrollment: 108 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Central Nervous System Neoplasm, Pineoblastoma, Recurrent Medulloblastoma, Recurrent Primitive Neuroectodermal Tumor, Refractory Medulloblastoma, Refractory Peripheral Primitive Neuroectodermal Tumor
Interventions: Bevacizumab, Irinotecan Hydrochloride, Temozolomide
First posted: 2010-10-08
Last updated: 2021-07-23
Results first posted: 2019-09-13

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Overall Survival	Up to 5 years after enrollment	Percentage Probability of remaining alive 5 years after enrollment estimated by the method of Kaplan and Meier
Secondary	Response	Up to 12 cycles of therapy (11 months)	Patient's best response during protocol therapy coded as complete response, partial response or no response.
Secondary	Event-free Survival	Up to 5 years after enrollment	Percentage Probability of remaining event-free 5 years after enrollment estimated by the method of Kaplan and Meier

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival	Up to 5 years after enrollment	Randomized eligible patients. 2 patients were excluded due to ineligibility.	percent probability	NUMBER
SECONDARY	Response	Up to 12 cycles of therapy (11 months)	Eligible patients who were enrolled and had measurable disease according to the protocol definition at the time of enrollment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Event-free Survival	Up to 5 years after enrollment	Randomized eligible patients. 2 patients were excluded due to ineligibility.	percent probability	NUMBER

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Category	Value	Spread	Units
Overall Survival	Arm I (Temozolomide, Irinotecan Hydrochloride)		2.43	95% Confidence Interval 0.2 to 10.9	percent probability
Overall Survival	Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)		13.6	95% Confidence Interval 4.7 to 27.1	percent probability
Response	Arm I (Temozolomide, Irinotecan Hydrochloride)	Complete Response	0		Participants
Response	Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)	Complete Response	8		Participants
Response	Arm I (Temozolomide, Irinotecan Hydrochloride)	Partial Response	16		Participants
Response	Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)	Partial Response	14		Participants
Response	Arm I (Temozolomide, Irinotecan Hydrochloride)	No Response	32		Participants
Response	Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)	No Response	24		Participants
Event-free Survival	Arm I (Temozolomide, Irinotecan Hydrochloride)		1.85	95% Confidence Interval 0.15 to 8.62	percent probability
Event-free Survival	Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)		15.4	95% Confidence Interval 7.2 to 26.4	percent probability

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Temozolomide, Irinotecan Hydrochloride)	55
Overall Study	STARTED	Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)	53
Overall Study	COMPLETED	Arm I (Temozolomide, Irinotecan Hydrochloride)	12
Overall Study	COMPLETED	Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)	12
Overall Study	NOT COMPLETED	Arm I (Temozolomide, Irinotecan Hydrochloride)	43
Overall Study	NOT COMPLETED	Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)	41

Source ClinicalTrials.gov

Adverse events188

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
other	Abdominal pain	Gastrointestinal disorders	Arm I (Temozolomide, Irinotecan Hydrochloride)	4	54
other	Abdominal pain	Gastrointestinal disorders	Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)	1	52
other	Acidosis	Metabolism and nutrition disorders	Arm I (Temozolomide, Irinotecan Hydrochloride)	1	54
other	Acidosis	Metabolism and nutrition disorders	Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)	0	52
other	Alanine aminotransferase increased	Investigations	Arm I (Temozolomide, Irinotecan Hydrochloride)	4	54
other	Alanine aminotransferase increased	Investigations	Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)	2	52
other	Allergic reaction	Immune system disorders	Arm I (Temozolomide, Irinotecan Hydrochloride)	1	54
other	Allergic reaction	Immune system disorders	Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)	0	52
other	Anaphylaxis	Immune system disorders	Arm I (Temozolomide, Irinotecan Hydrochloride)	1	54
other	Anaphylaxis	Immune system disorders	Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)	0	52

1 to 10 of 188Source ClinicalTrials.gov

See all 188 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (Temozolomide, Irinotecan Hydrochloride)	48	54
Total, all-cause mortality	Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)	42	52
Total, other adverse events	Arm I (Temozolomide, Irinotecan Hydrochloride)	31	54
Total, other adverse events	Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)	42	52
Total, serious adverse events	Arm I (Temozolomide, Irinotecan Hydrochloride)	9	54
Total, serious adverse events	Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab)	12	52

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants2

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	Source
U10CA180886	COG NCTN Network Group Operations Center	Hawkins, Douglas S.	COG RESEARCH FOUNDATION, LLC	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013	NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm I (Temozolomide, Irinotecan Hydrochloride) vs Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab): deaths from any cause	Trial comparisons
Arm I (Temozolomide, Irinotecan Hydrochloride) vs Arm II (Temozolomide, Irinotecan Hydrochloride, Bevacizumab): serious adverse events	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.

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.

GET https://conductscience.org/api/trials/v1/NCT01217437

GET https://conductscience.org/api/trials/v1/NCT01217437/events?page=2

API reference For AI assistants