Trial · NCT00042991

Gefitinib and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas

NCT00042991, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2011-07-11

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Gefitinib and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas. Trials, record NCT00042991. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00042991

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Trial

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

Title: Gefitinib and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas
NCT number: NCT00042991
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 69 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Untreated Childhood Anaplastic Astrocytoma, Untreated Childhood Anaplastic Oligodendroglioma, Untreated Childhood Brain Stem Glioma, Untreated Childhood Giant Cell Glioblastoma, Untreated Childhood Glioblastoma, Untreated Childhood Gliomatosis Cerebri, Untreated Childhood Gliosarcoma, Untreated Childhood Oligodendroglioma
Interventions: gefitinib, radiation therapy, pharmacological study, laboratory biomarker analysis
First posted: 2003-01-27
Last updated: 2014-05-28
Results first posted: 2011-07-11

Source ClinicalTrials.gov

Registered outcomes15

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

List	Outcome	Time frame	Description
Primary	Number of Participants in Phase I Stratum 1A With Dose-limiting Toxicities (DLT) Observed During the First 8 Weeks of Gefitinib Therapy	Day 1 of gefitinib therapy to end of week 8	The dose limiting toxicity (DLT) analysis population consists of stratum 1A phase I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (course 1 and 2) or who completed the MTD estimation period without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD based on the tradional 3+3 design, where a dose is considered a safe dose only when 0 out of 3, or at most 1 out of 6 patients has DLTs. When two or more patients in a group of 2 to 6 patients had DLTs, then that dose level was considered to be too toxic.
Primary	Median Progression-free Survival in Newly Diagnosed Brain Stem Gliomas	Assessed pre-radiation, every 8 weeks for 13 courses of therapy, and then every 12 weeks	Progression-free survival is defined as the interval from intiation of treatment to the earliest of disease progression (tumor increase of 25% over baseline tumor measurement; appearance of new lesion(s); or progressive/worsening neurlogical status) or death for patients who failed or to the last date of follow-up for patients without failure
Primary	Median Survival in Newly Diagnosed Brain Stem Gliomas	Assessed from the start of therapy until three years after initiation of gefitinib therapy	Overall survival is defined as the interval from initiation of treatment to death or date of last contact for surviving patients
Secondary	Change in Tumor Volume Measured on Fluid Attenuated Inversion Recovery (FLAIR) Imaging at Before the Protocol Therapy Started and at Two Weeks After Completion of Radiation	Baseline and two weeks post completion of radiation	This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. In this particular objective, the study aimed to investigate how radiation+gefitinib affect the tumor volume. Tumor volume is measured using Fluid Attenuated Inversion Recovery (FLAIR) before and after the radiation therapy.
Secondary	Change From Baseline in Volume Enhancing at Two Weeks After Completion of Radiation	Baseline and two weeks post completion of radiation	This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response,survival, etc.). Volume enhancing is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain.
Secondary	Change From Baseline in Diffusion Ratio at Two Weeks After Completion of Radiation	Baseline and two weeks post completion of radiation	This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response,survival, etc.). Diffusion ratio is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain.
Secondary	Change From Baseline in Perfusion Ratio at Two Weeks After Completion of Radiation	Baseline and two weeks post completion of radiation	This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response,survival, etc.). Perfusion ratio is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain.
Secondary	Mean Tumor to Gray Matter Ratio Measured at Baseline	Baseline	This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal gray matter to provide ratios of tumor/gray matter. Each patient has a mean tumor to gray matter ratio value and the median of these values across patients is reported.
Secondary	Mean Tumor to White Matter Ratio Measured at Baseline	Baseline	This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal white matter to provide ratios of tumor/gray matter. Each patient has a mean tumor to white matter ratio value and the median of these values across patients is reported.
Secondary	Peak Serum Concentration of Gefitinib (Cmax)	Week 2 of course 1

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants in Phase I Stratum 1A With Dose-limiting Toxicities (DLT) Observed During the First 8 Weeks of Gefitinib Therapy	Day 1 of gefitinib therapy to end of week 8	This cohort includes only the patients who were enrolled and treated on Gefitinib+Radiation during the Phase I component of the trial, where the safety of Gefitinib was assedded at Dose Levels 100 mg/m\^2, 250 mg/m\^2, and 375 mg/m\^2.	Participants	NUMBER
PRIMARY	Median Progression-free Survival in Newly Diagnosed Brain Stem Gliomas	Assessed pre-radiation, every 8 weeks for 13 courses of therapy, and then every 12 weeks	Here, we only report the results for Phase-II trial as this objective was specifically for the Phase-II trial. This cohort includes seven patients who were treated during Phase-I at Dose 250 mg/m\^2 of Gefitinib.	Months	MEDIAN
PRIMARY	Median Survival in Newly Diagnosed Brain Stem Gliomas	Assessed from the start of therapy until three years after initiation of gefitinib therapy		Months	MEDIAN
SECONDARY	Change in Tumor Volume Measured on Fluid Attenuated Inversion Recovery (FLAIR) Imaging at Before the Protocol Therapy Started and at Two Weeks After Completion of Radiation	Baseline and two weeks post completion of radiation	Out of 43 patients, 35 patients had brain MRI before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the volumetric data from these 35 patients.	cc	MEDIAN
SECONDARY	Change From Baseline in Volume Enhancing at Two Weeks After Completion of Radiation	Baseline and two weeks post completion of radiation	Out of 43 patients, for only 19 patients, enhacing tumor was greater than zero based on brain MRI scans before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the enhancing volumetric data from these 19 patients.	cc	MEDIAN
SECONDARY	Change From Baseline in Diffusion Ratio at Two Weeks After Completion of Radiation	Baseline and two weeks post completion of radiation	Out of 43 patients, 29 patients had diffusion scans before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the volumetric data from these 29 patients.	Ratio	MEDIAN
SECONDARY	Change From Baseline in Perfusion Ratio at Two Weeks After Completion of Radiation	Baseline and two weeks post completion of radiation	Out of 43 patients, 20 patients had perfusion scans before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the volumetric data from these 20 patients.	Ratio	MEDIAN
SECONDARY	Mean Tumor to Gray Matter Ratio Measured at Baseline	Baseline	Out of 43 patients, only 18 Patients had baseline PET scans. Therefore, this analysis is based on these 18 patients.	Ratio	MEDIAN
SECONDARY	Mean Tumor to White Matter Ratio Measured at Baseline	Baseline	Out of 43 patients, only 18 Patients had baseline PET scans. Therefore, this analysis is based on these 18 patients.	Ratio	MEDIAN
SECONDARY	Peak Serum Concentration of Gefitinib (Cmax)	Week 2 of course 1	PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m\^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.	mcg/ml	MEDIAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group32

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

Outcome	Group	Value	Spread	Units
Number of Participants in Phase I Stratum 1A With Dose-limiting Toxicities (DLT) Observed During the First 8 Weeks of Gefitinib Therapy	Stratum 1A-100 mg/m^2 of Gefitinib + Radiation	2		Participants
Number of Participants in Phase I Stratum 1A With Dose-limiting Toxicities (DLT) Observed During the First 8 Weeks of Gefitinib Therapy	Stratum 1A-250 mg/m^2 of Gefitinib + Radiation	0		Participants
Number of Participants in Phase I Stratum 1A With Dose-limiting Toxicities (DLT) Observed During the First 8 Weeks of Gefitinib Therapy	Stratum 1A-375 mg/m^2 of Gefitinib + Radiation	1		Participants
Median Progression-free Survival in Newly Diagnosed Brain Stem Gliomas	Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation	7.43	Full Range 1.25 to 37.95	Months
Median Survival in Newly Diagnosed Brain Stem Gliomas	Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation	12.12	Full Range 1.71 to 37.95	Months
Change in Tumor Volume Measured on Fluid Attenuated Inversion Recovery (FLAIR) Imaging at Before the Protocol Therapy Started and at Two Weeks After Completion of Radiation	Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation	-14.03	Full Range -48.64 to 30.56	cc
Change From Baseline in Volume Enhancing at Two Weeks After Completion of Radiation	Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation	0.35	Full Range -2.97 to 7.31	cc
Change From Baseline in Diffusion Ratio at Two Weeks After Completion of Radiation	Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation	-0.41	Full Range -1.38 to 0.39	Ratio
Change From Baseline in Perfusion Ratio at Two Weeks After Completion of Radiation	Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation	0.72	Full Range -11.09 to 4.68	Ratio
Mean Tumor to Gray Matter Ratio Measured at Baseline	Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation	0.55	Full Range 0.38 to 0.83	Ratio

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow35

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Stratum 1A-100 mg/m^2 of Gefitinib + Radiation	6
Overall Study	STARTED	Stratum 1A-250 mg/m^2 of Gefitinib + Radiation	43
Overall Study	STARTED	Stratum 1A-375 mg/m^2 of Gefitinib + Radiation	7
Overall Study	STARTED	Stratum-1B: 100 mg/m^2 of Gefitinib + Radiation	2
Overall Study	STARTED	Stratum-1B: 250 mg/m^2 of Gefitinib + Radiation	3
Overall Study	STARTED	Stratum-1B: 375 mg/m^2 of Gefitinib + Radiation	5
Overall Study	STARTED	Stratum-2: 100 mg/m^2 of Gefitinib + Radiation + EIACD	3
Overall Study	Phase-I Trial	Stratum 1A-100 mg/m^2 of Gefitinib + Radiation	6
Overall Study	Phase-I Trial	Stratum 1A-250 mg/m^2 of Gefitinib + Radiation	7
Overall Study	Phase-I Trial	Stratum 1A-375 mg/m^2 of Gefitinib + Radiation	7

1 to 10 of 35Source ClinicalTrials.gov

See all 35 participant flow

Adverse events861

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	ALT, SGPT (serum glutamic pyruvic transaminase)	Investigations	Stratum IA at Dose 100 mg/m^2	2	6
other	ALT, SGPT (serum glutamic pyruvic transaminase)	Investigations	Stratum IA at Dose 250 mg/m^2	22	43
other	ALT, SGPT (serum glutamic pyruvic transaminase)	Investigations	Stratum IA at Dose 375 mg/m^2	2	7
other	ALT, SGPT (serum glutamic pyruvic transaminase)	Investigations	Stratum IB at Dose 100 mg/m^2	0	2
other	ALT, SGPT (serum glutamic pyruvic transaminase)	Investigations	Stratum IB at Dose 250 mg/m^2	1	3
other	ALT, SGPT (serum glutamic pyruvic transaminase)	Investigations	Stratum IB at Dose 375 mg/m^2	1	5
other	ALT, SGPT (serum glutamic pyruvic transaminase)	Investigations	Stratum II at Dose 100 mg/m^2	1	3
other	AST, SGOT(serum glutamic oxaloacetic transaminase)	Investigations	Stratum IA at Dose 100 mg/m^2	2	6
other	AST, SGOT(serum glutamic oxaloacetic transaminase)	Investigations	Stratum IA at Dose 250 mg/m^2	13	43
other	AST, SGOT(serum glutamic oxaloacetic transaminase)	Investigations	Stratum IA at Dose 375 mg/m^2	1	7

1 to 10 of 861Source ClinicalTrials.gov

See all 861 adverse events

Adverse event totals21

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Stratum IA at Dose 100 mg/m^2
Total, all-cause mortality	Stratum IA at Dose 250 mg/m^2
Total, all-cause mortality	Stratum IA at Dose 375 mg/m^2
Total, all-cause mortality	Stratum IB at Dose 100 mg/m^2
Total, all-cause mortality	Stratum IB at Dose 250 mg/m^2
Total, all-cause mortality	Stratum IB at Dose 375 mg/m^2
Total, all-cause mortality	Stratum II at Dose 100 mg/m^2
Total, other adverse events	Stratum IA at Dose 100 mg/m^2	6	6
Total, other adverse events	Stratum IA at Dose 250 mg/m^2	43	43
Total, other adverse events	Stratum IA at Dose 375 mg/m^2	7	7

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

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