Trial · NCT00021229
Imatinib Mesylate With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed or Recurrent Glioma
NCT00021229, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2010-04-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Imatinib Mesylate With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed or Recurrent Glioma. Trials, record NCT00021229. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00021229
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Imatinib Mesylate With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed or Recurrent Glioma
- NCT number
- NCT00021229
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 85 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- imatinib mesylate, local irradiation therapy
- First posted
- 2003-01-27
- Last updated
- 2014-07-31
- Results first posted
- 2010-04-09
- Limitations and caveats
- The phase II component of the trial was terminated because of poor accrual. Only one patient enrolled to the phase II component and did not receive the investigational drug.
Source ClinicalTrials.gov
Registered outcomes10
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 I With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy | Day 1 of Imatinib Mesylate Therapy to Week 8 | The dose limiting toxicity (DLT) analysis population consists of phase I stratum I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (course 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD. The estimated MTD based on the 23 participants who either had a DLT during course 1 or 2 or completed courses 1 and 2 without DLT is 265 mg/m2/day. |
| Primary | Number of Participants in Phase I Stratum II With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy | Day 1 of Imatinib Mesylate Therapy to Week 8 | The dose limiting toxicity (DLT) analysis population consisted of phase I stratum II participants who developed DLT during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD. The estimated MTD based on the DLT analysis population of 20 in stratum IIA was 465 mg/m2/day. An MTD was not established in stratum IIB as no DLTs were observed at the higher dose levels of 620 and 800 mg/m2/day. |
| Primary | Median Progression-free Survival (PFS) | Assessed pre-radiation, before the first dose of imatinib, and then every 8 weeks | Progression-free survival is defined as the interval from initiation of treatment to the earliest of disease progression (tumor increase of 25% over baseline tumor measurement; appearance of new lesion(s); or progressive/worsening neurological status) or death for patients who failed, or to the last date of follow up for patients without failure. |
| Secondary | Change From Baseline in Volume FLAIR 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 radiation (RT) on changes in various neuroimaging variables in pediatric brainstem gliomas (stratum I). Neuroimaging changes may have some association with outcome (response, survival, etc.). Volume FLAIR is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain. Volume FLAIR was obtained at baseline (pre-radiation) and within two (+/- one) weeks after completion of RT. |
| Secondary | Peak Concentration (Cmax) | Day 1 of Course 1 | Peak concentration (cmax) is a pharmacokinetic measure defined as the highest concentration of a drug measured after the drug is administered. The cmax of imatinib mesylate on day 1 of course 1 is reported. Two milliliter (0.5 ml for children under the age of 5) blood samples were collected immediately prior to imatinib mesylate administration on Day 1 of Course 1 and at the following timepoints following drug administration: 0.5, 1, 1.5, 2, 4, 10 and 12 hours after the morning dose. |
| Secondary | Median Overall Survival | Assessed before radiation therapy, before the first dose of imatinib, then every 8 weeks. | Overall Survival (OS) is defined as the interval from initiation of treatment to death or date of last contact for surviving patients. |
| Secondary | Pre-treatment Basic Fibroblast Growth Factor Values From Urine | Pre-treatment | This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Basic fibroblast growth factor (bFGF) may play a role in tumor development by helping tumor vessels establish and grow. Urine was collected from participants before treatment to measure the baseline urine bFGF values. |
| Secondary | Pre-treatment Basic Fibroblast Growth Factor Values From Plasma | Pre-treatment | This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Basic fibroblast growth factor (bFGF) may play a role in tumor development by helping tumor vessels establish and grow. Blood (plasma) was drawn from participants before treatment to measure the baseline plasma bFGF values. |
| Secondary | Pre-treatment Vascular Endothelial Growth Factor From Urine | Pre-treatment | This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Vascular endothelial growth factor (VEGF) may play a role in tumor development by helping tumor vessels establish and grow. Urine was collected from participants before treatment to measure the baseline urine VEGF values. |
| Secondary | Pre-treatment Vascular Endothelial Growth Factor Values From Plasma | Pre-treatment | This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Vascular endothelial growth factor (VEGF) may play a role in tumor development by helping tumor vessels establish and grow. Blood (plasma) was drawn from participants before treatment to measure the baseline plasma VEGF values. |
Source ClinicalTrials.gov
Outcomes10
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 I With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy | Day 1 of Imatinib Mesylate Therapy to Week 8 | Per protocol, participants included phase I stratum I participants who developed dose-limiting toxicities during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without dose-limiting toxicities. | Participants | NUMBER |
| PRIMARY | Number of Participants in Phase I Stratum II With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy | Day 1 of Imatinib Mesylate Therapy to Week 8 | Per protocol, participants included phase I stratum II participants who developed dose-limiting toxicities (DLT) during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. | Participants | NUMBER |
| PRIMARY | Median Progression-free Survival (PFS) | Assessed pre-radiation, before the first dose of imatinib, and then every 8 weeks | Per protocol, 40 participants who received at least one dose of drug were needed for this objective. The analysis population consists of stratum I participants enrolled at the maximum tolerated dose (phase 1) and the participants enrolled to the phase II part. The study was terminated because of poor accrual and the objective was not met. | ||
| SECONDARY | Change From Baseline in Volume FLAIR at Two Weeks After Completion of Radiation | Baseline and two weeks post completion of radiation | The analysis population consists of Stratum I patients enrolled who had both pre and post radiation (RT) volume FLAIR measures. Stratum II participants did not receive RT and thus were not included. | cubic centimeters | MEAN |
| SECONDARY | Peak Concentration (Cmax) | Day 1 of Course 1 | The analysis population consists of participants who enrolled at the maximum tolerated dose (MTD) of the phase I component and who submitted day 1 course 1 samples for the PK studies. An MTD was not estimated in stratum IIB. For this stratum, reported are values at the stratum IIA MTD to allow comparison. | µg/ml | MEAN |
| SECONDARY | Median Overall Survival | Assessed before radiation therapy, before the first dose of imatinib, then every 8 weeks. | The analysis population consists of the stratum I participants who received imatinib mesylate at or above the maximum tolerated dose. The median survival reported is based on these 20 participants. | Days | MEDIAN |
| SECONDARY | Pre-treatment Basic Fibroblast Growth Factor Values From Urine | Pre-treatment | Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment urine samples for the biomarker study. | pg/ml | MEAN |
| SECONDARY | Pre-treatment Basic Fibroblast Growth Factor Values From Plasma | Pre-treatment | Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment blood samples for the biomarker study. | pg/ml | MEAN |
| SECONDARY | Pre-treatment Vascular Endothelial Growth Factor From Urine | Pre-treatment | Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment urine samples for the biomarker study. | pg/ml | MEAN |
| SECONDARY | Pre-treatment Vascular Endothelial Growth Factor Values From Plasma | Pre-treatment | Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment blood samples for the biomarker study. | pg/ml | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants in Phase I Stratum I With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy | Stratum I: Radiation + Imatinib Mesylate | 5 | Participants | ||
| Number of Participants in Phase I Stratum II With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy | Stratum IIA: Imatinib Mesylate | 2 | Participants | ||
| Number of Participants in Phase I Stratum II With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy | Stratum IIB: Imatinib Mesylate | 0 | Participants | ||
| Change From Baseline in Volume FLAIR at Two Weeks After Completion of Radiation | Stratum I: Radiation + Imatinib Mesylate | 7.62 | Full Range -17.95 to 41.32 | cubic centimeters | |
| Peak Concentration (Cmax) | Stratum I: Radiation + Imatinib Mesylate | 1.3 | Full Range .7 to 2.1 | µg/ml | |
| Peak Concentration (Cmax) | Stratum IIA: Imatinib Mesylate | 2.6 | Full Range 1.5 to 5.9 | µg/ml | |
| Peak Concentration (Cmax) | Stratum IIB: Imatinib Mesylate | 1.3 | Full Range .8 to 2.1 | µg/ml | |
| Median Overall Survival | Stratum I: Radiation + Imatinib Mesylate | 324.5 | 95% Confidence Interval 8.7 | Days | |
| Pre-treatment Basic Fibroblast Growth Factor Values From Urine | Stratum I: Radiation + Imatinib Mesylate | 5665 | Standard Deviation 4006 | pg/ml | |
| Pre-treatment Basic Fibroblast Growth Factor Values From Urine | Stratum IIA: Imatinib Mesylate | 10322 | Standard Deviation 14443 | pg/ml |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stratum I: Radiation + Imatinib Mesylate | 36 | |
| Overall Study | STARTED | Stratum IIA: Imatinib Mesylate | 33 | |
| Overall Study | STARTED | Stratum IIB: Imatinib Mesylate | 16 | |
| Overall Study | Enrolled in Phase I | Stratum I: Radiation + Imatinib Mesylate | 35 | |
| Overall Study | Enrolled in Phase I | Stratum IIA: Imatinib Mesylate | 33 | |
| Overall Study | Enrolled in Phase I | Stratum IIB: Imatinib Mesylate | 16 | |
| Overall Study | Maximum Tolerated Dose (MTD) Estimation | Stratum I: Radiation + Imatinib Mesylate | 23 | |
| Overall Study | Maximum Tolerated Dose (MTD) Estimation | Stratum IIA: Imatinib Mesylate | 20 | |
| Overall Study | Maximum Tolerated Dose (MTD) Estimation | Stratum IIB: Imatinib Mesylate | 12 | |
| Overall Study | Enrolled in Phase II | Stratum I: Radiation + Imatinib Mesylate | 14 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events444
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 | Abdominal pain or cramping | Gastrointestinal disorders | Stratum I: Radiation + Imatinib Mesylate | 8 | 36 | |
| other | Abdominal pain or cramping | Gastrointestinal disorders | Stratum IIA: Imatinib Mesylate | 2 | 33 | |
| other | Abdominal pain or cramping | Gastrointestinal disorders | Stratum IIB: Imatinib Mesylate | 2 | 16 | |
| other | Alkaline phosphatase | Investigations | Stratum I: Radiation + Imatinib Mesylate | 1 | 36 | |
| other | Alkaline phosphatase | Investigations | Stratum IIA: Imatinib Mesylate | 2 | 33 | |
| other | Alkaline phosphatase | Investigations | Stratum IIB: Imatinib Mesylate | 1 | 16 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Stratum I: Radiation + Imatinib Mesylate | 3 | 36 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Stratum IIA: Imatinib Mesylate | 0 | 33 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Stratum IIB: Imatinib Mesylate | 0 | 16 | |
| other | Anorexia | Metabolism and nutrition disorders | Stratum I: Radiation + Imatinib Mesylate | 10 | 36 |
1 to 10 of 444Source ClinicalTrials.gov
See all 444 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stratum I: Radiation + Imatinib Mesylate | ||
| Total, all-cause mortality | Stratum IIA: Imatinib Mesylate | ||
| Total, all-cause mortality | Stratum IIB: Imatinib Mesylate | ||
| Total, other adverse events | Stratum I: Radiation + Imatinib Mesylate | 33 | 36 |
| Total, other adverse events | Stratum IIA: Imatinib Mesylate | 31 | 33 |
| Total, other adverse events | Stratum IIB: Imatinib Mesylate | 14 | 16 |
| Total, serious adverse events | Stratum I: Radiation + Imatinib Mesylate | 13 | 36 |
| Total, serious adverse events | Stratum IIA: Imatinib Mesylate | 13 | 33 |
| Total, serious adverse events | Stratum IIB: Imatinib Mesylate | 5 | 16 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Stratum IIA: Imatinib Mesylate vs Stratum IIB: Imatinib Mesylate: Number of Participants in Phase I Stratum II With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy |
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/NCT00021229
GET https://conductscience.org/api/trials/v1/NCT00021229/events?page=2