Trial · NCT00049127
Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor
NCT00049127, Phase 1, Phase 2, Completed, Alliance for Clinical Trials in Oncology; results first posted 2014-10-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor. Trials, record NCT00049127. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00049127
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor
- NCT number
- NCT00049127
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Adult Anaplastic Oligodendroglioma, Adult Mixed Glioma, Adult Oligodendroglioma, Recurrent Adult Brain Neoplasm
- Interventions
- Imatinib Mesylate, Laboratory Biomarker Analysis, Pharmacological Study
- First posted
- 2003-01-27
- Last updated
- 2019-10-21
- Results first posted
- 2014-10-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6-month Progression-free Survival (PFS), Defined as a Patient Being Alive and Progression-free 183 Days After the Date of Registration. | 6 months | The proportion of successes will be estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 90% confidence interval estimated using the Duffy-Santer algorithm. Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), \>25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. |
| Secondary | Confirmed Response (i.e., an Objective Status of Complete Response (CR), Partial Response (PR), or Regression (REGR) on 2 Successive Evaluations at Least 4 Weeks Apart After the Start of Study Treatment). | Up to 5 years | Complete Response (CR) is defined using response criteria (the neurologic examination and the Magnetic resonance imaging (MRI) and/or Computerized Tomography (CT)), total disappearance of all tumor with patient off corticosteroids or only on adrenal replacement maintenance. Partial Response (PR) is defined using response criteria (the neurologic examination and the MRI and/or CT), \>=50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose. Regression (REGR) is defined using response criteria (the neurologic examination and the MRI and/or CT), unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose. |
| Secondary | Percentage of Patients Progression-free | Time from study registration to date of disease progression or last follow-up, assessed up to 5 years | The percentage of patient progression-free at 12 months, 18 months, and PFS will be estimated. Kaplan-Meier survival curves and logrank tests will be used to estimate progression-time distributions. Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), \>25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. |
| Secondary | Overall Time to Death | Time from date of registration to date of death due to any cause or last follow-up, assessed up to 5 years | Kaplan-Meier survival curves and logrank tests will be used to estimate survival distributions. |
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 | 6-month Progression-free Survival (PFS), Defined as a Patient Being Alive and Progression-free 183 Days After the Date of Registration. | 6 months | percentage of patients | NUMBER | |
| SECONDARY | Confirmed Response (i.e., an Objective Status of Complete Response (CR), Partial Response (PR), or Regression (REGR) on 2 Successive Evaluations at Least 4 Weeks Apart After the Start of Study Treatment). | Up to 5 years | percentage of confirmed responses | NUMBER | |
| SECONDARY | Percentage of Patients Progression-free | Time from study registration to date of disease progression or last follow-up, assessed up to 5 years | months | MEAN | |
| SECONDARY | Overall Time to Death | Time from date of registration to date of death due to any cause or last follow-up, assessed up to 5 years | months | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 6-month Progression-free Survival (PFS), Defined as a Patient Being Alive and Progression-free 183 Days After the Date of Registration. | Study 1 Arm C | 33.35 | percentage of patients | ||
| 6-month Progression-free Survival (PFS), Defined as a Patient Being Alive and Progression-free 183 Days After the Date of Registration. | Study 2 Arm B | 33.3 | percentage of patients | ||
| 6-month Progression-free Survival (PFS), Defined as a Patient Being Alive and Progression-free 183 Days After the Date of Registration. | Study 3 Arm E | 25 | percentage of patients | ||
Confirmed Response (i.e., an Objective Status of Complete Response (CR), Partial Response (PR), or Regression (REGR) on 2 Successive Evaluations at Least 4 Weeks Apart After the Start of Study Treatment). | Study 1 Arm C | 0 | percentage of confirmed responses | ||
Confirmed Response (i.e., an Objective Status of Complete Response (CR), Partial Response (PR), or Regression (REGR) on 2 Successive Evaluations at Least 4 Weeks Apart After the Start of Study Treatment). | Study 2 Arm B | 5.1 | percentage of confirmed responses | ||
Confirmed Response (i.e., an Objective Status of Complete Response (CR), Partial Response (PR), or Regression (REGR) on 2 Successive Evaluations at Least 4 Weeks Apart After the Start of Study Treatment). | Study 3 Arm E | 0 | percentage of confirmed responses | ||
| Percentage of Patients Progression-free | Study 1 Arm C | 1.9 | 95% Confidence Interval 1.7 to NA | months | |
| Percentage of Patients Progression-free | Study 2 Arm B | 4.0 | 95% Confidence Interval 1.9 to 6.2 | months | |
| Percentage of Patients Progression-free | Study 3 Arm E | 4.5 | 95% Confidence Interval 2.2 to NA | months | |
| Overall Time to Death | Study 1 Arm C | 14.2 | 95% Confidence Interval 8.8 to NA | months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Study 1 Arm C | 12 | |
| Overall Study | STARTED | Study 2 Arm A | 0 | |
| Overall Study | STARTED | Study 2 Arm B | 40 | |
| Overall Study | STARTED | Study 3 Arm D | 0 | |
| Overall Study | STARTED | Study 3 Arm E | 12 | |
| Overall Study | COMPLETED | Study 1 Arm C | 12 | |
| Overall Study | COMPLETED | Study 2 Arm A | 0 | |
| Overall Study | COMPLETED | Study 2 Arm B | 39 | |
| Overall Study | COMPLETED | Study 3 Arm D | 0 | |
| Overall Study | COMPLETED | Study 3 Arm E | 12 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events700
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 | Hemoglobin decreased | Blood and lymphatic system disorders | Study 2 Arm A | 0 | 0 | 0 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Study 2 Arm B | 13 | 39 | 82 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Study 1 Arm C | 4 | 12 | 19 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Study 3 Arm D | 0 | 0 | 0 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Study 3 Arm E | 2 | 12 | 29 |
| other | Hemoglobin for leukemia studies | Blood and lymphatic system disorders | Study 2 Arm A | 0 | 0 | 0 |
| other | Hemoglobin for leukemia studies | Blood and lymphatic system disorders | Study 2 Arm B | 2 | 39 | 6 |
| other | Hemoglobin for leukemia studies | Blood and lymphatic system disorders | Study 1 Arm C | 1 | 12 | 1 |
| other | Hemoglobin for leukemia studies | Blood and lymphatic system disorders | Study 3 Arm D | 0 | 0 | 0 |
| other | Hemoglobin for leukemia studies | Blood and lymphatic system disorders | Study 3 Arm E | 1 | 12 | 1 |
1 to 10 of 700Source ClinicalTrials.gov
See all 700 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Study 2 Arm A | ||
| Total, all-cause mortality | Study 2 Arm B | ||
| Total, all-cause mortality | Study 1 Arm C | ||
| Total, all-cause mortality | Study 3 Arm D | ||
| Total, all-cause mortality | Study 3 Arm E | ||
| Total, other adverse events | Study 2 Arm A | 0 | 0 |
| Total, other adverse events | Study 2 Arm B | 37 | 39 |
| Total, other adverse events | Study 1 Arm C | 12 | 12 |
| Total, other adverse events | Study 3 Arm D | 0 | 0 |
| Total, other adverse events | Study 3 Arm E | 11 | 12 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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 |
|---|---|---|---|---|---|
| U10CA025224 | North Central Cancer Treatment Group | BUCKNER, JAN C | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 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.
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/NCT00049127
GET https://conductscience.org/api/trials/v1/NCT00049127/events?page=2