Trial · NCT00079339
Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma
NCT00079339, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2010-09-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma. Trials, record NCT00079339. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00079339
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma
- NCT number
- NCT00079339
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Untreated Childhood Brain Stem Glioma
- Interventions
- radiation therapy, tipifarnib
- First posted
- 2004-03-10
- Last updated
- 2014-05-15
- Results first posted
- 2010-09-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants in the Phase I Component With Dose-limiting Toxicities (DLTs) Observed During the First 8 Weeks (Courses 1 and 2) of Tipifarnib Therapy | Day 1 of tipifarnib therapy to week 8 | The dose limiting toxicity (DLT) analysis population consists of phase I 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. |
| Primary | Progression-free Survival (PFS) | Assessed before the first dose of tipifarnib, every 8 weeks for the first 48 weeks, and then every 12 weeks. | PFS was 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 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 neuroimaging meaurements. Neuroimaging changes may have some association with outcome (response, survival, etc.). Perfusion values are obtained from magnetic resonance perfusion imaging and were measured at baseline, every 8 weeks for the first 48 weeks, and then every 12 weeks until treatment is discontinued. |
| 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 neuroimaging meaurements. Neuroimaging changes may have some association with outcome (response, survival, etc.). Diffusion values are obtained from magnetic resonance diffusion imaging and were measured at baseline, every 8 weeks for the first 48 weeks, and then every 12 weeks until treatment is discontinued. |
| 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 treatment on changes in various neuroimaging variables. 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 and within two weeks after completion of radiation. |
| 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/white matter. Each patient has a mean tumor to white matter ratio value and the median of these values across patients is reported. |
Source ClinicalTrials.gov
Outcomes7
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 the Phase I Component With Dose-limiting Toxicities (DLTs) Observed During the First 8 Weeks (Courses 1 and 2) of Tipifarnib Therapy | Day 1 of tipifarnib therapy to week 8 | Per protocol, participants included phase 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 | Progression-free Survival (PFS) | Assessed before the first dose of tipifarnib, every 8 weeks for the first 48 weeks, and then every 12 weeks. | Per protocol 40 participants who received at least one dose of tipifarnib were needed for this objective. The analysis population consists of phase I participants treated at the maximum tolerated dose (MTD) and the participants enrolled to the phase II part. | Months | MEDIAN |
| SECONDARY | Change From Baseline in Perfusion Ratio at Two Weeks After Completion of Radiation | Baseline and two weeks post completion of radiation | The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline perfusion ratio value and a second perfusion ratio value measured at approximately 8 weeks after starting treatment. | Ratio | MEDIAN |
| SECONDARY | Change From Baseline in Diffusion Ratio at Two Weeks After Completion of Radiation. | Baseline and two weeks post completion of radiation | The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline diffusion ratio value and a second diffusion ratio value measured at approximately 8 weeks after starting treatment. | Ratio | MEDIAN |
| 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 participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline volume FLAIR value and a second volume FLAIR value measured at approximately 8 weeks after starting treatment. | cubic centimeters | MEDIAN |
| SECONDARY | Mean Tumor to Gray Matter Ratio Measured at Baseline | Baseline | The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline PET scan. | Ratio | MEDIAN |
| SECONDARY | Mean Tumor to White Matter Ratio Measured at Baseline | Baseline | The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline PET scan. | Ratio | MEDIAN |
Source ClinicalTrials.gov
Results by group9
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 the Phase I Component With Dose-limiting Toxicities (DLTs) Observed During the First 8 Weeks (Courses 1 and 2) of Tipifarnib Therapy | Tipifarnib 100-mg/m2 | 0 | Participants | ||
| Number of Participants in the Phase I Component With Dose-limiting Toxicities (DLTs) Observed During the First 8 Weeks (Courses 1 and 2) of Tipifarnib Therapy | Tipifarnib 125-mg/m2 | 1 | Participants | ||
| Number of Participants in the Phase I Component With Dose-limiting Toxicities (DLTs) Observed During the First 8 Weeks (Courses 1 and 2) of Tipifarnib Therapy | Tipifarnib 150-mg/m2 | 4 | Participants | ||
| Progression-free Survival (PFS) | Tipifarnib 125-mg/m2 | 6.8 | Full Range .2 to 18.6 | Months | |
| Change From Baseline in Perfusion Ratio at Two Weeks After Completion of Radiation | Tipifarnib - Any Dose Level | -.42 | Full Range -7.35 to 4.3 | Ratio | |
| Change From Baseline in Diffusion Ratio at Two Weeks After Completion of Radiation. | Tipifarnib - All Dose Levels | -.13 | Full Range -1.61 to .93 | Ratio | |
| Change From Baseline in Volume FLAIR at Two Weeks After Completion of Radiation | Tipifarnib - All Dose Levels | -12.45 | Full Range -29.45 to 7.86 | cubic centimeters | |
| Mean Tumor to Gray Matter Ratio Measured at Baseline | Tipifarnib - All Dose Levels | .64 | Full Range .42 to 1.17 | Ratio | |
| Mean Tumor to White Matter Ratio Measured at Baseline | Tipifarnib - All Dose Levels | 1.44 | Full Range 1.17 to 1.91 | Ratio |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tipifarnib 100-mg/m2 | 5 | |
| Overall Study | STARTED | Tipifarnib 125-mg/m2 | 40 | |
| Overall Study | STARTED | Tipifarnib 150-mg/m2 | 6 | |
| Overall Study | Enrolled in Phase I | Tipifarnib 100-mg/m2 | 5 | |
| Overall Study | Enrolled in Phase I | Tipifarnib 125-mg/m2 | 6 | |
| Overall Study | Enrolled in Phase I | Tipifarnib 150-mg/m2 | 6 | |
| Overall Study | Maximum Tolerated Dose (MTD) Estimation | Tipifarnib 100-mg/m2 | 3 | |
| Overall Study | Maximum Tolerated Dose (MTD) Estimation | Tipifarnib 125-mg/m2 | 6 | |
| Overall Study | Maximum Tolerated Dose (MTD) Estimation | Tipifarnib 150-mg/m2 | 5 | |
| Overall Study | Enrolled in Phase II | Tipifarnib 100-mg/m2 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events498
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 | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Tipifarnib 100-mg/m2 | 1 | 5 | |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Tipifarnib 125-mg/m2 | 10 | 40 | |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Tipifarnib 150-mg/m2 | 3 | 6 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Tipifarnib 100-mg/m2 | 3 | 5 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Tipifarnib 125-mg/m2 | 29 | 40 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Tipifarnib 150-mg/m2 | 2 | 6 | |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Tipifarnib 100-mg/m2 | 4 | 5 | |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Tipifarnib 125-mg/m2 | 25 | 40 | |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Tipifarnib 150-mg/m2 | 4 | 6 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Tipifarnib 100-mg/m2 | 1 | 5 |
1 to 10 of 498Source ClinicalTrials.gov
See all 498 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tipifarnib 100-mg/m2 | ||
| Total, all-cause mortality | Tipifarnib 125-mg/m2 | ||
| Total, all-cause mortality | Tipifarnib 150-mg/m2 | ||
| Total, other adverse events | Tipifarnib 100-mg/m2 | 5 | 5 |
| Total, other adverse events | Tipifarnib 125-mg/m2 | 40 | 40 |
| Total, other adverse events | Tipifarnib 150-mg/m2 | 5 | 6 |
| Total, serious adverse events | Tipifarnib 100-mg/m2 | 3 | 5 |
| Total, serious adverse events | Tipifarnib 125-mg/m2 | 29 | 40 |
| Total, serious adverse events | Tipifarnib 150-mg/m2 | 3 | 6 |
Source ClinicalTrials.gov
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.
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/NCT00079339
GET https://conductscience.org/api/trials/v1/NCT00079339/events?page=2