Trial · NCT00095940
Lapatinib in Treating Young Patients With Recurrent or Refractory Central Nervous System Tumors
NCT00095940, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2012-02-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lapatinib in Treating Young Patients With Recurrent or Refractory Central Nervous System Tumors. Trials, record NCT00095940. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00095940
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lapatinib in Treating Young Patients With Recurrent or Refractory Central Nervous System Tumors
- NCT number
- NCT00095940
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Recurrent Childhood Anaplastic Astrocytoma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Ependymoma, Recurrent Childhood Giant Cell Glioblastoma, Recurrent Childhood Glioblastoma, Recurrent Childhood Gliosarcoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Oligodendroglioma
- Interventions
- lapatinib ditosylate, therapeutic conventional surgery, laboratory biomarker analysis, pharmacological study, positron emission tomography, magnetic resonance imaging
- First posted
- 2004-11-09
- Last updated
- 2014-05-23
- Results first posted
- 2012-02-06
- Limitations and caveats
Accrual to the Molecular Biology phase (MBP) was contingent upon accrual being open for the Phase II since some participants in the MBP could be counted in the phase II. The phase II enrolled rapidly thus limiting enrollment to the MBP.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relative Phosphorylation of ERBB2 (Molecular Biology Objective) | 7-14 days after starting therapy and prior to surgery | Lapatinib may be able to control the growth of tumor cells. To assess the ability of lapatinib to block a molecule, the ERBB2 receptor, that signals tumor cells to divide, fresh frozen tissue from the surgical resection is processed by quantitative western blot analysis to assess the phosphorylation of ERBB2. The relative phosphorylation is a ratio of the phosphorylated ERBB2 measured in the tumor normalized to the level of total receptor protein and housekeeping protein. Lower values suggests more inhibition of the ERRB2 receptor signal and a decreased ability for tumor cell division. |
| Primary | Number of Participants With a Sustained Objective Response (Complete or Partial Response) (Phase II Objective) | From start of therapy until the earliest of disease progression, death or end of the fourth course (recurrent medulloblastoma and recurrent high grade glioma) or end of the sixth course (recurrent ependymoma) | A complete response is defined as complete disappearance of all tumor accompanied by a stable or improving neurologic exam, and a partial response is defined as 50% or more reduction in the tumor size by bi-dimensional measurement and a stable or improving neurologic exam. The response must be sustained for at least 8 weeks. The number of patients with a sustained objective response will be reported separately for each of the three disease groups. |
| Secondary | Tumor to Plasma Lapatinib Concentration (Molecular Biology Objective) | First dose of lapatinib prior to surgery | For participants randomized to receive lapatinib 7-14 days prior to surgery, plasma samples will be obtained with the first dose of lapatinib prior to surgery. The lapatinib concentration is measured in both the plasma samples and the tumor tissue obtained at surgery. Reported is the concentration of lapatinib observed in the tumor expressed as a percentage of the concentration observed in plasma. |
| Secondary | Maximum Concentration of Lapatinib in Plasma (Phase II Objective) | First dose of lapatinib in course 1 | Serial plasma samples for pharmacokinetic studies of lapatinib will be collected from consenting participants with the first dose of course 1. |
| Secondary | Number of Participants With Tumors Expressing Total ERBB2 | Pre-treatment | Total ERBB2 expression is assessed in participants enrolled in both the molecular biology trial and the phase II trial who provided pre-treatment formalin fixed paraffin embedded tumor material. The tumor material is analyzed by immunohistochemistry for expression of total ERBB2. Low, moderate, and intense expression are combined into one group vs. no total ERBB2 expression. |
| Secondary | Number of Participants With Tumors Expressing Phosphorylated ERBB2 (Phase II Objective) | Pre-treatment | Phosphorylated ERBB2 expression is assessed in patients who provided pre-treatment formalin fixed paraffin embedded tumor material. The tumor material is analyzed by immunohistochemistry for expression of phosphorylated ERBB2. Low, moderate, and intense expression are combined into one group vs. no phosphorylated ERBB2 expression. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Relative Phosphorylation of ERBB2 (Molecular Biology Objective) | 7-14 days after starting therapy and prior to surgery | Participants enrolled on the molecular biology phase (MBP) and who submitted fresh frozen tissue were included in the analysis for this objective. One patient enrolled on the MBP did not provide fresh frozen tissue and was excluded. The sample size required for this objective was not met. | ratio | MEDIAN |
| PRIMARY | Number of Participants With a Sustained Objective Response (Complete or Partial Response) (Phase II Objective) | From start of therapy until the earliest of disease progression, death or end of the fourth course (recurrent medulloblastoma and recurrent high grade glioma) or end of the sixth course (recurrent ependymoma) | Participants with measureable residual disease who do not receive lapatinib prior to surgery or who do not have surgical resection of the tumor at study enrollment will be assessed for sustained objective response. Participants must have received at least one dose of lapatinib and remain on treatment for the specified time frame to be evaluable. | Participants | NUMBER |
| SECONDARY | Tumor to Plasma Lapatinib Concentration (Molecular Biology Objective) | First dose of lapatinib prior to surgery | The analysis population consists of recurrent medulloblastoma, high grade glioma, or ependymoma patients who were randomized to receive lapatinib prior to surgery, consented to the pharmacokinetic studies and received dose 1 of lapatinib. | percent | MEDIAN |
| SECONDARY | Maximum Concentration of Lapatinib in Plasma (Phase II Objective) | First dose of lapatinib in course 1 | The analysis population consists of participants with recurrent medulloblastoma, high grade glioma, or ependymoma who did not have surgical resection of the tumor at study enrollment, consented to the pharmacokinetic studies, and received the first dose of lapatinib in course 1. | nanogram/milliliter | MEDIAN |
| SECONDARY | Number of Participants With Tumors Expressing Total ERBB2 | Pre-treatment | Participants from the molecular biology trial or the phase II trial who consented to the biology studies and provided pre-treatment formalin fixed paraffin embedded tumor were included in the analysis population. | Participants | NUMBER |
| SECONDARY | Number of Participants With Tumors Expressing Phosphorylated ERBB2 (Phase II Objective) | Pre-treatment | Participants from the molecular biology trial or the phase II trial who consented to the biology studies and provided pre-treatment formalin fixed paraffin embedded tumor were included in the analysis population. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Relative Phosphorylation of ERBB2 (Molecular Biology Objective) | Lapatinib Prior to Surgery | .21 | Full Range .03 to .44 | ratio | |
| Relative Phosphorylation of ERBB2 (Molecular Biology Objective) | No Lapatinib Prior to Surgery | .50 | Full Range .05 to 1.66 | ratio | |
| Number of Participants With a Sustained Objective Response (Complete or Partial Response) (Phase II Objective) | Recurrent Medulloblastoma | 0 | Participants | ||
| Number of Participants With a Sustained Objective Response (Complete or Partial Response) (Phase II Objective) | Recurrent High Grade Glioma | 0 | Participants | ||
| Number of Participants With a Sustained Objective Response (Complete or Partial Response) (Phase II Objective) | Recurrent Ependymoma | 0 | Participants | ||
| Tumor to Plasma Lapatinib Concentration (Molecular Biology Objective) | Lapatinib Prior to Surgery | 18 | Full Range 11 to 22 | percent | |
| Maximum Concentration of Lapatinib in Plasma (Phase II Objective) | Lapatinib: No Surgery | 5050 | Full Range 1915 to 10500 | nanogram/milliliter | |
| Number of Participants With Tumors Expressing Total ERBB2 | Recurrent Medulloblastoma | 1 | Participants | ||
| Number of Participants With Tumors Expressing Total ERBB2 | Recurrent High Grade Glioma | 2 | Participants | ||
| Number of Participants With Tumors Expressing Total ERBB2 | Recurrent Ependymoma | 7 | Participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Molecular Biology Phase | STARTED | Medulloblastoma: Lapatinib Prior to Surgery | 2 | |
| Molecular Biology Phase | STARTED | Medulloblastoma: No Lapatinib Prior to Surgery | 2 | |
| Molecular Biology Phase | STARTED | Medulloblastoma: No Surgery | 0 | |
| Molecular Biology Phase | STARTED | High Grade Glioma: Lapatinib Prior to Surgery | 0 | |
| Molecular Biology Phase | STARTED | High Grade Glioma: No Lapatinib Prior to Surgery | 0 | |
| Molecular Biology Phase | STARTED | High Grade Glioma: No Surgery | 0 | |
| Molecular Biology Phase | STARTED | Ependymoma: Lapatinib Prior to Surgery | 2 | |
| Molecular Biology Phase | STARTED | Ependymoma: No Lapatnib Prior to Surgery | 2 | |
| Molecular Biology Phase | STARTED | Ependymoma: No Surgery | 0 | |
| Molecular Biology Phase | COMPLETED | Medulloblastoma: Lapatinib Prior to Surgery | 2 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events707
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 | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Medulloblastoma: Lapatinib Prior to Surgery | 0 | 2 | |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Medulloblastoma: No Lapatinib Prior to Surgery | 1 | 2 | |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Medulloblastoma: No Surgery | 4 | 16 | |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | High Grade Glioma: No Surgery | 4 | 13 | |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Ependymoma: Lapatinib Prior to Surgery | 0 | 2 | |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Ependymoma: No Lapatnib Prior to Surgery | 1 | 2 | |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Ependymoma: No Surgery | 7 | 14 | |
| other | AST, SGOT (serum glutamic oxaloacetic transaminase) | Investigations | Medulloblastoma: Lapatinib Prior to Surgery | 0 | 2 | |
| other | AST, SGOT (serum glutamic oxaloacetic transaminase) | Investigations | Medulloblastoma: No Lapatinib Prior to Surgery | 2 | 2 | |
| other | AST, SGOT (serum glutamic oxaloacetic transaminase) | Investigations | Medulloblastoma: No Surgery | 1 | 16 |
1 to 10 of 707Source ClinicalTrials.gov
See all 707 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Medulloblastoma: Lapatinib Prior to Surgery | ||
| Total, all-cause mortality | Medulloblastoma: No Lapatinib Prior to Surgery | ||
| Total, all-cause mortality | Medulloblastoma: No Surgery | ||
| Total, all-cause mortality | High Grade Glioma: No Surgery | ||
| Total, all-cause mortality | Ependymoma: Lapatinib Prior to Surgery | ||
| Total, all-cause mortality | Ependymoma: No Lapatnib Prior to Surgery | ||
| Total, all-cause mortality | Ependymoma: No Surgery | ||
| Total, other adverse events | Medulloblastoma: Lapatinib Prior to Surgery | 2 | 2 |
| Total, other adverse events | Medulloblastoma: No Lapatinib Prior to Surgery | 2 | 2 |
| Total, other adverse events | Medulloblastoma: No Surgery | 16 | 16 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 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 |
|---|---|---|---|---|---|
| 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/NCT00095940
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