Trial · NCT00602667
Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma
NCT00602667, Phase 2, Active not recruiting, St. Jude Children's Research Hospital; results first posted 2019-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma. Trials, record NCT00602667. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00602667
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma
- NCT number
- NCT00602667
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 293 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- Induction Chemotherapy, Low-Risk Therapy, High-Risk Therapy, Intermediate-Risk Therapy
- First posted
- 2008-01-28
- Last updated
- 2026-10-16
- Results first posted
- 2019-01-30
- Limitations and caveats
- Results for the some of the secondary objectives are not available yet. These results will be posted as they become available.
Source ClinicalTrials.gov
Registered outcomes82
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients | From date on treatment until date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment | Progression was defined as 25% increase in the size of any measurable lesion; the appearance of a new lesion; or the conversion of negative cerebrospinal fluid (CSF) cytology to positive. Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis. |
| Primary | Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup | From date on treatment to date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment | Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. Eligible medulloblastoma patients who received any methotrexate and had molecularly confirmed medulloblastoma are included in this analysis. Five patients were excluded as 3 had no archival tissue available and 2 were found to not be medulloblastoma by methylation profile. |
| Primary | Percent Probability of Event-free Survival (EFS) for Medulloblastoma Patients | From date on treatment to date of first progression, relapse, second malignancy or death from any cause or to date of last contact, estimated at 1 year after | Defined as the time interval from date on treatment until the date of first progression, second malignancy or death due to any cause; or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis. |
| Secondary | Number of Participants With Chromosomal Abnormalities | Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment | Amplifications and deletions (gains and losses) for chromosomes of interest are shown in the table of measured values. |
| Secondary | Numbers of Patients With Gene Alterations | Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment | Gene alterations, which include single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations are shown for specific genes of interest in the results table. |
| Secondary | Numbers of Patients With Molecular Abnormalities by Tumor Type | Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment | Alterations included single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations. Cytogenetic information shows gains and losses as specified in the table of measured values. |
| Secondary | Number of Successful Collections for Frozen and Fixed Tumor Samples | Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment | Successful collections will be defined as the number of patients who have frozen/fixed tumor samples available. |
| Secondary | Event-free Survival (EFS) Compared to Historical Controls | From date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years | EFS was measured from the date of initial treatment to the earliest date of disease progression, second malignancy or death for patients who fail; and to the date of last contact for patients who remain at risk for failure. 1-year EFS estimates are reported by risk group. EFS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals. |
| Secondary | Overall Survival (OS) Compared to Historical Controls | 1 year after treatment initiation of last patient | OS was measured from the date of initial treatment to date of death or to date of last contact for survivors. 1-year OS estimates were reported by risk group. OS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals. |
| Secondary | Percentage of Patients With Objective Responses Rate to Induction Chemotherapy | From on-study date to 2 months after completion of induction chemotherapy (up to 4 months after on-study date) | For patients treated in the intermediate and high risk strata with residual or metastatic disease we will estimate the stratum-specific objective response rate (complete response (CR) or partial response \[ PR\]). All patients who receive at least 1 -dose of methotrexate are evaluable for response. Objective responses must be sustained for at least eight weeks. |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 registered outcomesOutcomes82
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients | From date on treatment until date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment | All eligible medulloblastoma patients started methotrexate and were included (n=81). PFS estimates are reported by risk group. | Percent Probability | NUMBER |
| PRIMARY | Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup | From date on treatment to date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment | Eligible patients with molecularly confirmed medulloblastoma (n=76) were included. PFS estimates are reported by methylation subgroup and risk group. There were no low-risk group 3 or group 4 patients. | Percent Probability | NUMBER |
| PRIMARY | Percent Probability of Event-free Survival (EFS) for Medulloblastoma Patients | From date on treatment to date of first progression, relapse, second malignancy or death from any cause or to date of last contact, estimated at 1 year after | Eligible medulloblastoma patients (n=81) were included. EFS estimates are reported by risk group. | Percent Probability | NUMBER |
| SECONDARY | Number of Participants With Chromosomal Abnormalities | Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment | Eligible medulloblastoma patients (n=81) were included in these analyses. 23 of 23 low risk patients had data available for this objective, as did 27/32 and 24/26 intermediate and high risk patients. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Numbers of Patients With Gene Alterations | Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment | Eligible medulloblastoma patients (n=81) were included in these analyses. Not all patients had data available for each gene. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Numbers of Patients With Molecular Abnormalities by Tumor Type | Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment | Eligible patients with molecularly confirmed medulloblastoma (n=76) were included in these analyses. Not all patients had data available for each gene. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Successful Collections for Frozen and Fixed Tumor Samples | Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment | All eligible patients enrolled (n=290) were included in this analysis. The numbers of patients with pre-study samples were considered for these results. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Event-free Survival (EFS) Compared to Historical Controls | From date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years | Eligible medulloblastoma patients who received any methotrexate were included in this analysis. Hazard ratios with 95% confidence intervals are reported and compare SJYC07 patients to historical controls in each risk group. As there were too few low-risk historical controls, no hazard ratio is included for the low-risk group. | Percent probability | NUMBER |
| SECONDARY | Overall Survival (OS) Compared to Historical Controls | 1 year after treatment initiation of last patient | Eligible medulloblastoma patients who received any methotrexate were included in this analysis. Hazard ratios with 95% confidence intervals are reported and compare SJYC07 patients to historical controls in each risk group. As there were too few low-risk historical controls, no hazard ratio is included for the low-risk group. | Percent probability | NUMBER |
| SECONDARY | Percentage of Patients With Objective Responses Rate to Induction Chemotherapy | From on-study date to 2 months after completion of induction chemotherapy (up to 4 months after on-study date) | Eligible intermediate and high risk group patients who received at least 1 dose of methotrexate were included in this analysis. One of the high risk patients did not start therapy and was excluded. | Percentage of patients | NUMBER |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 outcomesResults by group787
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients | Low-Risk Group | 73.9 | 95% Confidence Interval 56.5 to 91.3 | Percent Probability | |
| Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients | Intermediate-Risk Group | 46.9 | 95% Confidence Interval 30.2 to 63.6 | Percent Probability | |
| Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients | High-Risk Group | 30.8 | 95% Confidence Interval 14.1 to 47.5 | Percent Probability | |
| Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup | Low-risk SHH Patients | 73.9 | 95% Confidence Interval 56.5 to 91.3 | Percent Probability | |
| Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup | Intermediate-risk SHH Patients | 50.0 | 95% Confidence Interval 19.0 to 81.0 | Percent Probability | |
| Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup | High-risk SHH Patients | 54.5 | 95% Confidence Interval 27.3 to 81.7 | Percent Probability | |
| Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup | Intermediate-risk Group 3 Patients | 30.8 | 95% Confidence Interval 8.5 to 53.1 | Percent Probability | |
| Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup | High-risk Group 3 Patients | 9.1 | 95% Confidence Interval 0.0 to 21.1 | Percent Probability | |
| Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup | Intermediate-risk Group 4 Patients | 62.5 | 95% Confidence Interval 31.9 to 93.1 | Percent Probability | |
| Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup | High-risk Group 4 Patients | 50.0 | 95% Confidence Interval 1.0 to 99.0 | Percent Probability |
1 to 10 of 787Source ClinicalTrials.gov
See all 787 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low-Risk Group | 57 | |
| Overall Study | STARTED | Intermediate-Risk Group | 156 | |
| Overall Study | STARTED | High-Risk Group | 77 | |
| Overall Study | COMPLETED | Low-Risk Group | 38 | |
| Overall Study | COMPLETED | Intermediate-Risk Group | 75 | |
| Overall Study | COMPLETED | High-Risk Group | 14 | |
| Overall Study | NOT COMPLETED | Low-Risk Group | 19 | |
| Overall Study | NOT COMPLETED | Intermediate-Risk Group | 81 | |
| Overall Study | NOT COMPLETED | High-Risk Group | 63 |
Source ClinicalTrials.gov
Adverse events198
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 | Febrile neutropenia | Blood and lymphatic system disorders | Low-Risk Group | 36 | 57 | 83 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Intermediate-Risk Group | 92 | 156 | 169 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | High-Risk Group | 48 | 76 | 120 |
| other | Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | Low-Risk Group | 32 | 57 | 60 |
| other | Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | Intermediate-Risk Group | 57 | 156 | 124 |
| other | Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | High-Risk Group | 10 | 76 | 20 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Low-Risk Group | 24 | 57 | 38 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Intermediate-Risk Group | 45 | 156 | 83 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | High-Risk Group | 6 | 76 | 11 |
| other | Vomiting | Gastrointestinal disorders | Low-Risk Group | 10 | 57 | 11 |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low-Risk Group | 10 | 57 |
| Total, all-cause mortality | Intermediate-Risk Group | 58 | 156 |
| Total, all-cause mortality | High-Risk Group | 49 | 77 |
| Total, other adverse events | Low-Risk Group | 55 | 57 |
| Total, other adverse events | Intermediate-Risk Group | 145 | 156 |
| Total, other adverse events | High-Risk Group | 70 | 76 |
| Total, serious adverse events | Low-Risk Group | 3 | 57 |
| Total, serious adverse events | Intermediate-Risk Group | 7 | 156 |
| Total, serious adverse events | High-Risk Group | 5 | 76 |
Source ClinicalTrials.gov
Papers3
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 |
|---|---|---|---|---|---|
| R01CA154619 | Anticancer Drug Pharmacology in Very Young Children | STEWART, CLINTON F | ST. JUDE CHILDREN'S RESEARCH HOSPITAL | NATIONAL CANCER INSTITUTE | 2012 to 2016 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intermediate-Risk Group vs High-Risk Group: Participants With PK-guided Dosage Adjustment Achieving Target System Exposure of Intravenous Topotecan | Trial comparisons |
| Intermediate-Risk Group vs High-Risk Group: Participants With Empirical Dosage Achieving Target System Exposure of Intravenous Topotecan | Trial comparisons |
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Verbal Fluency | Secondary outcome |
Source ConductCognition
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/NCT00602667
GET https://conductscience.org/api/trials/v1/NCT00602667/registered?page=2