High Risk Supratentorial PNET, Metastatic Medulloblastoma, Metastatic PNET
Conditions
Brief summary
The purpose of this study is to study the efficacy of the combination of reduced dose craniospinal radiation (reduced from standard of care dosing at 36 Gy to 24 Gy) with concurrent carboplatin and vincristine administration for metastatic classical histology medulloblastomas and high-risk supratentorial PNETs and metastatic PNETs.
Interventions
DRUGCarboplatin
Administered concurrently with craniospinal radiation.
DRUGVincristine
Administered concurrently with craniospinal radiation.
RADIATION24 Gy
Craniospinal radiation.
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Age greater than 3 years and less than 25 years * Patients with classic histology or desmoplastic histology metastatic medulloblastoma by histological diagnosis and by head and spine MRI. * Patients with high-risk supratentorial, non-metastatic, PNET * Patients with metastatic PNET * Newly diagnosed patients who have not received prior therapy, with the exception of one short course of emergent chemotherapy in newly presenting patients with neurological compromise per provider decision * Only patients who are expected to survive at least 6 weeks will be eligible for this study.
Exclusion criteria
* Patients who are pregnant may not be treated on this study * Patients with anaplastic histology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-free Survival | Up to 60 months. | MRIs of the head and spine. Number of participants with event free survival at 60 months is reported. |
| Overall Survival | up to 5 years | Overall Survival will be measured at the end of study. number of surviving participants is reported. |
| Intellectual Competence Measured by IQ Score: Week 8 | Week 8 | Neuropsychological testing will be performed after radiation in completed. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome. |
| Intellectual Competence Measured by IQ Score: Month 24 | Month 24 | Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome. |
| Intellectual Competence Measured by IQ Score: Month 60 | Month 60 | Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reduced Radiation With Concurrent Chemotherapy Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration
Carboplatin: Administered concurrently with craniospinal radiation.
Vincristine: Administered concurrently with craniospinal radiation.
24 Gy: Craniospinal radiation. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Reduced Radiation With Concurrent Chemotherapy |
|---|---|
| Age, Categorical <=18 years | 7 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 8.125 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 8 |
| other Total, other adverse events | 1 / 8 |
| serious Total, serious adverse events | 1 / 8 |
Outcome results
Primary
Event-free Survival
MRIs of the head and spine. Number of participants with event free survival at 60 months is reported.
Time frame: Up to 60 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reduced Radiation With Concurrent Chemotherapy | Event-free Survival | 7 Participants |
Primary
Intellectual Competence Measured by IQ Score: Month 24
Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.
Time frame: Month 24
Population: Not all participants were feeling well enough to complete testing at this timepoint.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Reduced Radiation With Concurrent Chemotherapy | Intellectual Competence Measured by IQ Score: Month 24 | 96.83 score on a scale |
Primary
Intellectual Competence Measured by IQ Score: Month 60
Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.
Time frame: Month 60
Population: Not all participants were feeling well enough to complete testing at this timepoint.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Reduced Radiation With Concurrent Chemotherapy | Intellectual Competence Measured by IQ Score: Month 60 | 79 score on a scale |
Primary
Intellectual Competence Measured by IQ Score: Week 8
Neuropsychological testing will be performed after radiation in completed. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.
Time frame: Week 8
Population: Not all participants were feeling well enough to complete testing at this timepoint.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Reduced Radiation With Concurrent Chemotherapy | Intellectual Competence Measured by IQ Score: Week 8 | 102.4 score on a scale |
Primary
Overall Survival
Overall Survival will be measured at the end of study. number of surviving participants is reported.
Time frame: up to 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reduced Radiation With Concurrent Chemotherapy | Overall Survival | 7 Participants |