Phase 2
N=8
Concurrent Carboplatin and Reduced Dose Craniospinal Radiation for Medulloblastoma and Primitive Neuroectodermal Tumor (PNET)
Metastatic Medulloblastoma · High Risk Supratentorial PNET · Metastatic PNET
Bottom Line
View on ClinicalTrials.gov: NCT01542736 ↗Enrolled (actual)
8
Serious AEs
12.5%
Results posted
Jan 2022
Primary outcome: Primary: Event-free Survival — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Carboplatin (Drug); Vincristine (Drug); 24 Gy (Radiation)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-free Survival |
7 | — |
| PRIMARY Overall Survival |
7 | — |
| PRIMARY Intellectual Competence Measured by IQ Score: Week 8 |
102.4 | — |
| PRIMARY Intellectual Competence Measured by IQ Score: Month 24 |
96.83 | — |
| PRIMARY Intellectual Competence Measured by IQ Score: Month 60 |
79 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01542736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.