| A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma (SJMB 12) |
NCT01878617 |
625 |
CSI reduction for low risk WNT |
|
| Vismodegib for SHH patients |
| Pemetrexed and Gemcitabine for non-WNT/non-SHH patients |
| A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients (COG ACNS1422) |
NCT02724579 |
45 |
Only open to WNT patients |
|
| Reduced CSI |
| Limited targeted radiation boost to the tumor bed |
| Reduced cisplatin, vincristine, and lomustine |
| Pilot Study Assessing the Feasibility of a Surgery and Chemotherapy-Only Approach in the Upfront Therapy of Children With Wnt Positive Standard Risk Medulloblastoma |
NCT02212574 |
13 |
Only open to WNT patients |
Suspended due to several early failures |
| Patients received no radiation |
| An International Prospective Study on Clinically Standard-risk Medulloblastoma in Children Older Than 3 to 5 Years With Low-risk Biological Profile (PNET 5 MB-LR) or Average-risk Biological Profile (PNET 5 MB-SR) |
NCT02066220 |
360 |
Reduced CSI and reduced cisplatin, vincristine, lomustine followed by cyclophosphamide and vincristine for WNT patients |
|
| HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue |
NCT02875314 |
250 |
Only open to patient ≤10 years old |
|
| After induction chemotherapy, non-WNT/non-SHH randomized to possible receive increased chemotherapy compared to WNT/SHH patients |
| Recurrent/relapsed |
|
|
|
|
| Molecularly-Driven Doublet Therapy for All Children With Refractory or Recurrent CNS Malignant Neoplasms and Young Adults With Refractory or Recurrent SHH Medulloblastoma |
NCT03434262 |
108 |
Three different treatment groups: Group 3/4 (ribociclib and gemcitabine), SHH/WNT (ribociclib and trametinib), and SHH of smoothened inhibitor with 9q loss or PTCH1 mutant (ribociclib and sonidegib) |
|
| St. Jude ELIOT: Phase 1 Evaluation of LY2606368, a Molecularly-Targeted CHK1/2 Inhibitor Therapy, in Combination With Cyclophosphamide or Gemcitabine for Children and Adolescents With Refractory or Recurrent Group 3/Group 4 or SHH Medulloblastoma Brain Tumors |
NCT04023669 |
100 |
Not open to patients with recurrent WNT medulloblastoma |
|
| Two treatment groups: Group3/4/SHH (prexasertib and cyclophosphamide) and Group 3/4 (prexasertib and gemcitabine) |
| PBTC-053: A Pediatric Brain Tumor Consortium Phase I/II and Surgical Study of CX-4945 in Patients With Recurrent SHH Medulloblastoma |
NCT03904862 |
60 |
Only open to patients with SHH medulloblastoma |
|
| An International, Randomized, Open-label Phase I/II Study of Vismodegib in Combination With Temozolomide Versus Temozolomide Alone in Adult Patients With Recurrent or Refractory Medulloblastomas Presenting an Activation of the Sonic Hedgehog (SHH) Pathway (MEVITEM) |
NCT01601184 |
24 |
Open to SHH adult patients only |
Terminated due to lack of success at first stage of Phase II |
| Not currently enrolling patients |
