Table 3 Complete Clinical Trials
Study | ClinicalTrials .gov Identifier | Sponsor | Tumor | Phase | Shh Drug inhibitor | Where it acts | Outcome of the clinical trials |
|---|---|---|---|---|---|---|---|
Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors | NCT00024258 | Memorial Sloan Kettering Cancer Center Collaborator: National Cancer Institute (NCI) | Brain and Central Nervous System Tumors | Phase 2 | arsenic trioxide | Gli 1 inhibitor | Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
Radiation Therapy, Arsenic Trioxide, and Temozolomide in Treating Patients With Newly Diagnosed High-Grade Glioma | NCT00720564 | City of Hope Medical Center Collaborator: National Cancer Institute (NCI) | Brain and Central Nervous System Tumors | Phase 1 | arsenic trioxide | Gli 1 inhibitor | No Study Results Posted |
Arsenic Trioxide and Radiation Therapy in Treating Young Patients With Newly Diagnosed Gliomas | NCT00095771 | Sidney Kimmel Comprehensive Cancer Center Collaborator: National Cancer Institute (NCI) | Brain and Central Nervous System Tumors | Phase 1 | arsenic trioxide | Gli 1 inhibitor | No Study Results Posted |
Phase I Trial of Arsenic Trioxide and Stereotactic Radiotherapy for Recurrent Malignant Glioma | NCT00185861 | Stanford University Collaborators: Cephalon CTI BioPharma | Brain Cancer | Phase 1 | arsenic trioxide | Gli 1 inhibitor | No Study Results Posted |
Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma | NCT00045565 | National Cancer Institute (NCI) | Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma | Phase 1 | arsenic trioxide | Gli 1 inhibitor | No Study Results Posted |
Curcumin Bioavailability in Glioblastoma Patients | NCT01712542 | Johann Wolfgang Goethe University Hospital | Glioblastoma | Early Phase 1 | Curcumin | Shh inhibitor | No Study Results Posted |
GDC-0449 in Treating Young Patients With Medulloblastoma That is Recurrent or Did Not Respond to Previous Treatment | NCT00822458 | National Cancer Institute (NCI) | Recurrent Childhood Medulloblastoma | Phase 1 | GDC-0449 (vismodegib) (Erivedge) | Smo inhibitor | No Study Results Posted |
GDC-0449 in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery | NCT00980343 | National Cancer Institute (NCI) | Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor | Phase 2 | GDC-0449 (vismodegib) (Erivedge) | Smo inhibitor | The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60Â days. The sponsor cannot require changes to the communication and cannot extend the embargo. |
Vismodegib in Treating Younger Patients With Recurrent or Refractory Medulloblastoma | NCT01239316 | National Cancer Institute (NCI) | Recurrent Childhood Medulloblastoma | Phase 2 | GDC-0449 (vismodegib) (Erivedge) | Smo inhibitor | Resulted in the following paper: |
| Â | Â | Â | Â | Â | Â | Robinson et al., 2015 | |
Vismodegib in Treating Patients With Recurrent or Refractory Medulloblastoma | NCT00939484 | National Cancer Institute (NCI) | Adult Medulloblastoma | Phase 2 | GDC-0449(vismodegib) (Erivedge) | Smo inhibitor | Resulted in the following paper: Robinson et al., 2015 |
Erivedge (Vismodegib) in the Treatment of Pediatric Patients With Refractory Pontine Glioma | NCT01774253 | Giselle Sholler Collaborators: Spectrum Health Hospitals Phoenix Children’s Hospital | Pontine Glioma | Phase 2 | GDC-0449(vismodegib) (Erivedge) | Smo inhibitor | Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data Posted |
Efficacy of Prophylactic Itraconazole in High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation | NCT00336531 | Samsung Medical Center | Neuroblastoma Brain Tumor Retinoblastoma | Phase 4 | itraconazole | downregulatio n in GLI | No Study Results Posted |
A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors | NCT01106508 | Novartis Pharmaceuticals | Recurrent or Refractory Medulloblastoma | Phase 1 | LEQ506 | Smo inhibitor | No Study Results Posted |
Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors | NCT00880308 | Novartis Pharmaceuticals | Medulloblastoma | Phase 1 | LDE225(Sonidegib) | Smo inhibitor | No Study Results Posted |
An East Asian Study of | NCT01208831 | Novartis Pharmaceuticals | Medulloblastoma | Phase 1 | LDE225 | Smo inhibitor | No Study Results |
LDE225 | Â | Â | Â | Â | (Sonidegib) | Â | Posted |
A Phase I Dose Finding and Safety Study of Oral LDE225 in Children and a Phase II Portion to Assess Preliminary Efficacy in Recurrent or Refractory MB | NCT01125800 | Novartis Pharmaceuticals | Medulloblastoma Rhabdomyosarcoma Neuroblastoma Hepatoblastoma Glioma Astrocytoma | Phase 1 Phase 2 | LDE225 (Sonidegib) | Smo inhibitor | Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. |
Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors | NCT01576666 | Novartis Pharmaceuticals | Recurrent Glioblastoma Multiforme | Phase 1 | LDE225 (Sonidegib) | Smo inhibitor | No Study Results Posted |
A Phase II Study of Oral LDE225 in Patients With Hedge-Hog (Hh)- Pathway Activated Relapsed Medulloblastoma (MB) | NCT01708174 | Novartis Pharmaceuticals | Medulloblastoma | Phase 2 | LDE225 (Sonidegib) | Smo inhibitor | Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed |
Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors | NCT01413906 | Bristol-Myers Squibb | Solid Tumors including Glioblastoma | Phase 1 | BMS- 833923 (XL139) | Smo inhibitor | No Study Results Posted |
Imiquimod/Brain Tumor Initiating Cell (BTIC) Vaccine in Brain Stem Glioma | NCT01400672 | MasonicCancer Center, Universityof Minnesota | Diffuse Intrinsic Pontine Glioma | Phase 1 | Imiquimod | Shhpathwayi nhibitor | No Study Results Posted |