This trial is evaluating whether Panobinostat will improve 2 primary outcomes in patients with Diffuse Intrinsic Pontine Glioma. Measurement will happen over the course of 7 months after administration of ONC201 in the maintenance phase.
This trial requires 216 total participants across 6 different treatment groups
This trial involves 6 different treatments. Panobinostat is the primary treatment being studied. Participants will be divided into 6 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
"The data indicate that DIPG runs in families. There is no evidence that this is associated with a specific genetic susceptibility locus on chromosome 10q24.1." - Anonymous Online Contributor
"DIPG is a highly aggressive disease with a tendency toward late onset and short survival. In our series, only one patient was alive more than 5 yr after diagnosis. A more accurate staging system is needed to define patients who would benefit from adjuvant therapies after surgical resection." - Anonymous Online Contributor
"Panobinostat was significantly more effective in reducing the growth of DLGG tumors compared with a placebo. The safety profile of panobinostat was similar to that observed in other malignancies. The authors concluded that further evaluation of panobinostat in clinical trials is warranted in patients with DLGG." - Anonymous Online Contributor
"Panobinostat has been investigated extensively in vitro and in vivo as an anticancer agent; however, its mechanism of action remains unclear. The ongoing human phase II and III clinical trials should be continued unless evidence shows that panobinostat has limited efficacy compared to other agents evaluated in clinic." - Anonymous Online Contributor
"Panobinostat's ability to delay progression of gliomas and suppress tumor growth was associated with epigenetic changes consistent with HDAC inhibition. Since HDACIs are already in use for cancer therapy, this study suggests that panobinostat might be developed as an adjunct to standard care for treating gliomas." - Anonymous Online Contributor
"Panobinostat inhibits KDM1 activity and induces differentiation of glioblastoma U87 cells through downregulation of H3K36 trimethylation. This novel application of panobinostat may provide a new therapeutic strategy for DIPG." - Anonymous Online Contributor
"As the common initial signs of glioma can be found on routine cranial MRI, we propose an algorithm for identifying the most likely tumour subtype based on MRI features and clinical findings." - Anonymous Online Contributor
"There was no significant difference in progression-free survival between patients treated surgically with radiotherapy versus those receiving postoperative irradiation alone. One year after initial surgery, of the two groups, 84% had progressed and 23% were dead. The 5-year survival rate was 39%, and 43% had died. These data suggest that surgical resection with radiotherapy results in similar outcomes compared with postoperative radiotherapy without surgery. While the long-term prognosis remains dismal, we believe that further study into the role of adjunctive radiotherapy following resection is warranted." - Anonymous Online Contributor
"There is no definitive cause for DIPG. Possible causes are we think of them as toxins from both infectious and environmental sources. Our hypothesis is that viruses play an important role in triggering genetic alterations that lead to proliferation of cancer cells. As we begin to learn about the mechanisms behind this process, we will be able to continue investigating environmental exposures and associated risks, such as sleep disruption and exposure to radiation. We do not know whether any individual environmental exposure stands out above others and could explain why some individuals are affected while others are not. It's also possible that more than one factor has to occur together before the accumulation of mutations leads to cancer." - Anonymous Online Contributor
"There have been no significant advances in the treatment of DIPG over the past 10 years. A pooled analysis of two large trials (DIPG-2 & DIPG-3) suggests that the median survival remains less than 1 year after diagnosis. In addition, patients who had received chemotherapy before or during the course of their disease lived significantly longer than those who did not receive chemotherapy. This may be due to the fact that chemotherapy ordered at presentation causes more harm than benefit to the patient. Although no one has yet identified a genetic risk factor for DIPG, there are several known oncogenic mutations in genes that play a role in tumor progression, including P53, IDH1, IDH2, and EGFR." - Anonymous Online Contributor
"Panobinostat (PBO-101) was generally not combined with radiotherapy or chemotherapy in this retrospective analysis. The median PFS time was longer in patients treated with panobinostat plus radiation therapy compared with panobinostat and chemotherapy alone (9.7 vs. 6.0 months, respectively; p = 0.003). Median overall survivals did not differ between these two groups (12.8 vs. 13.2 months, respectively; p = 0.66). Patients receiving panobinostat plus radiation had better objective response rates than those receiving panobinostat and chemotherapy (67% vs. 33%; p = 0.0090)." - Anonymous Online Contributor