Funding Status: Funded!

This grant has been fully funded!

Lorem Sit Amet Dolor
Researcher: Lorem Sit Amet

123 abc lane, Townsville, ZZ 00000, USA
Funding Progress: $§ / $§§§§§

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COllaborative Network for NEurooncology Clinical Trials (CONNECT)
Clinical
DIPG, Childhood (Brain Cancer)
Lay Summary

CONNECT’s goal is to establish an international clinical trials collaboration for the conduct of scientifically rational, pilot studies to assess feasibility and early efficacy of incorporating promising novel agents to established frontline therapeutic regimens in children with newly-diagnosed, high-risk brain tumors. This collaboration builds on the existing infrastructure and partnerships established through the International DIPG Registry and SIOPE Registries.

Pediatric NCI-funded phase I consortia (e.g. COG DVL and PBTC) as well as non-NCI funded consortia (e.gPNOC, POETIC and ITCC) have helped to ensure that novel agents undergo phase I testing to define toxicities and preliminary pharmacokinetic and pharmacodynamics endpoints in children with recurrent tumors. Similarly, the Children’s Oncology Group and the SIOPE disease networks, as well as other national consortia, have played a critical role in conducting large phase II/III trials to establish current therapeutic standards in frontline regimens for children with CNS malignancies. However, phase II/III trials require the commitment of extensive time and resources to demonstrate improved outcomes. As our expanding knowledge of biological targets points to numerous potential targeted agents, judicious decisions must be made before larger efficacy studies are conducted incorporating novel agents in the frontline setting.

CONNECT’s goal is to fill this critical gap by conducting nimble, scientifically-rational, international trials to demonstrate the safety and feasibility of incorporating novel agents and therapeutic modalities into the most effective current regimens for children with newly-diagnosed high-risk brain tumors. To accomplish this goal CONNECT will leverage the considerable strength in basic science and translational expertise among its global collaborative partners. These sites all have a well-deserved reputation for robust clinical research programs, with strong leadership and expertise in early phase clinical trials, pharmacology, translational research, and imaging. A preclinical initiative among member institutions will assess promising agents in a broad array of preclinical disease models to fast-track development of promising experimental agents in high-risk pediatric brain tumors. The neuropathology, neuroimaging, and genomics cores will develop and support rational inquiries and correlative studies that will lead to scientific discovery and inform future clinical trials. Sixteen institutions have agreed to work together to conduct testing of novel agents in high-risk, poor-prognosis pediatric CNS tumors such as diffuse intrinsic pontine glioma (DIPG), high-grade gliomas (HGG), atypical teratoid rhabdoid tumor(ATRT), and high-risk medulloblastoma (MB). All of these centers have been active members of the International or SIOPE DIPG Registries and have a proven track record of working effectively as collaborators. All sites have expertise in conducting early phase and complex clinical trials and are members and leaders of other key consortia such as COG, PBTC, DVL, PNOC, ITCC, and SIOPE.

Studies will be conducted in small cohorts of patients to establish safety and tolerability as well as to detect early efficacy of novel, intensified regimens in order to accelerate development of promising regimens. CONNECT will work collaboratively to translate feasible, tolerable and promising novel regimens in children with newly diagnosed, high-risk, poor-prognosis CNS malignancies to larger consortia with appropriate infrastructure to conduct definitive phase II and III trials (e.g. COG, SIOPE, others).

Executive Summary

CONNECT’s goal is to establish an international clinical trials collaboration for the conduct of scientificallrational, pilot studies to assess feasibility and early efficacy of incorporating promising novel agents testablished frontline therapeutic regimens in children with newly-diagnosed, high-risk brain tumors. Thicollaboration builds on the existing infrastructure and partnerships established through the International DIPRegistry and SIOPE Registries.

Pediatric NCI-funded phase I consortia (e.g. COG DVL and PBTC) as well as non-NCI funded consortia (e.gPNOC, POETIC and ITCC) have helped to ensure that novel agents undergo phase I testing to define toxicitieand preliminary pharmacokinetic and pharmacodynamics endpoints in children with recurrent tumors. Similarlythe Children’s Oncology Group and the SIOPE disease networks, as well as other national consortia, have playea critical role in conducting large phase II/III trials to establish current therapeutic standards in frontline regimenfor children with CNS malignancies. However, phase II/III trials require the commitment of extensive time anresources to demonstrate improved outcomes. As our expanding knowledge of biological targets points tnumerous potential targeted agents, judicious decisions must be made before larger efficacy studies arconducted incorporating novel agents in the frontline setting.

CONNECT’s goal is to fill this critical gap by conducting nimble, scientifically-rational, international trials tdemonstrate the safety and feasibility of incorporating novel agents and therapeutic modalities into the moseffective current regimens for children with newly-diagnosed high-risk brain tumors. To accomplish this goaCONNECT will leverage the considerable strength in basic science and translational expertise among its globacollaborative partners. These sites all have a well-deserved reputation for robust clinical research programs, witstrong leadership and expertise in early phase clinical trials, pharmacology, translational research, and imagingA preclinical initiative among member institutions will assess promising agents in a broad array of preclinicadisease models to fast-track development of promising experimental agents in high-risk pediatric brain tumorsThe neuropathology, neuroimaging, and genomics cores will develop and support rational inquiries ancorrelative studies that will lead to scientific discovery and inform future clinical trials. Sixteen institutions havagreed to work together to conduct testing of novel agents in high-risk, poor-prognosis pediatric CNS tumorsuch as diffuse intrinsic pontine glioma (DIPG), high-grade gliomas (HGG), atypical teratoid rhabdoid tumor(ATRT), and high-risk medulloblastoma (MB). All of these centers have been active members of the Internationaor SIOPE DIPG Registries and have a proven track record of working effectively as collaborators. All sites havexpertise in conducting early phase and complex clinical trials and are members and leaders of other keconsortia such as COG, PBTC, DVL, PNOC, ITCC, and SIOPE.

Studies will be conducted in small cohorts of patients to establish safety and tolerability as well as to detect earlefficacy of novel, intensified regimens in order to accelerate development of promising regimens. CONNECT wilwork collaboratively to translate feasible, tolerable and promising novel regimens in children with newlydiagnosedhigh-risk, poor-prognosis CNS malignancies to larger consortia with appropriate infrastructure tconduct definitive phase II and III trials (e.g. COG, SIOPE, others).

Description of Research Proposal

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Curabitur ut ipsum non odio malesuada vulputate. Morbi maximus, est eu lobortis molestie, tortor sapien hendrerit nisi, in cursus odio diam ut odio. Fusce pulvinar volutpat velit. Aliquam erat volutpat. Integer rhoncus mollis suscipit. Praesent non ipsum mollis, finibus nunc a, scelerisque nibh. In feugiat iaculis velit, eu semper lacus dignissim nec. Praesent vitae nisi leo. Cras venenatis dictum magna ut semper. Sed eget eros nibh. Sed vitae quam sed dolor faucibus elementum. Curabitur interdum porttitor finibus. Nullam tincidunt odio lectus, sit amet rhoncus libero dapibus sed. Sed mollis egestas enim, vel porta tortor volutpat eget.

Morbi orci urna, ornare non pretium eget, pulvinar eget magna. Ut consectetur efficitur varius. Fusce ac aliquet mauris, at mattis ligula. Quisque est libero, interdum id orci et, ornare luctus diam. Proin commodo lectus id accumsan blandit. Nulla eu turpis interdum, luctus ante ac, imperdiet tellus. In semper enim eu tristique aliquam.

Integer fermentum vestibulum lacinia. Duis id aliquam nibh, ut mattis leo. Nulla ac dui at sapien posuere facilisis ut quis ex. Aliquam vestibulum blandit tristique. Integer pretium dui ac nulla accumsan, et finibus velit euismod. Proin placerat, nunc eu sodales facilisis, tellus justo efficitur risus, non blandit diam nulla ac ligula. Aliquam ullamcorper quam leo, porttitor dictum ex tempor ac. Ut efficitur, justo et auctor volutpat, ex ex pulvinar est, sed consequat turpis leo nec ipsum. Nunc tempor, turpis ut ullamcorper tempor, dolor dui varius dui, et congue quam nisi vel nunc.

Class aptent taciti sociosqu ad litora torquent per conubia nostra, per inceptos himenaeos. Donec faucibus, turpis sit amet maximus dapibus, sapien nisl bibendum turpis, pharetra commodo tellus libero vel nulla. Sed nec velit viverra, congue sapien et, gravida libero. Proin eget ante eget turpis egestas accumsan. Aliquam arcu nibh, aliquam rhoncus vulputate in, pellentesque at sem. Maecenas cursus tempus nibh id tempus. Mauris dolor sapien, lacinia sit amet condimentum at, dapibus eget lectus. Phasellus vel pellentesque ex. Nunc aliquam in ligula at tristique. In mollis suscipit felis eu finibus. Nullam non dignissim nibh, nec suscipit ex. Suspendisse tincidunt et mauris id finibus. Aliquam vehicula a sem quis venenatis.

Suspendisse leo odio, rutrum et viverra ut, consequat finibus enim. Vivamus dolor nisl, viverra eu egestas vel, blandit in nulla. Curabitur auctor purus non est volutpat bibendum. Proin fringilla magna sed metus maximus, in dictum neque suscipit. Sed ornare ut mi ut sodales. Nulla efficitur urna nunc, non molestie nunc egestas ut. Nunc arcu lorem, semper ut tincidunt ac, eleifend quis elit.

Sed at tortor et tortor tincidunt feugiat id in dui. Vivamus eget justo nisl. Aenean congue laoreet nisl a elementum. Nunc consectetur velit non ligula sollicitudin, quis eleifend urna sollicitudin. Sed tincidunt, nisl quis varius venenatis, dui massa condimentum tellus, sed sollicitudin diam magna mollis augue. Sed venenatis commodo purus id malesuada. Aenean volutpat elit vel gravida consectetur. Vestibulum diam quam, lacinia ac tortor eget, tincidunt dapibus dui. Pellentesque habitant morbi tristique senectus et netus et malesuada fames ac turpis egestas. Proin nisl leo, pretium sed arcu imperdiet, hendrerit sollicitudin sem. Duis non magna at nunc sagittis ullamcorper a id est. Maecenas cursus nisl in faucibus hendrerit.

Sed hendrerit vitae purus et tempor. Aenean vitae varius velit. Nullam aliquet ipsum elit. Mauris vestibulum purus et metus imperdiet, quis gravida eros pretium. Curabitur rutrum nunc vitae tincidunt condimentum. Aenean sit amet augue velit. Nunc tristique quis lorem id pharetra. Pellentesque sollicitudin, eros sed egestas rutrum, nulla nisl sodales elit, ut imperdiet nunc lectus sit amet nulla. Ut malesuada finibus libero. Curabitur mi dolor, sollicitudin quis bibendum quis, dictum sed enim.

Pellentesque nibh erat, egestas sit amet sagittis malesuada, rhoncus at neque. Mauris maximus commodo tortor, non egestas magna finibus vitae. Sed hendrerit nulla vel venenatis tempor. Suspendisse tristique tincidunt libero et placerat. Nam tincidunt condimentum lorem, vel pharetra est iaculis sed. Nullam ac tincidunt orci. Quisque pharetra ut sem sit amet aliquam. Phasellus risus libero, varius in condimentum vel, commodo id ipsum. Aliquam in metus cursus, mattis diam ut, aliquam magna. Suspendisse facilisis dui et orci varius, suscipit facilisis augue dapibus. In eget nibh ipsum. Suspendisse eget pharetra est, quis condimentum felis. Fusce scelerisque congue libero, sed aliquam mi elementum a. Etiam scelerisque ante non auctor porta. Nam eu nunc id ex finibus dictum. Praesent dui ex, dictum ac massa eget, rutrum gravida nisi.

Sed egestas arcu in dui euismod, eget faucibus massa iaculis. Etiam efficitur lectus et purus lobortis, ac blandit eros rutrum. Proin bibendum consectetur leo vel gravida. Etiam et ultricies sapien. Nam lacinia tellus erat, id facilisis est consequat et. Morbi quis risus in neque iaculis pharetra ut consectetur libero. Aenean feugiat tempor mi eu posuere.

Budget

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Integer gravida non felis non euismod. Fusce finibus aliquet consequat. Nam ac metus bibendum, iaculis purus sed, suscipit ligula. Proin et nisi libero. Mauris non urna urna. Nullam augue eros, fringilla sed mauris vitae, porta tincidunt risus. Aliquam sed tincidunt sem. Quisque lacinia quam tortor, imperdiet efficitur odio iaculis in. Sed ultricies condimentum volutpat. Vivamus dignissim faucibus porta.

Curabitur ut ipsum non odio malesuada vulputate. Morbi maximus, est eu lobortis molestie, tortor sapien hendrerit nisi, in cursus odio diam ut odio. Fusce pulvinar volutpat velit. Aliquam erat volutpat. Integer rhoncus mollis suscipit. Praesent non ipsum mollis, finibus nunc a, scelerisque nibh. In feugiat iaculis velit, eu semper lacus dignissim nec. Praesent vitae nisi leo. Cras venenatis dictum magna ut semper. Sed eget eros nibh. Sed vitae quam sed dolor faucibus elementum. Curabitur interdum porttitor finibus. Nullam tincidunt odio lectus, sit amet rhoncus libero dapibus sed. Sed mollis egestas enim, vel porta tortor volutpat eget.

Morbi orci urna, ornare non pretium eget, pulvinar eget magna. Ut consectetur efficitur varius. Fusce ac aliquet mauris, at mattis ligula. Quisque est libero, interdum id orci et, ornare luctus diam. Proin commodo lectus id accumsan blandit. Nulla eu turpis interdum, luctus ante ac, imperdiet tellus. In semper enim eu tristique aliquam.

Collaborations and Conflicts of Interest

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Integer gravida non felis non euismod. Fusce finibus aliquet consequat. Nam ac metus bibendum, iaculis purus sed, suscipit ligula. Proin et nisi libero. Mauris non urna urna. Nullam augue eros, fringilla sed mauris vitae, porta tincidunt risus. Aliquam sed tincidunt sem. Quisque lacinia quam tortor, imperdiet efficitur odio iaculis in. Sed ultricies condimentum volutpat. Vivamus dignissim faucibus porta.

Curabitur ut ipsum non odio malesuada vulputate. Morbi maximus, est eu lobortis molestie, tortor sapien hendrerit nisi, in cursus odio diam ut odio. Fusce pulvinar volutpat velit. Aliquam erat volutpat. Integer rhoncus mollis suscipit. Praesent non ipsum mollis, finibus nunc a, scelerisque nibh. In feugiat iaculis velit, eu semper lacus dignissim nec. Praesent vitae nisi leo. Cras venenatis dictum magna ut semper. Sed eget eros nibh. Sed vitae quam sed dolor faucibus elementum. Curabitur interdum porttitor finibus. Nullam tincidunt odio lectus, sit amet rhoncus libero dapibus sed. Sed mollis egestas enim, vel porta tortor volutpat eget.