Kathleen H Dorris Study Chair Children's Hospital Colorado Todd C Hankinson Study Chair Children's Hospital Colorado Maryam Fouladi Principal Investigator Nationwide Children's Hospital
Kontakt
Leonie Mikael Kontakt: Phone: 16147223284 E-Mail: leonie.mikael@nationwidechildrens.org» Kontaktdaten anzeigen
Studienlocations (3 von 17)
Hopp Children's Cancer Center at NCT Heidelberg (KiTZ) 69120 Heidelberg (Baden-Württemberg) GermanyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Olaf Witt, MD Phone: 49 6221 42 3570 E-Mail: o.witt@kitz-heidelberg.de» Ansprechpartner anzeigenChildren's Hospital Colorado 80045 Aurora United StatesRekrutierend» Google-Maps Ansprechpartner: Kathleen Dorris, MD Phone: 720-777-8314 E-Mail: kathleen.dorris@childrenscolorado.org» Ansprechpartner anzeigenChildren's National Medical Center 20010 Washington United StatesNoch nicht rekrutierend» Google-Maps Ansprechpartner: Eugene Hwang, MD Phone: 202-476-2800 E-Mail: ehwang@childrensnational.org» Ansprechpartner anzeigen
Ann & Robert H. Lurie Children's Hospital of Chicago 60611 Chicago United StatesNoch nicht rekrutierend» Google-Maps Ansprechpartner: Ashley Plant, MD Phone: 312-227-4090 E-Mail: Aplant@luriechildrens.org» Ansprechpartner anzeigenDana Farber Cancer Institute 02215 Boston United StatesNoch nicht rekrutierend» Google-Maps Ansprechpartner: Susan Chi, MD Phone: 617-632-4386 E-Mail: Susan_Chi@dfci.harvard.edu» Ansprechpartner anzeigenDuke University Health System 27708 Durham United StatesNoch nicht rekrutierend» Google-Maps Ansprechpartner: David H Ashley Phone: 919-681-3824 E-Mail: david.ashley@duke.edu» Ansprechpartner anzeigenCincinnati Children's Hospital Medical Center 45229 Cincinnati United StatesRekrutierend» Google-Maps Ansprechpartner: Peter de Blank, MD Phone: 513-517-2068 E-Mail: Peter.deBlank@cchmc.org» Ansprechpartner anzeigenNationwide Children's Hospital 43205 Columbus United StatesRekrutierend» Google-Maps Ansprechpartner: Maryam Fouladi, MD Phone: 614-722-5758 E-Mail: Maryam.fouladi@nationwidechildrens.org» Ansprechpartner anzeigenTexas Children's Hospital 77030 Houston United StatesNoch nicht rekrutierend» Google-Maps Ansprechpartner: Patricia Baxter, MD Phone: 832-824-4681 E-Mail: pabaxter@txch.org» Ansprechpartner anzeigenSeattle Children's Hospital 98105 Seattle United StatesNoch nicht rekrutierend» Google-Maps Ansprechpartner: Sarah Leary, MD Phone: 206-987-2106 E-Mail: sarah.leary@seattlechildrens.org» Ansprechpartner anzeigenSydney Children's Hospital 2031 Randwick AustraliaRekrutierend» Google-Maps Ansprechpartner: Neevika Manoharan, MBBS Phone: 61 2 9382 1730 E-Mail: Neevika.Manoharan@health.nsw.gov.au» Ansprechpartner anzeigenQueensland Children's Hospital 4101 South Brisbane AustraliaNoch nicht rekrutierend» Google-Maps Ansprechpartner: Tim Hassall, MBBS Phone: 61 7 3068 3593 E-Mail: tim.hassall@health.qld.gov.au» Ansprechpartner anzeigenPerth Children's Hospital 6000 Perth AustraliaRekrutierend» Google-Maps Ansprechpartner: Santosh Valvi, MBBS Phone: 61 8 6456 2222 E-Mail: Santosh.Valvi@health.wa.gov.au» Ansprechpartner anzeigenThe Hospital for Sick Children (SickKids) M5G1X8 Toronto CanadaNoch nicht rekrutierend» Google-Maps Ansprechpartner: Eric Bouffet, MD Phone: 416-813-7457 E-Mail: eric.bouffet@sickkids.ca» Ansprechpartner anzeigenMontreal Children's Hospital H4A3J1 Montréal CanadaNoch nicht rekrutierend» Google-Maps Ansprechpartner: Genevieve Legault, MD Phone: 514-412-4400 Phone (ext.): 60497 E-Mail: Genevieve.legault4@mcgill.ca» Ansprechpartner anzeigenPrincess Máxima Center 3720 Utrecht NetherlandsNoch nicht rekrutierend» Google-Maps Ansprechpartner: Jasper van der Lugt, MD, PhD Phone: +31618559694 E-Mail: J.vanderLugt@prinsesmaximacentrum.nl» Ansprechpartner anzeigenGreat Ormond Street Hospital WC1N 3JH London United KingdomNoch nicht rekrutierend» Google-Maps Ansprechpartner: Darren Hargrave, MD Phone: 0207 813 8525 E-Mail: darren.hargrave@nhs.net» Ansprechpartner anzeigen
1. Sustained objective response rate of patients with recurrent/progressive previously irradiated ACP to treatment with oral binimetinib (Time Frame - From Day 1 of treatment through 30 days following end of protocol treatment): To calculate the number of patients who experience sustained objective response rate [minor response (MR) + partial response (PR) + complete response (CR)] of patients with recurrent/progressive previously irradiated Adamantinomatous Craniopharyngioma to treatment with oral binimetinib (Stratum 1).
2. Sustained objective response rate of patients with measurable ACP who have undergone surgery but have not been previously treated with radiation to treatment with oral binimetinib (Time Frame - From Day 1 of treatment through 30 days following end of protocol treatment): To calculate the number of patients who experience sustained objective response rate (MR + PR + CR) of patients with measurable Adamantinomatous Craniopharyngioma who have undergone surgery but have not been previously treated with radiation to treatment with oral binimetinib (Stratum 2).
Secondary outcome:
1. Biological effects of binimetinib on ACP tumor tissue and cyst fluid. (Time Frame - From Day 1 of treatment through 30 days following end of protocol treatment): To measure concentrations of various chemokines including IL-6, IL-8, IL-10 and CXCL1in cyst fluid or tumor or blood of ACP patients treated with binimetinib. Comparisons will be made with known levels in the literature and among patient samples from within the study.
2. Toxicities associated with tocilizumab in children with ACP (Time Frame - 24 months): To calculate the number of participants with, as well as frequency and severity of, binimetinib-related Adverse Events as assessed by CTCAE v5.0 in children with recurrent or refractory ACP
3. PFS of ACP patients treated with binimetinib after radiation (Time Frame - 12 months): To assess one-year progression-free survival (PFS) rates for patients with ACP who are treated with binimetinib following progression after radiation (Stratum 1).
4. PFS of ACP patients treated with binimetinib who have not received radiation (Time Frame - 12 months): To assess one-year progression-free survival (PFS) rates for patients with ACP who are treated with binimetinib who have not previously received radiation (Stratum 2).