Clinical Trials

20110261-TVEC: A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects with Advanced Non Central Nervous System Tumors That are Amenable to Direct Injection

• Ages: 2 Years to 21 Years

PURPOSE: This is a phase 1 study to evaluate the safety of intralesional talimogene laherparepvec administration in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection. DETAILED DESCRIPTION: This is a phase 1, multicenter, open-label study of talimogene laherpa ...More

A031102: A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

PURPOSE: This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. ...More

ADVL1312: A Phase 1/2 Study of MK-1775 in Combination With Irinotecan in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors

• Ages: From 1 to 21 years old

This phase I/II trial studies the side effects and best dose of WEE1 inhibitor MK-1775 and irinotecan hydrochloride in treating younger patients with solid tumors that have come back or that have not responded to standard therapy. WEE1 inhibitor MK-1775 and irinotecan hydrochloride may stop the grow ...More

ADVL1412: A Phase 1/2 Study of Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Solid Tumors as a Single Agent and in Combination With Ipilimumab

• Ages: From 1 to 30 years old

PURPOSE: This phase I/II trial studies the side effects and best dose of nivolumab when given with or without ipilimumab to see how well they work in treating younger patients with solid tumors or sarcomas that have come back (recurrent) or do not respond to treatment (refractory). Monoclonal ...More

ADVL1414: A Phase 1 Study of Selinexor (KPT-330, IND#125052), a Selective XPO1 Inhibitor, in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors.

• Ages: From 1 to 21 years old

PURPOSE: The investigators will conduct a phase 1 trial of Selinexor in children with recurrent or refractory solid tumors, including CNS tumors using the Rolling Six design. The aims of the trial will be to establish the maximum tolerated pediatric doses of tablet formulation; to investigate ...More

ADVL1416: A Phase 1 Study of Ramucirumab, a Human Monoclonal Antibody Against the Vascular Endothelial Growth Factor-2 (VEGFR-2) Receptor in Children With Refractory Solid Tumors, Including CNS Tumors

PURPOSE: The main purpose of this study is to evaluate the safety of the study drug known as ramucirumab in children with recurrent or refractory solid tumors including central nervous system (CNS) tumors. DETAILED DESCRIPTION: Primary Outcome Measures: Maximum Tolerated Dose of Ramucirumab [ T ...More

ADVL1513: A Phase 1 Study of Entinostat, an Oral Histone Deacetylase Inhibitor, in Pediatric Patients with Recurrent or Refractory Solid Tumors, Including CNS Tumors and Lymphoma

PURPOSE: This phase I trial studies the side effects and best dose of entinostat in treating pediatric patients with solid tumors that have come back or have not responded to treatment. Entinostat may block some of the enzymes needed for cell division and it may help to kill tumor cells. DETAILED D ...More

ADVL1515: A Phase 1 Study of LY2606368, a CHK1/2 Inhibitor, in Pediatric Patients With Recurrent or Refractory Solid Tumors, Including CNS Tumors

PURPOSE: This phase I trial studies the side effects and best dose of prexasertib in treating pediatric patients with solid tumors that have come back after a period of time during which the tumor could not be detected or does not respond to treatment. Checkpoint kinase 1 inhibitor LY2606368 may sto ...More

ADVL1614: A Phase 1/2 Trial of VX15/2503 in Children, Adolescents, or Young Adults With Recurrent or Relapsed Solid Tumors

PURPOSE: This phase I/II trial studies the side effects and best dose of anti-SEMA4D monoclonal antibody VX15/2503 (VX15/2503) and to see how well it works in treating younger patients with solid tumors that have come back after treatment, or do not respond to treatment. Monoclonal antibodies, such ...More

ADVL1615: A Phase 1 Study of Pevonedistat (MLN4924, IND# 136078), a NEDD8 Activating Enzyme (NAE) Inhibitor, in Combination with Temozolomide and Irinotecan in Pediatric Patients with Recurrent or Refractory Solid Tumors

OFFICIAL TITLE A Phase 1 Study of Pevonedistat (MLN4924), a Cullin Ligase Inhibitor, in Combination With Temozolomide and Irinotecan in Pediatric Patients With Recurrent or Refractory Solid Tumors BRIEF SUMMARY: This phase I trial studies the side effects and best dose of pevonedistat when giving t ...More