Clinical Trials

First-in-Child Phase I Studies

Since POETIC's inception, two first-in-child clinical trials have been conducted increasing early access to novel molecularly targeted agents for treatment of children and adolescents with refractory malignancies after completion of adult Phase I studies. One of the studies resulted in evidence of clinical benefit in patients with tumors of the central nervous system using a novel agent targeting the epidermal growth factor receptor, cetuximab. These findings have provided the scientific rationale for a Phase II study targeting high grade central nervous system tumors, which is on-going.

Click the names below to list the trials in each section.

First-in-Child Clinical Trials
  • Multicenter Phase I Trial of 17-N-allylamino-17-demethoxy Geldanamycin (17-AAG, NSC#330507) in Patients with Recurrent/Refractory Pediatric Solid Tumors (Ewing's Sarcoma, Desmoplastic Small Round Cell Tumor, Osteosarcoma, Neuroblastoma, and Rhabdomyosarcoma) and Leukemia, NCI Protocol Number 6323 (NCI/CTEP)
  • Phase I and Pharmacokinetic Study of Cetuximab and Irinotecan in Children with Refractory Solid Tumors (BMS)
  • A Multi-Center Phase 1 Study of Intravenous Deforolimus (AP23573, MK-8669) Administered QDX5 Every Other Week in Pediatric Patients with Advanced Solid Tumors
Active Clinical Trials
  • A Phase II Trial of Cyclophosphamide, Topotecan, and Bevacizumab (CTB) in Patients with Relapsed/Refractory Ewing's Sarcoma and Neuroblastoma
  • A Phase I/II Clinical Study of Vorinostat in Combination with Etoposide in Pediatric Patients < 21 Years at Diagnosis with Refractory Solid Tumors
Completed Studies
  • A Phase II trial of external beam radiation therapy and cetuximab followed by irinotecan and cetuximab for children and young adults with newly diagnosed diffuse pontine tumors and high-grade astrocytomas
  • A Phase II Study of RAD001 (Everolimus) for Children with Chemotherapy-Refractory Progressive or Recurrent Low-Grade Gliomas
  • A Phase I Study Using Plerixafor as a Chemosensitizing Agent for Relapsed Acute Leukemia and MDS in Pediatric Patients
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