NCT01975116

p28 in Treating Younger Patients With Recurrent or Progressive Central Nervous System Tumors

A Phase I Trial of p28 (NSC745104), a Non-HDM2 Mediated Peptide Inhibitor of p53 Ubiquitination in Pediatric Patients With Recurrent or Progressive CNS Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Pediatric Brain Tumor Consortium · Network
• Sex: All
• Age: 3 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of azurin-derived cell-penetrating peptide p28 (p28) in treating patients with recurrent or progressive central nervous system tumors. Drugs used in chemotherapy, such as azurin-derived cell-penetrating peptide p28, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description

PRIMARY OBJECTIVES: I. To establish whether the adult recommended phase II dose of 3x/week bolus infusions of p28is safe for pediatric patients with recurrent/refractory central nervous system (CNS) tumors. II. To describe dose-limiting toxicities of 3x/week bolus infusions of p28 in pediatric patients with recurrent/refractory CNS tumors. III. To evaluate and characterize the plasma pharmacokinetics of p28 in children with recurrent/ refractory CNS tumors. SECONDARY OBJECTIVES: I. To describe in the context of a phase I trial any observed antitumor activity of p28. II. To investigate levels of p53 in clinical tumor specimens of patients with pediatric gliomas and other pediatric CNS tumors treated with p28. III. To document the type/site(s) of p53 mutation in tumor tissue specimens. IV. To evaluate and characterize the intratumoral pharmacokinetics of p28 in children with recurrent/ refractory CNS tumors, if available. OUTLINE: This is a dose-escalation study. Patients receive azurin-derived cell-penetrating peptide p28 intravenously (IV) over 15 minutes thrice weekly for 4 weeks. Treatment repeats every 6 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for at least 30 days.

Conditions

• Teratoid Tumor, Atypical
• Choroid Plexus Neoplasms
• Anaplastic Astrocytoma
• Anaplastic Oligodendroglioma
• Brainstem Tumors
• Giant Cell Glioblastoma
• Glioblastoma
• Gliosarcoma
• Medulloblastoma
• Neuroectodermal Tumor, Primitive

Interventions

Type	Name	Description
DRUG	azurin-derived cell-penetrating peptide p28	Given IV

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2013-11-04
• Last updated: 2017-08-07

Locations

11 sites across 1 country: United States