PNOC001: Phase II Study of Everolimus for Recurrent or Progressive Low-Grade Gliomas in Children (CC #120817)

Categories:

Brain Tumor

Phase I/II

Diseases Treated:

Recurrent or progressive low grade gliomas (brain tumors)

Eligibility Overview:

  • Participant is three (3) to twenty-one (21) years of age.
  • Patient has refractory, progressive or recurrent confirmed low-grade glioma (WHO grade I or II) that was confirmed histologically at initial diagnosis.
  • Participant received his or her last dose of myelosuppressive anticancer chemotherapy at least three (3) weeks prior to study registration, or at least six (6) weeks if nitrosourea.
  • Participant received his or her last dose of other investigational or biological agent more than seven (7) days prior to study entry.

Description

This study will be enrolling patients who have been diagnosed with a low grade brain tumor (glioma) that has either come back since having treatment (relapsed) or has continued to grow after treatment (progressive). The study team wants to learn what effects the drug everolimus has on patient tumors. People who are not in a study are usually treated with additional surgeries, radiation, and/or chemotherapy using medications that are considered standard of care. Participants in this study may receive everolimus for about two (2) years as long as their tumor does not get worse and they do not have severe side effects. After treatment, participants will be followed by telephone calls or review of medical records every three (3) months for five (5) years to learn about long-term effects of the study.

Objectives

  • Estimate the Progression Free Survival (PFS) rate at six (6) months associated with everolimus therapy for symptomatic, progressive or recurrent pediatric low-grade glioma patients with measurable disease with the aim of determining whether everolimus warrants additional study only inpatients with activated PI3K/Akt/mTOR pathway or in entire population.
  • Estimate PFS and OS (overall survival) distributions as well as objective response (CR+PR) rates associated with everolimus treatment in recurrent pediatric Low Grade Gliomas.

Eligibility

Inclusion: (among others)

  • Participant is three (3) to twenty-one (21) years of age.
  • Patient has refractory, progressive or recurrent confirmed low-grade glioma (WHO grade I or II) that was confirmed histologically at initial diagnosis.
  • Participant received his or her last dose of myelosuppressive anticancer chemotherapy at least three (3) weeks prior to study registration, or at least six (6) weeks if nitrosourea
  • Participant received his or her last dose of other investigational or biological agent more than seven (7) days prior to study entry

Exclusion: (among others)

  • Participant is receiving concomitant medication(s) that may interfere with study outcome.
  • Participant has known history of HIV seropositivity.
  • Participant has received immunization with attenuated live vaccine within one (1) week of study entry or will receive during study period.
  • Participant has received therapy for this recurrence (including radiation).
  • Participant is receiving other concurrent anticancer or investigational therapy

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Ibrahim Qaddoumi, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Phone: 901-595-2544 or 901-595-4599
Fax: 901-595-6211

OR

Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
MS 260
262 Danny Thomas Place
Memphis, TN 38105
Phone: (901) 595-2544
FAX: (901) 595-6211

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.