Peginterferon alfa-2b in Treating Younger Patients with Recurrent or Refractory and Radiographically or Clinically Progressive Pilocytic Astrocytomas and Optic Pathway Gliomas

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor Brain Tumor Cancer-Related Syndrome Unknown Primary	NCT ID:	NCT02343224
Trial Phases:	Phase II	Protocol IDs:	IRB00074563 (primary)
Eligibility:	4 - 25 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Children's Healthcare of Atlanta - Egleston
NCI Full Details:	http://clinicaltrials.gov/show/NCT02343224

Summary

This phase II trial studies how well peginterferon alfa-2b works in treating younger patients with pilocytic astrocytomas or optic pathway gliomas that have come back or do not respond to treatment and are growing, spreading, or getting worse. Peginterferon alfa-2b may stop tumor growth by preventing cell division and formation of blood vessels in the tumor, and by activating the immune system to attack tumor cells.

Objectives

PRIMARY OBJECTIVES:
I. To determine the objective response of children with recurrent or refractory and radiographically or clinically progressive juvenile pilocytic astrocytomas and optic pathway gliomas who are treated with pegylated interferon alpha-2b (peginterferon alfa-2b).

SECONDARY OBJECTIVES:
I. To estimate event free survival (EFS) (based on standard two or three-dimensional tumor measurements) for children with recurrent, refractory or progressive juvenile pilocytic astrocytomas and optic pathway gliomas who are treated with peginterferon (peginterferon alfa-2b).
II. To define the toxicities of long term weekly pegylated interferon alpha-2b in pediatric patients with refractory, recurrent and progressive juvenile pilocytic astrocytomas and optic pathway gliomas.
III. To compare response categories and EFS across the 3 magnetic resonance (MR) sequences (T2-weighted, fluid attenuation inversion recovery [FLAIR], T1-weighted post-contrast).
IV. To evaluate the quality of life for patients with recurrent, refractory and progressive juvenile pilocytic astrocytomas and optic pathway gliomas who receive therapy with pegylated interferon alpha-2b.

OUTLINE:
Patients receive peginterferon alfa-2b subcutaneously (SC) once weekly. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

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