NCT01964300

Peginterferon Alfa-2b in Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery

Phase II Study of Peginterferon Alfa-2b (Sylatron) for Pediatric Patients With Unresectable or Recurrent Craniopharyngioma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Pediatric Brain Tumor Consortium · Network
• Sex: All
• Age: 18 Months – 25 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well peginterferon alfa-2b works in treating younger patients with craniopharyngioma that is recurrent or cannot be removed by surgery. Peginterferon alfa-2b may interfere with the growth of tumor cells and slow the growth of craniopharyngioma.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the 1-year disease stabilization rate associated with the use of Sylatron (peginterferon alfa-2b) in patients with progressive unresectable or recurrent craniopharyngiomas following surgery alone who have not received radiation therapy. II. To estimate the sustained objective response rate (partial response (PR) + complete response (CR)) to Sylatron in patients with craniopharyngiomas which progress or recur following radiation therapy. SECONDARY OBJECTIVES: I. To estimate the response rate in patients with progressive unresectable or recurrent craniopharyngioma treated with Sylatron by study stratum. II. To estimate the progression-free survival distribution for patients with unresectable or recurrent craniopharyngiomas treated with Sylatron by study stratum. III. To evaluate the toxicity profile of Sylatron in children with unresectable or recurrent craniopharyngiomas. IV. To compare the protocol specific disease assessment criteria to MacDonald criteria during the first year of treatment in stratum I and at the time of objective response and progressive disease in both strata. V. To characterize evidence of WNT pathway activation by immunohistochemistry and MAPK pathway activation by pyrosequencing in resected tumor tissue in patients with craniopharyngiomas, and correlate these results with outcome and response data. OUTLINE: Patients receive peginterferon alfa-2b subcutaneously (SC) weekly for 6 weeks. Treatment may repeat every 6 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Childhood Craniopharyngioma

Interventions

Type	Name	Description
BIOLOGICAL	peginterferon alfa-2b	Given subcutaneously (SC)
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2014-04-01
• Primary completion: 2018-12-01
• Completion: 2019-01-01
• First posted: 2013-10-17
• Last updated: 2020-02-24
• Results posted: 2020-02-24

Locations

9 sites across 1 country: United States