PBTC39: Peginterferon Alfa-2b in Treating Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery

Phase II Study of Peginterferon alfa-2b (PEGIntron) for Pediatric Patients with Unresectable or Recurrent Craniopharyngioma (PBTC-039)

Categories:

Brain Tumor

Phase I/II

Diseases Treated:

Unresectable or recurrent craniopharyngioma

Eligibility Overview:

  • Participant has a histologically verified diagnosis of craniopharyngioma.
  • Participant has recovered from acute toxicities of all prior therapy before entering this study.
  • Participant has not received prior interferon, either systemic or into the tumor cyst.
  • Participant does not have evidence of metastatic tumor.

Description

The purpose of this study is to test any good and bad effects of the study drug called PEGIntron. Past studies have shown that PEGIntron was effective at shrinking the tumor size or delaying the growth of the tumor for some patients with relapsed and progressive craniopharyngioma. PEGIntron is not FDA (Food and Drug Administration) approved to treat brain tumors, so its use in this study is considered experimental.

All study participants will get the study drug PEGIntron, given as an injection under the skin once a week. A course is 6 weeks long and you will receive 6 injections (one each week) per course. Every six-week period of treatment is considered one “course” of therapy.

Objectives

  • To learn if the tumors of participants treated on this study will shrink or stop growing
  • To learn if symptoms caused by the tumor will improve.
  • To test any good and bad effects of the study drug called PEGIntron.

Eligibility criteria, among others, include:

  • Participant has a histologically verified diagnosis of craniopharyngioma
  • Participant has recovered from acute toxicities of all prior therapy before entering this study.
  • Participant has not received prior interferon, either systemic or into the tumor cyst.
  • Participant does not have evidence of metastatic tumor.
  • Participant is not on steroids other than physiologic replacement.
  • Participant does not have a severe psychiatric illness, including major depression or any previous suicide attempts.

Contact

Alberto Broniscer, 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.