Spots Global Cancer Trial Database for Peginterferon Alfa-2b in Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Peginterferon Alfa-2b in Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery
Official Title: Phase II Study of Peginterferon Alfa-2b (Sylatron) for Pediatric Patients With Unresectable or Recurrent Craniopharyngioma
Study ID: NCT01964300
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Los Angeles, Los Angeles, California, United States
Stanford University and Lucile Packard Children Hospital, Palo Alto, California, United States
Children's National Medical Center, Washington, District of Columbia, United States
Lurie Children's Hospital, Chicago, Illinois, United States
National Cancer Institute Pediatric Oncology Branch, Bethesda, Maryland, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Children Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
St. Jude Children Research Hospital, Memphis, Tennessee, United States
Texas Children's Hospital, Houston, Texas, United States
Contact Details
Name: Stewart Goldman
Affiliation: Ann & Robert H. Lurie Children Hospital of Chicago
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
