Peginterferon Alfa-2b in Treating Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery
|Childhood Craniopharyngioma||Biological: peginterferon alfa-2b Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Peginterferon Alfa-2b (Sylatron) for Pediatric Patients With Unresectable or Recurrent Craniopharyngioma|
- Rate of disease stabilization for 1 year (i.e. 9 courses of treatment) (Stratum 1) [ Time Frame: Up to 1 year ]Exact confidence interval estimates will be provided for the true 1-year disease stabilization rate for stratum 1.
- Sustained objective response (PR+CR) rate in the cystic and/or soft tissue component observed during the first year of treatment (Stratum 2) [ Time Frame: Up to 1 year ]Exact confidence interval estimates will be provided for the true sustained objective response rate for stratum 2.
- Sustained objective response rate (Stratum 1) [ Time Frame: Up to 2 years ]Exact confidence interval estimates will be provided for the true rate of sustained objective response.
- Progression-free survival [ Time Frame: From the date of initial treatment to the earliest date of disease progression, second malignancy, or death, assessed up to 2 years ]Kaplan-Meier estimates of distributions of PFS for all eligible patients will be provided separately for each stratum.
|Study Start Date:||September 2013|
|Estimated Primary Completion Date:||January 2019 (Final data collection date for primary outcome measure)|
Experimental: Treatment (peginterferon alfa-2b)
Patients receive peginterferon alfa-2b 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.
Biological: peginterferon alfa-2b
Given SCOther: laboratory biomarker analysis
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01964300
|United States, California|
|Children's Hospital Los Angeles||Recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Girish Dhall 323-361-4629 firstname.lastname@example.org|
|Principal Investigator: Girish Dhall|
|Stanford University and Lucile Packard Children Hospital||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Paul G Fisher 650-721-5889 email@example.com|
|Principal Investigator: Paul G Fisher|
|United States, District of Columbia|
|Children's National Medical Center||Recruiting|
|Washington, D.C., District of Columbia, United States, 20010|
|Contact: Roger J. Packer 202-884-2120 firstname.lastname@example.org|
|Principal Investigator: Roger J. Packer|
|United States, Illinois|
|Lurie Children's Hospital||Recruiting|
|Chicago, Illinois, United States, 60614|
|Contact: Stewart Goldman 312-227-4844 email@example.com|
|Principal Investigator: Stewart Goldman|
|United States, Maryland|
|National Cancer Institute Pediatric Oncology Branch||Not yet recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: Kathlerine E. Warren 301-435-4683 firstname.lastname@example.org|
|Principal Investigator: Kathlerine E. Warren|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Ira Dunkel 212-639-2153 email@example.com|
|Principal Investigator: Ira Dunkel|
|United States, Pennsylvania|
|Children Hospital of Pittsburgh of UPMC||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15224|
|Contact: Ian Pollack 412-692-5881 Pollaci@chp.edu|
|Principal Investigator: Ian Pollack|
|United States, Tennessee|
|St. Jude Children Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: Alberto Broniscer 901-595-4925 firstname.lastname@example.org|
|Principal Investigator: Alberto Broniscer|
|United States, Texas|
|Texas Children's Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Murali Chintagumpala 832-822-4266 email@example.com|
|Principal Investigator: Murali Chintagumpala|
|Principal Investigator:||Stewart Goldman||Ann & Robert H. Lurie Children Hospital of Chicago|