Peginterferon Alfa-2b in Treating Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery
Biological: peginterferon alfa-2b
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Peginterferon Alfa-2b (PEGIntron) 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 PegIntron (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 PegIntron 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 PegIntron by study stratum.
II. To estimate the progression-free survival distribution for patients with unresectable or recurrent craniopharyngiomas treated with PegIntron by study stratum.
III. To evaluate the toxicity profile of PegIntron 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 wingless-related integration site (WNT) pathway activation in resected tumor tissue in patients with craniopharyngiomas by immunohistochemistry 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|
|Los Angeles, California, United States, 90027|
|Stanford University and Lucile Packard Children Hospital|
|Palo Alto, California, United States, 94304|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010|
|United States, Illinois|
|Lurie Children's Hospital|
|Chicago, Illinois, United States, 60614|
|United States, Maryland|
|National Cancer Institute Pediatric Oncology Branch|
|Bethesda, Maryland, United States, 20892|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|Children Hospital of Pittsburgh of UPMC|
|Pittsburgh, Pennsylvania, United States, 15224|
|United States, Tennessee|
|St. Jude Children Research Hospital|
|Memphis, Tennessee, United States, 38105|
|United States, Texas|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Stewart Goldman||Ann & Robert H. Lurie Children Hospital of Chicago|