Peginterferon Alfa-2b in Treating Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery
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.
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:||November 2013|
|Estimated Primary Completion Date:||January 2100 (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||Not yet 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's Hospital||Not yet recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Paul Graham Fisher 650-721-5889 email@example.com|
|Principal Investigator: Paul Graham Fisher|
|United States, District of Columbia|
|Children's National Medical Center||Not yet recruiting|
|Washington, 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||Not yet 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||Not yet recruiting|
|New York, New York, United States, 10065|
|Contact: Ira Dunkel 212-639-2153 email@example.com|
|Principal Investigator: Ira Dunkel|
|United States, North Carolina|
|Duke University Medical Center||Not yet recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Sridharan Gururangan 919-684-3506 firstname.lastname@example.org|
|Principal Investigator: Sridharan Gururangan|
|United States, Pennsylvania|
|>Children's Hospital of Pittsburgh of UPMC||Not yet recruiting|
|Pittsburgh, Pennsylvania, United States, 15224|
|Contact: Regina I. Jakacki 412-692-7056 email@example.com|
|Principal Investigator: Regina I. Jakacki|
|United States, Tennessee|
|St. Jude Children's Research Hospital||Not yet 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||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Contact: Murali Chintagumpala 832-822-4266 email@example.com|
|Principal Investigator: Murali Chintagumpala|
|Principal Investigator:||Regina Jakacki||Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania, United States|