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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Given subcutaneously (SC)
Correlative studies
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 D.C., District of Columbia, United States
Rate of Disease Stabilization at 1 Year (i.e., 9 Courses of Treatment) (for Stratum 1 Patients Only)
The percentage of stratum 1 patients with disease stabilization at 1 year is reported, along with a 95% exact confidence interval for the estimate of the true 1-year disease stabilization rate.
Time frame: Up to 1 year
Sustained Objective Response (PR+CR) Rate Observed During the First Year of Treatment (for Stratum 2 Patients Only)
Objective responses had to be sustained for 3 months. The percentage of participants with sustained objective responses is reported with an exact 95% confidence interval of the true sustained objective response rate.
Time frame: Up to 1 year
Sustained Objective Response (PR+CR) Rate Observed During the First Year of Treatment (for Stratum 1 Patients Only)
Objective responses had to be sustained for 3 months. The percentage of participants with sustained objective responses is reported with an exact 95% confidence interval of the true sustained objective response rate.
Time frame: Up to 1 year
Progression-free Survival (PFS)
PFS estimates for each stratum were estimated using the method of Kaplan and Meier. PFS was defined as the time interval from date on treatment to the earliest date of disease progression, second malignancy, or death; or to date of last contact for patients without events. One- and two-year PFS estimates are reported by stratum. Only eligible patients were included in this analysis (7 stratum 1 patients and 11 stratum 2 patients).
Time frame: 2 years after treatment start
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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