Peginterferon alfa-2b in Treating Younger Patients with Craniopharyngioma That is Recurrent or Cannot Be Removed by Surgery

Inclusion Criteria

• Patient must have a histologically verified diagnosis of craniopharyngioma * Stratum 1: patients with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who have not received radiation therapy; patients with unresectable craniopharyngiomas, (i.e. residual measurable disease following surgical resection) will be enrolled at the time of progression * Stratum 2: patients with progressive or recurrent craniopharyngiomas following radiation therapy; the patient must be at least 6 months post irradiation to be eligible
• All patients must have measurable residual disease defined as tumor measurable in two perpendicular diameters on magnetic resonance imaging (MRI); measurements are required for both the solid and cystic components
• Subjects must have recovered from the acute toxicities of all prior therapy before entering this study; for those acute baseline adverse events attributable to prior therapy, recovery is defined as a toxicity grade =< 2, using Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0, unless otherwise specified in the inclusion and exclusion criteria
• Myelosuppressive chemotherapy: * Subjects must have received their last dose of known myelosuppressive anticancer chemotherapy at least three (3) weeks prior to study registration or at least six (6) weeks if nitrosourea
• Subjects must have received their last dose of investigational or biologic agent >= 7 days prior to study registration * In the event that a subject has received an investigational or biologic agent and has experienced >= grade 2 myelosuppression, then at least three (3) weeks must have elapsed prior to registration * If the investigational or biologic agent has a prolonged half-life (>= 7 days) then at least three (3) weeks must have elapsed prior to registration
• Subjects must have completed at least 3 half-life periods from the last dose of monoclonal antibody prior to registration * Note: a list of half-lives of commonly used monoclonal antibodies is available on the Pediatric Brain Tumor Consortium (PBTC) website under Generic Forms and Templates
• Stratum 1: patients must not have received radiation therapy
• Stratum 2: patients must have received radiation therapy, which may include gamma knife or phosphorus-32 (P32) * More than 6 months from the time of enrollment if the recurrence is predominantly solid * More than 12 months from the time of enrollment if the recurrence is predominantly cystic
• At least 7 days since the completion of therapy with a hematopoietic growth agent (filgrastim, sargramostim, and erythropoietin) and 14 days for long-acting formulations
• Karnofsky performance scale (KPS for >= 16 years [yrs] of age) or Lansky performance score (LPS for < 16 years of age) >= 60 assessed within two weeks prior to registration
• Minimum weight 20 kilograms is required to be eligible for the study since the minimum injection volume of SYLATRON is 0.05 ml, 20 mcg, subcutaneously (SQ) as suggested by Merck
• Absolute neutrophil count (ANC) >= 1000/ul (unsupported)
• Platelets >= 100,000/ul (unsupported)
• Hemoglobin (Hg) >= 8g/dL (unsupported)
• Alanine aminotransferase (ALT) =< 2.5 x the upper limit of institutional normal
• Total bilirubin =< x 1.5 upper limit of institutional normal
• Serum creatinine =< 1.5 x the upper limit of normal for age, or calculated creatinine clearance or nuclear glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 * =< 0.6 mg/dL (1 to < 2 years of age) * =< 0.8 mg/dL (2 to < 6 years of age) * =< 1.0 mg/dL (6 to < 10 years of age) * =< 1.2 mg/dL (10 to < 13 years of age) * =< 1.4 mg/dL (females >= 13 years of age) * =< 1.5 mg/dL (males 13 to < 16 years of age) * =< 1.7 mg/dL (males >= 16 years of age)
• Patients must have evidence of radiographic progression as defined below: * Stratum 1: defined as >= 25% increase in the product of the greatest perpendicular diameters of the tumor as a whole (solid and cystic component) AND >= 0.4 cm increase in each of at least two dimensions of the tumor as a whole OR any new or worsening neurologic/vision deficit in conjunction with a lesser change in the solid or cystic component * Stratum 2: ** For patients more than 6 months following radiation therapy (RT) (including radiosurgery or P32), progression is defined as a >= 25% increase in the product of the greatest perpendicular diameters of the solid component AND >= 0.4 cm increase in each of at least two dimensions of the solid component ** For patients more than 12 months following RT (including radiosurgery or P32), progression is defined as >= 25% increase in each of the product of the greatest perpendicular diameters of the solid tumor AND >= 0.4 cm increase in each of at least two dimensions of the solid tumor; patients demonstrating predominantly cystic progression more than 12 months after RT must show a continued increase in the cystic component on two serial MRI scans performed at least 4 weeks apart OR re-accumulation of the cyst following one or more cyst aspirations; patients with progressive neurologic signs and/or symptoms associated with isolated cyst formation or progression are eligible if the neurologic signs and/or symptoms do not improve within 4 weeks of cyst aspiration
• Female subjects of childbearing potential must not be pregnant or breast-feeding; female subjects of childbearing potential must have a negative serum or urine pregnancy test; (pregnancy test must be repeated within 72 hours prior to the start of therapy)
• Subjects of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Stratum 1 patients: must not have had > 3 surgical debulking procedures/resections
• Patients may not have received prior interferon, either systemic or intra-cystic
• Patients must not have evidence of metastatic tumor or other cancer
• Patients must not be on steroids other than for physiologic replacement
• Patients must not have a severe psychiatric illness, including major depression or any previous suicide attempts
• Patients must not be on phenytoin, warfarin or methadone
• Patients must not have known hypersensitivity reactions, such as urticaria, angioedema, bronchoconstriction, anaphylaxis, Steven-Johnson syndrome, and toxic epidermal necrolysis to interferon alpha or any other products component
• Subjects with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy