Peginterferon Alfa-2b in Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery

Stopped early · Phase 2

Conditions studied: Childhood Craniopharyngioma

In brief

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.

Key facts

Study ID

NCT01964300

Run by

Pediatric Brain Tumor Consortium

People needed

19

Starts

2014-04-01

Expected to finish

2019-01-01

Last updated by the study team

2020-02-24

Who can join

Age: 2 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• All patients must have measurable residual disease defined as tumor measurable in two perpendicular diameters on magnetic resonance imaging (MRI)
• Please note: 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 Criterial for Adverse Events (CTCAE) version (v.) 4.0, unless otherwise specified in the inclusion and exclusion criteria
• Myelosuppressive chemotherapy (includes intra-cystic bleomycin):
• 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, including 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
• Age: 18 months - 25 years (Minimum weight 20 Kilogram 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

You may not qualify if…

• 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
• 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 due to potential drug interactions
• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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