A Phase II Study of Pegylated Interferon Alfa-2b (Peg-Intron (TM)) in Children With Diffuse Pontine Gliomas
Children with diffuse pontine gliomas have a dismal prognosis. Because surgery in this area
is difficult, radiation therapy has been the mainstay of treatment. Although some children
may improve clinically after radiation therapy, the effect is short-lived and almost all
progress within several months. Chemotherapy has not had a significant impact on survival.
Interferon-alpha is a cytokine that has been studied in patients with gliomas and has
demonstrated some activity in prior clinical trials.
- To compare the 2-year survival of pediatric patients with diffuse pontine gliomas
receiving weekly subcutaneous low-dose pegylated interferon alfa-2b (PEG-Intron[TM])
injections after standard radiation therapy versus historical controls who have
received radiation therapy alone.
- To define the toxicities of weekly low-dose pegylated interferon alfa-2b
(PEG-Intron(Trademark)) in pediatric patients.
Age: Patients must be less than or equal to 21 years of age.
Histological Diagnosis: Histologic confirmation is not required for this study. Patients
must have a diffuse pontine glioma as diagnosed by MRI criteria below.
Radiologic Appearance: Patients must have a diffuse intrinsic tumor with the epicenter
presumed to be in the pons. The T-2 weighted sequence must reveal a diffuse signal
abnormality involving at least 50 percent of the pons.
Prior Therapy: The patient must have received adequate radiation therapy. Radiation must
be completed between 2-10 weeks prior to the start of treatment with Peg-Intron[TM].
In this study, we plan to administer pegylated interferon alfa-2b (PEG-Intron[TM])
subcutaneously once a week to pediatric patients with diffuse pontine gliomas who have
completed radiation therapy. The endpoint of the trial will be 2-year survival compared to
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Two Year Survival of Pediatric Patients With Diffuse Pontine Gliomas
Survival is measured from the date the patient is registered onto the protocol until the day of death and the date of diagnosis to the date of patient death.
8 yrs 6 mo 0 days
Kathy Warren, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|