A Trial of Poly-ICLC in the Management of Recurrent Pediatric Low Grade Gliomas
Status:
Completed
Trial end date:
2019-07-01
Target enrollment:
Participant gender:
Summary
This study is for patients up to 21 years of age who have a tumor called a low grade glioma
of the central nervous system (brain and spinal cord). The tumor has grown despite attempts
to control it with chemotherapy or radiation. Low grade gliomas are a group of tumors that
tend to grow slowly and could be cured if every bit of the tumor were surgically removed.
These tumors are called Grade I or II astrocytomas.
These tumors often grow in parts of the brain that prevent total removal without devastating
neurologic complications or death. Although some low grade gliomas never grow, most will and
are treated with either chemotherapy or radiation. There is good data showing that the growth
of most low grade gliomas can be controlled with chemotherapy or radiation. However, some low
grade gliomas in children and young adults grow despite these treatments. Poly-ICLC is a new
drug that has been used safely in children and adults with different types of brain tumors.
Earlier studies showed that this drug worked better for children and young adults with low
grade gliomas than for children with more aggressive brain tumors. The main purpose of this
study is to use Poly-ICLC treatment in a larger number of patients to see how well it works
and how many side effects occur.
As Poly-ICLC is not FDA approved, this study is authorized to use it under IND# 43984, held
by Oncovir.
Subjects will get injections of Poly-ICLC into muscle two times weekly. The first treatments
will be given in the clinic so allergic or other severe reactions, if any, can be monitored.
If subjects tolerate the injections and don't have a severe reaction, then the rest of the
injections will be given at home. Subjects/caregivers will be trained to give injections.
Treatment will last for about 2 years. Subjects may stay on treatment for longer than 2 years
if their tumor shrinks in response to the injections, if study doctors think it is safe, if
subjects want to remain on treatment, and if Poly-ICLC is available.
Risks: Poly-ICLC has been used safely in children and adults at the dose used in this study,
and at higher doses. Frequently seen side effects include irritation of the skin at the
injection site and mild flu-like symptoms. These are usually relieved or avoided by use of
over-the-counter medicines like acetaminophen (Tylenol).
Funding Source: FDA OOPD