Pilocytic Astrocytoma and Optic Pathway Glioma Treatment with Lenalidomide – Phase II

Trial of Lenalidomide in Pediatric Patients with Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas

Protocol Description

Through this multicenter trial by the Children’s Oncology Group, researchers will compare how well low-dose lenalidomide works compared with high-dose lenalidomide in treating younger patients with juvenile pilocytic astrocytomas or optic nerve pathway gliomas that have come back (recurrent), have not responded to treatment (refractory), or are growing, spreading, or getting worse (progressive). Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to patients of both genders up to 21 years of age, who have refractive, recurrent, or progressive juvenile pilocytic astrocytoma or optic nerve pathway gliomas.
Males and Females: Up to 21 years of age


Patients enrolled in the study will be randomly placed into one of two study groups, each of which will receive different dosage levels of the study drug. Participants in both groups will take the drug orally for the first 21 days of a 28-day cycle. At specific intervals, participant’s tumors will be evaluated through imaging studies and treatment will continue for up to 26 cycles, providing the tumor is not growing and the child is not experiencing bad side effects.
Visits: The same as required by standard chemotherapy for these conditions.
Duration: Up to 2 years, depending on patient response to therapy

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ACNS1022)
National Cancer Institute

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinator Angela Connelly, RN, BSN